LacticAcid ARC CHEM
LacticAcid ARC CHEM
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: 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
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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.
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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
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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.
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ARCHITECT c SYSTEMS ASSAY PARAMETERS
† 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.
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AEROSET SYSTEM ASSAY PARAMETERS
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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