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LacticAcid ARC CHEM

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0% found this document useful (0 votes)
59 views8 pages

LacticAcid ARC CHEM

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QC Lab
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
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LACTIC ACID

9D89-20
30-4266/R6

LACTIC ACID
This package insert contains information to run the Lactic Acid assay on the ARCHITECT c Systems and the
AEROSET System.

NOTE: Changes Highlighted

NOTE: This package insert must be read carefully prior to product use. Package insert instructions must be
followed accordingly. Reliability of assay results cannot be guaranteed if there are any deviations from the
instructions in this package insert.

Customer Support
United States: 1-877-4ABBOTT
Canada: 1-800-387-8378 (English speaking customers)
1-800-465-2675 (French speaking customers)
International: Call your local Abbott representative

Symbols in Product Labeling

Concentration Catalog number/List number


Authorized Representative in the
Serial number
European Community
Ingredients Consult instructions for use

In vitro diagnostic medical device Manufacturer

Batch code/Lot number Temperature limitation

Reagent 1 Use by/Expiration date

ABBOTT LABORATORIES ABBOTT


Abbott Park, IL 60064, USA Max-Planck-Ring 2
65205 Wiesbaden
Germany
+49-6122-580
March 2009
©2002, 2009 Abbott Laboratories

1
NAME REAGENT HANDLING AND STORAGE (Continued)
LACTIC ACID Instructions for Use
1. Remove the reagent caps from two bottles of .
INTENDED USE
2. Prepare the Working Reagent by adding 10 mL of sterile water to
The Lactic Acid assay is used for the quantitation of lactic acid in each of the two bottles.
human plasma.

SUMMARY AND EXPLANATION OF TEST


10 mL
Lactic acid, an intermediary in carbohydrate metabolism, is derived
H2 O
+ R1
=
predominantly from skeletal muscle, brain, and erythrocytes. The blood
lactate concentration is dependent on the rate of production and the
rate of metabolism in the liver and kidneys. Approximately 30% of total
lactate production is used by the liver. Moderate increase in lactate
production results in increased hepatic lactate clearance, but uptake 10 mL
by the liver is saturable when concentrations exceed 2 mmol/L. For H2 O
+ R1
= Working
example, during strenuous exercise, lactate concentrations may increase
significantly, from an average concentration of about 0.9 mmol/L to more Reagent 1
than 20 mmol/L within 10 seconds.1
3. Replace the reagent caps and mix each bottle by gentle
The review by Stacpoole2 describes the biochemistry and pathobiology inversion until completely dissolved. Do Not Shake.
of lactate metabolism. A pivotal characteristic of this metabolism is
that lactate can only arise from reduction of pyruvate. Elevated lactate 4. Pour contents of both bottles into one of the empty bar code
associated with reduced arterial pH is called lactic acidosis. Tissue labeled cartridges provided with the reagent kit. Remove air bubbles,
hypoxia is the most common cause of lactic acidosis and is classified if present in the cartridge, with a new applicator stick.
as Type A, while lactic acidosis that is nonhypoxic is classified as 5. Place the cartridge in Reagent Supply Center 1.
Type B. Under normal conditions, the concentration of lactate is about
10-fold higher than that of pyruvate. WARNINGS AND PRECAUTIONS
Shock is perhaps the most widely recognized cause of lactic acidosis; Precautions for Users
however, in some cases, excess lactate production may precede 1. For in vitro diagnostic use.
shock. Such conditions as myocardial infarction, severe congestive 2. Do not use components beyond the expiration date.
heart failure, pulmonary edema, and blood loss are common causes
of shock associated with lactic acidosis. Other causes of lactic 3. Do not mix materials from different kit lot numbers.
acidosis include intravenous infusion of substances such as fructose, 4. CAUTION: This product requires the handling of human specimens.
sorbitol, or epinephrine, and large doses of drugs such as ethanol or It is recommended that all human sourced materials be considered
acetaminophen. Hepatic necrosis, neoplasms, lymphomas, and various potentially infectious and be handled in accordance with the OSHA
forms of leukemia have been reported to cause lactic acidosis. In Standard on Bloodborne Pathogens.4 Biosafey Level 25 or other
diabetic coma, lactic acidosis is common.3 appropriate biosafety practices6,7 should be used for materials that
contain or are suspected of containing infectious agents.
PRINCIPLES OF PROCEDURE 5. is classified per applicable European Community (EC) Directives
Lactic acid is converted to pyruvate and hydrogen peroxide (H2O2) as: Irritant (Xi). The following are the appropriate Risk (R) and Safety
by lactate oxidase. Peroxidase catalyzes the oxidation of chromogen (S) phrases:
precursor by H2O2 to produce a colored dye. The increase in R36/37/38 Irritating to eyes, respiratory system and skin.
absorbance at 548 nm is directly proportional to the lactic acid S26 In case of contact with eyes, rinse
concentration in the sample. immediately with plenty of water and seek
Methodology: Lactic Acid to Pyruvate medical advice.
S35 This material and its container must be
REAGENTS disposed of in a safe way.
Reagent Kit S46 If swallowed, seek medical advice
immediately and show this container or label.
9D89 Lactic Acid is supplied as a lyophilized, single reagent kit
which contains:
SPECIMEN COLLECTION AND HANDLING
10 x 10 mL
Funnels (5) Suitable Specimens
Bar code labeled cartridges (5) Plasma is the acceptable specimen.
Estimated tests per kit: 393 Plasma: Use plasma collected by standard venipuncture techniques
Calculation is based on the minimum reagent fill volume per kit. into glass or plastic tubes without gel barriers. The acceptable
anticoagulant is sodium fluoride/potassium oxalate. Venous specimens
Reactive Ingredients Concentration should be obtained without the use of a tourniquet or immediately
after the tourniquet has been applied. If there is any delay in obtaining
Lactate Oxidase 400 U/L the specimen, the tourniquet should be removed after the puncture
Peroxidase (Horseradish) 2,400 U/L has been performed, and the blood should be allowed to circulate
for at least two minutes before sample is withdrawn. Patients should
Chromogen precursors As required avoid exercise of the hand or arm immediately before and during the
Inactive Ingredients: Contains buffer, fillers, and stabilizers. procedure. Centrifuge the specimen as soon after collection as possible
and immediately remove the plasma from the red blood cells.1 Ensure
REAGENT HANDLING AND STORAGE centrifugation is adequate to remove platelets.
For total sample volume requirements, refer to the instrument-specific
Reagent Handling ASSAY PARAMETERS section of this package insert and Section 5 of
Remove air bubbles, if present in the reagent cartridge, with a new the instrument-specific operations manual.
applicator stick. Alternatively, allow the reagent to sit at the appropriate
storage temperature to allow the bubbles to dissipate. To minimize Specimen Storage
volume depletion, do not use a transfer pipette to remove the bubbles. Plasma: Separated plasma may be analyzed immediately, stored at
CAUTION: Reagent bubbles may interfere with proper detection of 2 to 8°C, or frozen. Samples are stable for 14 days at 2 to 8°C or up to
reagent level in the cartridge, causing insufficient reagent aspiration 4 weeks at -20°C.
which could impact results. Specimen stability was verified in an in-house study of 20 sodium
fluoride/potassium oxalate plasma samples.
Reagent Storage
NOTE: Stored specimens must be inspected for particulates. If present,
Unopened reagents are stable until the expiration date when stored mix and centrifuge the specimen to remove particulates prior to testing.
at 2 to 8°C. Do not pool reagents.
Reagent stability is 7 days if the reagent is uncapped and onboard.

2
PROCEDURE RESULTS
Materials Provided Refer to the instrument-specific operations manual for information on
results calculations.
9D89 Lactic Acid Reagent Kit
• ARCHITECT System Operations Manual—Appendix C
Materials Required but not Provided • AEROSET System Operations Manual—Appendix A
• 1E75 Lactic Acid Calibrator 1 x 10 mL Representative performance data are given in the EXPECTED VALUES
• Control Material and SPECIFIC PERFORMANCE CHARACTERISTICS sections of this
• Saline (0.85% to 0.90% NaCl) for specimens that require dilution package insert. Results obtained in individual laboratories may vary.
Assay Procedure LIMITATIONS OF THE PROCEDURE
For a detailed description of how to run an assay, refer to Section 5 of
Refer to the SPECIMEN COLLECTION AND HANDLING and SPECIFIC
the instrument-specific operations manual.
PERFORMANCE CHARACTERISTICS sections of this package insert.
Specimen Dilution Procedures The performance characteristics of Lactic Acid on an analyzer other
The ARCHITECT c Systems and the AEROSET System have automatic than an ARCHITECT c Systems or the AEROSET System must be
dilution features; refer to Section 2 of the instrument-specific operations validated and verified.
manual for additional information.
Plasma: Specimens with lactic acid values exceeding 120.0 mg/dL EXPECTED VALUES
(13.32 mmol/L) are flagged and may be diluted using the Automated Reference Range
Dilution Protocol or the Manual Dilution Procedure.
Plasma8
Automated Dilution Protocol
If using the Automated Dilution Protocol, the system performs a dilution Range (mg/dL) Range (mmol/L)
of the specimen and automatically corrects the concentration by Venous 4.5 to 19.8 0.5 to 2.2
multiplying the result by the appropriate dilution factor. To set up the
automatic dilution feature, refer to Section 2 of the instrument-specific To convert results from mg/dL to mmol/L, multiply mg/dL by 0.111.
operations manual for additional information. A study was conducted using 204 plasma samples from 99 female and
105 male volunteers. Data were analyzed as described by Solberg9
Manual Dilution Procedure
and Clinical and Laboratory Standards Institute (CLSI) protocol NCCLS
Manual dilutions should be performed as follows: C28-A.10 From this study, 95% of male specimens fell within 5.0 to
• Use saline (0.85% to 0.90% NaCl) to dilute the sample. 19.4 mg/dL, with male samples ranging from 3.9 to 20.6 mg/dL. For
• The operator must enter the dilution factor in the patient or control female specimens, 95% fell within 4.7 to 16.8 mg/dL, with female
order screen. The system uses this dilution factor to automatically samples ranging from 4.5 to 18.6 mg/dL.
correct the concentration by multiplying the result by the entered It is recommended that each laboratory determine its own reference
factor. range based upon its particular locale and population characteristics.
• If the operator does not enter the dilution factor, the result must
be multiplied by the appropriate dilution factor before reporting the SPECIFIC PERFORMANCE CHARACTERISTICS
result. Linearity
NOTE: If a diluted sample result is flagged indicating it is less than the Lactic Acid is linear up to 120.0 mg/dL (13.32 mmol/L). Linearity was
linear low limit, do not report the result. Rerun using an appropriate verified using CLSI protocol NCCLS EP6-A.11
dilution.
For detailed information on ordering dilutions, refer to Section 5 of the Limit of Detection (LOD)
instrument-specific operations manual. The LOD for Lactic Acid is 0.05 mg/dL (0.006 mmol/L). The LOD is the
mean concentration of an analyte-free sample + 2 SD, where SD = the
CALIBRATION pooled, within-run standard deviation of the analyte-free sample.
Calibration is stable for approximately 7 days (168 hours). Limit of Quantitation (LOQ)
Calibration is required whenever a new reagent is reconstituted. The LOQ for Lactic Acid is 0.18 mg/dL (0.020 mmol/L). The LOQ is the
Verify calibration curve with at least two levels of controls according analyte concentration at which the CV = 20%.
to the established quality control requirements for your laboratory. If
control results fall outside acceptable ranges, recalibration may be
Interfering Substances
necessary. Interference studies were conducted on the AEROSET System using
CLSI protocol NCCLS EP7-P.12 Interference effects were assessed by
For a detailed description of how to calibrate an assay, refer to Dose Response and Paired Difference methods, at the medical decision
Section 6 of the instrument-specific operations manual. level of the analyte.
For information on calibrator standardization, refer to the Lactic Acid
Calibrator package insert. Interfering Interferent Concentration N Target Observed
Substance (mg/dL) (% of Target)
QUALITY CONTROL
15 mg/dL (257 μmol/L) 4 19.9 90.9
The following process is the recommendation of Abbott Laboratories Bilirubin
for quality control. As appropriate, refer to your laboratory standard 30 mg/dL (513 μmol/L) 4 19.9 80.2
operating procedure(s) and/or quality assurance plan for additional 500 mg/dL (5.0 g/L) 4 18.7 109.2
quality control requirements and potential corrective actions. Hemoglobin
• Two levels of controls (normal and abnormal) are to be run every 750 mg/dL (7.5 g/L) 4 18.7 114.5
24 hours. Human 750 mg/dL (8.5 mmol/L) 4 20.8 97.4
• If more frequent control monitoring is required, follow the established triglyceride 1,000 mg/dL (11.3 mmol/L) 4 20.8 97.1
quality control procedures for your laboratory.
• If quality control results do not meet the acceptance criteria 125 mg/dL (1.25 g/L) 4 19.7 109.1
Intralipid
defined by your laboratory, patient values may be suspect. Follow 250 mg/dL (2.50 g/L) 4 19.7 117.9
the established quality control procedures for your laboratory.
Recalibration may be necessary. Bilirubin solutions at the above concentrations were prepared by
• Review quality control results and acceptable criteria following a addition of a bilirubin stock to human plasma pools. Hemoglobin
change of reagent or calibrator lot. solutions at the above concentrations were prepared by addition of
hemolysate to human plasma pools. Human triglyceride solutions at the
above concentrations were prepared by mixing an elevated triglyceride
human plasma pool with a normal triglyceride human plasma pool.
Intralipid solutions at the above concentrations were prepared by
addition of Intralipid to human plasma pools.
Interferences from medications or endogenous substances may affect
results.13

3
SPECIFIC PERFORMANCE CHARACTERISTICS BIBLIOGRAPHY
(Continued) 1. Burtis CA, Ashwood ER, editors. Tietz Textbook of Clinical
Chemistry, 2nd ed. Philadelphia, PA: WB Saunders; 1994:975–6.
Precision
2. Stacpoole PW. Lactic acidosis. In: Ober PK, editor. Endocrinology
The imprecision of the Lactic Acid assay is ≤ 6.3% Total CV.
and Metabolism Clinics of North America. Philadelphia, PA: WB
Representative data from studies using CLSI protocol NCCLS EP5-T214
Saunders; 1993:221–45.
are summarized below.
3. Henry JB, editor. Clinical Diagnosis and Management by Laboratory
Control Level 1 Level 2 Methods, 19th ed. Philadelphia, PA: WB Saunders; 1996:206–7.
N 80 80 4. US Department of Labor, Occupational Safety and Health
Administration. 29 CFR Part 1910.1030, Bloodborne Pathogens.
Mean (mg/dL) 46.2 15.6 5. US Department of Health and Human Services. Biosafety in
SD 0.59 0.25 Microbiological and Biomedical Laboratories, 5th ed. Washington,
Within Run DC: US Government Printing Office, January 2007.
%CV 1.3 1.6
6. World Health Organization. Laboratory Biosafety Manual, 3rd ed.
SD 0.81 0.18 Geneva: World Health Organization, 2004.
Between Run 7. Sewell DL, Bove KE, Callihan DR, et al. Protection of Laboratory
%CV 1.7 1.1
Workers from Occupationally Acquired Infections; Approved
SD 0.69 0.41 Guideline—Third Edition (M29-A3). Wayne, PA: Clinical and
Between Day Laboratory Standards Institute, 2005.
%CV 1.5 2.6
8. Tietz NW, editor. Clinical Guide to Laboratory Tests, 3rd ed.
SD 1.21 0.51 Philadelphia, PA: WB Saunders; 1995:382.
Total
%CV 2.6 3.3 9. Solberg HE. Establishment and use of reference values. In: Burtis
CA, Ashwood ER, editors. Tietz Textbook of Clinical Chemistry,
Method Comparison 2nd ed. Philadelphia, PA: WB Saunders; 1994:454–84.
Correlation studies were performed using CLSI protocol NCCLS 10. Sasse EA, Aziz KJ, Harris EK, et al. How to Define and Determine
EP9-A.15 Reference Intervals in the Clinical Laboratory; Approved Guideline
Plasma results from the Lactic Acid assay on the AEROSET System (C28-A). Villanova, PA: The National Committee for Clinical
were compared with those from a commercially available lactate Laboratory Standards, 1995.
oxidase methodology. 11. Tholen DW, Kroll M, Astles JR, et al. Evaluation of the Linearity
Plasma results from the Lactic Acid assay on an ARCHITECT c System of Quantitative Measurement Procedures: A Statistical Approach;
were compared with the Lactic Acid assay on the AEROSET System. Approved Guideline (EP6-A). Wayne, PA: The National Committee
for Clinical Laboratory Standards, 2003.
AEROSET vs. ARCHITECT 12. Powers DM, Boyd JC, Glick MR, et al. Interference Testing in
Comparative Method vs. AEROSET Clinical Chemistry; Proposed Guideline (EP7-P). Villanova, PA: The
N 78 52 National Committee for Clinical Laboratory Standards, 1986.
Y - Intercept 0.774 0.021 13. Young DS. Effects of Drugs on Clinical Laboratory Tests, 4th ed.
Washington, DC: AACC Press; 1995:3-43–6.
Correlation Coefficient 0.999 0.999 14. Kennedy JW, Carey RN, Coolen RB, et al. Evaluation of Precision
Slope 1.018 0.993 Performance of Clinical Chemistry Devices—Second Edition;
Tentative Guideline (EP5-T2). Villanova, PA: The National
Range (mg/dL)* 6.2 to 92.3 7.00 to 116.30
Committee for Clinical Laboratory Standards, 1992.
*AEROSET Range 15. Kennedy JW, Carey RN, Coolen RB, et al. Method Comparison and
Bias Estimation Using Patient Samples; Approved Guideline
(EP9-A). Wayne, PA: The National Committee for Clinical
Laboratory Standards, 1995.

TRADEMARKS
The ARCHITECT c System family of instruments consists of c 4000,
c 8000, and c 16000 instruments.
AEROSET, ARCHITECT, c 4000, c 8000, c 16000, and c System are
trademarks of Abbott Laboratories.
All other trademarks, brands, product names, and trade names are
property of their respective companies.

4
ARCHITECT c SYSTEMS ASSAY PARAMETERS

Lactic Acid Plasma—Conventional and SI Units


Configure assay parameters — General Configure assay parameters — SmartWash
● General о Calibration о SmartWash о Results о Interpretation о General о Calibration ● SmartWash о Results о Interpretation
Assay: Lact Type: Photometric Version: † Assay: Lact
Number: 1050
COMPONENT REAGENT / ASSAY WASH Volume Replicates
● Reaction definition о Reagent / Sample о Validity checks Cuvette Trig 10% Detergent B 345
Reaction mode: End up
Primary Secondary Read times
Wavelength: 548 / 700 Main: 16 – 25
Last required read: 25
Absorbance range: ___ – ___ Color correction: ___ – ___ Lactic Acid Plasma—Conventional Units
Sample blank type: None Configure assay parameters — Results — Conventional Units
о General о Calibration о SmartWash ● Results о Interpretation
о Reaction definition ● Reagent / Sample о Validity checks Assay: Lact Assay number: 1050
R1 Dilution default range: Result units: mg/dL
Reagent: LACT0 Reagent volume: 200 Low-Linearity: 0.2‡‡
Diluent: Saline Water volume: ___ High-Linearity: 120.0
Diluent dispense mode: Type 0 Dispense mode: Type 0 Gender and age specific ranges:
Diluted Default GENDER AGE (UNITS) NORMAL EXTREME
Dilution name Sample sample Diluent Water Dilution factor dilution Either 0 – 130 (Y) 4.5 – 19.8
STANDARD 2.0 ___ ___ ___ = 1:1.00 ●
_________ : ___ ___ ___ ___ = о
_________ : ___ ___ ___ ___ = о
Configure result units — Conventional Units
о Reaction definition о Reagent / Sample ● Validity checks Assay: Lact
Reaction check: None Version: †
Result units: mg/dL
Decimal places: 1 [Range 0 – 4]
Maximum absorbance variation: ___ Correlation factor: 1.0000
Intercept: 0.0000

Configure assay parameters — Calibration Lactic Acid Plasma—SI Units


о General ● Calibration о SmartWash о Results о Interpretation Configure assay parameters — Results — SI Units
Assay: Lact Calibration method: Linear
о General о Calibration о SmartWash ● Results о Interpretation
● Calibrators о Volumes о Intervals о Validity checks Assay: Lact Assay number: 1050
Calibrator set: Calibrator level: Concentration: Dilution default range: Result units: mmol/L
Lactic Blank: Water 0†† Low-Linearity: 0.02‡‡
Cal 1: Lactic1 ‡ High-Linearity: 13.32
Replicates: 3 [Range 1 – 3] Gender and age specific ranges:
GENDER AGE (UNITS) NORMAL EXTREME
о Calibrators ● Volumes о Intervals о Validity checks Either 0 – 130 (Y) 0.50 – 2.20
Calibrator: Lactic Diluted
Calibrator level Sample sample Diluent Water
Blank: Water 2.0 ___ ___ ___
Cal 1: Lactic1 2.0 ___ ___ ___
Configure result units — SI Units
Assay: Lact
о Calibrators о Volumes ● Intervals о Validity checks Version: †
Calibration intervals:
Result units: mmol/L
Full interval: 168 (hours)
Decimal places: 2 [Range 0 – 4]
Calibration type:
Correlation factor: 1.0000
Adjust type: None
Intercept: 0.0000
о Calibrators о Volumes о Intervals ● Validity checks
Blank absorbance range: _____ – _____
Span: Blank – Blank
Span absorbance range: _____ – _____
Expected cal factor: 0.00
Expected cal factor tolerance %: 0

† Due to differences in instrument systems and unit configurations, version numbers may vary.
†† Displays the number of decimal places defined in the decimal places parameter field.
‡ Refer to the concentration specified on calibrator labeling or value sheet. In ARCHITECT software version 5.00 and above, these values are
defined on the Configure calibrator set screen.
‡‡ The linear low value (Low-Linearity) is LOQ rounded up to the number of decimal places defined in the decimal places parameter field.

5
AEROSET SYSTEM ASSAY PARAMETERS

Lactic Acid Plasma—Conventional Units Lactic Acid Plasma—SI Units

Assay Configuration: Outline Page Assay Configuration: Outline Page


Assay Name Assay # Line Assay Name Assay # Line
Lact 50 A-Line Lact 50 A-Line
Quantitative Ranges Quantitative Ranges
Min Text Min Panic-L L-Reference-H Panic-H Max Max Text Min Text Min Panic-L L-Reference-H Panic-H Max Max Text
* 0.0* 0.0 4.5 19.8 0.0 0.0* * * 0.0* 0.0 0.5 2.2 0.0 0.0* *
0.2** L-Linear Range-H 120.0 0.02** L-Linear Range-H 13.32
Reference Ranges* Reference Ranges*
Age Male Female Age Male Female
0 Year 0.0 – 0.0 0.0 – 0.0 0 Year 0.0 – 0.0 0.0 – 0.0
0.0 – 0.0 0.0 – 0.0 0.0 – 0.0 0.0 – 0.0
0 Year 0 Year
0.0 – 0.0 0.0 – 0.0 0.0 – 0.0 0.0 – 0.0
0 Year 0.0 – 0.0 0.0 – 0.0 0 Year 0.0 – 0.0 0.0 – 0.0
Qualitative Ranges N/A Qualitative Ranges N/A

Assay Configuration: Base Page Assay Configuration: Base Page


Reaction Mode Wavelength-Prim/Sec Read time-Main/Flex AbsMaxVar Reaction Mode Wavelength-Prim/Sec Read time-Main/Flex AbsMaxVar
END UP 548 / 700 16 – 25 / 0 – 0 0.0 END UP 548 / 700 16 – 25 / 0 – 0 0.0
Sample Blank Test Blank Read Time Abs Window Abs Limits Sample Blank Test Blank Read Time Abs Window Abs Limits
_____ ( ___ ) 0–0 0–0 0.0 – 0.0 _____ ( ___ ) 0–0 0–0 0.0 – 0.0
[Link] [Link] [Link] [Link] [Link] [Link] [Link] [Link]
Standard 2.0 0.0 0 0 Rgt Name/Pos Standard 2.0 0.0 0 0 Rgt Name/Pos
Dil 1 2.0 0.0 0 0 Diluent: _____ _–__* Dil 1 2.0 0.0 0 0 Diluent: _____ _–__*
Dil 2 2.0 0.0 0 0 Type# 0 Dil 2 2.0 0.0 0 0 Type# 0
Rgt Name/Pos [Link] [Link] Type# Rgt Name/Pos [Link] [Link] Type#
Reagent 1 LACT011 – ___* 200 0 0 Reagent 1 LACT011 – ___* 200 0 0
Reaction Check Read Time – A/B Range Minimum Reaction Check Read Time – A/B Range Minimum
___________ 1–1/1–1 0.0 – 0.0 0.0 ___________ 1–1/1–1 0.0 – 0.0 0.0
Factor/Intercept Decimal Places Units Factor/Intercept Decimal Places Units
1.0 / 0.0 1 mg/dL 1.0 / 0.0 2 mmol/L

Assay Configuration: Calibration Page Assay Configuration: Calibration Page


Calib Mode Interval (H) Calib Mode Interval (H)
Linear 168 Linear 168
Blank/Calib Replicates Extrapolation % Span Span Abs Range Blank/Calib Replicates Extrapolation % Span Span Abs Range
3/3 0 BLK – 1 0.0 – 0.0 3/3 0 BLK – 1 0.0 – 0.0
Sample [Link] [Link] [Link] [Link] Blk Abs Range Sample [Link] [Link] [Link] [Link] Blk Abs Range
BLK Water 2.0 0.0 0 0 0.0 – 0.0 BLK Water 2.0 0.0 0 0 0.0 – 0.0
C1 Lactic 2.0 0.0 0 0 Cal Deviation C1 Lactic 2.0 0.0 0 0 Cal Deviation
C2 2.0 0.0 0 0 0.0 C2 2.0 0.0 0 0 0.0
FAC Limit (%) FAC Limit (%)
10 10

Assay Configuration: SmartWash Page Assay Configuration: SmartWash Page


Rgt Probe Rgt Probe
Reagent Wash Vol Reagent Wash Vol
— — — — — —
Cuvette Cuvette
Assay Name Wash Vol Assay Name Wash Vol
— — — — — —
Sample Probe Sample Probe
Wash Wash
— —

Refer to Assay Configuration in Section 2 of the AEROSET System Operations Manual for information regarding assay parameters.
* User defined or instrument defined.
** The linear low value (L-Linear Range) is LOQ rounded up to the number of decimal places defined in the decimal places parameter field.

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