TRIGLYCERIDE 7D74-20 30-3140/R3 TRIGLYCERIDE This package insert contains information to run the Triglyceride 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: Canada: International: 1-877-4ABBOTT 1-800-387-8378 (English speaking customers) 1-800-465-2675 (French speaking customers) Call your local Abbott representative Symbols in Product Labeling Calibrators 1 and 2 Catalog number/List number Concentration Serial number Authorized Representative in the European Community Consult instructions for use Ingredients Manufacturer In vitro diagnostic medical device Temperature limitation Batch code/Lot number Use by/Expiration date Reagent 1 ABBOTT LABORATORIES Abbott Park, IL 60064, USA ABBOTT Max-Planck-Ring 2 65205 Wiesbaden Germany +49-6122-580 September 2006 ©2002, 2006 Abbott Laboratories 1 NAME REAGENT HANDLING AND STORAGE TRIGLYCERIDE Reagent Handling INTENDED USE Remove air bubbles, if present in the reagent cartridge, with a new applicator stick. Alternatively, allow the reagent to sit at the appropriate storage temperature to allow the bubbles to dissipate. To minimize volume depletion, do not use a transfer pipette to remove the bubbles. CAUTION: Reagent bubbles may interfere with proper detection of reagent level in the cartridge, causing insufficient reagent aspiration which could impact results. The Triglyceride assay is used for the quantitation of triglyceride in human serum or plasma. SUMMARY AND EXPLANATION OF TEST Triglycerides are a family of lipids absorbed from the diet and produced endogenously from carbohydrates and fatty acids. Measurement of triglyceride is important in the diagnosis and management of hyperlipidemia. These diseases can be genetic or secondary to other disorders including nephrosis, diabetes mellitus, and endocrine disturbances. The National Cholesterol Education Program (NCEP) cites evidence that triglycerides are an independent risk factor for atherosclerosis.1 Individuals with hypertension, obesity, and/or diabetes are at greater risk than are those without these conditions.2,3 The Adult Treatment Panel of the NCEP recommends that all adults 20 years of age and over should have a fasting lipoprotein profile (total cholesterol, LDL cholesterol, HDL cholesterol, and triglyceride) once every five years to screen for coronary heart disease risk.1 PRINCIPLES OF PROCEDURE Triglycerides are enzymatically hydrolyzed by lipase to free fatty acids and glycerol. The glycerol is phosphorylated by adenosine triphosphate (ATP) with glycerol kinase (GK) to produce glycerol-3-phosphate and adenosine diphosphate (ADP). Glycerol-3-phosphate is oxidized to dihydroxyacetone phosphate (DAP) by glycerol phosphate oxidase (GPO) producing hydrogen peroxide (H2O2). In a color reaction catalyzed by peroxidase, the H2O2 reacts with 4-aminoantipyrine (4-AAP) and 4-chlorophenol (4-CP) to produce a red colored dye. The absorbance of this dye is proportional to the concentration of triglyceride present in the sample. This analytical methodology is based on the reaction sequence described by Fossati et al.4 and by McGowan et al.5 In this reagent, 4-chlorophenol is used rather than 2-hydroxy-3,5-dichlorobenzenesulfonate, used in the Fossati and McGowan studies. Methodology: Glycerol Phosphate Oxidase REAGENTS Reagent Kit 7D74 Triglyceride is supplied as a liquid, ready-to-use, single reagent kit which contains: 10 x 84 mL Estimated tests per kit: 3,032 Calculation is based on the minimum reagent fill volume per kit. Reactive Ingredients ATP Mg2+ 4-Aminoantipyrine 4-Chlorophenol Peroxidase (Horseradish) GK (Microbial) GPO (Microbial) Lipoprotein Lipase (Microbial) Concentration 2.5 mmol/L 2.5 mmol/L 0.4 mmol/L 2 mmol/L > 2,000 U/L > 600 U/L > 6,000 U/L > 3,000 U/L Reagent Storage Unopened reagents are stable until the expiration date when stored at 2 to 8°C. Reagent stability is 42 days if the reagent is uncapped and onboard. WARNINGS AND PRECAUTIONS Precautions for Users 1. 2. 3. 4. For in vitro diagnostic use. Do not use components beyond the expiration date. Do not mix materials from different kit lot numbers. Certain disease states may cause endogenous serum triglyceride values to be grossly elevated. Samples that are grossly lipemic by visual examination should be diluted prior to analysis. 5. CAUTION: This product requires the handling of human specimens. It is recommended that all human sourced materials be considered potentially infectious and handled in accordance with the OSHA Standard on Bloodborne Pathogens.6 Biosafety Level 27 or other appropriate biosafety practices8,9 should be used for materials that contain or are suspected of containing infectious agents. SPECIMEN COLLECTION AND HANDLING Suitable Specimens Serum and plasma are acceptable specimens. The National Cholesterol Education Program (NCEP) recommends using fasting specimens.1 • Serum: Use serum collected by standard venipuncture techniques into glass or plastic tubes with or without gel barriers. Ensure complete clot formation has taken place prior to centrifugation. Separate serum from red blood cells or gel as soon after collection as possible. Some specimens, especially those from patients receiving anticoagulant or thrombolytic therapy, may take longer to complete their clotting processes. Fibrin clots may subsequently form in these sera and the clots could cause erroneous test results. • Plasma: Use plasma collected by standard venipuncture techniques into glass or plastic tubes. Acceptable anticoagulants are lithium heparin (with or without gel barrier) and sodium heparin. Ensure centrifugation is adequate to remove platelets. Separate plasma from red blood cells or gel as soon after collection as possible. Refer to the specimen collection tube manufacturer’s instructions for processing and handling requirements. For total sample volume requirements, refer to the instrument-specific ASSAY PARAMETERS section of this package insert and Section 5 of the instrument-specific operations manual. 2 SPECIMEN COLLECTION AND HANDLING (Continued) QUALITY CONTROL Specimen Storage The following is the recommendation of Abbott Laboratories for quality control. As appropriate, refer to your laboratory standard operating procedure(s) and/or quality assurance plan for additional quality control requirements and potential corrective actions. • Two levels of controls (normal and abnormal) are to be run every 24 hours. • If more frequent control monitoring is required, follow the established quality control procedures for your laboratory. • If quality control results do not meet the acceptance criteria defined by your laboratory, patient values may be suspect. Follow the established quality control procedures for your laboratory. Recalibration may be necessary. • Review quality control results and acceptance criteria following a change of reagent or calibrator lot. Serum and plasma Temperature 20 to 25°C 2 to 8°C -20°C Maximum Storage 2 days 7 days > 1 year Bibliographic Reference 10 10, 11 10 Guder et al.10 suggest storage of frozen specimens at -20°C for no longer than the time interval cited above. However, limitations of laboratory equipment make it necessary in practice for clinical laboratories to establish a range around -20°C for specimen storage. This temperature range may be established from either the freezer manufacturer’s specifications or your laboratory standard operating procedure(s) for specimen storage. NOTE: Stored specimens must be inspected for particulates. If present, mix and centrifuge the specimen to remove particulates prior to testing. PROCEDURE Materials Provided 7D74 Triglyceride Reagent Kit Materials Required but not Provided RESULTS Refer to the instrument-specific operations manual for information on results calculations. • ARCHITECT System Operations Manual—Appendix C • AEROSET System Operations Manual—Appendix A Representative performance data are given in the EXPECTED VALUES and SPECIFIC PERFORMANCE CHARACTERISTICS sections of this package insert. Results obtained in individual laboratories may vary. LIMITATIONS OF THE PROCEDURE • 1E65 Multiconstituent Calibrator, 3 x 5 mL • Control Material • Saline (0.85% to 0.90% NaCl) for specimens that require dilution Refer to the SPECIMEN COLLECTION AND HANDLING and SPECIFIC PERFORMANCE CHARACTERISTICS sections of this package insert. Assay Procedure EXPECTED VALUES For a detailed description of how to run an assay, refer to Section 5 of the instrument-specific operations manual. Reference Range Serum/Plasma1 Specimen Dilution Procedures The ARCHITECT c Systems and the AEROSET System have automatic dilution features; refer to Section 2 of the instrument-specific operations manual for additional information. Serum and plasma: Specimens with triglyceride values exceeding 1,420 mg/dL (16.05 mmol/L) are flagged and may be diluted using the Automated Dilution Protocol or the Manual Dilution Procedure. Automated Dilution Protocol If using the Automated Dilution Protocol, the system performs a 1:4 dilution of the specimen and automatically corrects the concentration by multiplying the result by the appropriate dilution factor. Manual Dilution Procedure Manual dilutions should be performed as follows: • Use saline (0.85% to 0.90% NaCl) to dilute the sample. • The operator must enter the dilution factor in the patient or control order screen. The system uses this dilution factor to automatically correct the concentration by multiplying the result by the entered factor. • If the operator does not enter the dilution factor, the result must be multiplied by the appropriate dilution factor before reporting the result. NOTE: If a diluted sample result is flagged indicating it is less than the linear low limit, do not report the result. Rerun using an appropriate dilution. For detailed information on ordering dilutions, refer to Section 5 of the instrument-specific operations manual. Normal Borderline High High Very High Range (mg/dL) < 150 150 to 199 200 to 499 ≥ 500 Range (mmol/L) < 1.70 1.70 to 2.25 2.26 to 5.64 ≥ 5.65 To convert results from mg/dL to mmol/L, multiply mg/dL by 0.0113. The National Cholesterol Education Program (NCEP) Adult Treatment Panel III Report recommends the classification shown above. Laboratories should follow recommendations for lipid ranges effective in their locale if they differ from those of the NCEP. SPECIFIC PERFORMANCE CHARACTERISTICS Linearity Triglyceride is linear up to 1,420 mg/dL (16.05 mmol/L). Linearity was verified using Clinical and Laboratory Standards Institute (CLSI) protocol NCCLS EP6-P.12 Limit of Detection (LOD) The LOD for Triglyceride is 5.0 mg/dL (0.06 mmol/L). The LOD is the mean concentration of an analyte-free sample + 2 SD, where SD = the pooled, within-run standard deviation of the analyte-free sample. A study performed on an ARCHITECT c System and an AEROSET System produced an LOD for the Triglyceride assay of 1.00 mg/dL (0.012 mmol/L). Limit of Quantitation (LOQ) CALIBRATION Calibration is stable for approximately 41 days (984 hours) and is required with each change in reagent lot number. Verify calibration with at least two levels of controls according to the established quality control requirements for your laboratory. If control results fall outside acceptable ranges, recalibration may be necessary. For a detailed description of how to calibrate an assay, refer to Section 6 of the instrument-specific operations manual. For information on calibrator standardization, refer to the Multiconstituent Calibrator package insert. 3 The LOQ for Triglyceride is 6.2 mg/dL (0.071 mmol/L). The LOQ is the analyte concentration at which the CV = 20%. SPECIFIC PERFORMANCE CHARACTERISTICS (Continued) Interfering BIBLIOGRAPHY Substances13 Interference studies were conducted using CLSI protocol NCCLS EP7-P.14 Interference effects were assessed by Dose Response and Paired Difference methods, at the medical decision level of the analyte. Interfering Substance Interferent Concentration 7.5 mg/dL 15 mg/dL 750 mg/dL Hemoglobin 1,000 mg/dL 1.5 mg/dL Ascorbate 3.0 mg/dL Bilirubin (128 µmol/L) (257 µmol/L) (7.5 g/L) (10.0 g/L) (85 µmol/L) (170 µmol/L) N 3 3 4 4 4 4 Target Observed (mg/dL) (% of Target) 211.0 106.6 211.0 111.3 193.1 109.6 193.1 111.2 220.4 97.0 220.4 94.0 Bilirubin solutions at the above concentrations were prepared by addition of a bilirubin stock to human serum pools. Hemoglobin solutions at the above concentrations were prepared by addition of hemolysate to human serum pools. Ascorbate solutions at the above concentrations were prepared by addition of ascorbic acid to human serum pools. Precision The imprecision of the Triglyceride assay is ≤ 5% Total CV. Representative data from studies using CLSI protocol NCCLS EP5-A15 are summarized below. Control N Mean (mg/dL) Within Run Between Run Between Day Total SD %CV SD %CV SD %CV SD %CV Level 1 80 209.4 1.42 0.7 0.75 0.4 3.25 1.6 3.63 1.7 Level 2 80 100.0 0.80 0.8 0.64 0.6 1.67 1.7 1.96 2.0 Method Comparison Correlation studies were performed using CLSI protocol NCCLS EP9-A.16 Serum results from the Triglyceride assay on the AEROSET System were compared with those from a commercially available glycerol phosphate oxidase methodology. Serum results from the Triglyceride assay on an ARCHITECT c System were compared with the Triglyceride assay on an AEROSET System. N Y - Intercept Correlation Coefficient Slope Range (mg/dL)* AEROSET vs. Comparative Method 76 0.311 0.994 1.048 ARCHITECT vs. AEROSET 36.1 to 990.6 37.60 to 1,370.40 91 5.858 0.999 0.989 1. Executive summary of the third report of the National Cholesterol Education Program (NCEP) Expert Panel on detection, evaluation, and treatment of high blood cholesterol in adults (Adult Treatment Panel III). JAMA 2001;285:2486–97. 2. Rubins HB. Triglycerides and coronary heart disease: implications of recent clinical trials. J Cardiovasc Risk 2000;7(5):339–45. 3. Forrester JS. Triglycerides: risk factor or fellow traveler? Curr Opin Cardiol 2001;16:261–4. 4. Fossati P, Prencipe L. Serum triglycerides determined colorimetrically with an enzyme that produces hydrogen peroxide. Clin Chem 1982;28:2077–80. 5. McGowan MW, Artiss JD, Strandbergh DR, et al. A peroxidase-coupled method for the colorimetric determination of serum triglycerides. Clin Chem 1983;29:538–42. 6. US Department of Labor, Occupational Safety and Health Administration. 29 CFR Part 1910.1030, Occupational exposure to bloodborne pathogens. 7. US Department of Health and Human Services. Biosafety in Microbiological and Biomedical Laboratories. HHS Publication (CDC), 4th ed. Washington, DC: US Government Printing Office, May 1999. 8. World Health Organization. Laboratory Biosafety Manual. Geneva: World Health Organization, 2004. 9. Sewell DL, Bove KE, Callihan DR, et al. Protection of Laboratory Workers from Occupationally Acquired Infections; Approved Guideline—Third Edition (M29-A3). Wayne, PA: Clinical and Laboratory Standards Institute, 2005. 10. Guder WG, Narayanan S, Wisser H, et al. List of analytes—preanalytical variables. Annex In: Samples: From the Patient to the Laboratory. Darmstadt, Germany: GIT Verlag; 1996:Annex 22–3. 11. US Pharmacopeial Convention, Inc. General notices. In: US Pharmacopeia National Formulary, 1995 ed (USP 23/NF 18). Rockville, MD: The US Pharmacopeial Convention, Inc; 1994:11. 12. Passey RB, Bee DE, Caffo A, et al. Evaluation of the Linearity of Quantitative Analytical Methods; Proposed Guideline (EP6-P). Villanova, PA: The National Committee for Clinical Laboratory Standards, 1986. 13. Young DS. Effects of Drugs on Clinical Laboratory Tests, 4th ed. Washington, DC: AACC Press; 1995:3-573–3-589. 14. Powers DM, Boyd JC, Glick MR, et al. Interference Testing in Clinical Chemistry; Proposed Guideline (EP7-P). Villanova, PA: The National Committee for Clinical Laboratory Standards, 1986. 15. Kennedy JW, Carey RN, Coolen RB, et al. Evaluation of Precision Performance of Clinical Chemistry Devices; Approved Guideline (EP5-A). Wayne, PA: The National Committee for Clinical Laboratory Standards, 1999. 16. 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 AEROSET and ARCHITECT are registered trademarks of Abbott Laboratories. c System is a trademark of Abbott Laboratories. All other trademarks, brands, product names, and trade names are the property of their respective companies. *AEROSET Range 4 ARCHITECT c SYSTEMS ASSAY PARAMETERS Triglyceride Serum/Plasma—Conventional and SI Units Configure assay parameters — General ● General Configure assay parameters — SmartWash о Calibration о SmartWash о Results о Interpretation о General о Calibration ● SmartWash о Results о Interpretation Assay: Trig COMPONENT REAGENT / ASSAY WASH Volume Replicates Cuvette Trig 10% Detergent B*** 345 Assay: Trig Type: Photometric Version: 1 Number: 1017 ● Reaction definition о Reagent / Sample о Validity checks Reaction mode: End up Primary Secondary Read times Wavelength: 500 / 660 Main: 15 – 17 Last required read: 17 Absorbance range: ___ – ___ Color correction: ___ – ___ Sample blank type: None о Reaction definition Reagent: TRIG0 Diluent: Saline Diluent dispense mode: Type 0 Diluted Dilution name Sample sample STANDARD : 2.4 ___ 1:4 : 25.0 2.4 __________ : ___ ___ *** Select “Detergent B” for software prior to version 2.2. Triglyceride Serum/Plasma—Conventional Units Configure assay parameters — Results ● Reagent / Sample о Validity checks Reagent volume: Water volume: Dispense mode: Diluent ___ 75 ___ Water Dilution factor ___ = 1:1.00 ___ = 1:4.00 ___ = о Reaction definition о Reagent / Sample Reaction check: End Subtraction о General о SmartWash ● Results о Interpretation Assay: Trig Result units: mg/dL Assay defaults: Low-Linearity: 7† High-Linearity: 1420 Gender and age specific ranges: GENDER AGE (UNITS) NORMAL EXTREME Either 0 – 130 (Y) 0 – 149 R1 240 ___ Type 0 Default dilution ● о о ● Validity checks Read time: Calculation limits: Maximum absorbance variation: 0.0100 о Calibration Configure result units Assay: Version: Result units: Decimal places: Correlation factor: Intercept: A B 9–9 11 – 11 - 0.1000 – 0.1000 Trig 1 mg/dL 0 [Range 0 – 4] 1.0000 0.0000 Configure assay parameters — Calibration о General Assay: ● Calibration о SmartWash о Results Trig ● Calibrators о Volumes Calibrator set: MCC Replicates: 3 о Calibrators Calibrator: MCC Blank: Cal 1: Cal 2: [Range 1 – 3] о Intervals Calibrator level: Blank: Water Cal 1: MCC1 Cal 2: MCC2 ● Volumes Calibrator level Water MCC1 MCC2 о Calibrators о Volumes Calibration intervals: Full interval: 984 Calibration type: Adjust type: None о Calibrators о Interpretation Triglyceride Serum/Plasma—SI Units Calibration method: Linear о Volumes Blank absorbance range: Span: Span absorbance range: Expected cal factor: Expected cal factor tolerance %: о Intervals Sample 2.4 2.4 2.4 Diluted sample ___ ___ ___ ● Intervals Configure assay parameters — Results о Validity checks о General о SmartWash ● Results о Interpretation Assay: Trig Result units: mmol/L Assay defaults: Low-Linearity: 0.08† High-Linearity: 16.05 Gender and age specific ranges:* GENDER AGE (UNITS) NORMAL EXTREME Either 0 – 130 (Y) 0.00 – 1.69 Concentration: 0†† ‡ ‡ о Validity checks Diluent ___ ___ ___ Water ___ ___ ___ Configure result units Assay: Version: Result units: Decimal places: Correlation factor: Intercept: о Validity checks (hours) о Intervals _____ – _____ Blank – Blank _____ – _____ 0.00 0 о Calibration Trig 1 mmol/L 2 [Range 0 – 4] 1.0000 0.0000 ● Validity checks † The linear low value (Low-Linearity) is LOQ rounded up to the number of decimal places defined in the decimal places parameter field. ‡ Refer to concentration specified on calibrator labeling or value sheet. †† Displays the number of decimal places defined in the decimal places parameter field. 5 AEROSET SYSTEM ASSAY PARAMETERS Triglyceride Serum/Plasma—Conventional Units Triglyceride Serum/Plasma—SI Units Assay Configuration: Outline Page Assay Name Assay # Trig 17 Quantitative Ranges Min Text Min Panic-L * 0.0* 0.0 7** Reference Ranges* Age L-Reference-H 0 149 L-Linear Range-H 0.0 0.0 0.0 0.0 0 Year 0 Year 0 Year Qualitative Ranges Assay Configuration: Outline Page Line B-Line Male – – – – 0.0 0.0 0.0 0.0 Panic-H 0.0 1420 0.0 0.0 0.0 0.0 Max 0.0* Assay Name Assay # Trig 17 Quantitative Ranges Min Text Min Panic-L * 0.0* 0.0 0.08** Reference Ranges* Age Max Text * Female – 0.0 – 0.0 – 0.0 – 0.0 Line B-Line L-Reference-H 0.00 1.69 L-Linear Range-H 0.0 0.0 0.0 0.0 0 Year 0 Year 0 Year N/A Qualitative Ranges Male – – – – 0.0 0.0 0.0 0.0 Panic-H Max 0.0 0.0* 16.05 0.0 0.0 0.0 0.0 Max Text * Female – 0.0 – 0.0 – 0.0 – 0.0 N/A Assay Configuration: Base Page Assay Configuration: Base Page Reaction Mode Wavelength-Prim/Sec Read time-Main/Flex AbsMaxVar END UP 500 / 660 15 – 17 / 0 – 0 0.01 Sample Blank Test Blank Read Time Abs Window Abs Limits _____ ( ___ ) 0–0 0–0 0.0 – 0.0 S.Vol DS.Vol D.Vol W.Vol Standard 2.4 0.0 0 0 Rgt Name/Pos Dil 1 25.0 2.4 75 0 Diluent: DILUENT D–18* Dil 2 2.4 0.0 0 0 Type# 0 Rgt Name/Pos R.Vol W.Vol Type# Reagent 1 TRIG061 – ___* 240 0 0 Reaction Check Read Time – A/B Range Minimum END SUB 9 – 9 / 11 – 11 -0.1 – 0.1 0.0 Factor/Intercept Decimal Places Units 1.0 / 0.0 0 mg/dL Reaction Mode Wavelength-Prim/Sec Read time-Main/Flex AbsMaxVar END UP 500 / 660 15 – 17 / 0 – 0 0.01 Sample Blank Test Blank Read Time Abs Window Abs Limits _____ ( ___ ) 0–0 0–0 0.0 – 0.0 S.Vol DS.Vol D.Vol W.Vol Standard 2.4 0.0 0 0 Rgt Name/Pos Dil 1 25.0 2.4 75 0 Diluent: DILUENT D–18* Dil 2 2.4 0.0 0 0 Type# 0 Rgt Name/Pos R.Vol W.Vol Type# Reagent 1 TRIG061 – ___* 240 0 0 Reaction Check Read Time – A/B Range Minimum END SUB 9 – 9 / 11 – 11 -0.1 – 0.1 0.0 Factor/Intercept Decimal Places Units 1.0 / 0.0 2 mmol/L Assay Configuration: Calibration Page Calib Mode Linear Blank/Calib Replicates 3/3 Sample S.Vol BLK Water 2.4 C1 MCC 1 2.4 C2 MCC 2 2.4 Extrapolation % 0 DS.Vol D.Vol 0.0 0 0.0 0 0.0 0 Assay Configuration: Calibration Page Interval (H) 984 Span Span Abs Range BLK – 1 0.0 – 0.0 W.Vol Blk Abs Range 0 0.0 – 0.0 0 Cal Deviation 0 0.0 FAC Limit (%) 10 Calib Mode Linear Blank/Calib Replicates 3/3 Sample S.Vol BLK Water 2.4 C1 MCC 1 2.4 C2 MCC 2 2.4 Assay Configuration: SmartWash Page Extrapolation % 0 DS.Vol D.Vol 0.0 0 0.0 0 0.0 0 Interval (H) 984 Span Span Abs Range BLK – 1 0.0 – 0.0 W.Vol Blk Abs Range 0 0.0 – 0.0 0 Cal Deviation 0 0.0 FAC Limit (%) 10 Assay Configuration: SmartWash Page Rgt Probe Rgt Probe Reagent — Wash — Vol — Assay Name — Wash — Vol — Cuvette Reagent — Wash — Vol — Assay Name — Wash — Vol — Cuvette 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. 6 7 8
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