^ANDOX C€

SAFETY PRECAUTIONS AND WARNINGS

INTENDED USE Reagent Rla contains Sodium Azide. Avoid ingestion or contact
For the quantitative in vitro determination of Triglycerides in serum with skin or mucous membranes. In case of skin contact, flush
and plasma. This product is suitable for manual use and on the Rx affected area with copious amounts of water.
Monza analysen. In case of contact with eyes or if ingested, seek immediate
medical attention.
Cat. No.
TR 210 RI a. Buffer 1 x 100 ml
6 x 15 ml R1 b. Enzyme Reagent 6 x 15 ml Sodium Azide reacts with lead and copper plumbing, to form
CAL. Standard 1 x 5.5 ml potentially explosive azides. When disposing of such reagents
GTIN: 05055273206593 flush with large volumes of water to prevent azide build up.
Exposed metal surfaces should be cleaned with 10% sodium
TR 213 Rla. Buffer 10 x 50 ml
hydroxide.
10 x 50 ml R1 b. Enzyme Reagent 10 x 50 ml
CAL. Standard 1 x 5.5 ml
GTIN: 0505S2732066I6 Health and Safety Data Sheets are available on request.

TR 212 R1 a. Buffer 5 x 100 ml Please dispose of all Biological and Chemical materials according
5 x 100 ml R1 b. Enzyme Reagent 5 x 100 ml to local guidelines.
CAL. Standard 1 x 5.5 ml
GTIN: 05055273206609
The reagents must be used only for the purpose
CLINICAL SIGNIFICANCE intended by suitably qualified laboratory personnel,
Triglyceride measurements are used in the diagnosis and treatment under appropriate laboratory conditions.
of diseases involving lipid metabolism and various endorcrine
disorders e.g. diabetes mellitus, nephrosis and liver obstruction.
STABILITY AND PREPARATION OF REAGENTS
COLORIMETRIC METHOD O Rla. Buffer
The triglycerides are determined after enzymatic Contents ready for use. Stable up to the expiry date
hydrolysis with lipases. The indicator is a quinoneimine formed from when stoned at +2 to +8°C.
hydrogen-peroxide. 4-aminophenazone and 4-chlorophenol under
the catalytic influence of peroxidase.
Rib. Enzyme Reagent
PRINCIPLEI2-3’4) Cat. No. TR 210
lipases Reconstitute one vial of Enzyme reagent Rib with IS ml
Triglycerides + H2O -------*• glycerol + fatty acids of Buffer Rla. Stable for 21 days at +2 to +8°C or 3 days
GK at +15 to +25°C stoned protected from light.
Glycerol + ATP -------► glycerol-3-phosphate + ADR
GPO
Glycerol-3-phosphate + O2 —► dihydroxyacetone- Cat. Nos. TR 213 and TR 212
phosphate + H2O2 Reconstitute one vial of Enzyme Reagent RI b with a
POD portion of Buffer RI a and then transfer entire contents to
2H2O2 + 4-aminophenazone + 4 chlorophenol —► bottle RI a, rinsing vial RI b several times. Stable for 21
quinoneimine + HCI + 4H2O
days at +2 to +8°C or 3 days at +15 to +25°C stored
SAMPLE PREPARATIONC) protected from light.
Serum, free of haemolysis.
RI = Enzyme Reagent
Triglycerides are stable in serum for 7 days at +2 to +8°C.(6) R2 = None

REAGENT COMPOSITION
MATERIALS PROVIDED
Contents Concentrations Buffer
in the Test Enzyme Reagent
Standard
Rla. Buffer
Pipes Buffer 40 mmol/l. pH 7.6 MATERIALS REQUIRED BUT NOT PROVIDED
4-chloro-phenol 5.5 mmol/l
Randox Assayed Multi-sera Level 2 (Cat. No. HN 1530) and
Magnesium-ions 17.5 mmol/l
Rib. Enzyme Reagent Level 3 (Cat. No. HE 1532)
4-aminophenazone 0.5 mmol/l Randox Calibration Serum Level 3 (Cat. No. CAL 2351).
ATP 1.0 mmol/l
Lipases >150 U/ml
Glycerol-kinase > 0.4 U/ml
Glycerol-3-phosphate oxidase > 1.5 U/ml
Peroxidase > 0.5 U/ml
CAL. Standard See lot specific insert

Randox Laboratories Ltd, 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom
T +44 (0) 28 9442 2413 F +44 (0) 28 9445 2912 E [email protected] I www.randox.com PAGE I OF 4
RAND®X MANUAL TR2I0 C€
PROCEDURE QUALITY CONTROL
Using fresh ddHaO perform a new Gain Calibration in cuvette Randox Assayed Multi-sera, Level 2 and Level 3 are recommended
mode. Select TRI in the Run Test screen and carry out a water for daily quality control. Two levels of Controls should be assayed
blank as instructed. at least once a day. Values obtained should fall within a specified
range. If these values feil outside the range and repetition excludes
Pipette into a cuvette: error, the following steps should be taken:
1. Check instrument settings and light source.
Reagent Blank S0 Standard SI Sample 2. Check cleanliness of all equipment in use.
3. Check water, Contaminants, i.e. bacterial growth, may
ddHzO _ _ _
contribute to inaccurate results.
Standard - 5 PI -
4. Check reaction temperature.
Sample - - 5 Pl 5. Check expiry date of kit and contents.
Reagent R1 500 PI 500 pl 0.50 ml
6. Contact Randox Laboratories Technical
Services, Northern Ireland +44 (0) 28 9445 1070.
Mix, incubate for 10 min at 20-25°C or 5 min at 37°C.
Insert into the RX Monza flowcell holden and press Read within
Quality control requirements should be determined in
60 mins.
conformance with government regulations or accreditation
CALIBRATION FOR RX MONZA requirements.
Recommended with change of reagent lot or as inidicated by
quality control procedures, using CAL Standard provided in kit LIMITATIONS
or Randox Calibration Serum Level 3. This method does not correct for free glycerol and therefore
high levels of free glycerol if present in a sample will elevate test
results. To correct for free glycerol, subtract 10 mg/dl (0.1 I
FOR MANUAL USE
mol/l) from the triglyceride value obtained. (6>
A list of interfering substances and conditions known to affect
Wavelength: 500 nm: Hg 546 nm
triglyceride levels in vivo, is given by both Young
Cuvette; I cm
et al(s> and Friedman et a/.(9) No representation is made by
Temperature: 20-25°C or 37°C
Randox Laboratories Ltd regarding the completeness of these
Measurement: against reagent blank
lists or the accuracy of the information contained therein.
only one reagent blank per
series is required
EXPECTED VALUES (7>
The NCEP (American National Cholesterol Education Program)
Pipette into test tubes:
has established the following classification for triglyceride levels
according to the risk of developing coronary heart diseases:
Reagent Blank Standard Sample
Pl Pl PI
Normal < 150 mg/dl
Borderline-high 150 — 199 mg/dl
Sample - - 10
High 200 - 499 mg/dl
Standard (CAL) - 10 -
Very High > 500 mg/dl
Reagent(Rl) 1000 1000 1000
SPECIFIC PERFORMANCE CHARACTERISTICS
Mix, incubate for 10 minutes at 20-25°C or 5 minutes at 37°C. The following performance data were obtained using an Rx
Measure the absorbance of the sample (Asampie) and Standard Monza analysen running at a temperature of 25°C.
(Astandard) against the reganet blank within 60 minutes.
INTERFERENCE
MANUAL CALCULATION The method is not influenced by haemoglobin concentrations up
I. When using a Standard to 6 g/l (600 mg/dl) or by bilirubin concentrations up to 500
Asampie Standard Pmol/I (29 mg/dl).
Triglyceride concentration - x conc =mmol/l
Astandard (mmol/l)

Asample
Standard
X conc. - mg/ai
Astandard (mg/dl)

2. When using a factor;

Triglyceride Concentration
Wavelength mmol/l mg/dl

Hg 546 nm 1 1.95 1048

Randox Laboratories Ltd, 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom
T +44 (0) 28 9442 2413 F +44 (0) 28 9445 2912 E [email protected] I www.randox.com PAGE 2 OF 4
RAm&K MANUAL TR2I0 C€
LINEARSTY
The test is linear up to a triglyceride concentration of I 172
mg/dl. If the sample concentration exceeds this value, dilute the
sample I +4 with 0.9% NaCI solution and reassay. Multiply the
result by 5.

SENSITIVITY
The minimum detectable concentration of Triglycerides with an
acceptable level of precision was determined as 22.9 mg/dl.

PRECISION

Intra Assay
Level 2 Level
Mean (mg/dl) 110 259
SD 3.19 6.42
CV (%) 2.90 2.48
n 20 20

Inter Assay
Level 2 Level
Mean (mg/dl) 1 10 259
SD 5.85 9.89
CV (%) 5.32 3.82
n 20 20

CORRELATION
This method (Y) was compared with another commercially
available method (X) and the following linear regression equation
obtained:

Y = 0.902 X + 16.1
and a correlation coëfficiënt of r = 0.9965

42 patiënt samples were analyzed spanning the range 45 to 417

REFERENCES
1. Jacobs NJ, Van Denmark, P.J., Arch Biochem. Biophys. 1960;
88 250-255.
2. Koditscheck L K, Umbreit, W.W., J Bacteriol 1969; 98:
1063-1068.
3. Bucola G. David H: Clin. chem 1973: 19:476
4. Wahlefeld A: Methods of enzymatic analysis, 2nd English
edition. Hill. Bergmayer, ed. New York, Academie Press Ine,
I974 p I83I.
5. Trinder P, Ann. Clin Biochem 1969: 6; 24-27.
6. Tietz NW; Clinical Guide to Laboratory tests Philaelphia, W
B Saunders Co, 1963, pg 484.
7. ATP III Guidelines At-A-Glance Quick Desk Reference,
National Cholesterol Education Program, National Institute
of Health Publication No. 01-3305, May 2001
8. Young D.S et al Clin Chem. 1975 21 :No 5: I D-432D
9. Friedman E.B et al: Clin Chem 1980 : 26 No 4: ID-476D

Revised 07 Jun 16 ml
Rev. 003

Randox Laboratories Ltd, 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom
T +44 (0) 28 9442 2413 F +44 (0) 28 9445 2912 E [email protected] I www.randox.com PAGE 3 OF 4
RAND®X

THIS PAGE IS INTENTIONALLY BLANK

Randox Laboratories Ltd, SS Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom
PAGE 4 OF 4
T +44 (0) 28 9442 2413 F +44 (0) 28 9445 2912 E [email protected] I www,randox.com