2 x 30 mL, 2 x 50 mL, 2 x 125 mL, 4 x 125 mL

ALKALINE PHOSPHATASE 51401002, 51401003, 51401006, 51401007

Intended Use Sample

This reagent is intended for in vitro quantitative determination of Al kaline Serum/Plasma (free of haemolysis).
Phosphatase in serum or plasma.
Interferences
- DGKC – SCE recommended procedure
No interference for
- Linear up to 700 U/L
Haemoglobin up to 1000 mg/dL
- Working reagent can be prepared as per requirement
Bilirubin up to 10 mg/dL
- Pack sizes suit to al l types of laboratories
Ascorbic Acid up to 50 mg/dL
Cl inical Significance Materials Provided
Al kaline phosphatase (ALP) is widely d istributed throughout the body, but
Al kaline Phosphatase R1 & Al kaline Phosphatase R2.
clinically important one for diagnostic reasons are in bone, liver, placenta and
intestine. Growing bone is associated with the release of ALP and so in child hood Materials required but not provided
the level of ALP is around 3 times of that of adult. During pregnancy in 2 nd and l Pipettes& Tips
3 rdtrimester the enzyme rises considerably due to placenta releasing ALP. It can be
l Test Tubes & racks
used to examine placental function.
l Timer
Elevated levels are seen in bone diseases, e.g. Paget’s disease, Rickets, Osteoblastic
metastatic and in obstructive disease of biliary tract. l Incubator
Decreased levels are rarely seen. e.g. in Vitamin A resistant rickets. l Analyzer

Principle Test Parameters

Kinetic determination of ALP accord ing to the fol lowing reaction Mode of Reaction Kinetic
ALP
Para-nitrophenyl phosphate + H 2O > p-nitrophenol+Inorgnic phosphate Slope of reaction Increasing
ALP = Al kaline Phosphatase Wavelength 405 nm
0
Kit Components Temperature 37 C
Factor 2750
Reagent/ Product Code Description Blank DI water
Component 51401002 51401003 51401006 51401007
Linearity 700 U/L
Al kaline 2 x 24 mL 2 x 40 mL 2 x 100 mL 4 x 100mL Diethanolamine Delay time 60 sec
Phosphatase buffer (pH10.2) No of readings 3
(S.L) R1 125 mmol/L
Magnesium Interval 60 sec
Chloride - Sample volume 20 µL
-0.625mmol/L
Reagent volume 1000 µL
Al kaline 2 x 6 mL 2 x 10 mL 2 x 25 mL 4 x 25mL P-Nitro phenyl
Cuvette 1 cm light path
Phosphatase phosphate
( S.L) R2 50 mmol /L Application parameters for various instrument are available. Please contact
customer support department for specific information.
Risk & Safety
Calibration
Material safety data sheets (MSDS) wil l be provided on request.
Agappe multicalibrator is recommended for calibration of this assay on fully auto
Reagent Preparation analyzers.
Use provided factor (2750) for estimation of ALP semi auto analyzers.
Mix 4 volume of Reagent 1 (R1) with 1 volume Reagent 2 (R2)
The working reagent is stable for 30 days at 2-80 C. Procedure notes
Note : Discard the working reagent if the blank absorbance exceeds 1.00 at 405 Laboratory Procedure for Semi Auto
nm.
Working reagent 1000 µL
Reagent Storage and Stabil ity
Sample 20 µL
The sealed reagents are stable upto the expiry date stated on the label, when stored 0
at 2-8 0C and protected from light. Mix and incubate at 37 C for one minute. Measure the change in absorbance
per minute ( OD/min) during 3 minutes.
Open Vial Stability Calculation
o
Once opened the reagent is stable up to 4 weeksat 2- 8 C, if contamination is avoided ALP Activity (U/L) = ( OD / min.) x 2750.
Onboard Cal ibration Stability
Quality Control
Onboard calibration stability is 7 days.
It is recommended to use Agappe Qualicheck Norm and Path (51601001) to verify
Reagent Deterioration the performance of the assay. Each laboratory has to establish its own internal
Turbidity or precipitation in any kit component indicates deterioration and the quality control scheme and procedure for corrective action, if control do not recover
component must be discarded. Values outside the recommended acceptable range within the acceptable range.
for the Agappe control may also be an indication of reagent instability and
associated results are invalid. Sample should be retested using a fresh vial of Reference Range
reagents. It is recommended that each laboratory establish its own reference values. The
following value may be used as guide line.
Precaution
To avoid contamination, use clean laboratory wares. Avoid direct exposure of Women : 64 - 306 U/L
working reagent to light. Men : 80 - 306 U/L

Waste Management Children : 180 - 1200 U/L

Reagent must be disposed off in accordance with local regulation. Results obtained for patient samples are to be correlated with clinical finding of
patient for interpretation and diagnosis.

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AGAPPE DIAGNOSTICS SWITZERLAND GmbH

Knonauerstrasse 54 - 6330 Cham Switzerland
Tel. +41 41 780 60 10 Fax: +41 41 780 60 11
[email protected] | www.agappeswiss.com ISO 9001 : 2008
REV. NO.: ADS/IFU/ALP/LIQ/R00 EN ISO 13485: 2012
 2 x 30 mL, 2 x 50 mL, 2 x 125 mL, 4 x 125 mL
ALKALINE PHOSPHATASE 51401002, 51401003, 51401006, 51401007

Performance Inter Run

1. Linearity
The reagent is linear, upto 700 U/L. Control Level 1 Control Level 2
n 20 20
If the concentration is greater than linearity (700 U/L), dilute the sample with
Mean (U/L) 163.6 655.0
normal saline & repeat the assay. Multiply the result with dilution factor.
SD 6.80 27.52
2. Comparison CV(%) 4.15 4.20
A comparison study has been performed between Agappe reagent and another
internationally available reagent yielded a correlation coefficient of r2 = 0.9949 Accuracy ( U/L )
and a regression equation of y =0.9545x.
Control Expected Value Measured Value
3. Precision
Control Level 1 160 ± 55 164.6
Intra Run Control Level 2 510 ± 95 509.4
Control Level 1 Control Level 2 Qualichek Norm 170 ± 18 179.6
Qualichek Path 400 ± 51 392.4
n 20 20
Sensitivity
Mean (U/L) 173.1 660.6
Lower detection Limit is 1.5 U/L
SD 6.04 22.94 Bibliography
CV(%) 3.49 3.47 1. Schlebusch, H., et al.; Dtsch .Med. Wschr. 99, 765 (1974)
2. Z. Klin. Chem. Klin Biochem. 8,658 (1980) 10, 182 (1972)

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AGAPPE DIAGNOSTICS SWITZERLAND GmbH

Knonauerstrasse 54 - 6330 Cham Switzerland
Tel. +41 41 780 60 10 Fax: +41 41 780 60 11
[email protected] | www.agappeswiss.com ISO 9001 : 2008
REV. NO.: ADS/IFU/ALP/LIQ/R00 EN ISO 13485: 2012
 4 x 5 mL, 4 x 10 mL, 1 x 50 mL, 1 x 100 mL
AMYLASE 51402005, 51402002, 51402006, 51402007
Interferences
Intended Use No interference for
This reagent is intended for in vitro quantitative determination of amylase in serum, Bilirubin up to 10 mg/dL
plasma & urine. Ascorbic acid up to 50 mg/dL
- CNPG3 methodology Hemoglobin up to 1000 mg/dL
Materials Provided
- Linear up to 2000 U/L
Amylase Reagent .
Cl inical Significance
Materials required but not provided
Amylase occurs in the salivary glands, fallopian tubes & in pancreas. Alpha-amylase l Pipettes& Tips
is secreted by the pancreas from where it enters the duodenum, through the
pancreatic duct. Any obstruction to these ducts causes alpha-amylase enzyme to l Test Tubes & racks
enter the blood stream. l Timer
Elevated levels seen in acute pancreatitis, peptic ulcers, biliary disease, parotitis l Incubator
& other intestinal obstructions. l Analyzer
Decreased levels are seen in chronic pancreatic disorders having pancreatic cell
destruction. Test Parameters
Principle Mode of Reaction Kinetic
Amylase Slope of reaction Increasing
5CNPG3 > 3 CNP +2CNPG2+3 Maltotriose + 2 Glucose. Wavelength 405 nm
0
CNP = 2-Chloro-4-nitrophenol Temperature 37 C
CNP-G2= 2-chloro -4-nitrophenyl-a-maltoside Factor 3178
Kit Components Linearity 2000 U/L
Blank DI water
Reagent/ Product Code Description
Delay time 60 sec
Component 51402005 51402002 51402006 51402007
No.of readings 3
Alpha Amylase 4 x 5 mL 4 x 10 mL 1 x 50 mL 1 x 100 mL MES Buffer (pH6.0)
Interval 60 sec
50 mmol/L
(S.L) R1 CNPG3 2.27 mmol/L Sample volume 25 µL
Calcium chloride
60 mmoL Reagent volume 1000 µL
Sodium chloride Cuvette 1 cm light path
70 mmol/L
Application parameters for various instrument are available. Please contact
Activator customer support department for specific information.
900 mmol/L
Unit Conversion
Risk & Safety
Material Safety data sheets (MSDS) wil l be provided on request. Traditional Unit SI Unit Conversion from Traditional to SI

Reagent Preparation U/L mKat/L x 0.017

Amylase reagent is ready to use. Calibration
Reagent Storage and Stabil ity Agappe multicalibrator is recommended for calibration of this assay on fully auto
analyzer.
The sealed reagents are stable up to the expiry date stated on the label, when
stored at 2- 8 oC and protected from light. Use provided factor (3178) for estimation of Amylase on semi auto analyzer.
Open Vial Stability Procedure notes
Once opened, the reagent is stable up to 4 weeks if contamination is avoided.
Laboratory Procedure for Semi Auto Analyzer
On-board Cal ibration Stabil ity
On-board Calibration stability is 20 days. Reagent (R1) 1000 µL

Reagent Deterioration Sample 25 µL

0
Turbidity or precipitation in any kit component indicates deterioration and the Mix and incubate for 1 min. at 37 C . Measure the change in absorbance per
component must be discarded. Values outside the recommended acceptable range minute ( OD/min) during 3 minutes.
for the Agappe Qualichek Norm & Path control may also be an indication of reagent
instability and associated results are invalid. Sample should be retested using fresh
vial of reagent. Calculation
Alpha-Amylase activity (U/L) = ( OD/ min.) x 3178.
Precaution
To avoid contamination, use clean laboratory wares. Use clean, dry d isposable Quality Control
pipette tips for d ispensing. Close reagent bottles immed iately after use. It is recommended to use Agappe Qualicheck Norm & Path (51601001) to verify
the performance of the assay. Each laboratory has to establish its own internal
Avoid d irect exposure of reagent to light. Do not blow into the reagent bottles. quality control scheme and procedure for corrective action, if control do not recover
within the acceptable range.
This reagent is only for IVD use and follow the normal precautions required for
hand ling al l laboratory reagents. Reference Range
Waste Management It is recommended that each laboratory establish its own reference values. The
Reagents must be disposed off in accordance with local regulations. following value may be used as guide line.

Sample Serum / plasma : 25 - 86 U/L

Fresh serum / plasma (free of hemolysis) / Urine (1/3 d iluted). Urine : < 470 U/L
Results obtained for patient samples are to be correlated with clinical findings of
patient for interpretation and diagnosis.

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AGAPPE DIAGNOSTICS SWITZERLAND GmbH

Knonauerstrasse 54 - 6330 Cham Switzerland
Tel. +41 41 780 60 10 Fax: +41 41 780 60 11
[email protected] | www.agappeswiss.com ISO 9001 : 2008
REV. NO.: ADS/IFU/AMY/LIQ/R00 EN ISO 13485: 2012
 4 x 5 mL, 4 x 10 mL, 1 x 50 mL, 1 x 100 mL
AMYLASE 51402005, 51402002, 51402006, 51402007

Performance Inter Run

1. Linearity Control Level 1 Control Level 2
The reagent is linear, upto 2000 U/L. n 20 20
If the concentration is greater than linearity (2000 U/L), dilute the sample Mean (U/L) 74.3 854.9
with normal saline & repeat the assay. Multiply the result with dilution factor.
SD 2.0 22.6
2. Comparison CV(%) 2.7 2.6
A comparison study has been performed between Agappe reagent and another
internationally available reagent yielded a correlation coefficient of r2= 0.9909 Accuracy (U/L)
and a regression equation of y =1.0464x.
3. Precision Control Expected Value Measured Value
Control Level 1 64.7 ± 23 65
Intra Run
Control Level 2 425 ± 75 430.3
Control Level 1 Contro Level 2 Qualichek Norm 70 ± 14.80 73
n 20 20 Qualichek Path 175 ± 23 183

Mean (U/L) 73.9 860.8 4. Sensitivity

Lower detection Limit is 2.0 U/L.
SD 2.0 10.1
Bibliography
CV(%) 2.7 1.2 1. Junge, W., et al.; Clin. Biochem. 22, 109(1989)
2. Hohenwal lnern, W.; J.Clin. chem. Clin. Biochem. 27,97(1989)

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AGAPPE DIAGNOSTICS SWITZERLAND GmbH

Knonauerstrasse 54 - 6330 Cham Switzerland
Tel. +41 41 780 60 10 Fax: +41 41 780 60 11
[email protected] | www.agappeswiss.com ISO 9001 : 2008
REV. NO.: ADS/IFU/AMY/LIQ/R00 EN ISO 13485: 2012
 5 x 25 mL, 5 x 100 mL, 4 x 250 mL
CHOLESTEROL 51403002, 51403003, 51403007

Intended Use Precaution

This reagent is intended for in vitro quantitative determination of Cholesterol in To avoid contamination, use clean laboratory wares. Avoid direct
serum or plasma. exposure of working reagent to light.
- CHOD-PAP methodology Waste Management
- Linear upto 600 mg/dL Reagent must be d isposed off in accordance with local regulation.
- Contains LCF (Lipid clearing factor) which minimizes rerun Sample
Cl inical Significance Fresh serum / plasma (free of haemolysis)
It is the main lipid found in the blood, bile & brain tissues. It is also one of the Interferences
most important steroids of the body & is a precursor of many steroid hormones. No interference for
Two thirds of cholesterol present in the blood is esterified. The liver metabolizes Bilirubin up to 10 mg/dL
the cholesterol & it is transported in the blood stream by lipoproteins.
Ascorbic acid up to 50 mg/dL
Increased levels are found in hypercholesterolaemia, hyperl ipidaemia, Haemoglobin up to 1000 mg/dL
hypothyroidism, uncontrol led diabetes, nephritic syndrome & cirrhosis.
Materials Provided
Decreased levels are found in malabsorption, malnutrition, hyperthyroid ism, Cholsterol Reagent & Standarad.
anaemia & liver diseases.
Materials required but not provided
Principle l Pipettes& Tips
Enzymatic colorimetric determination of total cholesterol accord ing to the l Test Tubes & racks
fol lowing reactions.
l Timer
Cholesterol esterase l Incubator
Cholesterol ester +H 2 O > Cholesterol + fatty acids l Analyzer
Cholesterol Oxidase
Cholesterol + O 2 > 4-Cholesten-3- one + H 2 O2 Test Parameter
Peroxidase
Mode of Reaction End point
2H 2 O2 +Phenol+4-Aminoantipyrine > - Red quinone + 4H2 O
Slope of reaction Increasing
Kit Components
Wavelength I 505 (492 -550) nm
Reagent/ Product Code Description
Component 51403002 51403003 51403007 Wavelength II 630 nm
0
Cholesterol 5 x 25 mL 5 x 100 mL 4 x 250 mL Pipes Buffer Temperature 37 C
Reagent (pH 6.70) 50 mmol/L Standard Concentration 200 mg/dL
Phenol- 24 mmol/L Blank Reagent
Sodium Cholate
0.5 mmol/L Linearity 600 mg/dL
4 -Aminoantipyrine Incubation time 5 min
0.5 mmol/L Sample volume 10 µL
Cholesterol Esterase
>180 U/L Reagent volume 1000 µL
Cholesterol Oxidase Cuvette 1 cm light path
>200 U/L
Peroxidase >1000 U/L Application parameters for various instrument are available. Please contact
customer support department for specific information.
Cholesterol 1 x 4 mL 1 x 4 mL 1 x 4 mL Cholesterol std.
Standard Conc. 200 mg/dL Unit Conversion
Risk & Safety
Unit (Conventional) Unit (SI) Conversion to SI unit
Material safety data sheets (MSDS) wil l be provided on request.
mg/dL mmol/L x0.026
Reagent Preparation
Cholesterol Reagent & standard are ready to use.
Calibration
Reagent Storage and Stabil ity Agappe multicalibrator is recommended for calibration of this assay on fully auto
The sealed reagents are stable upto the expiry date stated on the label when stored analyzers.
at 2- 80 C and protected from light. Provided Standard is recommended for calibration of this assay on semi auto
analyzers.
Open Vial Stability
o
Once opened the reagent is stable up to 4 weeks at 2- 8 C if contamination is avoided Procedure notes
On-board Cal ibration Stability
Laboratory procedure For Semi Auto
On board calibration stability is 20 days.
Blank Standard Sample
Reagent Deterioration Working Reagent 1000 µL 1000 µL 1000 µL
Turbidity or precipitation in any kit component indicates deterioration and the
Standard - 10 µL -
component must be discarded. Values outside the recommended acceptable range
for the Agappe Qualicheck Norm & Path control may also be an indication of Sample - - 10 µL
reagent instabil ity and associated results are invalid. Sample should be retested 0
Mix, and incubate for 5 min.at 37 C. Measure the absorbance of sample and
using fresh vial of reagent. standard against reagent blank

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AGAPPE DIAGNOSTICS SWITZERLAND GmbH

Knonauerstrasse 54 - 6330 Cham Switzerland
Tel. +41 41 780 60 10 Fax: +41 41 780 60 11
[email protected] | www.agappeswiss.com ISO 9001 : 2008
REV. NO.: ADS/IFU/CHO/LIQ/R00 EN ISO 13485: 2012
 5 x 25 mL, 5 x 100 mL, 4 x 250 mL
CHOLESTEROL 51403002, 51403003, 51403007

Calculation Absorbance of sample 3. Precision

Cholesterol Conc. (mg/dL) = > x 200 Intra Run
Absorbance of standard
Quality Control Control Level 1 Control Level 2
It is recommended to use Agappe Qualicheck Norm and Path (51601001) to verify n 20 20
the performance of the assay.Each laboratory has to establish its own internal Mean ( mg/dL) 239.3 95.7
quality control scheme and procedure for corrective action,if control do not recover
within the acceptable range. SD 7.11 3.23
CV(%) 2.97 3.37
Reference Range
It is recommended that each laboratory has to establish its own reference values.
Inter Run
The fol lowing value may be used as guide line.
Serum / Plasma : 150 – 220 mg/dL Control Level 1 Control Level 2
Results obtained for patient samples are to be correlated with clinical finding of n 20 20
patient for interpretation and diagnosis. Mean (mg/dL) 236.60 94.58
SD 4.96 2.89
Performance
CV % 2.10 3.06
1. Linearity
This reagent is linear upto 600 mg/dL.
Accuracy (mg/dL)
If the concentration is greater than linearity (600 mg/dL), dilute the sample
with normal saline and repeat the assay. Multiply the result with dilution factor. Control Expected Value Measured Value
2. Comparison Control Level 1 263 ± 54.0 268
A comparison study has been performed between Agappe reagent and another Control Level 2 105 ± 24.0 109
international ly available reagent yielded a correlation coefficient of r2 = 0.998 Qualichek Norm 97 ± 18.0 94.4
and a regression equation of y =1.0019x.
Qualichek Path 195 ± 15.0 195.7

4.Sensitivity
Lower detection Limit is 3 mg/dL.
Bibliography
Al lain, C.C., et al.; Clin.Chem 20 (1974), 470

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AGAPPE DIAGNOSTICS SWITZERLAND GmbH

Knonauerstrasse 54 - 6330 Cham Switzerland
Tel. +41 41 780 60 10 Fax: +41 41 780 60 11
[email protected] | www.agappeswiss.com ISO 9001 : 2008
REV. NO.: ADS/IFU/CHO/LIQ/R00 EN ISO 13485: 2012
 2 x 10 mL
CHOLINESTERASE 51419002

Intended Use Waste Management

This reagent is intended for in vitro quantitative determination of cholinesterase Reagent must be disposed off in accordance with local regulation.
in serum or plasma.
Sample
- New DGKC method Use fresh serum / plasma.
- Ready to use liquid stable reagents
Do not use sodium fluoride as an anticoagulant because it inhibits cholinesterase.
0
- High linearity and high sensitivity Samples are stable for 15 days at 2-8 C.
Clinical Significance Interferences
Cholinesterase also known as acetyl-cholinesterase and is found mainly in the No interference for
nerve endings and the grey matter of brain. It hydrolyses acetylcholine, released Bilirubin up to 20 mg/dL
at the nerve endings to mediate transmission of impulses. A similar enzyme acyl
Hemoglobin up to 500 mg/dL
choline acyl hydrolase also known as pseudocholinesterase is present in the serum,
brain, heart, liver and pancreas but its biological role is unknown. Triglycerides up to 1000 mg/dL

Cholinesterase levels in serum are useful as a test of liver function and as an Materials Provided
indicator of possible insecticide poisoning. Among the organic phosphorous Cholinesterase S.L Reagent R 1 & R2
compounds that inhibit cholinesterase activity are mainly insectisides such as
Parathion, Sarin and Tetraethylpyrophosphate. During poisoning the level of Materials required but not provided
enzymes decreases as its activity is inhibited. l Pipettes& Tips
l Test Tubes & racks
Principle
l Timer
Cholinesterase catalyses the hydrolysis of butyrylthiocholine substrate forming l Incubator
butyrate and thiocholine.
l Analyzer
CHE
butyrylthiocholine + H 2O > Thiocholine + Butyrate Test Procedure
Thiocholine reduces hexacyanoferrate(3) to hexacyanoferrate(2)
Mode of Reaction Kinetic
Thiocholine + hexacyanoferrate(3) > Hexacyanoferrate(2)
Slope of reaction Decreasing
The decrease of absorbance is fol lowed at 405 nm and is proportional to the activity
of cholinesterase in the sample Wavelength 405 nm
0
Kit Components Temperature 37 C

Reagent/ Product Code Description Factor 22653

Component 51419002
Linearity 41400 U/L
Cholinesterase 2 x 8 mL Pyrophosphate Buffer,(pH 7.6) - 75mmoL
(S.L) R1 Hexa cynoferrate(3) 2 mmol/L Blank DI Water

Cholinesterase 2 x 2 mL Butyrylthiocholine 15 mmol/L Delay 30 sec

(S.L) R2 No of reading 3
Interval 30 sec
Risk & Safety
Sample volume 50 µL
Material Safety data sheets (MSDS) wil l be provided on request.
Reagent volume 1000 µL
Reagent Preparation
Mix 4 volume of Reagent 1 (R1) with 1 volume of Reagent 2 (R2) Cuvette 1 cm light path
o
Working reagent is stable only for 3 hrs at 15 – 25 C.
Application parameters for various instrument are available. Please contact
Reagent Storage customer support department for specific information.
The sealed reagents are stable up to the expiry date stated on the label, when Unit Conversion
o
stored at 2- 8 C and protected from light.
Traditional Unit SI Unit Conversion from Traditional to SI
Open Vial Stability
o
Once opened, the reagent is stable up to 4 weeks at 2-8 C if contamination is U/L µ Kat/L x 0.01667
avoided.
Calibration
Onboard Calibration Stabil ity
Agappe multicalibrator is recommended for calibration of this assay on fully auto
On-board Calibration stability is 7 days analyzers.
Reagent Deterioration
Use provided factor (22653) for estimation of this assay on semi auto analyzers.
Turbid ity or precipitation in any kit component ind icates deterioration and the
component must be discarded. Values outside the recommended acceptable range Procedure notes
for the Agappe control may also be an indication of reagent instabil ity and
associated results are invalid. Sample should be retested using fresh vial of reagent. Laboratory procedure for Semi Auto Analyzer
Precaution Working reagent 1000 µL
To avoid contamination, use clean laboratory wares. Avoid d irect exposure of
Sample 50 µL
working reagent to light.
0
Mix and incubate at 37 C for 30 seconds. Measure the change in absorbance
per 30 second during 90 seconds.

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AGAPPE DIAGNOSTICS SWITZERLAND GmbH

Knonauerstrasse 54 - 6330 Cham Switzerland
Tel. +41 41 780 60 10 Fax: +41 41 780 60 11
[email protected] | www.agappeswiss.com ISO 9001 : 2008
REV. NO.: ADS/IFU/CHE/LIQ/R00 EN ISO 13485: 2012
 2 x 10 mL
CHOLINESTERASE 51419002

Calculation 2. Precision
Cholinesterase activity (U/L) = ( OD/ 60 sec) x 22653
Accuracy (U/L)
Quality Control
Control Expected Value Measured Value
It is recommended to use Agappe Qualicheck Norm & Path ( 51601001) to verify
the performance of the assay. Each laboratory has to establish its own internal
quality control scheme and procedure for corrective action, if control do not recover Agappe Control Level 1 5850 ± 715 5850
within the acceptable range.
Agappe Control Level 2 5900 ± 690 5925
Reference Range
It is recommended that each laboratory has to establish its own reference values. Control Level 1 7587 ± 2564 7426
The fol lowing value may be used as guide line. Control Level 2 5168 ± 2128 4979
Females : 3930 – 10800 U/L
Males : 4620 – 11500 U/L
3. Sensitivity
Results obtained for patient samples are to be correlated with clinical findings of Lower detection Limit is -50 U/L
patient for interpretation and diagnosis.
Bibliography
Performance 1. Eur. J. Clin. Chem; Clin. Biochem 30, 163(1992)
1. Linearity 2. Tietz, Text book of Clinical chemistry, 2nd Edition, Brutis, Ashwood (1994)
This reagent is linear upto 41400 U/L. 3. Knedel, M and Bottger, R; Klin. Wschr. 1967; 45;30

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AGAPPE DIAGNOSTICS SWITZERLAND GmbH

Knonauerstrasse 54 - 6330 Cham Switzerland
Tel. +41 41 780 60 10 Fax: +41 41 780 60 11
[email protected] | www.agappeswiss.com ISO 9001 : 2008
REV. NO.: ADS/IFU/CHE/LIQ/R00 EN ISO 13485: 2012
 2 x 20 mL, 2 x 75 mL
CK-MB 51405004, 51405008

Intended Use Interferences

This reagent is intended for in vitro quantitative determination of CK-MB in human No interference for
serum or plasma. Bilirubin up to 6 mg/dL
- Immuno – inhibition methodology Haemoglobin up to 5 g/L
- Linear up to 600 U/L Turbid ity up to 580 mg/dL
- Convenient pack sizes for al l laboratories Materials Provided
Clinical Significance CK-MB reagent R1, R2 .
CK – MB levels increases significantly 4-6 hours following a myocardial infarction Materials required but not provided
& peak at around 12 to 24 hours after the infarct. The levels return to normal in l Pipettes& Tips
case of no further myocardial damage after 24 - 48 hours. Hence the increased l Test Tubes & racks
levels of CK-MB along with elevated levels of CK-NAC is a good indicator of l Timer
myocardial infarction.
l Incubator
Principle l Analyzer
The procedure involves measurement of CK-activity in the presence of an antibody
to CK-M monomer. This antibody completely inhibits the activity of CK-MM & Test Parameter
half of the activity of CK-MB, while not affecting the B subunit activity of CK-MB Mode of Reaction Kinetic
&CK –BB. Then we use CK method to quantitatively determine CK-B activity. The Slope of reaction Increasing
CK-MB activity is obtained by multiplying the CK-B activity by two. Wavelength 340 nm
0
Kit Components Temperature 37 C
Factor 8254
Reagent/ Product Code Description Linearity 600 U/L
Component 51405004 51405008
Blank DI Water
CK-MB (S.L) R1 2 x 16 mL 2 x 60 mL Imidazole(pH 6.7) 125 mmol/L Delay 100 sec
D-Glucose - 25 mmol/L No of reading 5
N-Acetyle-L-Cysteine 25mmol/L Interval 60 sec
Magnesium acetate 12.5mmol/L Sample volume 40 µL
NADP -2.52 mmol/L
Reagent volume 1000 µL
EDTA - 2.02 mmol/L
Hexokinase >6800 U/L Cuvette 1 cm light path
Anti human polyclonal CK-M
antibody(sheep)sufficient to Calibration
inhibit up to 2000U/L of CK-MM Use provided factor (8254) for estimation of this assay on semi automated analyzer
CK-MB (S.L) R2 2 x 4 mL 2 x 15 mL Creatine phosphate 250 mmol/L
ADP 15.2 mmol/L
Procedure notes
AMP 25 mmol/L Laboratory procedure for Semi Auto Analyzer
Diadenosine Working reagent 1000 µL
pentaphosphate 103 mmol/L
G-6-PDH > 8800 U/L Sample 40 µL
0
Mix and incubate at 37 C for100 seconds. Read the change in
absorbance per minute (OD/ minute) during 5 minutes.
Risk & Safety
Material Safety data sheets (MSDS) wil l be provided on request. Calculation
Reagent Preparation CK-MB Activity (U/L) = OD/Min x 8254
Mix 4 volume of Reagent 1 (R1) with 1 volume of Reagent 2 (R2)
0
Working reagent is stable for 14 days at 2-8 C. Quality Control
Note: Discard the working reagent ,if the blank absorbance exceeds 1.0 at 340 nm. It is recommended to use control to verify the performance of the assay.Each
laboratory has to establish its own internal quality control scheme and procedure
Reagent Storage for corrective action, if control do not recover within the acceptable range.
The sealed reagents are stable up to the expiry date stated on the label, when
stored at 2-8 0 C and protected from light. Reference Range
It is recommended that each laboratory should establish its own reference values.
Open Vial Stability The fol lowing value may be used as guide line.
o
Once opened, the reagent is stable up to 4 weeks at 2- 8 C if contamination is Serum up to : 24 U/L
avoided.
% CK- MB : 6 - 25 %
Reagent Deterioration Results obtained for patient samples are to be correlated with clinical findings of
Turbidity or precipitation in any kit component indicates deterioration and the patient for interpretation and diagnosis.
component must be discarded. Values outside the recommended acceptable range Performance
for the control may also be an indication of reagent instability and associated
results are inval id. Sample should be retested using fresh vial of reagent.
1.Linearity
This reagent is l inear up to 600 U/L.
Precaution If the concentration is greater than linearity (600 U/L), dilute the sample with
To avoid contamination, use clean laboratory wares. Avoid direct exposure of normal saline and repeat the assay. Multiply the result with dilution factor.
working reagent to light. 2.Sensitivity
Waste Management Lower detection Limit is 1 U/L
Reagent must be disposed off in accordance with local regulation. Bibliography
1.DGKC, J.Clin. Chem Clin. Bioch. 15, 255(1977)
Sample 2.Di. Witt, C Trendelendurg, J. Clin. Chem, Clin Bioch. 20, 235 (1982)
Serum /Plasma ( free of Haemolysis).

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AGAPPE DIAGNOSTICS SWITZERLAND GmbH

Knonauerstrasse 54 - 6330 Cham Switzerland
Tel. +41 41 780 60 10 Fax: +41 41 780 60 11
[email protected] | www.agappeswiss.com ISO 9001 : 2008
REV. NO.: ADS/IFU/CKMB/LIQ/R00 EN ISO 13485: 2012
 2 x 10 mL, 2 x 30 mL, 1 x 125 mL
CK-NAC 51404001, 51404002, 51404006

Precaution
Intended Use To avoid contamination, use clean laboratory wares. Use clean, dry disposable
This reagent is intended for in vitro quantitative determination of Creatine Kinase pipette tips for dispensing. Close reagent bottles immediately after use.
in human serum or plasma. Avoid direct exposure of reagent to light. Do not blow into the reagent bottles.
- Optimized IFCC Method This reagent is only for IVD use and fol low the normal precautions required for
- Linear up to 1700 U/L hand ling all laboratory reagents.
- Working Reagent can be prepared as per requirements Waste Management
Clinical Significance Reagents must be d isposed off in accordance with local regulations.
It is mainly found in al l muscle (Cardiac & Skeletal) & brain tissues. It plays an Sample
important role in energy storing mechanism of the tissues. It’s iso-enzymes: CK- Serum / Plasma (Free of haemolysis).
MB mainly exists in cardiac muscle tissues, CK-MM in skeletal muscle tissues &
CK-BB in brain. Increased levels are found in myocard ial infarction, muscular Interferences
dystrophy, cerebrovascular-d isease, pulmonary infarction, electrical shocks & No interference for
hypothyroidisim. Decreased levels are, sometimes seen in early pregnancy, alcoholic Ascorbic acid up to 40 mg/dL
liver d iseases and RA.
Haemoglobin up to 5 g/L
Principle Turbid ity up to 600 mg/dL
Kinetic determination of Creatine Kianse is based on fol lowing reactions:-
CK
Materials Provided
Creatine Phosphate + ADP > Creatine +ATP CK-NAC reagent R1& R2
HK Materials required but not provided
ATP + Glucose > ADP + Glucose – 6- phosphate l Pipettes & Tips
G6P – DH l Test Tubes & racks
G-6-P + NADP > D-Gluconate -6-phosphate + NADPH + H + l Timer
CK – Creatine Kinase l Incubator
HK – Hexokinase l Analyzer
G-6-P-Glucose-6-phosphate Test Parameter
G-6-PDH-Glucose-6-Phosphate dehydrogenase.
Mode of Reaction Kinetic
Kit Components
Slope of reaction Increasing
Reagent/ Product Code
Component Description Wavelength 340 nm
0
51404001 51404002 51404006 Temperature 37 C
CK-NAC 2 x 8 mL 2 x 24 mL 1 x 100 mL Immidazole buffer 125 mmolL Factor 4127
(S.L) R1 D-Glucose 25 mmol/L Linearity 1700 U/L
N-Acetyl-L-cysteine
Blank Distil led Water
25 mmol/L
Magnesium acetate Delay time 100 sec.
12.5 mmol/L No of readings 3
NADP 2.4 mmol/L
Interval 60 sec
EDTA 2.0 mmol/L
Hexokinase >6800 U/L Reagent volume 1000 µL
CK-NAC 2 x 2 mL 2 x 6 mL 1 x 25 mL Creatine Phosphate Sample volume 40 µL
(S.L) R2 250 mmol/L
Cuvette 1 cm light path
Risk & Safety
Application parameters for various instrument are available. Please contact
Material Safety data sheets (MSDS) wil l be provided on request. customer support department for specific information.
Reagent Preparation
Unit Conversion
Mix 4 volume of Reagent 1 (R1) with 1 volume of Reagent 2 (R2)
0
The working reagent is stable for 14 days at 2-8 C. Traditional Unit SI Unit Conversion from Traditional to SI
Note: Discard the working reagent if the blank absorbance exceeds 1.0 at 340 nm.
U/L µKat/L x 0.017
Reagent Storage
The sealed reagents are stable up to the expiry date stated on the label, when Calibration
o
stored at 2- 8 C and protected from light. Agappe multicalibrator is recommended for calibration of this assy on ful ly auto
analyzers.
Open Vial Stability
0
Once opened, the reagent is stable up to 4 weeks at 2-8 C if contamination is Use provided factor (4127) for estimation of this assay on Semi automated analyzer.
avoided.
On-board Cal ibration Stability Procedure notes
On-board Calibration stability is 20 days. Laboratory procedure for Semi Auto Analyzer.(Mono reagent Procedure)
Reagent Deterioration Working reagent 1000 µL
Turbidity or precipitation in any kit component indicates deterioration and the Sample 40 µL
component must be discarded. Values outside the recommended acceptable range 0
for the Agappe Qualicheck Norm & Path control may also be an indication of Mix and incubate at 37 C for 1 minute. Measure the change in absorbance per
reagent instability and associated results are invalid. Sample should be retested minute (OD/min) during 3 minutes.
using fresh vial of reagent.

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AGAPPE DIAGNOSTICS SWITZERLAND GmbH

Knonauerstrasse 54 - 6330 Cham Switzerland
Tel. +41 41 780 60 10 Fax: +41 41 780 60 11
[email protected] | www.agappeswiss.com ISO 9001 : 2008
REV. NO.: ADS/IFU/CKNAC/LIQ/R00 EN ISO 13485: 2012
 2 x 10 mL, 2 x 30 mL, 1 x 125 mL
CK-NAC 51404001, 51404002, 51404006

3. Precision
Two reagent Procedure
Intra Run
Reagent R1 200 µL
Reagent R2 50 µL Control Level 1 Control Level 2

Mix and wait for 25 second and add sample 10 µL. mix wel l and incubate for n 20 20
0
2 minutes at 37 C.measure the variation of absorbance per minute during 3 minute Mean (U/L) 130.2 445.4
SD 4.20 15.19
Calculation
CV(%) 3.23 3.41
Creatine Kinase Activity (U/L) = ( OD /min.) x 4127

Quality Control Inter Run

It is recommended to use Agappe Qualicheck Norm & Path ( 51601001) to verify Control Level 1 Control Level 2
the performance of the assay. Each laboratory has to establish its own internal n 20 20
quality control scheme and procedure for corrective action, if control do not recover
within the acceptable range. Mean (U/L) 126.9 434.9
SD 4.8 16.7
Reference Range CV(%) 3.8 3.8
It is recommended that each laboratory establish its own reference value.
The fol lowing value may be used as guide line.
Accuracy ( U/L )
Men upto : < 171 U/L
Women upto : < 145 U/L Control Expected Value Measured Value
Results obtained for patient samples are to be correlated with clinical findings of Control Level 1 141 ±28 131.8
patient for interpretation and diagnosis. Control Level 2 457 ± 91 435
Performance Qualicheck Norm 145 ± 22.3 152.1
1. Linearity Qualicheck Path 510 ± 80 490
This reagent is linear upto 1700 U/L. 4. Sensitivity
If the concentration is greater than l inearity (1700 U/L) dilute the sample with Lower detection Limit is 2.0 U/L.
normal saline and repeat the assay. Multiply the result with dilution factor.
2. Comparison Bibliography
1. DGKC, J.Clin. chem.Clin. Bioch.15, 255 (1977).
A comparison study has been performed between Agappe reagent and another
international ly available reagent yielded a correlation coefficient of r 2 = 2. Di. Witt, C. Tren delenburg, J. Clin chemie, Clin. Bioch. 20,235 (1982).
0.9802and a regression equation of y =1.035x.

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AGAPPE DIAGNOSTICS SWITZERLAND GmbH

Knonauerstrasse 54 - 6330 Cham Switzerland
Tel. +41 41 780 60 10 Fax: +41 41 780 60 11
[email protected] | www.agappeswiss.com ISO 9001 : 2008
REV. NO.: ADS/IFU/CKNAC/LIQ/R00 EN ISO 13485: 2012
 2 x 40 mL, 2 x 60 mL
ENZYMATIC CREATININE 51420002, 51420003

Intended Use
This reagent is intended for in vitro quantitative determination of creatinine in This reagent is only for IVD use and fol low the normal precautions required for
serum, plasma and urine. hand ling al l laboratory reagents
· Enzymatic Method Waste Management
· High Linearity of 200 mg/dL Reagents must be disposed off in accordance with local regulations.
· Ready to use reagents
Sample
Clinical Significance Fresh Serum/plasma & urine (24 hour).
Creatinine is formed in muscles from phosphocreatinine. It is an important form Interferences
of energy by being a store of high energy phosphate. Creatinine determinations
No interference for
have one advantage over urea determination that it is not affected by a high protein
diet. Bilirubin up to 20 mg/dL
Serum creatinine is more specific & sensitive ind icator of renal function. Ascorbic acid up to 40 mg/dL
Simultaneous estimations of serum urea & creatinine provide better information. Haemoglobin up to 500 mg/dL
Serum urea nitrogen & creatinine ratio is > 15 in prerenal failure & < 10 in renal
failure. Decreased levels are found in muscle dystrophy. Materials Provided
Enzymatic creatinine reagent R1, R2 & Standard.
Principle
Creatininase Materials required but not provided
Creatinine +H 2O > Creatine l Pipettes& Tips
Creatinase l Test Tubes & racks
Creatine + H2O > Sarcosine +Urea l Timer
Sarcosine Oxidase l Incubator
Sarcosine + O2 +H 2O > Glycine + HCHO + H2O 2 l Analyzer
Peroxidase
Test Parameter
2 H 2O2+ 4-AA *1+ TOOS *2 > Quinone pigment +4 H 2O
* 1 : 4- Aminoantipyrine, Semi Auto Analyser
* 2 : N-ethyl-N-(2-hydroxy -3-sulfopropyl)-m-toluidine Mode of reaction End Point
Creatinine concentration can be obtained by measuring quinone pigment
Slope of Reaction Increasing
photometrical ly.
Wavelength I 546 nm
Kit Components
Wavelength II 630 nm
Reagent/ Product Code Description
Temperature 37 oC
Component 51420002 51420003
Standard concentration 2 mg/dL
E.Creatinine 2 x 30 mL 2 x 45 mL Creatinase - 175000 IU/L Linearity 200 mg/dL
(S.L) R1 Sarcosine Oxidase1500 IU/L
Incubation time 5 +5 min
TOOS 1.13 mmoL
Blank Reagent
E.Creatinine 2 x 10 mL 1 x 30 mL Creatininase 75000 IU/L Sample Volume 10 µL
(S.L) R2 Peroxidase 4500 units/L
4-AA 0.75 mmol Reagent 1 Volume 450 µL
Reagent 2 Volum 150 µL
Creatinine 1 x 4 mL 1 x 4 mL Creatinine Std.Conc.2 mg/dL
Standard Cuvette 1 cm light path

Risk & Safety Application parameters for various instrument are available. Please contact
customer support department for specific information.
Material Safety data sheets (MSDS) will be provided on request.
Unit Conversion
Reagent Preparation
Reagent 1, Reagent 2 & Standard are ready to use. Traditional Unit SI Unit Conversion from Traditional to SI
Reagent Storage and stability mg/dL mmol/L x 88.40
The sealed reagents are stable up to the expiry date stated on the label, when
o
stored at 2- 8 C and protected from light. Calibration
Agappe multicalibrator is recommended for Calibration of this assay in ful ly
Open Vial Stability
0 auto analyzers.
Once opened, the reagent is stable up to 20 days at 2-8 C if contamination is
avoided. Enzymatic creatinine standard is recommended for calibration of this assay on
Semi auto analyzer.
On-board Calibration Stabil ity
Procedure notes
On-board Calibration stability is 10 days.
Reagent Deterioration Laboratory procedure for Semi Auto Analyzer.
Turbidity or precipitation in any kit component ind icates deterioration and the Blank Calibrator Sample/control
component must be discarded. Values outside the recommended acceptable range E. CRT R1 450 µL 450 µL 450 µL
for the Agappe Qualichek Norm & Path control may also be an indication of reagent
instability and associated results are invalid. Sample should be retested using a Standard - 10 µL -
fresh vial of reagent. Sample / control - - 10 µL
Precaution 0
Mix & incubate for 5 min at 37 C then add
To avoid contamination, use clean laboratory wares. Use clean, dry disposable E.CRT R2 150 µL 150 µL 150 µL
pipette tips for dispensing. Close reagent bottles immediately after use. o
Mix and incubate for 5 min at 37 C and read absorbance of sample and
Avoid direct exposure of reagent to light. Do not blow into the reagent bottles. standard against the reagent blank.

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AGAPPE DIAGNOSTICS SWITZERLAND GmbH

Knonauerstrasse 54 - 6330 Cham Switzerland
Tel. +41 41 780 60 10 Fax: +41 41 780 60 11
[email protected] | www.agappeswiss.com ISO 9001 : 2008
REV. NO.: ADS/IFU/ENZ/LIQ/R00 EN ISO 13485: 2012
 2 x 40 mL, 2 x 60 mL
ENZYMATIC CREATININE 51420002, 51420003

Quality Control 3. Precision

It is recommended to use Agappe Qualicheck Norm & Path (51601001) to verify Intra Run
the performance of the assay. Each laboratory has to establish its own internal
quality control scheme and procedure for corrective action, if control do not recover Control Level 1 Control Level 2
within the acceptable range.
n 20 20
Mean (mg/dL) 1.7 4.8
Reference Range SD 0.04 0.1
it is recommended that each laboratory establish its own reference value. CV(%) 2.13 2.08
The fol lowing value may be used as guide line.
Serum/Plasma : Male : 0.6 – 1.1 mg/dL Inter Run
: Female : 0.5- 0.8 mg/dL Control Level 1 Control Level 2
Urine : Male : 1070-2150 mg/dL (24 hrs accumulated urine) n 20 20
: Female : 769 – 1200 mg/dL (24 hrs accumulated urine) Mean (mg/dL) 1.78 4.71
Results obtained for patient samples are to be correlated with clinical findings of SD 0. 07 0.13
patient for interpretation and diagnosis. CV(%) 3.8 2.69

Performance
Accuracy ( mg/dL )
1. Linearity Control Expected Value Measured Value
This reagent is linear upto 200 mg/dL. Control Level 1 1.79 ± 0.36 1.7
Control Level 2 4.96 ± 0.99 5
If the concentration is greater than linearity dilute the sample with normal Qualicheck Norm 1.0 ± 0.26 1
saline and repeat the assay. Multiply the result with dilution factor. Qualicheck Path 4 ± 0.75 3.8
2. Comparison 4. Sensitivity
A comparison study has been performed between Agappe reagent and another Lower detection Limit is 0.1 mg/dL
internationally available reagent yielded a correlation coefficient of r 2= 0.9907
and a regression equation of y =1.0362x
Bibliography
1. Artiss J.D,Mc Enroe,Zak,B.
2. Clin chem,30 (1984) 1389.

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AGAPPE DIAGNOSTICS SWITZERLAND GmbH

Knonauerstrasse 54 - 6330 Cham Switzerland
Tel. +41 41 780 60 10 Fax: +41 41 780 60 11
[email protected] | www.agappeswiss.com ISO 9001 : 2008
REV. NO.: ADS/IFU/ENZ/LIQ/R00 EN ISO 13485: 2012
 2 x 30 mL, 1 x 125 mL, 4 x125mL
GAMMA GT 51416002, 51416006, 51416007

Intended Use Interferences

This reagent is intended for in vitro Quantitative determination of Gamma GT in No interference for
serum. Bilirubin up to 20 mg/dL
- Szasz methodology Ascorbic acid up to 10 mg/dL
- Linear upto 232 U/L Triglycerides up to 700 mg/dL
- Working reagent can be prepared as per requirements
Materials Provided
Clinical Significance GGT Reagent R1& R2.
GGT activity is elevated in al l forms of liver diseases. It is highest in cases of
intrahepatic or post hepatic biliary obstruction. (It may be 5 to 30 times higher Materials required but not provided
than normal). It is more sensitive than al kaline phosphatase NTP leucine amino l Pipettes& Tips
peptidase and transaminases in detection of obstructive jaund ice, cholangitis, l Test Tubes & racks
cholecystis neoplasm, it rises earlier than other enzyme and persists longer. l Timer
Moderate increase is observed in infectious hepatitis (2 to 5 times). Increases may l Incubator
also be observed in cases of drug intoxication, acute and chronic pancreatitis. l Analyzer
Principle Test Parameter
Kinetic determination of Gamma GT accord ing to the fol lowing reaction. Mode of Reaction Kinetic
Gamma GT Slope of reaction Increasing
GLUPA-C+Glycylglycine > L-Gamma-Glutamyl-GlycyLglycine +
5-Amino-2-nitrobenzoic acid. Wavelength 405 nm
Temperature 37 0C
GLUPA-C: L-Gamma -Glutamyl-3 Carboxy-p-nitroanilide
Factor 1158
Linearity 232 U/L
Kit Components
Blank DI Water
Reagent/ Product Code
Delay 60 sec
Component Description
51416002 51416006 51416007 No of readings 3
Gamma GT 2 x 24 mL 1 x 100 mL 4 x 100 mL Tris buffer pH (8.25) -133 mmol/L Interval 60 sec
R1 Glycylglycine - 138 mmol/L Sample volume 100 µL
Gamma GT 2 x 6 mL 1 x 25 mL 4 x 25 mL GLUPA-C - 23 mmol/L Reagent volume 1000 µL
R2
Cuvette 1 cm light path
Risk & safety
Material Safety data sheets (MSDS) wil l be provided on request. Application parameters for various instrument are available. Please contact
customer support department for specific information.
Reagent Preparation
Mix 4 volume of Reagent 1 (R1) with 1 volume of reagent 2 (R2). This working Unit Conversion
0
reagent is stable for 21 days at 2-8 C.
Note: Discard the working reagent if the blank absorbance exceeds 1.0 at 405 nm. Traditional Unit SI Unit Conversion from
Traditional to SI
Reagent Storage and Stabil ity
U/L µ Kat/L x 0.017
The sealed reagents are stable up to the expiry date stated on the label, when
o
stored at 2- 8 C and protected from light.
Open Vial Stabil ity
Calibration
0 Agappe multi calibrator is recommended for calibration of this assay on ful ly auto
Once opened, the reagent is stable up to 4 weeks at 2-8 C. if contamination is analyzers.
avoided.
On-board Cal ibration Stabil ity Use provided factor (1158) for estimation of Gamma GT on semi auto analyzers.
On-board Calibration stability is 20 days Procedure notes
Reagent Deterioration Laboratory procedure for Semi Auto Analyzer
Turbidity or precipitation in any kit component indicates deterioration and the
component must be discarded. Values outside the recommended acceptable range Working reagent 1000 µL
for the Agappe Qualichek Norm & Path control may also be an indication of reagent Sample 100 µL
instability and associated results are invalid. Sample should be retested using fresh o
vial of reagent. Mix and incubate for 1 minute at 37 C. Read the change in absorbance
per minute ( OD/min) during 3 minutes.
Precaution
To avoid contamination, use clean laboratory wares. Use clean, dry d isposable Calculation
pipette tips for d ispensing. Close reagent bottles immed iately after use. Gamma GT activity (U/L) = ( OD/min) x 1158
Avoid direct exposure of reagent to light.Do not blow into the reagent bottles. Quality Control
This reagent is only for IVD use and fol low the normal precautions required for It is recommended to use Agappe Qualicheck Norm & Path ( 51601001) to verify
hand ling al l laboratory reagents the performance of the assay. Each laboratory has to establish its own internal
quality control scheme and procedure for corrective action, if control do not recover
Waste Management within the acceptable range.
Reagents must be disposed off in accordance with local regulations.
Reference Range
Sample It is recommended that each laboratory should establish its own reference values.
Fresh Serum (free of haemolysis).

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AGAPPE DIAGNOSTICS SWITZERLAND GmbH

Knonauerstrasse 54 - 6330 Cham Switzerland
Tel. +41 41 780 60 10 Fax: +41 41 780 60 11
[email protected] | www.agappeswiss.com ISO 9001 : 2008
REV. NO.: ADS/IFU/GGT/LIQ/R00 EN ISO 13485: 2012
 2 x 30 mL, 1 x 125 mL, 4 x125mL
GAMMA GT 51416002, 51416006, 51416007

The following value may be used as guide line.

Female : 5 - 32 U/L Inter Run
Male : 10 - 45 U/L
Control Level 1 Control Level 2
Results obtained for patient samples are to be correlated with clinical findings of n 20 20
patient for interpretation and diagnosis.
Performance Mean (U/L) 51.25 128.62
1. Linearity SD 1.25 2.73
This reagent is linear up to 232 U/L. CV(%) 2.43 2.13
If the concentration is greater than linearity (232 U/L) dilute the sample with
normal saline and repeat the assay. Multiply the result with dilution factor. Accuracy ( U/L)
2. Comparison Control Expected Value Measured Value
A comparison study has been performed between Agappe Reagent and another
internationally available reagent yielded a correlation coefficient of r2= 0.9936 Control Level 1 44.8 ± 8.2 47
and a regression equation of y = 1.0128x .
3. Precision Control Level 2 135 ± 29 140

Intra Run Qualichek Norm 45.20 ± 7.10 43

Control Level 1 Control Level 2
Qualichek Path 220 ± 40 219.4
n 20 20
Mean (U/L) 51.7 129.7
4. Sensitivity
SD 0.50 1.57
Lower detection Limit is 1.5 U/L.
CV(%) 0.97 1.21
Bibliography
1. Szasz, G.; Clin.Chem., 22, (1976),2051.
2. Scand. J.Clin. Lab.Invest 36:711 (1976)
3. Tietz, N.W.; Text book of Clin.Chem. 678-686 : (1986)

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AGAPPE DIAGNOSTICS SWITZERLAND GmbH

Knonauerstrasse 54 - 6330 Cham Switzerland
Tel. +41 41 780 60 10 Fax: +41 41 780 60 11
[email protected] | www.agappeswiss.com ISO 9001 : 2008
REV. NO.: ADS/IFU/GGT/LIQ/R00 EN ISO 13485: 2012
 2 x 30 mL
LDH-P 51407002

Intended Use Interferences

This reagent is intended for in vitro quantitative determination of Lactate No interference for
dehydrogenase in serum or plasma. Bilirubin up to 20 mg/dL
- Based on SCE recommended method Turbid ity up to 600 mg/dL
- Linear up to 2400 U/L Note: Haemolysed sera should not be used since significant haemolysis may
Clinical Significance increase LDH concentration because of high levels of LDH in erythrocytes.
This enzyme is found in all organ cel ls, but especially plentiful in cardiac & skeletal Materials Provided
muscle, liver, kidney & RBC. LDH is found in the form of iso-enzymes based on LDH-P (S.L) Reagent R1& R2
their electrophoretic mobility with each iso-enzymes being primarily from different
organs. Materials required but not provided
l Pipettes& Tips
Elevated levels are found in myocard ial infarction, l iver d iseases, hemolytic
anaemias, pernicious anaemia, Leukemia & Pulmonary diseases. Elevations in acute l Test Tubes & racks
MI reaches a peak in 48-72 hrs. belonged elevations, (10-14 days) are useful in the l Timer
late diagnosis of the condition. l Incubator
Principle l Analyzer
Kinetic determination of lactate dehydrogenase according to the fol lowing
reaction.
Test Parameter
LDH Mode of Reaction Kinetic
Pyruvate + NADH + H+ > L-Lactate +NAD+ Slope of reaction Decreasing
Kit Components Wavelength 340 nm
0
Temperature 37 C
Reagent/ Product Code Description
Component 51407002 Factor 16030
Blank DI Water
LDH-P (S.L) R1 2 x 24 mL Tris buffer (pH 7.4) 80 mmol/L
Pyruvate 1.6 mmol/L Linearity 2400 U/L
Sodium chloride 200 mmol/L Delay 60 sec.
LDH-P (S.L) R2 2 x 6 mL NADH-240 mmol/L No of reading 3
Interval 60 sec
Risk & safety Sample volume 10 µL
Material Safety data sheets (MSDS) wil l be provided on request. Reagent volume 1000 µL
Reagent Preparation Cuvette 1 cm light path
Mix 4 volumes of Reagent 1 (R1) with 1 volume of Reagent 2 (R2)
0
The working reagent is stable for 21 days at 2-8 C. Application parameters for various instrument are available. Please contact
NOTE: Discard the working reagent if the blank absorbance is less than 1.0 at 340 nm. customer support department for specific information.

Reagent Storage and Stability Unit Conversion

The sealed reagents are stable up to the expiry date stated on the label, when
stored at 2- 8 oC and protected from light. Traditional Unit SI Unit Conversion from
Traditional to SI
Open Vial Stability
Once opened, the reagent is stable up to 4 weeks if contamination is avoided. U/L µKat/L x 0.017
On-board Cal ibration Stabil ity
On-board Calibration stability is 20 days Calibration
Agappe multi calibrator is recommended for calibration of this assay on fully auto
Reagent Deterioration analyzer.
Turbid ity or precipitation in any kit component ind icates deterioration and the
Use provided factor (16030) for estimation of LDH-P on semi auto analyzers
component must be discarded. Values outside the recommended acceptable range
for the Agappe Qualichek Norm & Path control may also be an indication of reagent Procedure notes
instability and associated results are invalid. Sample should be retested using a
fresh vial of reagent. Laboratory procedure for Semi Auto Analyzer
Precaution Working reagent 1000 µL
To avoid contamination, use clean laboratory wares. Use clean, dry disposable
Sample 10 µL
pipette tips for dispensing. Close reagent bottles immediately after use.
0
Mix and incubate at 37 C for 1 minute. Measure the change in absorbance
Avoid direct exposure of reagent to light. Do not blow into the reagent bottles.
per minute ( OD/min) during 3 minutes.
This reagent is only for IVD use and fol low the normal precautions required for
hand ling all laboratory reagents. Calculation
Waste Management LDH-P activity (U/L) = ( OD/min) x 16030
Reagents must be d isposed off in accordance with local regulations.
Quality Control
Sample It is recommended to use Agappe Qualicheck Norm & Path (51601001) to verify
Serum / plasma (free of haemolysis). the performance of the assay. Each laboratory has to establish its own internal
quality control scheme and procedure for corrective action, if control do not recover
within the acceptable range.

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AGAPPE DIAGNOSTICS SWITZERLAND GmbH

Knonauerstrasse 54 - 6330 Cham Switzerland
Tel. +41 41 780 60 10 Fax: +41 41 780 60 11
[email protected] | www.agappeswiss.com ISO 9001 : 2008
REV. NO.: ADS/IFU/LDH/LIQ/R00 EN ISO 13485: 2012
 LDH-P 2 x 30 mL
51407002

Reference Range
It is recommended that each laboratory establish its own reference values. Inter Run
The fol lowing values may be used as guide line. Control Level 1 Control Level 2
Serum /Plasma : 225-450 U/L n 20 20
Results obtained for patient samples are to be correlated with clinical findings of
patient for interpretation and diagnosis. Mean (U/L) 347.73 835.01

Performance SD 7.35 24.34

1. Linearity CV(%) 2.11 2.92
This reagent is linear up to 2400 U/L.
If the concentration is greater than linearity (2400 U/L) dilute the sample with
Accuracy ( U/L )
normal saline and repeat the assay. Multiply the result with dilution factor.
2. Comparison Control Expected Value Measured Value
A comparison study has been performed between Agappe reagent and another
Control Level 1 365 ± 90 380
international ly available reagent yielded a correlation coefficient of r 2= 0.988
and a regression equation of y = 0.9963 .
Control Level 2 855 ± 180 910
3. Precision
Qualichek Norm 335 ± 75 335.4
Intra Run
Qualichek Path 600 ± 75 621.8
Control Level 1 Control Level 2
Sensitivity
n 20 20
Lower detection Limit is 0.2 U/L.
Mean (U/L) 351.3 850.6
Bibliography
SD 9.7 17.2
1. Z.Klin. chem. Klin Biochem.8,658 (1970), 1, 1820(1972)
CV(%) 2.8 2.0
2. Wei Bhaar, D., et al.; Med.Welt 26,387 (1975)

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AGAPPE DIAGNOSTICS SWITZERLAND GmbH

Knonauerstrasse 54 - 6330 Cham Switzerland
Tel. +41 41 780 60 10 Fax: +41 41 780 60 11
[email protected] | www.agappeswiss.com ISO 9001 : 2008
REV. NO.: ADS/IFU/LDH/LIQ/R00 EN ISO 13485: 2012
 1 x 25 mL
LIPASE 51417001

Intended Use Waste Management

This reagent is intended for in vitro quantitative determination of lipase in human Reagents must be disposed off in accordance with local regulations.
serum or plasma.
Sample
- Methyl resorufin method
Serum / plasma (with Sodium Citrate, EDTA or Heparin).
- Linear up to 300 U/L
- Reagent is ready for use Interferences
No interference for
Clinical Significance
Bilirubin up to 20 mg/dL
Lipase is a pancreatic enzyme necessary for the absorption and digestion of
nutrients that catalyses the hydrolysis of glycerol esters of fatty acids. Haemoglobin up to 1000 mg/dL
Determination of lipase is used for diagnosis of diseases such as acute and chronic Materials Provided
pancreatitis and obstruction of the pancreatic duct. Clinical diagnosis should not
be made on a single test result; it should integrate clinical and other laboratory Lipase Reagent R1, R2 & Calibrator.
data. Materials required but not provided
Principle l Pipettes& Tips
In the presence of colipase and bile acids lipase splits the synthetic substrate (1,2- l Test Tubes & racks
O-Dilauryl-rac-glycero-3-glutaricacid (6-methyl-resorufin-ester) to glycerol and l Timer
methylresorufin-ester, which is spontaneously degraded to glutaric acid and l Incubator
methylresorufin. The rate of methylresorufin formation, measured photometrically l Analyzer
is proportional to the catalytic concentration of lipase present in the sample.
Kit Components Test Parameters
Mode of Reaction Kinetic Fixed Time
Reagent/ Component Product Description
Code: 51417001 Slope of reaction Increasing Increasing
Wavelength 580 nm 580 nm
Lipase (S.L) R1 2 x 10 mL Goods Buffer (pH 8.0) 40 mmol/L 0 0
Taurodeoxycholate 3.4 mmol/L Temperature 37 C 37 C
Deoxycholate 6.4 mmol/L Calibrator concentration As on the vial Label As on the vial Label
Calcium chloride 12 mmol/L Linearity 300 U/L 300 U/L
Colipase 1.7 mg/dL
Blank Reagent Reagent
Lipase (S.L) R2 1 x 5 mL Tartrate Buffer (pH 4.0) 1.5 mmol/L Delay time 120 sec. 120 sec
Taurodeoxycholate 3.4 mmol/L
Color substrate 0.13 mmol/L No of reading 2 -
Interval 60 sec 120 sec
Lipase Calibrator 1 x 2 mL Calibrator concentration is stated
on the vial label. Sample volume 20 µL 20 µL
Reagent volume 1250 µL (1000+250) 1250 µL (1000 + 250)
Risk & Safety Cuvette 1cm light path 1 cm light path
Material Safety data sheets (MSDS) wil l be provided on request.
Reagent Preparation Application parameters for various instrument are available. Please contact
customer support department for specific information.
Reagent 1 & 2 are ready to use.
Calibrator : Reconstitute with 2 mL of d istil led water. Dissolve the content of the Unit Conversion
vial by swirling gently to avoid the formation of foam.
Reconstituted calibrator is stable only for 7 days at 2-8 0C and 3 months at -20 0C. Traditional Unit SI Unit Conversion from
Traditional to SI
Reagent Storage and Stability
U/L µKat/L x 0.017
The sealed reagents are stable up to the expiry date stated on the label, when
stored at 2- 80 C and protected from light. Reconstituted calibrator is stable only
0 Calibration
for 7 days at 2-8 C or 3 months at -20 0 C.
Agappe Lipase calibrator is recommended for calibration of this assay.
Open Vial Stability
Once opened, the reagent is stable up to 4 weeks at 2 – 8 C if contamination is
0 Procedure notes
avoided. Laboratory Procedure for Semi Auto Analyzer
On-board Calibration Stabil ity Blank Calibrator Sample
On-board Calibration stability is 15 days
Reagent 1 1000 µL 1000 µL 1000 µL
Reagent Deterioration
Calibrator - 20 µL -
Turbidity or precipitation in any kit component ind icates deterioration and the
component must be d iscarded. Values outside the recommended acceptable range Sample - - 20 µL
for the Agappe Qualichek Norm & Path control may also be an indication of reagent
Dist. water 20 µL - -
instability and associated results are invalid. Sample should be retested using fresh
0
vial of reagent. Mix careful ly (do not vortex); incubate for 1-5 minutes at 37 C. Then add
Precaution Reagent 2 250 µL 250 µL 250 µL
To avoid contamination, use clean laboratory wares. Use clean, dry disposable o
Mix and incubate for 2 min at 37 C, read absorbance against reagent blank.
pipette tips for dispensing. Close reagent bottles immediately after use.
Measure the change in absorbance per minute ( OD/min) during 2 min.
Avoid direct exposure of reagent to light. Do not blow into the reagent bottles. or
This reagent is only for IVD use and fol low the normal precautions required for
Mix and read the optical density (T1) 120 seconds after the Reagent 2 addition.
hand ling all laboratory reagents.
Take second reading (T2) exactly after 120 seconds

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AGAPPE DIAGNOSTICS SWITZERLAND GmbH

Knonauerstrasse 54 - 6330 Cham Switzerland
Tel. +41 41 780 60 10 Fax: +41 41 780 60 11
[email protected] | www.agappeswiss.com ISO 9001 : 2008
REV. NO.: ADS/IFU/LIP/LIQ/R00 EN ISO 13485: 2012
 1 x 25 mL
LIPASE 51417001

Calculation 3. Precision
Lipase U/L =
( OD/min) Sample - ( OD/min) Blank Intra Run
> x Calibrator Concentration
( OD/min) cal ibrator - ( OD/min) Blank
Control Level 1 Control Level 2

or n 20 20
(T2-T1 ) of sample Mean (U/L) 30.2 55.4
> x Calibrator concentration SD 1.17 2.66
(T2-T1 ) of Calibrator CV(%) 3.88 4.79

Quality Control
Inter Run
It is recommended to use Agappe Qualicheck Norm & Path (51601001) to verify
the performance of the assay. Each laboratory has to establish its own internal Control Level 1 Control Level 2
quality control scheme and procedure for corrective action, if control do not recover
n 20 20
within the acceptable range.
Mean (U/L) 30.74 55.39
Reference Range
SD 1.35 2.32
It is recommended that each laboratory establish its own reference values.
CV(%) 4.38 4.19
The fol lowing values may be used as guide line.
Serum / Plasma : Up to 60 U/L
Results obtained for patient samples are to be correlated with clinical findings of Accuracy ( U/L )
patient for interpretation and diagnosis.
Control Expected Value Measured Value
Performance Control Level 1 43.2 ± 8.6 46.7
1. Linearity Control Level 2 71.8 ± 14.4 76.5
This reagent is linear up to 300 U/L. Qualichek Norm 48.8 ± 9.2 50.7
If the concentration is greater than linearity (300 U/L), dilute the sample with Qualichek Path 122 ± 20 122.1
normal saline and repeat the assay. Multiply the result with dilution factor.
4. Sensitivity
2. Comparison
Lower detection Limit is 3 U/L
A comparison study has been performed between Agappe Reagent and another
international ly available reagent yielded a correlation coefficient of r2= 0.9579 Bibliography
and a regression equation of y = 1.0035x. 1. Mc Neely , M. ; Lipase. Kaplan, A. et al.; Clin. Chem. The C.V.Mosby Co. St
Louis, Toronto. Princeton 1984, 1130-1135.
2. Burtis, A., et al. ; Tietz Textbook of Clinical chemistry, 3 rd ed AACC
3. Neumann, U., et al.; Methods of Enzymatic Analysis, Vol 4, 3 rd Ed.

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AGAPPE DIAGNOSTICS SWITZERLAND GmbH

Knonauerstrasse 54 - 6330 Cham Switzerland
Tel. +41 41 780 60 10 Fax: +41 41 780 60 11
[email protected] | www.agappeswiss.com ISO 9001 : 2008
REV. NO.: ADS/IFU/LIP/LIQ/R00 EN ISO 13485: 2012
 5 x 100 mL, 1 x 1000 mL
GLUCOSE 51406001, 51406002

Waste Management
Intended Use Reagents must be disposed off in accordance with local regulations
This reagent is intended for in vitro quantitative determination of Glucose in serum,
Sample
plasma & CSF.
Serum / plasma (free of hemolysis) / CSF
- GOD-PAP methodology
Interferences
- Linear upto 600 mg/dL
No interference for
Clinical Significance
Bilirubin up to 20 mg/dL
Glucose is a major carbohydrate present in the blood & serves as a primary source
Haemoglobin up to 1000 mg/dL
of energy. It is usual ly obtained from ingested starch & sugar. The glucose
concentration is normal ly maintained at a constant level. Excessive glucose is stored Materials Provided
as inactive glycogen mainly in the liver & little in the muscles.
Glucose reagent & Standard
Elevated blood glucose levels are found in diabetes mel litus, hyperthyroidism,
hyperadrenalism & certain liver diseases. Materials required but not provided
l Pipettes & Tips
Decreased levels are found in Insulinoma, hypothyroidism, hypopituitarism. l Test Tubes & racks
Principle l Timer
Enzymatic colorimetric determination of glucose accord ing to the fol lowing l Incubator
reaction. l Analyzer
Glucose Oxidase
Glucose+ O2 + H2O > Gluconic acid + H2 O2 Test Procedure
Peroxidase Semi Auto Analyser
2H 2O2 +phenol + 4-Aminoantipyrine > Quinonimine + 4H2 O
Mode of Reaction End Point
Kit Components
Slope of reaction Increasing
Reagent/ Product Code Description
Component 51406001 51406002 Wavelength 505 (490-550 nm)
0
Temperature 37 C
Glucose 5 x 100 mL 1 x 1000 mL Tris Buffer (pH 7.40) -
92 mmol/L Standard Concentration 100 mg/dL
Reagent R1
Phenol - 0.3 mmol/L Linearity 600 mg/dL
Glucose Oxidase - 15000 U/L
4- Aminophenazone - Incubation Time 10 Minutes
2.6 mmol/L
Blank Reagent
Glucose 1 x 4 mL 1 x 4 mL Glucose
Standard standard concentration Sample volume 10 µL
-100 mg/dL
Reagent volume 1000 µL

Risk & Safety Cuvette 1 cm light path

Material Safety data sheets (MSDS) wil l be provided on request
Application parameters for various instrument are available. Please contact
customer support department for specific information.
Reagent Preparation
Glucose Reagent & Standard are ready to use. Unit Conversion
Trad itional Unit SI Unit Conversion from Trad itional to SI
Reagent Storage and Stability
mg / dL mmol/L x 0.055
The sealed reagents are stable up to the expiry date stated on the label, when
o
stored at 2- 8 C and protected from light.
Calibration
Open Vial Stability Agappe multicalibrator is recommended for Calibration of this assay in ful ly
0 auto analyzers.
Once opened, the reagent is stable up to 4 weeks at 2-8 C,if contamination is
avoided. Provided standard is recommended for calibration of this assay on Semi auto
analyzer.
Onboard Calibration Stabil ity
Procedure notes
On-board Calibration stability is 20 days
Laboratory procedure for Semi Auto Analyzer
Reagent Deterioration
Turbid ity or precipitation in any kit component ind icates deterioration and the Blank Calibrator Sample/control
component must be discarded. Values outside the recommended acceptable range Glucose Reagent 1000 µL 1000 µL 1000 µL
for the Agappe Qualicheck Norm & Path control may also be an indication of
reagent instability and associated results are invalid. Sample should be retested Standard - 10 µL -
using a fresh vial of reagent.
Sample / control - - 10 µL
Precaution o
Mix & incubate for 10 minutes at 37 C . Read the absorbance of standard and
To avoid contamination, use clean laboratory wares use clean, drydisposable pipette sample against reagent blank.
tips for dispensing. Close reagent bottles immediately after use.
Avoid direct exposure of reagent to light. Do not blow into the reagent bottles. Calculation
Absorbance of sample
This reagent is only for IVD use and fol low the normal precautions required for Glucose Concentration (mg/dL) = > x standard conc.
Absorbance of standard
hand ling all laboratory reagents

SYMBOLSUSEDONTHELABELS

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AGAPPE DIAGNOSTICS SWITZERLAND GmbH

Knonauerstrasse 54 - 6330 Cham Switzerland
Tel. +41 41 780 60 10 Fax: +41 41 780 60 11
[email protected] | www.agappeswiss.com ISO 9001 : 2008
REV. NO.: ADS/IFU/GLU/LIQ/R00 EN ISO 13485: 2012
 5 x 100 mL, 1 x 1000 mL
GLUCOSE 51406001, 51406002

Quality Control
It is recommended to use Agappe Qualicheck Norm & Path (51601001) to verify Inter Run
the performance of the assay. Each laboratory has to establish its own internal
Control Level 1 Control Level 2
quality control scheme and procedure for corrective action, if control do not recover
within the acceptable range. n 20 20
Reference Range Mean (mg/dL) 87.20 269.43
It is recommended that each laboratory establish its own reference values.
SD 2.48 8.86
The fol lowing value may be used as guide line.
CV(%) 2.84 3.29
Serum / Plasma : 70-105 mg/dL
CSF : 50 -70 mg/dL
Results obtained for patient samples are to be correlated with clinical findings of Accuracy (mg/dL)
patient for interpretation and diagnosis.
Control Expected Value Measured Value
Performance
Control Level 1 90 ± 19.60 89.7
1. Linearity
This reagent is linear upto 600 mg/dL. Control Level 2 289 ± 48 294.8
If the concentration is greater than linearity (600 mg/dL)dilute the sample with Qualicheck Norm 95 ± 10.60 97.3
normal saline and repeat the assay. Multiply the result with dilution factor.
Qualicheck Path 259 ± 27 264.4
2. Comparison
A comparison study has been performed between Agappe reagent and another
international ly available reagent yielded a correlation coefficient of r2 = 0.9989
4. Sensitivity
and a regression equation of y = 1.0016x. Lower detection Limit is 1.0 mg/dL

3. Precision Bibliography
Intra Run 1. Trinder, P.; Ann Clin Biochem. 6,24 (1969)

Control Level 1 Control Level 2 2. Dingeon, B.; Ann.Bio.Clin 33,3 (1975)

3. Lott, J. ; Clin.Chem. 21, 1754 (1975)
n 20 20

Mean (mg/dL) 88.4 273.2

SD 2.56 8.77
CV(%) 2.89 3.21

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AGAPPE DIAGNOSTICS SWITZERLAND GmbH

Knonauerstrasse 54 - 6330 Cham Switzerland
Tel. +41 41 780 60 10 Fax: +41 41 780 60 11
[email protected] | www.agappeswiss.com ISO 9001 : 2008
REV. NO.: ADS/IFU/GLU/LIQ/R00 EN ISO 13485: 2012
 2 x 40 mL ,2 x 60 mL
HDL-CHOLESTEROL (D) WITH CALIBRATOR 51414003,52013001

Intended Use
This reagent is intended for in vitro quantitative determination of HDL Cholesterol
in serum or plasma. Reagent Deterioration
- Direct determination of HDL Cholesterol – Highly specific to HDL determination Turbidity or precipitation in any kit component ind icates deterioration and the
- Selective Inhibition Method component must be discarded. Values outside the recommended acceptable range
for the Agappe Qualicheck Norm & Path control may also be an indication of
- Linear up to 150 mg/dL reagent instability and associated results are invalid. Sample should be retested.
- Ready to use liquid stable reagents
Precaution
Clinical Significance To avoid contamination, use clean laboratory wares. Use clean, dry disposable
Blood total cholesterol levels have long been known to be related to coronary heart
pipette tips for d ispensing. Close reagent bottles immed iately after use.
disease (CHD). In recent years, in add ition to total cholesterol, high density
lipoprotein cholesterol (HDL-C) has become an important tool used to assess an Avoid direct exposure of reagent to light.
individual risk of developing CHD since a strong negative relationship between
HDL-C concentration and the incidence of CHD was reported. Do not blow into the reagent bottles.

Principle This reagent is only for IVD use and fol low the normal precaution required
forhand ling al l laboratory reagents
The reaction between cholesterol other than HDL and the enzyme for cholesterol
assay is suppressed by the electrostatic interaction between polyanions & cationic Waste Management
substances. Hydrogen peroxide is formed by the free cholesterol in HDL by
Reagents must be disposed off in accordance with local regulations
cholesterol oxidase. Oxidative condensation of EMSE and 4-AA is caused by
hydrogen peroxide in the presence of peroxidase, and the absorbance of the Sample
resulting red-purple Quinone is measured to obtain the cholesterol value in HDL
Fresh serum/Plasma (free of haemolysis)
Polyanions
Other lipoproteins than HDL > Suppress reaction with enzyme
Interferences
Cationic substances No interference for :
Bilirubin up to 40 mg/dL
Cholesterol esterase
HDL (cholesterol esters) + H2O > HDL (free cholesterol) + Ascorbic acid up to 50 mg/dL
Free fatty acids Haemoglobin up to 500 mg/dL
cholesterol oxidase Triglyceride up to 1000 mg/dL
HDL (free cholesterol) + O 2 + H + > Cholestenone + H2 O2 *(when triglyceride in a sample exceeds 1000 mg/dL, dilute the sample 1+9 with
saline, repeat the assay and multiply result by 10)
Peroxidase
2H 2O2 + 4-AA + EMSE + H3 + O > Violet quinone + 5 H 2O Materials Provided
Kit Components HDL- D Reagent R1, R2& Calibrator

Product Code
Materials required but not provided
Reagent/ Description
Component 51414003 52013001 l Pipettes & Tips
l Test Tubes & racks
HDL–C Direct R1 2 x 30 mL 2 x 45 mL N—ethyl-N-(3-methylphenyl)- l Timer
N’succinylethyenediame (EMSE) l Incubator
l Analyzer
HDL–C Direct R2 2 x 10 mL 2 x 30 mL Cholesterol Oxidase
4-Aminoantipyrin (4-AA)
Test Parameters
HDL–C Direct 1 x 2 mL 1 x 2 mL Calibrator Concentration as
Calibratior mentioned on the vial label Ful ly Auto Analyser Semi Auto Analyser
Mode of reaction End Point (Differential) End Point
Risk & Safety
Slope of Reaction Increasing Increasing
Material safety data sheets (MSDS) wil l be provided on request
Wavelength I 600 nm 578 nm ( 578 – 610)
Reagent Preparation Wavelength II 700 nm 630 nm ( 630 – 700)
o o
The Reagent1 & Reagent 2 are ready to use. Temperature 37 C 37 C

Calibrator: Reconstitute with 2 mL of distil led water. Let it stand for 30 minutes at Calibrator concentration As on the vial label As on the vial label x
room temperature. Dissolve the content of the vial by swirling gently to avoid the x dilution factor dilution factor
formation of foam. Linearity 150 mg/dL 150 mg/dL
Incubation time 5 + 5 min 5 + 5 min
Reagent Storage and Stability
Blank Reagent Reagent
The sealed reagents are stable up to the expiry date stated on the label, when
0
stored at 2 - 8 C, protected from light. Do not freeze. Sample Volume 3 µL 5 µL
Reagent 1 Volume 270 µL 450 µL
Stability: Reconstituted calibrator is stable only for 7 days at 2- 8 C. 0
Reagent 2 Volume 90 µL 150 µL
Open Vial Stability Cuvette 1 cm l ight path 1 cm light path
0
Once opened, the reagent is stable up to 4 weeks at 2- 8 C if contamination is
avoided. Application parameters for various instrument are available. Please contact
customer support department for specific information.
Onboard Calibration Stabil ity Unit Conversion
On board Calibration stability is 20 days.
Trad itional Unit SI Unit Conversion from Trad itional to SI
mg / dL mmol/L x 0.026

SYMBOLSUSEDONTHELABELS

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AGAPPE DIAGNOSTICS SWITZERLAND GmbH

Knonauerstrasse 54 - 6330 Cham Switzerland
Tel. +41 41 780 60 10 Fax: +41 41 780 60 11
[email protected] | www.agappeswiss.com ISO 9001 : 2008
REV. NO.: ADS/IFU/HDLC/LIQ/R00 EN ISO 13485: 2012
 2 x 40 mL ,2 x 60 mL
HDL-CHOLESTEROL (D) WITH CALIBRATOR
51414003,52013001

Calibration Performance
Agappe HDL Calibrator is recommended for calibration this assay.Reconstitute with 1. Linearity
2 mL of distil led water. Let it stand for 30 minutes at room temperature. Dissolve This reagent is linear up to 150 mg/dL
the content of the vial by swirl ing gently to avoid the formation of
0
foam.Reconstituted calibrator is stable only for 7 days at 2- 8 C. If the concentration is greater than linearity (150 mg/dL), dilute the sample with
normal saline and repeat the assay. Multiply the result with dilution factor
Procedure notes
2. Comparison
Laboratory Procedure for Ful ly Auto Analyzer
A comparison study has been performed between Agappe reagent and another
Blank Calibrator Sample/control international ly available reagent yielded a correlation coefficient of r2 = 0.9848
and a regression equation of y =0.9854x.
Reagent 270 µL 270 µL 270 µL
3. Precision
Calibrator - 3 µL -
Sample / control - - 3 µL Intra Run
0
Mix & incubate for 5 min at 37 C. Control Level 1 Control Level 2

Reagent 90 µL 90 µL 90 µL n 20 20
o
Mix and incubate for 5 min at 37 C and read absorbance of calibrator &sample Mean (mg/dL) 67.1 27.1
against reagent blank at 578 & 630 nm. SD 0.87 0.85
CV(%) 1.30 3.14
Calculation

HDL-C Concentration (mg/dL) = (OD2 – OD1) sample

x standard conc. Inter Run
>
(OD2 – OD1) Calibrator Control Level 1 Control Level 2

Laboratory Procedure for Semi Auto Analyzer n 20 20

Blank Calibrator Sample/control Mean (mg/dL) 66.48 27.16

Reagent 1 450 µL 450 µL 450 µL SD 1.21 0.55

Calibrator - 5 µL - CV(%) 1.82 2.04

Sample / control - - 5 µL
Mix & incubate for 5 min at 37 C.
0
Accuracy (mg/dL)
Reagent 150 µL 150 µL 150 µL Control Expected Value Measured Value

Mix and incubate for 5 min at 37 C and read absorbance of calibrator & sample
o Control Level 1 65 ± 9.8 69.7
against reagent blank at 578 & 630 nm.
Control Level 2 24 ± 6.6 26.6
Calculation Qualicheck Norm 30 ± 4.5 32
Qualicheck Path 85 ± 15.5 83.9
Absorbance of sample
HDL-C Concentration (mg/dL) = > x Calibrator Conc.
Absorbance of Calibrator 4. Sensitivity
Quality Control Lower detection Limit is 1 mg/dL
It is recommended to use Agappe Qualicheck Norm & Path (51601001) to verify
Bibliography
the performance of the assay. Each laboratory has to establish its own internal
quality control scheme and procedure for corrective action, if control do not recover 1. Wil liams, P., et al.; High density lipoprotein and coronary risk factor, Lancet.
within the acceptable range. 1:72 (1979)
2. Gordon,T., Castelli, W.P., Hjortland, M.C. et al. Am. J.Med. 62, 707-714 (1977)
Reference Range
It is recommended that each laboratory establish its own reference values.
The fol lowing value may be used as guide line.
Male : 35 - 80 mg/dL
Female : 42 - 88 mg/dL
Results obtained for patient sample are to be correlated with clinical findings of
patient for interpretation and diagnosis.

SYMBOLSUSEDONTHELABELS

IN VITRO DIAGNOSTIC USE SEE PACKAGE INSERT FOR PROCEDURE LOT NUMBER MANUFACTURER’S ADDRESS MANUFACTURING DATE EXPIRY DATE TEMPERATURE LIMIT

AGAPPE DIAGNOSTICS SWITZERLAND GmbH

Knonauerstrasse 54 - 6330 Cham Switzerland
Tel. +41 41 780 60 10 Fax: +41 41 780 60 11
[email protected] | www.agappeswiss.com ISO 9001 : 2008
REV. NO.: ADS/IFU/HDLC/LIQ/R00 EN ISO 13485: 2012
 LDL-CHOLESTEROL (D) WITH CALIBRATOR 2 x 40 mL ,2 x 60 mL
51415003,52014001

Intended Use Precaution

This reagent is intended for in vitro quantitative determination of LDL Cholesterol To avoid contamination, use clean laboratory wares. Use clean, dry disposable
in serum or plasma. pipette tips for dispensing. Close reagent bottles immediately after use.
- Direct determination of LDL Cholesterol Avoid direct exposure of reagent to light.
- Selective Solubilisation Method Do not blow into the reagent bottles.
- Linear up to 700 mg/dL This reagent is only for IVD use and fol low the normal precaution required for
- Ready to use liquid stable reagents hand ling all laboratory reagents

Cl inical Significance Waste Management

Blood total cholesterol levels have long been known to be related to coronary Reagents must be d isposed off in accordance with local regulations
heart d isease (CHD). In recent years, in addition to total cholesterol, low density
l ipoprotein cholesterol (LDL-C) has become an important tool used to assess
Sample
an ind ividual risk of developing CHD since a strong positive relationship Fresh serum /Plasma (free of haemolysis)
between LDL-C concentration and the incidence of CHD was reported. LDL
Cholesterol acts as a key factor in the pathogenesis of atherosclerosis and Interferences
coronary artery disease. No interference for :

Principle Bilirubin up to : 20 mg/dL

This assay method uses a surfactant for selectively solubilizing LDL alone in Ascorbic acid up to : 50 mg/dL
the cholesterol assay system that employs cholesterol esterase and cholesterol Haemoglobin up to : 500 mg/dL
oxidase. It passes the ester cholesterol and free cholesterol contained in the Triglyceride up to : 3000 mg/dL
LDL to the cholesterol reaction system to determine LDL cholesterol. The en-
zyme reactions to other, non-LDL l ipoproteins (HDL, VLDL, chilomicrons) are *(when triglyceride in a sample exceeds 1000 mg/dL, dilute the sample 1+9 with
inhibited by the syrfactant and by the sugar compounds. These l ipoproteins saline, repeat the assay and multiply result by 10)
are therefore not passed to the cholesterol reaction system and consequently
remain in the reaction l iquid as lipoproteins. Based on this principle it is thus Materials Provided
possible to d irectly determine LDL-cholesterol on its own. LDL Direct Reagent R1,R2 & Calibrator

Kit Components Materials required but not provided

l Pipettes & Tips
Reagent/ Product Code Description l Test Tubes & racks
Component
51415003 52014001 l Timer
l Incubator
LDL–C Direct R1 2 x 30 mL 2 x 45 mL HSDA - 1mmol/L
Good’s buffer pH 6.3 l Analyzer
Cholesterol esterase Test Parameters
LDL–C Direct R2 2 x 10 mL 2 x 30 mL Cholesterol oxidase Ful ly Auto Analyser Semi Auto Analyser
4-Aminoantipyrin
Good’s buffer pH 6.3 Mode of reaction End Point (Differential) End Point
Slope of Reaction Increasing Increasing
LDL–C Direct 1 x 2 mL 1 x 2 mL Calibrator Concentration as
Calibrator mentioned on the vial label Wavelength I 600 nm 578 nm ( 578 – 610)
Wavelength II 700 nm 630 nm ( 630 – 700)
Risk & safety Temperature
o
37 C
o
37 C
Material safety data sheets (MSDS) wil l be provided on request
Calibrator concentration As on the vial label As on the vial label
Reagent Preparation
Linearity 700 mg/dL 700 mg/dL
Reagent1 & Reagent 2 are ready to use.
Incubation time 5 +5 min 5 +5 min
Calibrator : Reconstitute with 2 mL of d istil led water. Let it stand for 2 hrs at
room temperature. Dissolve the content of the vial by swirling gently to avoid the Blank Reagent Reagent
formation of foam.
Sample Volume 3 µL 5 µL
Reagent Storage and Stabil ity
Reagent 1 Volume 270 µL 450 µL
The sealed reagents are stable up to the expiry date stated on the label, when
stored at 2 - 8 0C, protected from light. Do not freeze Reagent 2 Volume 90 µL 150 µL
Stabil ity : Reconstituted calibrator is stable only for 7 days at 2- 80 C. Cuvette 1 cm light path 1 cm light path
Open Vial Stability Application parameters for various instrument are available. Please contact
Once opened, the reagent is stable up to four weeks at 2- 80 C if contamination is customer support department for specific information.
avoided.
Unit Conversion
Onboard Cal ibration Stability
Trad itional Unit SI Unit Conversion from Trad itional to SI
Onboard Calibration stability is 20 days
mg/dL mmol/L x 0.026
Reagent Deterioration
Turbidity or precipitation on in any kit component indicates deterioration and
Calibration
the component must be discarded. Values outside the recommended acceptable Agappe LDL- C Calibrator is recommended for calibration of this assay.
range for the Agappe Qualicheck Norm & Path control may also be an ind ication
of reagent instabil ity and associated results are invalid. Sample should be retested Reconstitute with 2 mL of distil led water. Let it stand for 2 hrs at room temperature.
using fresh vial of reagent. Dissolve the content of the vial by swirling gently to avoid the formation of
foam.Reconstituted calibrator is stable only for 7 days at 2- 8 0C.

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AGAPPE DIAGNOSTICS SWITZERLAND GmbH

Knonauerstrasse 54 - 6330 Cham Switzerland
Tel. +41 41 780 60 10 Fax: +41 41 780 60 11
[email protected] | www.agappeswiss.com ISO 9001 : 2008
REV. NO.: ADS/IFU/LDLC/LIQ/R00 EN ISO 13485: 2012
 LDL-CHOLESTEROL (D) WITH CALIBRATOR 2 x 40 mL ,2 x 60 mL
51415003,52014001

Procedure Notes
Laboratory Procedure for Ful ly Auto Analyzer Performance
1. Linearity
Blank Calibrator Sample/control
This reagent is linear upto 700 mg/dL
Reagent 1 270 µL 270 µL 270 µL
If the concentration is greater than linearity (700 mg/dL), dilute the sample with
Calibrator - 3 µL - normal saline and repeat the assay. Multiply the result with dilution factor
Sample / control - 3 µL 2. Comparison
0
Mix & incubate for 5 min at 37 C. Measure the absorbance (OD1) at 600 nm/ A comparison study has been performed between Agappe Reagent and another
700 nm. international ly available reagent yielded a correlation coefficient of r2 =0.9922 and
a regression equation of y =0.9592x.
Reagent 2 90 µL 90 µL 90 µL
0
Mix and incubate for 5 min at 37 C.Measure the absorbance (OD2) at 600 nm/ 3. Precision
700 nm.
Intra Run
Calculation
Control Level 1 Control Level 2
(OD2-OD1) Sample n 20 20
LDL-C Concentration (mg/dL) = > x Calibrator Concentration
Mean (mg/dL) 108.7 50.5
(OD2-OD1) Calibrator
SD 2.11 1.19
Laboratory Procedure for Semi Auto Analyzer CV(%) 1.94 2.36

Blank Calibrator Sample/control

Inter Run
Reagent 1 450 µL 450 µL 450 µL
Control Level 1 Control Level 2
Calibrator - 5 µL -
n 20 20
Sample / control - - 5 µL
0
Mean (mg/dL) 109.66 51.08
Mix & incubate for 5 min at 37 C.
SD 4.07 2.00
Reagent 2 150 µL 150 µL 150 µL
0
CV(%) 3.71 3.92
Mix and incubate for 5 min at 37 C. Measure the absorbance of calibrator
&sample against reagent blank at 578 & 630 nm.
Accuracy (mg/dL)
Calculation
Control Expected Value Measured Value
Absorbance of sample Control Level 1 130 ± 26 131.4
LDL-C Concentration (mg/dL) = > x Cal ibrator Conc.
Absorbance of Calibrator Control Level 2 56 ± 12.2 55.1
Quality Control Qualicheck Norm 63 ± 9.0 62.8
It is recommended to use Agappe Qualicheck Norm & Path ( 51601001) to verify Qualicheck Path 115 ± 18.5 118.3
the performance of the assay. Each laboratory has to establish its own internal
quality control scheme and procedure for corrective action, if control do not recover
within the acceptable range. 4. Sensitivity
Reference Range Lower detection Limit is 1.0 mg/dL
It is recommended that each laboratory establish its own reference values. Bibliography
The fol lowing value may be used as guide line. 1. Crouse, J.R., et al.; Studies of Low Density Lipoprotein molecular weight in
Desirable < 130 mg/dL human being with coronary artery d isease. J.Lipid Res 26:5666 (1985)
Borderline High Risk for CHD 130-159 mg/dL
High Risk for CHD >160 mg/dL
Results obtained for patient samples are to be correlated with clinical findings of
the patient for interpretation and d iagnosis.

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AGAPPE DIAGNOSTICS SWITZERLAND GmbH

Knonauerstrasse 54 - 6330 Cham Switzerland
Tel. +41 41 780 60 10 Fax: +41 41 780 60 11
[email protected] | www.agappeswiss.com ISO 9001 : 2008
REV. NO.: ADS/IFU/LDLC/LIQ/R00 EN ISO 13485: 2012
 2 x 30 mL, 3 x 50 mL, 4 x 125 mL
SGOT 51408002, 51408003, 51408004

Intended Use Precaution

This reagent is intended for in vitro quantitative determination of SGOT in serum To avoid contamination, use clean laboratory wares. Use clean, dry d isposable
or plasma. pipette tips for dispensing. Close reagent bottles immed iately after use.
- IFCC recommended procedure
Avoid direct exposure of reagent to light. Do not blow into the reagent bottles.
- Linear up to 1000 U/L
This reagent is only for IVD use and fol low the normal precautions required
- Working reagent can be prepared as per requirements
forhandling all laboratory reagents.
Clinical Significance Waste Management
It is present in most of the tissues. Especial ly in cardiac muscle, liver cells, skeletal Reagents must be disposed off in accordance with local regulations.
muscle & kidneys. Injury to these tissues results in the release of the enzyme in
blood stream. Sample
Increased levels are found in myocardial infarction. The duration & extent of Serum /Plasma (free of haemolysis)
increase is related to the infract. GOT determination is of considerable value to
differentiate myocardial infarction from other cardiac disorders.
Interferences
No interference for :
Increased levels are also found in various types of liver disease, skeletal muscle
trauma & in renal d iseases. Bilirubin up to : 10 mg/dL
Ascorbic acid up to : 500 mg/dL
Decreased levels may be found in pregnancy, Beri-Beri & Diabetic ketoacidosis.
Haemoglobin up to : 1000 mg/dL
Principle
Materials provided
Kinetic determination of Aspartate Aminotrasferase (AST) based upon the
fol lowing reaction. SGOT Reagent R1, R2

AST Materials required but not provided

L- Asparate + alpha - ketoglutarate > Oxaloacetate + L-Glutamate. l Pipettes & Tips
MDH l Test Tubes & racks
Oxaloacetate + NADH + H+ > L- Malate + NAD + l Timer
l Incubator
AST: Aspartate aminotransferase.
l Analyzer
MDH : Malate dehydrogenase.
Test Parameters
Kit Components Normal procedure High Linearity procedure

Product Code Mode of Reaction Kinetic Kinetic

Reagent/ Description Slope of reaction Decreasing Decreasing
Component
51408002 51408003 51408004 Wavelength 340 nm 340 nm
0
Temperature 37 C 37 0C
SGOT (S.L) R1 2 x 24 mL 3 x 40 mL 4 x 100 m L Tris Buffer (pH 7.8)
88 mmol/L Factor 1745 1745
L-Aspartate260 mmol/L Linearity 350 U/L 1000 U/L
LDH > 1500 U/L Blank DI Water DI Water
MDH > 900 U/L
Delay 60 sec 60 sec
SGOT (S.L) R2 2 x 6 mL 3 x 10 mL 4 x 25 mL alpha –ketoglutarate No of reading 3 3
12 mmol/L Interval 60 sec 20 sec
NADH - 0.24 mmol/L Sample volume 100 µL 100 µL
Reagent volume 1000 µL 1000 µL
Risk & safety Cuvette 1 cm light path 1 cm light path
Material Safety data sheets (MSDS) wil l be provided on request Application parameters for various instrument are available. Please contact
customer support department for specific information.
Reagent Preparation
Mix 4 volume of Reagent 1 (R1) with 1 volume of Reagent 2 (R2). Unit Conversion
This Working reagent is stable for 30 days at 2-80C. Trad itional Unit SI Unit Conversion from Trad itional to SI

Note: Discard the working reagent, if the blank absorbance is less than 1.0 at 340 U/L µKat/L x 0.017
nm.
Calibration
Reagent Storage and Stabil ity Agappe multicalibrator is recommended for calibration of this assay on fully auto
The sealed reagents are stable up to the expiry date stated on the label, when analyzer.
stored at 2- 8oC and protected from light.
Use provided factor (1745) for estimation of this assay on semi auto analyzers
Open Vial Stability
o
Once opened, the reagent is stable up to 4 weeks at 2- 8 C if contamination is Procedure notes
avoided.
Laboratory procedure for Semi Auto Analyzer
Onboard Calibration Stabil ity Working reagent 1000 µL
Onboard Calibration stability is 20 days Sample 100 µL
0
Reagent Deterioration Mix and incubate at 37 C for 1 minute. Measure the change in absorbance per
Turbidity or precipitation in any kit component indicates deterioration and the minute ( OD/min) during 3 minutes.
component must be discarded. Values outside the recommended acceptable range High Linearity Procedure
for the Agappe Qualichek Norm & Path control may also be an indication of reagent 0
Mix and incubate at for 1 minutes 37 C. Read the change in absorbance per 20
instability and associated results are invalid. Sample should be retested using a sec, during 1 minute.
fresh vial of reagent.
Calculation
SGOT activity (U/L) = ( OD/min) x 1745

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AGAPPE DIAGNOSTICS SWITZERLAND GmbH

Knonauerstrasse 54 - 6330 Cham Switzerland
Tel. +41 41 780 60 10 Fax: +41 41 780 60 11
[email protected] | www.agappeswiss.com ISO 9001 : 2008
REV. NO.: ADS/IFU/SGOT/LIQ/R00 EN ISO 13485: 2012
 2 x 30 mL, 3 x 50 mL, 4 x 125 mL
SGOT 51408002, 51408003, 51408004

Quality Control
It is recommended to use Agappe Qualicheck Norm & Path ( 51601001) to verify
Inter Run
the performance of the assay. Each laboratory has to establish its own internal Control Level 1 Control Level 2
quality control scheme and procedure for corrective action, if control do not recover
within the acceptable range. n 20 20
Reference Range Mean (U/L) 39.05 209.34
It is recommended that each laboratory establish its own reference values. SD 1.25 3.44
The fol lowing value may be used as guide line.
CV(%) 3.19 1.64
Serum up to : 46 U/L
Results obtained for patient samples are to be correlated with clinical findings of
patient for interpretation and diagnosis.
Accuracy (U/L)
Performance
Control Expected Value Measured Value
1. Linearity
This reagent is linear up to 1000 U/L. Control Level 1 49 ± 8.2 46.3
If the concentration is greater than 350 U/L, fol low the high linearity procedure to Control Level 2 223 ± 26.0 219
get higher linearity of 1000 U/L.
If the concentration is greater than linearity, dilute the sample with normal saline Qualichek Norm 51 ± 13.80 53.2
and repeat the assay. Multiply the result with dilution factor.
Qualichek Path 163 ± 25 161.7
2. Comparison
4. Sensitivity
A comparison study has been performed between Agappe reagent and another
international ly available reagent yielded a correlation coefficient of r2= 0.9985 Lower detection Limit is 0.5 U/L
and a regression equation of y = 1.0071x.
Bibliography
3. Precision
1. Clin. Chem, Acta. 70, 19-42 (1976)
Intra Run 2. Thefeld, W., et al.; Dtsch. Med Wschr.99, 343 (1974)
Control Level 1 Control Level 2
n 20 20
Mean (U/L) 40 210
SD 1.46 4.16
CV(%) 3.65 1.98

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AGAPPE DIAGNOSTICS SWITZERLAND GmbH

Knonauerstrasse 54 - 6330 Cham Switzerland
Tel. +41 41 780 60 10 Fax: +41 41 780 60 11
[email protected] | www.agappeswiss.com ISO 9001 : 2008
REV. NO.: ADS/IFU/SGOT/LIQ/R00 EN ISO 13485: 2012
 SGPT 2 x 30 mL, 3 x 50 mL, 4 x 125 mL
51409002, 51409003, 51409004

Intended Use This reagent is only for IVD use and fol low the normal precautions required for
This reagent is intended for in vitro quantitative determination of SGPT in serum hand ling all laboratory reagents
or plasma. Waste Management
- IFCC recommended methodology Reagents must be d isposed off in accordance with local regulations
- Linear up to 1000 U/L
Sample
- Working reagent can be prepared as per requirements Serum /Plasma (free of haemolysis)
Cl inical Significance Interferences
It is present in most of the tissues, but mainly found in the liver. Increased levels No interference for
are found in hepatitis, cirrhosis, obstructive jaundice & other hepatic disease. SGPT
activity is markedly elevated even before clinical signs of jaundice become apparent Bilirubin up to : 10 mg/dL
in disease associated with hepatic necrosis. Slight elevations are also found in Ascorbic acid up to : 500 mg/dL
myocardial infarction. Haemoglobin up to : 1000 mg/dL
Principle Materials Provided
Kinetic determination of Alanine Aminotransferase (ALT) according to the SGPT Reagent R1& R2
fol lowing reaction.
Materials required but not provided
ALT
l Pipettes & Tips
L-Alanine + alpha-ketoglutarate >Pyruvate +L-Glutamate
l Test Tubes & racks
LDH l Timer
+
Pyruvate +NADH+ H > L-Lactate +NAD+ l Incubator
ALT – Alanine aminotransferase l Analyzer
LDH - Lactate dehydrogenase
Test Parameters
Kit Components
Normal procedure High Linearity procedure
Reagent/ Product Code Description Mode of Reaction Kinetic Kinetic
Component 51409003 51409004
51409002 Slope of reaction Decreasing Decreasing
Wavelength 340 nm 340 nm
SGPT (S.L) R1 2 x 24 mL 3 x 40 mL 4 x 100 mL Tris buffer (pH 7.5)
Temperature 37 0C 37 0C
110 mmol/L
L-Alanine 600 mmol/L Factor 1745 1745
LDH > 1500 U/L Linearity 350 U/L 1000 U/L
SGPT (S.L) R2 2 x 6 mL 3 x 10 mL 4 x 25 mL alpha –ketoglutarate Blank DI Water DI Water
16 mmol/L Delay 60 sec 60 sec
NADH 0.24 mmol/L
No of reading 3 3
Interval 60 sec 20 sec
Risk & Safety
Sample volume 100 µL 100 µL
Material Safety data sheets (MSDS) wil l be provided on request
Reagent volume 1000 µL 1000 µL
Reagent Preparation Cuvette 1 cm light path 1 cm light path
Mix 4 volume of Reagent 1 (R1) with 1 volume of Reagent 2 (R2)
This Working reagent is stable for 30 days at 2-80C. Application parameters for various instrument are available. Please contact
customer support department for specific information.
Note: Discard the working reagent, if the blank absorbance is less than 1.0 at 340
nm. Unit Conversion
Reagent Storage and Stabil ity Trad itional Unit SI Unit Conversion from Trad itional to SI
The sealed reagents are stable up to the expiry date stated on the label, when U/L µKat/L x 0.017
stored at 2- 8 oC and protected from light.
Open Vial Stability Calibration
o
Once opened, the reagent is stable up to 4 weeks at 2–8 C if contamination is Agappe multicalibrator is recommended for calibration of this assay on fully auto
avoided. analyzer.
Use provided factor (1745) for estimation of this assay on semi auto analyzer
Onboard Cal ibration Stability
On-board Calibration stability is 20 days
Procedure notes
Reagent Deterioration
Turbidity or precipitation in any kit component indicates deterioration and the Laboratory procedure for Semi Auto Analyzer
component must be discarded. Values outside the recommended acceptable range Working reagent 1000 µL
for the Agappe Qualicheck Norm & Path control may also be an indication of
reagent instabil ity and associated results are invalid. Sample should be retested Sample 100 µL
using a fresh vial of reagent. Mix and incubate at 370C for 1 minute. Measure the change in absorbance per
Precaution minute ( OD/min) during 3 minutes.
To avoid contamination, use clean laboratory wares. Use clean, dry d isposable High Linearity Procedure
pipette tips for d ispensing. Close reagent bottles immed iately after use. 0
Mix and incubate for 1 minute at 37 C. Read the change in absorbance per 20
Avoid d irect exposure of reagent to light.Do not blow into the reagent bottles. sec during 1 minutes.

Calculation
SGPT activity (U/L) = ( OD/min) x 1745

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AGAPPE DIAGNOSTICS SWITZERLAND GmbH

Knonauerstrasse 54 - 6330 Cham Switzerland
Tel. +41 41 780 60 10 Fax: +41 41 780 60 11
[email protected] | www.agappeswiss.com ISO 9001 : 2008
REV. NO.: ADS/IFU/SGPT/LIQ/R00 EN ISO 13485: 2012
 2 x 30 mL, 3 x 50 mL, 4 x 125 mL
SGPT 51409002, 51409003, 51409004

Quality Control
Inter Run
It is recommended to use Agappe Qualicheck Norm & Path ( 51601001) to verify
the performance of the assay. Each laboratory has to establish its own internal Control Level 1 Control Level 2
quality control scheme and procedure for corrective action, if control do not recover
within the acceptable range. n 20.00 20.00

Reference Range Mean (U/L) 38.7 115.1

It is recommended that each laboratory has to establish its own reference values.
SD 1.2 2.7
The fol lowing value may be used as guide line.
Serum up to : 49 U/L CV(%) 3.1 2.3
Results obtained for patient samples are to be correlated with clinical findings of
patient for interpretation and diagnosis. Accuracy (U/L)
Performance Control Expected Value Measured Value
1. Linearity
Control Level 1 28 ± 10.2 31.3
This reagent is l inear up to 1000 U/L.
If the concentration is greater than 350 U/L, fol low the high linearity procedure to Control Level 2 98.5 ± 25 106.1
get higher linearity of 1000 U/L.
Qualichek Norm 48 ± 9.8 52.4
If the concentration is greater than linearity dilute the sample with normal saline
and repeat the assay. Multiply the result with dilution factor. Qualichek Path 125 ± 30 130
2. Comparison 4. Sensitivity
A comparison study has been performed between Agappe reagent and another Lower detection Limit is 0.5 U/L
international ly available reagent yielded a correlation coefficient of r2 = 0.9997
and a regression equation of y = 0.9906x. Bibliography
3. Precision 1. Clin. Chem, Acta. 105, 147-172 (1780)

Intra Run 2. Thefeld, W., et al.; Dtsch. Med Wschr.99, 343 (1994)

Control Level 1 Control Level 2

n 20 20
Mean (U/L) 38.0 115.9
SD 1.08 3.29
CV(%) 2.86 2.84

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AGAPPE DIAGNOSTICS SWITZERLAND GmbH

Knonauerstrasse 54 - 6330 Cham Switzerland
Tel. +41 41 780 60 10 Fax: +41 41 780 60 11
[email protected] | www.agappeswiss.com ISO 9001 : 2008
REV. NO.: ADS/IFU/SGPT/LIQ/R00 EN ISO 13485: 2012
 5x25 mL, 4x50 mL, 5x100 mL
TRIGLYCERIDES 51410002, 51410005 , 51410004

Intended Use Precaution

This reagent is intended for in vitro quantitative determination of triglycerides in To avoid contamination, use clean laboratory wares. Use clean, dry d isposable
serum or plasma. pipette tips for dispensing. Close reagent bottles immed iately after use.
- GPO-TOPS methodology Avoid direct exposure of reagent to light. Do not blow into the reagent bottles.
- Linear up to 1000 mg/dL This reagent is only for IVD use and fol low the normal precautions required for
- Contains LCF (Lipaemic clearing factor) which minimizes rerun. hand ling all laboratory reagents.
Clinical Significance Waste Management
Triglycerides are simple lipids, formed in the liver by glycerol & fatty acids. They Reagents must be disposed off in accordance with local regulations.
are transported by VLDL, LDL & constitute about 95% of fat, stored as source of
energy in the tissue & plasma.
Sample
Serum / plasma (free of haemolysis).
Increased levels are found in hyperlipidemias, diabetes, nephrotic syndrome &
hypothyroid ism. Increased levels are risk factor for arteriosclerotic coronary Interferences
disease, peripheral vascular disease, acute pancreatitis & hyperlipoproteinaemia. No interference for
Decreased levels are found in malnutrition & hyperthyroidism. Bilirubin up to 20 mg/dL
Principle Haemoglobin up to 1000 mg/dL
Enzymatic determination of triglyceride is based on fol lowing reactions: Materials Provided
LPL Triglycerides Reagent & Standard.
TGL+H2 O > Glycerol + Fatty acid
Materials required but not provided
GK l Pipettes& Tips
Glycerol + ATP > Glycerol-3-phosphate + ADP l Test Tubes & racks
Mg++ l Timer
GPO l Incubator
l Analyzer
Glycerol-3-phospahte+O2 > Dihydroxyacetone phosphate +H 2O2
POD Test Parameters
2H 2O2+4-Aminoantipyrine+ TOPS > Violet coloured complex
Mode of Reaction End Point
GPO = Glycereol-3-phosphate Oxidase.
Slope of reaction Increasing
LPL = Lipoprotein Lipase
Wavelength I 546 nm (540-560 nm)
GK = Glycerol Kinase
Wavelength II 630 nm
Kit Components Temperature
0
37 C
Reagent/ Product Code Standard Concentration 200 mg/dL
Description
Component 51410002 51410005 51410004 Linearity 1000 mg/dL
Triglycerides 5x 25 mL 4 x 50 mL 5 x 100 mL Pipes–buffer (pH7.00)5 mmol/L Blank Reagent
TOPS 5.3 mmol/L Potassium Incubation time 5 min
ferrocynate 10 mmol/L
Magnesium Salt 17 mmol/L Sample volume 10 µL
4-Aminoantipyrine 0.9 mmol/L Reagent volume 1000 µL
ATP 3.15mmol/L Lipoprotein
Cuvette 1 cm light path
Lipase > 1800 U/L Glycerol
Kinase > 450 U/L Glycerol–3- Application parameters for various instrument are available. Please contact
phosphate oxidase > 3500 U/L customer support department for specific information.
Peroxidase > 450
Triglycerides 1 x 4 mL 1 x 4 mL 1 x 4 mL Triglycerides standard Unit Conversion
Standard concentration 200 mg/dL
Traditional Unit SI Unit Conversion from Traditional to SI
Risk & safety mg/dL mmol/L x 0.0114
Material Safety data sheets (MSDS) wil l be provided on request.
Calibration
Reagent Preparation
Agappe multicalibrator is recommended for Calibration of this assay on ful ly
Triglycerides Reagent & Standard are ready to use. auto analyzers.
Reagent Storage Use provided Triglycerides standard for calibration of this assay on Semi auto
analyzer.
The sealed reagents are stable up to the expiry date stated on the label, when
stored at 2- 8 oC and protected from light. Procedure notes
Open Vial Stability Laboratory procedure for Semi Auto Analyzer.
o
Once opened, the reagent is stable up to 4 weeks at 2- 8 C if contamination is
avoided. Blank Standard Sample
On-board Cal ibration Stabil ity Reagent 1000 µL 1000 µL 1000 µL
On-board Calibration stability is 20 days
Standard - 10 µL -
Reagent Deterioration
Sample - - 10 µL
Turbid ity or precipitation in any kit component ind icates deterioration and the
0
component must be discarded. Values outside the recommended acceptable range Mix and incubate for 5 minutes at 37 C. Measure the change in absorbance
for the Agappe Qualichek Norm & Path control may also be an indication of reagent of standard and sample against reagent blank.
instability and associated results are invalid. Sample should be retested using a
fresh vial of reagent.

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IN VITRO DIAGNOSTIC USE SEE PACKAGE INSERT FOR PROCEDURE LOT NUMBER MANUFACTURER’S ADDRESS MANUFACTURING DATE EXPIRY DATE TEMPERATURE LIMIT

AGAPPE DIAGNOSTICS SWITZERLAND GmbH

Knonauerstrasse 54 - 6330 Cham Switzerland
Tel. +41 41 780 60 10 Fax: +41 41 780 60 11
[email protected] | www.agappeswiss.com ISO 9001 : 2008
REV. NO.: ADS/IFU/TGL/LIQ/R00 EN ISO 13485: 2012
 5x25 mL, 4x50 mL, 5x100 mL
TRIGLYCERIDES 51410002, 51410005 , 51410004

Calculation 3. Precision
Absorbance of Sample Intra Run
Triglycerides Con. (mg/dL) = > x 200 Control Level 1 Control Level 2
Absorbance of Standard n 20 20
Quality Control Mean (mg/dL) 184.8 85.1
It is recommended to use Agappe Qualicheck Norm & Path ( 51601001) to verify SD 4.03 2.19
the performance of the assay. Each laboratory has to establish its own internal CV(%) 2.18 2.57
quality control scheme and procedure for corrective action, if control do not recover
within the acceptable range. Inter Run
Reference Range Control Level 1 Control Level 2
It is recommended that each laboratory establish its own reference values. n 20 20
The fol lowing value may be used as guide line. Mean (mg/dL) 184.65 84.56
SD 3.48 2.10
Male : 60 - 165 mg/dL
CV(%) 1.89 2.48
Female : 40 -140 mg/dL
Results obtained for patient samples are to be correlated with clinical findings of Accuracy (mg/dL)
patient for interpretation and diagnosis.
Control Expected Value Measured Value
Performance Control Level 1 185± 42 189.5
1. Linearity Control Level 2 75 ± 10 79.2
This reagent is linear up to 1000 mg/dL. Qualichek Norm 110 ± 12 109.6
If the concentration is greater than linearity (1000 mg/dL), dilute the sample Qualichek Path 210 ± 35 209.4
with normal saline and repeat the assay. Multiply the result with dilution factor.
4. Sensitivity
2. Comparison
Lower detection Limit is 2 mg/dL.
A comparison study has been performed between Agappe reagent and another
internationally available reagent yielded a correlation coefficient of r2 = 0.9932 Bibliography
and a regression equation of y = 0.965x.
1. Schettler, G., Nussel, E.; Arav. Med 10, 25 (1975)
2. Jacobs, N.J. , VanDemark, P.J.; Arch, Biochem, Biophy. 88, 250 – 255 (1960)

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AGAPPE DIAGNOSTICS SWITZERLAND GmbH

Knonauerstrasse 54 - 6330 Cham Switzerland
Tel. +41 41 780 60 10 Fax: +41 41 780 60 11
[email protected] | www.agappeswiss.com ISO 9001 : 2008
REV. NO.: ADS/IFU/TGL/LIQ/R00 EN ISO 13485: 2012
 2 x 50 mL, 2 x125 mL, 4 x 125 mL
UREA U.V 51412002 , 51412003 , 51412004

Intended Use
This reagent is intended for in vitro quantitative determination of urea in serum, Avoid direct exposure of reagent to light.Do not blow into the reagent bottles.
plasma & urine. This reagent is only for IVD use and fol low the normal precautions required for
- Urease / GLDH methodology hand ling all laboratory reagents.
- Linear up to 300 mg/dL Waste Management
- Working reagent can be prepared as per requirement Reagents must be disposed off in accordance with local regulations.
Clinical Significance Sample
Proteins cannot be stored in human body, so excess should be broken down. Amino Serum, Plasma (free of hemolyses). Do not use anticoagulants containing
acids which from the components of proteins, break down to give ammonia. This Fluoride or Ammonium Ions.
is toxic & so through a series of chemical reactions (urea cycle) non toxic urea is
produced & this is released into the blood which is filtered in the kidney & excreted Urine(1/100 diluted with distil led water (DI water). Multiply result with dilution
in the urine. factor.

Elevated levels are seen during increased protein breakdown, dehydration, Interferences
vomiting, d iarrhea. Also seen in any kind of renal disorder l ike Glomerular No interference for
nephritis, Chronic nephritis & Nephritic syndrome. Bilirubin up to 20 mg/dL

Decreased levels are found in liver failure & pregnancy. Ascorbic acid up to 50 mg/dL
Haemoglobin up to 1000 mg/dL
Principle
Enzymatic determination of Urea according to the fol lowing reaction. Materials Provided
Urea U.V reagent R1, R2 & Standard.
Urease
Urea + H2O > 2NH 3 + CO2 Materials required but not provided
GLDH l Pipettes& Tips
2 NH3 + 2- α− ketoglutarate + 2NADH > L-Glutamate +2NAD + + 2H 2O l Test Tubes & racks
l Timer
Kit Components
l Incubator
l Analyzer
Reagent/ Product Code Description
Component 51412002 51412003 51412004 Test Parameter
Urea U.V 2 x 40 mL 2 x 100 mL 4 x 100 mL Tris Buffer (pH 7.60) Mode of Reaction Fixed Time
(S.L) R1 100 mmol/L
ADP 0.7 mmol/L Slope of reaction Decreasing
a-ketoglutarate 9.0 mmol/L Wavelength 340
Urease > 6500 U/L 0
GLDH > 1100 U/ Temperature 37 C
Urea U.V 2 x 10 mL 2 x 25 mL 4 x 25 mL NADH 0.25 mmol/L Blank DI Water
(SL) R2 2-Oxoglutarate 5 mmol/L
Standard Concentration 50 mg/dL
Urea U.V 1 x 4 mL 1 x 4 mL 1 x 4 mL Standard concentration of Linearity 300 mg/dL
Standard Urea 50 mg/dL
Delay time 30 sec
Interval 60 sec
Risk & Safety
Sample volume 10 µL
Material Safety data sheets (MSDS) wil l be provided on request.
Reagent volume 1000 µL
Reagent Preparation
Cuvette 1 cm light path
Mix 4 volume of Reagent 1 (R1) with 1 volume of Reagent 2 (R2)
Working reagent is stable for 30 days at 2-8 C. 0
Application parameters for various instrument are available. Please contact
customer support department for specific information.
Discard the working reagent if the blank absorbance is less than 1.0 at 340 nm.
Unit Conversion
Reagent Storage
The sealed reagents are stable up to the expiry date stated on the label, when
o Traditional Unit SI Unit Conversion from Traditional to SI
stored at 2- 8 C and protected from light.
mg/dL mmol/L x 0.1665
Note:Discard the woring reagent if the blank absorbance is less than 1.0 at340nm.
Open Vial Stability Calibration
o
Once opened, the reagent is stable up to 4 weeks at 2- 8 C if contamination is Agappe multicalibrator is recommended for Calibration of this assay in ful ly
avoided. auto analyzers.
On-board Calibration Stability Use provided standard for calibration of this assay on Semi auto analyzer.
On-board Calibration stability is 20 days.
Procedure notes
Reagent Deterioration Laboratory procedure for Semi Auto Analyzer
Turbidity or precipitation in any kit component indicates deterioration and the
component must be discarded. Values outside the recommended acceptable range Standard Sample
for the Agappe Qualichek Norm & Path control may also be an indication of reagent Reagent 1000 µL 1000 µL
instability and associated results are invalid. Sample should be retested using fresh
Standard 10 µL -
vial of reagent.
Sample - 10 µL
Precaution
To avoid contamination, use clean laboratory wares. Use clean, dry d isposable Mix and read the optical density (T1) 30 seconds after the sample or standard
pipette tips for dispensing. Close reagent bottles immed iately after use. addition. Take second reading (T2) exactly 60 seconds after the first reading.

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AGAPPE DIAGNOSTICS SWITZERLAND GmbH

Knonauerstrasse 54 - 6330 Cham Switzerland
Tel. +41 41 780 60 10 Fax: +41 41 780 60 11
[email protected] | www.agappeswiss.com ISO 9001 : 2008
REV. NO.: ADS/IFU/UUV/LIQ/R00 EN ISO 13485: 2012
 2 x 50 mL, 2 x125 mL, 4 x 125 mL
UREA U.V 51412002 , 51412003 , 51412004

Calculation 3. Precision
( T1 –T2)of Sample Intra Run
Urea Conc. (mg/dL) = > x 50
(T1-T2) of standard Control Level 1 Control Level 2
(T1 –T2) of Sample n 20 20
Urea BUN Conc. (mg/dL) = > x 23.4 Mean (mg/dL) 35.8 95.5
(T1-T2) of standard SD 1.17 2.11
Quality Control CV(%) 3.28 2.21
It is recommended to use Agappe Qualicheck Norm & Path ( 51601001) to verify
the performance of the assay. Each laboratory has to establish its own internal Inter Run
quality control scheme and procedure for corrective action, if control do not Control Level 1 Control Level 2
recover within the acceptable range.
n 20 20
Reference Range Mean (mg/dL) 35.15 94.69
It is recommended that each laboratory establish its own reference values.
SD 0.92 2.31
The fol lowing value may be used as guide line.
CV(%) 2.63 2.44
Serum/ Plasma : 10-50 mg/dL
Urine : 20-35 gm/24 hr Accuracy (mg/dL)
Results obtained for patient samples are to be correlated with clinical findings
of patient for interpretation and diagnosis. Control Expected Value Measured Value
Control Level 1 32.6 ± 9.8 32.3
Performance
Control Level 2 102 ± 23 103
1. Linearity
This reagent is linear up to 300 mg/dL. Qualichek Norm 40 ± 8.42 41.6
If the concentration is greater than linearity (300 mg/dL), dilute the Qualichek Path 126 ± 18 127.3
sample with normal saline and repeat the assay. Multiply the result with 4. Sensitivity
dilution factor.
Lower detection Limit is 1 mg/dL.
2. Comparison
A comparison study has been performed between Agappe Reagent and Bibliography
another internationally available reagent yielded a correlation coefficient 1. Kassirer, J.P. New eng. J. Med.285, 385 (1971)
of r2 = 0.9963 and a regression equation of y = 0.9549x. 2. Tal ke, H., Schubert, G.E. ; Klin. Wochenschr, 43, 174(1965)

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AGAPPE DIAGNOSTICS SWITZERLAND GmbH

Knonauerstrasse 54 - 6330 Cham Switzerland
Tel. +41 41 780 60 10 Fax: +41 41 780 60 11
[email protected] | www.agappeswiss.com ISO 9001 : 2008
REV. NO.: ADS/IFU/UUV/LIQ/R00 EN ISO 13485: 2012
 2x30 mL, 2x50 mL, 2x100 mL, 5x100 mL
URIC ACID
51413001, 51413002, 51413003, 51413005

Intended Use Waste Management

This reagent is intended for in vitro quantitative determination of uric acid in Reagents must be disposed off in accordance with local regulations.
serum, plasma & urine.
Sample
- Uricase TOPS Method Serum / EDTA or Heparin plasma (free of haemolysis),Urine (1/10 diluted with
- Linear up to 25 mg/dL distil led water).
0
- Fast incubation, just 5 minutes at 37 C Interferences
Clinical Significance No interference for
Bilirubin up to 10 mg/dL
Uric acid is the end product of purine metabolism. Uric acid is excreted by the
kidneys. Increased levels are found in Gout, arthritis, impaired renal functions & Haemoglobin up to 1000 mg/dL
starvation. Decreased levels are found in yellow atrophy of the liver. Materials Provided
Principle Uric Acid reagent & Standard.
Uricase transforms uric acid into al lantoin, with formation of hydrogen peroxide. Materials required but not provided
In presence of peroxidase (POD) it reacts with ethyl-sulphopropyl toluidine (ESTP)
l Pipettes& Tips
and 4-aminophenazone, to produce a colored complex whose color intensity is
directly proportional to the uric acid concentration in the sample. l Test Tubes & racks
l Timer
Enzymatic determination of uric acid accord ing to the fol lowing reactions.
l Incubator
Uricase l Analyzer
Uric acid + 2H2 O+O2 > Al lantoin + CO2 + H2O2
Test Parameter
Peroxidase
2H 2O2 + 4 -Aminoantipyrine + TOPS > Violet coloured complex Mode of Reaction End point
TOPS: N-Ethyl-N(Sulphopropyl)-3-Methyl Aniline Slope of reaction Increasing
Kit Components Wavelength I 546 nm (540 - 560)
Reagent/ Product Code
Component Description Wavelength II 630 nm
51413001 51413002 51413003 51413005 0
Temperature 37 C
Uric Acid 2x30mL 2x50mL 2x100mL 5x100mL Phosphate Buffer (pH 7.0)
Reagent 180 mmol/L Standard Concentration 8 mg/dL
TOPS 1.10mmol/ L
Blank Reagent
Amino-4- antipyrine
0.25 mmol/L Incubation time 5 minutes
Uricase > 50 UL
Peroxidase > 100 U/L Linearity 25 mg/dL
Preservatives and
Sample volume 25 µL
Stabilizers
Reagent volume 1000 µL
Uric Acid 1 x 4 mL 1 x 4 mL 1 x 4 mL 1 x 4 mL Uric acid standard Cuvette 1 cm light path
Standard concentration 8 mg/dL
Risk & safety
Application parameters for various instrument are available. Please contact
Material Safety data sheets (MSDS) wil l be provided on request. customer support department for specific information.
Reagent Preparation Unit Conversion
Uric Acid Reagent & Standard are ready to use.
Traditional Unit SI Unit Conversion from Traditional to SI
Reagent Storage
The sealed reagents are stable up to the expiry date stated on the label, when mg/dL mmol/L x 0.059
stored at 2- 8 oC and protected from light. Calibration
Open Vial Stabil ity Agappe multicalibrator is recommended for calibration of this assay on ful ly auto
Once opened, the reagent is stable up to 4 weeksat 2 – 8oC if contamination is analyzer.
avoided.
Provided standard can beused for estimation of this assay on semi auto analyzer.
On-board Calibration Stabil ity
On-board Calibration stability is 20 days.
Procedure notes
Reagent Deterioration
Laboratory procedure for Semi Auto Analyzer.
Turbid ity or precipitation in any kit component ind icates deterioration and the
Blank Standard Sample
component must be discarded. Values outside the recommended acceptable range
for the Agappe Qualicheck Norm & Path control may also be an indication of Reagent 1000 µL 1000 µL 1000 µL
reagent instability and associated results are invalid. Sample should be retested Standard - 25 µL -
using fresh vial of reagent.
Sample - - 25 µL
Precaution 0
To avoid contamination, use clean laboratory wares. Use clean, dry disposable Mix and incubate 5 min. at 37 C. Measure absorbance of sample and standard
pipette tips for dispensing. Close reagent bottles immediately after use. against the reagent blank.
Avoid direct exposure of reagent to light.Do not blow into the reagent bottles.
Calculation
This reagent is only for IVD use and fol low the normal precautions required for
hand ling al l laboratory reagents. Absorbance of Sample
Uric Acid Con. (mg/dL) = > x8
Absorbance of Standard

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AGAPPE DIAGNOSTICS SWITZERLAND GmbH

Knonauerstrasse 54 - 6330 Cham Switzerland
Tel. +41 41 780 60 10 Fax: +41 41 780 60 11
[email protected] | www.agappeswiss.com ISO 9001 : 2008
REV. NO.: ADS/IFU/UAC/LIQ/R00 EN ISO 13485: 2012
 2x30 mL, 2x50 mL, 2x100 mL, 5x100 mL
URIC ACID
51413001, 51413002, 51413003, 51413005

Quality Control 3.Precision

It is recommended to use Agappe Qualicheck Norm & Path (51601001) to verify Intra Run
the performance of the assay. Each laboratory has to establish its own internal Control Level 1 Control Level 2
quality control scheme and procedure for corrective action, if control do not recover n 20 20
within the acceptable range. Mean (mg/dL) 4.7 9.7
SD 0.10 0.25
Reference Range CV(%) 2.25 2.57
It is recommended that each laboratory establish its own reference values.
The fol lowing value may be used as guide line. Inter Run
Serum / Plasma Control Level 1 Control Level 2
Men : 3.6 - 7.7 mg/dL n 20 20
Mean (mg/dL) 4.6 9.5
Women : 2.5 - 6.8 mg/dL SD 0.1 0.2
Urine : 250 - 750 mg/24 hr urine CV(%) 2.5 2.4

Results obtained for patient samples are to be correlated with clinical findings of
patient for interpretation and diagnosis. Accuracy (mg/dL)
Control Expected Value Measured Value
Performance Control Level -1 4.53 ± 0.96 4.8
Control Level -2 8.68 ± 1.9 8.2
1. Linearity Qualichek Norm 4.15 ± 0.71 4.0
This reagent is linear up to 25 mg/dL. Qualichek Path 10.0 ± 1.3 9.9
If the concentration is greater than linearity (25 mg/dL), dilute the sample
4. Sensitivity
with normal saline and repeat the assay. Multiply the result with dilution factor.
Lower detection Limit is 0.2 mg/dL.
2. Comparison
A comparison study has been performed between Agappe reagent and another Bibliography
internationally available reagent yielded a correlation coefficient of r2= 0.973 1. Barham, D., Trinder; Analyst 97, 142(1972)
and a regression equation of y = 1.0987x . 2. Fossati P., Prencipe L., Berti G., Clin. Chem. , 26, 227 (1980)
3. Kaplan LA, Pesce AJ., Clinical Chemistry, Mosby Ed. 1989.

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AGAPPE DIAGNOSTICS SWITZERLAND GmbH

Knonauerstrasse 54 - 6330 Cham Switzerland
Tel. +41 41 780 60 10 Fax: +41 41 780 60 11
[email protected] | www.agappeswiss.com ISO 9001 : 2008
REV. NO.: ADS/IFU/UAC/LIQ/R00 EN ISO 13485: 2012
 2 x 20 mL
Combi HDL/LDL 51418001

Part:1 - HDL Direct

Intended Use Precaution

This reagent is intended for in vitro quantitative determination of HDL Cholesterol To avoid contamination, use clean laboratory wares. Use clean, dry disposable
in serum or plasma.
pipette tips for d ispensing. Close reagent bottles immed iately after use.
- Direct determination of HDL Cholesterol – Highly specific to HDL determination
Avoid direct exposure of reagent to light.
- Selective Inhibition Method
- Linear up to 150 mg/dL Do not blow into the reagent bottles.
- Ready to use liquid stable reagents This reagent is only for IVD use and fol low the normal precaution required
forhandling al l laboratory reagents
Clinical Significance
Blood total cholesterol levels have long been known to be related to coronary heart Waste Management
disease (CHD). In recent years, in add ition to total cholesterol, high density Reagents must be disposed off in accordance with local regulations
lipoprotein cholesterol (HDL-C) has become an important tool used to assess an
individual risk of developing CHD since a strong negative relationship between Sample
HDL-C concentration and the incidence of CHD was reported. Fresh serum/Plasma (free of haemolysis)
Principle Interferences
The reaction between cholesterol other than HDL and the enzyme for cholesterol No interference for :
assay is suppressed by the electrostatic interaction between polyanions & cationic Bilirubin up to 40 mg/dL
substances. Hydrogen peroxide is formed by the free cholesterol in HDL by
cholesterol oxidase. Oxidative condensation of EMSE and 4-AA is caused by Ascorbic acid up to 50 mg/dL
hydrogen peroxide in the presence of peroxidase, and the absorbance of the Haemoglobin up to 500 mg/dL
resulting red-purple Quinone is measured to obtain the cholesterol value in HDL
Triglyceride up to 1000 mg/dL
Polyanions *(when triglyceride in a sample exceeds 1000 mg/dL, dilute the sample 1+9 with
Other lipoproteins than HDL > Suppress reaction with enzyme saline, repeat the assay and multiply result by 10)
Cationic substances
Materials Provided
Cholesterol esterase
HDL- D Reagent R1, R2& Calibrator
HDL (cholesterol esters) + H2O > HDL (free cholesterol) +
Free fatty acids Materials required but not provided
cholesterol oxidase l Pipettes & Tips
HDL (free cholesterol) + O 2 + H + > Cholestenone + H2 O2 l Test Tubes & racks
l Timer
Peroxidase
2H 2O2 + 4-AA + EMSE + H3 + O > Violet quinone + 5 H 2O l Incubator
l Analyzer
Risk & Safety
Test Parameters
Material safety data sheets (MSDS) wil l be provided on request
Ful ly Auto Analyser Semi Auto Analyser
Reagent Preparation Mode of reaction End Point (Differential) End Point
The Reagent1 & Reagent 2 are ready to use. Slope of Reaction Increasing Increasing
Calibrator: Reconstitute with 2 mL of distil led water. Let it stand for 30 minutes at Wavelength I 600 nm 578 nm ( 578 – 610)
room temperature. Dissolve the content of the vial by swirling gently to avoid the Wavelength II 700 nm 630 nm ( 630 – 700)
formation of foam. o o
Temperature 37 C 37 C
Reagent Storage and Stability Calibrator concentration As on the vial label As on the vial label x
The sealed reagents are stable up to the expiry date stated on the label, when x dilution factor dilution factor
0
stored at 2 - 8 C, protected from light. Do not freeze. Linearity 150 mg/dL 150 mg/dL
Stability: Reconstituted calibrator is stable only for 7 days at 2- 8 0C. Incubation time 5 + 5 min 5 + 5 min
Blank Reagent Reagent
Open Vial Stability Sample Volume 3 µL 5 µL
0
Once opened, the reagent is stable up to 4 weeks at 2- 8 C if contamination is Reagent 1 Volume 270 µL 450 µL
avoided.
Reagent 2 Volume 90 µL 150 µL
Onboard Calibration Stability Cuvette 1 cm light path 1 cm light path
On board Calibration stability is 20 days. Application parameters for various instrument are available. Please contact
customer support department for specific information.
Unit Conversion
Reagent Deterioration
Turbid ity or precipitation in any kit component indicates deterioration and the Trad itional Unit SI Unit Conversion from Trad itional to SI
component must be discarded. Values outside the recommended acceptable range
for the Agappe Qualicheck Norm & Path control may also be an indication of mg / dL mmol/L x 0.026
reagent instability and associated results are invalid. Sample should be retested.

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AGAPPE DIAGNOSTICS SWITZERLAND GmbH

Knonauerstrasse 54 - 6330 Cham Switzerland
Tel. +41 41 780 60 10 Fax: +41 41 780 60 11
[email protected] | www.agappeswiss.com ISO 9001 : 2008
REV. NO.: ADS/IFU/HDLDL/LIQ/R00 EN ISO 13485: 2012
 2 x 20 mL
Combi HDL/LDL
51418001
Part:1 - HDL Direct

Calibration Performance
Reconstitute with 2 mL of distil led water. Let it stand for 30 minutes at room 1. Linearity
temperature. Dissolve the content of the vial by swirling gently to avoid the This reagent is linear up to 150 mg/dL
0
formation of foam.Reconstituted calibrator is stable only for 7 days at 2- 8 C.
If the concentration is greater than linearity (150 mg/dL), dilute the sample with
normal saline and repeat the assay. Multiply the result with dilution factor
Procedure notes
2. Comparison
Laboratory Procedure for Ful ly Auto Analyzer
A comparison study has been performed between Agappe reagent and another
Blank Calibrator Sample/control international ly available reagent yielded a correlation coefficient of r2 = 0.9848
and a regression equation of y =0.9854x.
Reagent 270 µL 270 µL 270 µL
3. Precision
Calibrator - 3 µL -
Sample / control - - 3 µL Intra Run
0
Mix & incubate for 5 min at 37 C. Control Level 1 Control Level 2

Reagent 90 µL 90 µL 90 µL n 20 20
o
Mix and incubate for 5 min at 37 C and read absorbance of calibrator &sample Mean (mg/dL) 67.1 27.1
against reagent blank at 578 & 630 nm. SD 0.87 0.85
CV(%) 1.30 3.14
Calculation

HDL-C Concentration (mg/dL) = (OD2 – OD1) sample

x standard conc. Inter Run
>
(OD2 – OD1) Calibrator Control Level 1 Control Level 2

Laboratory Procedure for Semi Auto Analyzer n 20 20

Blank Calibrator Sample/control Mean (mg/dL) 66.48 27.16

Reagent 1 450 µL 450 µL 450 µL SD 1.21 0.55

Calibrator - 5 µL - CV(%) 1.82 2.04

Sample / control - - 5 µL
Mix & incubate for 5 min at 37 C.
0
Accuracy (mg/dL)
Reagent 150 µL 150 µL 150 µL Control Expected Value Measured Value

Mix and incubate for 5 min at 37oC and read absorbance of calibrator & sample Control Level 1 65 ± 9.8 69.7
against reagent blank at 578 & 630 nm.
Control Level 2 24 ± 6.6 26.6
Calculation Qualicheck Norm 30 ± 4.5 32
Qualicheck Path 85 ± 15.5 83.9
Absorbance of sample
HDL-C Concentration (mg/dL) = > x Calibrator Conc.
Absorbance of Calibrator 4. Sensitivity
Quality Control Lower detection Limit is 1 mg/dL
It is recommended to use Agappe Qualicheck Norm & Path (51601001) to verify
Bibliography
the performance of the assay. Each laboratory has to establish its own internal
quality control scheme and procedure for corrective action, if control do not recover 1. Wil liams, P., et al.; High density lipoprotein and coronary risk factor, Lancet.
within the acceptable range. 1:72 (1979)
2. Gordon,T., Castelli, W.P., Hjortland, M.C. et al. Am. J.Med. 62, 707-714 (1977)
Reference Range
It is recommended that each laboratory establish its own reference values.
The following value may be used as guide line. Combi HDL/LDL Kit Components
Male : 35 - 80 mg/dL
Female : 42 - 88 mg/dL Reagent/ Product Code Description
Component 51418001
Results obtained for patient sample are to be correlated with clinical findings of
HDL–C Direct R1 1 x 15 mL N—ethyl-N-(3-methylphenyl)-
patient for interpretation and diagnosis.
N’succinylethyened iame (EMSE)
HDL–C Direct R2 1 x 5 mL Cholesterol Oxidase
4-Aminoantipyrin (4-AA)
LDL–C Direct R1 1 x 15 mL HSDA - 1mmol/L
Good’s buffer pH 6.3
LDL–C Direct R2 1 x 5 mL Cholesterol esterase
Cholesterol oxidase
4-Aminoantipyrin
Good’s buffer pH 6.3
HDL / LDL Calibrator 1 x 2 mL Calibrator Concentration is
mentioned on the vial label

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AGAPPE DIAGNOSTICS SWITZERLAND GmbH

Knonauerstrasse 54 - 6330 Cham Switzerland
Tel. +41 41 780 60 10 Fax: +41 41 780 60 11
[email protected] | www.agappeswiss.com ISO 9001 : 2008
REV. NO.: ADS/IFU/HDLDL/LIQ/R00 EN ISO 13485: 2012
 Combi HDL/LDL 2 x 20 mL
51418001

Part:2 - LDL Direct

Intended Use Waste Management

This reagent is intended for in vitro quantitative determination of LDL Cholesterol Reagents must be d isposed off in accordance with local regulations
in serum or plasma. Sample
- Direct determination of LDL Cholesterol Fresh serum /Plasma (free of haemolysis)
- Selective Solubilisation Method Interferences
- Linear up to 700 mg/dL No interference for :
- Ready to use liquid stable reagents Bilirubin up to : 20 mg/dL
Cl inical Significance Ascorbic acid up to : 50 mg/dL
Blood total cholesterol levels have long been known to be related to coronary Haemoglobin up to : 500 mg/dL
heart d isease (CHD). In recent years, in addition to total cholesterol, low density Triglyceride up to : 3000 mg/dL
l ipoprotein cholesterol (LDL-C) has become an important tool used to assess
an ind ividual risk of developing CHD since a strong positive relationship *(when triglyceride in a sample exceeds 1000 mg/dL, dilute the sample 1+9 with
between LDL-C concentration and the incidence of CHD was reported. LDL saline, repeat the assay and multiply result by 10)
Cholesterol acts as a key factor in the pathogenesis of atherosclerosis and
coronary artery disease. Materials Provided
LDL Direct Reagent R1,R2 & Calibrator
Principle
This assay method uses a surfactant for selectively solubilizing LDL alone in Materials required but not provided
the cholesterol assay system that employs cholesterol esterase and cholesterol l Pipettes & Tips
oxidase. It passes the ester cholesterol and free cholesterol contained in the l Test Tubes & racks
LDL to the cholesterol reaction system to determine LDL cholesterol. The en-
l Timer
zyme reactions to other, non-LDL l ipoproteins (HDL, VLDL, chilomicrons) are
inhibited by the syrfactant and by the sugar compounds. These l ipoproteins l Incubator
are therefore not passed to the cholesterol reaction system and consequently l Analyzer
remain in the reaction l iquid as lipoproteins. Based on this principle it is thus
possible to d irectly determine LDL-cholesterol on its own. Test Parameters
Ful ly Auto Analyser Semi Auto Analyser
Kit Components
Mode of reaction End Point (Differential) End Point
Risk & safety
Slope of Reaction Increasing Increasing
Material safety data sheets (MSDS) wil l be provided on request
Wavelength I 600 nm 578 nm ( 578 – 610)
Reagent Preparation
Reagent1 & Reagent 2 are ready to use. Wavelength II 700 nm 630 nm ( 630 – 700)
o o
Calibrator : Reconstitute with 2 mL of d istil led water. Let it stand for 2 hrs at Temperature 37 C 37 C
room temperature. Dissolve the content of the vial by swirling gently to avoid the
Calibrator concentration As on the vial label As on the vial label
formation of foam.
Linearity 700 mg/dL 700 mg/dL
Reagent Storage and Stabil ity
The sealed reagents are stable up to the expiry date stated on the label, when Incubation time 5 +5 min 5 +5 min
stored at 2 - 8 0C, protected from light. Do not freeze
Blank Reagent Reagent
Stabil ity : Reconstituted calibrator is stable only for 7 days at 2- 80 C.
Sample Volume 3 µL 5 µL
Open Vial Stability
Reagent 1 Volume 270 µL 450 µL
Once opened, the reagent is stable up to four weeks at 2- 80 C if contamination is
avoided. Reagent 2 Volume 90 µL 150 µL

Onboard Cal ibration Stability Cuvette 1 cm light path 1 cm light path

Onboard Calibration stability is 20 days Application parameters for various instrument are available. Please contact
Reagent Deterioration customer support department for specific information.
Turbidity or precipitation on in any kit component indicates deterioration and Unit Conversion
the component must be discarded. Values outside the recommended acceptable
range for the Agappe Qualicheck Norm & Path control may also be an ind ication Trad itional Unit SI Unit Conversion from Trad itional to SI
of reagent instabil ity and associated results are invalid. Sample should be retested mg/dL mmol/L x 0.026
using fresh vial of reagent.
Precaution Calibration
To avoid contamination, use clean laboratory wares. Use clean, dry disposable
Reconstitute with 2 mL of distil led water. Let it stand for 2 hrs at room temperature.
pipette tips for d ispensing. Close reagent bottles immed iately after use. Dissolve the content of the vial by swirling gently to avoid the formation of
Avoid direct exposure of reagent to light. foam.Reconstituted calibrator is stable only for 7 days at 2- 8 0C.
Do not blow into the reagent bottles.
This reagent is only for IVD use and fol low the normal precaution required for
hand ling al l laboratory reagents

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AGAPPE DIAGNOSTICS SWITZERLAND GmbH

Knonauerstrasse 54 - 6330 Cham Switzerland
Tel. +41 41 780 60 10 Fax: +41 41 780 60 11
[email protected] | www.agappeswiss.com ISO 9001 : 2008
REV. NO.: ADS/IFU/HDLDL/LIQ/R00 EN ISO 13485: 2012
 Combi HDL/LDL 2 x 20 mL
51418001

Part:2 - LDL Direct

Procedure Notes
Laboratory Procedure for Ful ly Auto Analyzer Performance
1. Linearity
Blank Calibrator Sample/control
This reagent is linear upto 700 mg/dL
Reagent 1 270 µL 270 µL 270 µL
If the concentration is greater than linearity (700 mg/dL), dilute the sample with
Calibrator - 3 µL - normal saline and repeat the assay. Multiply the result with dilution factor
Sample / control - 3 µL 2. Comparison
0
Mix & incubate for 5 min at 37 C. Measure the absorbance (OD1) at 600 nm/ A comparison study has been performed between Agappe Reagent and another
700 nm. international ly available reagent yielded a correlation coefficient of r2 =0.9922 and
a regression equation of y =0.9592x.
Reagent 2 90 µL 90 µL 90 µL
0
Mix and incubate for 5 min at 37 C.Measure the absorbance (OD2) at 600 nm/ 3. Precision
700 nm.
Intra Run
Calculation
Control Level 1 Control Level 2
(OD2-OD1) Sample n 20 20
LDL-C Concentration (mg/dL) = > x Calibrator Concentration
Mean (mg/dL) 108.7 50.5
(OD2-OD1) Calibrator
SD 2.11 1.19
Laboratory Procedure for Semi Auto Analyzer CV(%) 1.94 2.36

Blank Calibrator Sample/control

Inter Run
Reagent 1 450 µL 450 µL 450 µL
Control Level 1 Control Level 2
Calibrator - 5 µL -
n 20 20
Sample / control - - 5 µL
0
Mean (mg/dL) 109.66 51.08
Mix & incubate for 5 min at 37 C.
SD 4.07 2.00
Reagent 2 150 µL 150 µL 150 µL
0
CV(%) 3.71 3.92
Mix and incubate for 5 min at 37 C. Measure the absorbance of calibrator
&sample against reagent blank at 578 & 630 nm.
Accuracy (mg/dL)
Calculation
Control Expected Value Measured Value
Absorbance of sample Control Level 1 130 ± 26 131.4
LDL-C Concentration (mg/dL) = > x Calibrator Conc.
Absorbance of Calibrator Control Level 2 56 ± 12.2 55.1
Quality Control Qualicheck Norm 63 ± 9.0 62.8
It is recommended to use Agappe Qualicheck Norm & Path ( 51601001) to verify Qualicheck Path 115 ± 18.5 118.3
the performance of the assay. Each laboratory has to establish its own internal
quality control scheme and procedure for corrective action, if control do not recover
within the acceptable range. 4. Sensitivity
Reference Range Lower detection Limit is 1.0 mg/dL
It is recommended that each laboratory establish its own reference values.
The fol lowing value may be used as guide line. Bibliography
Desirable < 130 mg/dL 1. Crouse, J.R., et al.; Studies of Low Density Lipoprotein molecular weight in
Borderline High Risk for CHD 130-159 mg/dL human being with coronary artery disease. J.Lipid Res 26:5666 (1985)
High Risk for CHD >160 mg/dL
Results obtained for patient samples are to be correlated with clinical findings of
the patient for interpretation and d iagnosis.

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