This package insert contains information to run the Carbon Dioxide assay on the ARCHITECT c Systems and the AEROSET System.

Transcription

1 CARBON DIOXIDE 3L80-21 and 3L /R1 CARBON DIOXIDE This package insert contains information to run the Carbon Dioxide 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: Canada: International: ABBOTT (English speaking customers) (French speaking customers) Call your local Abbott representative Symbols in Product Labeling Calibrators 1 and 2 Reagent 1 Concentration Contents of kit Contains sodium azide. Contact with acids liberates very toxic gas. Authorized Representative in the European Community Ingredients In vitro diagnostic medical device Catalog number/list number Serial number Consult instructions for use Manufacturer Temperature limitation Use by/expiration date Batch code/lot number November Abbott Laboratories 1

2 NAME CARBON DIOXIDE INTENDED USE The Carbon Dioxide assay is used for the quantitation of carbon dioxide in human serum or plasma. SUMMARY AND EXPLANATION OF TEST The determination of serum carbon dioxide total (CO 2 ) in conjunction with other clinical and laboratory information is necessary for the evaluation of acid base status. A high CO 2 content may be observed in compensated respiratory acidosis and metabolic alkalosis. A low CO 2 content may be observed in compensated respiratory alkalosis and metabolic acidosis. Additional laboratory determinations will permit differentiation between metabolic and respiratory conditions. 1 PRINCIPLES OF PROCEDURE Carbon dioxide, as bicarbonate (HCO 3 ), and phospho(enol)pyruvate (PEP) are converted to oxalacetate and phosphate in the reaction catalyzed by phospho(enol)pyruvate carboxylase (PEPC). Malate dehydrogenase (MDH) catalyzes the reduction of oxalacetate to malate with the concomitant oxidation of reduced nicotinamide adenine dinucleotide (NADH) analog. 2 The resulting decrease in absorbance at 404 nm is proportional to the CO 2 content in the sample. Methodology: PEP Carboxylase REAGENTS Reagent Kit Carbon Dioxide is supplied as a liquid, ready to-use, single reagent kit which contains: 3L x 15 ml Estimated tests per kit: 1,500* 3L x 34 ml Estimated tests per kit: 7,500* *Calculation is based on the minimum reagent fill volume per kit. Reactive Ingredients Phospho(enol)pyruvate NADH analog Phospho(enol)pyruvate Carboxylase (Microbial) Malate Dehydrogenase (Mammalian) Inactive Ingredients: preservative. contains sodium azide (0.08%) as a Concentration 63 mmol/l 3.0 mmol/l > 2,000 U/L > 20,000 U/L REAGENT HANDLING AND STORAGE Reagent Handling 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. Reagent Storage Unopened reagents are stable until the expiration date when stored at 2 to 8 C. Reagent stability is 14 days if the reagent is uncapped and onboard. Indications of Deterioration Deterioration should be suspected if there are visible signs of leakage, extreme turbidity, microbial growth, or if quality control results are outside of the acceptable range defined by your laboratory. WARNINGS AND PRECAUTIONS Precautions for Users 1. For in vitro diagnostic use. 2. Do not use components beyond the expiration date. 3. Do not mix materials from different kit lot numbers. 4. CAUTION: This product requires the handling of human specimens. It is recommended that all human sourced materials be considered potentially infectious and be handled in accordance with the OSHA Standard on Bloodborne Pathogens. 3 Biosafety Level 2 4 or other appropriate biosafety practices 5,6 should be used for materials that contain or are suspected of containing infectious agents. 5. This product contains sodium azide. For a specific listing, refer to the REAGENTS section of this package insert. Contact with acids liberates very toxic gas. This material and its container must be disposed of in a safe way. NOTE: Refer to Section 8 of the instrument-specific operations manual for proper handling and disposal of reagents containing sodium azide. SPECIMEN COLLECTION AND HANDLING Suitable Specimens Serum and plasma are acceptable specimens. 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. When processing samples, separate serum from blood cells or gel according to the specimen collection tube manufacturer s instructions. 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. When processing samples, separate plasma from blood cells or gel according to the specimen collection tube manufacturer s instructions. 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. Specimen Storage Serum and Plasma: Keep tube tightly capped for storage. 7 A consequent decrease in the CO 2 value of up to 6 meq/l can occur in the course of an hour once the specimen has been exposed to ambient air. 8 Temperature Maximum Storage Bibliographic Reference 20 to 25 C 1 day 7 2 to 8 C 7 days 7, 9-20 C 2 weeks 7 Guder et al. 7 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. 2

3 PROCEDURE Materials Provided 3L80 Carbon Dioxide Reagent Kit Materials Required but not Provided 1E64 Carbon Dioxide Calibrator, 3 x 5 ml Control Material Saline (0.85% to 0.90% NaCl) for specimens that require dilution Assay Procedure For a detailed description of how to run an assay, refer to Section 5 of the instrument-specific operations manual. 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 carbon dioxide values exceeding 50 meq/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 1:2 dilution of the specimen and automatically corrects the concentration by multiplying the result by the appropriate dilution factor. To set up the automatic dilution feature, refer to Section 2 of the instrument-specific operations manual for additional information. 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. CALIBRATION Calibration is stable for approximately 14 days (336 hours) and is required with each change in reagent lot number. Verify calibration curve 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 Carbon Dioxide Calibrator package insert. QUALITY CONTROL The following process 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. 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 Refer to the SPECIMEN COLLECTION AND HANDLING and SPECIFIC PERFORMANCE CHARACTERISTICS sections of this package insert. Reagent cross contamination testing for the Carbon Dioxide assay ( 3L80) was performed on an ARCHITECT c System and the AEROSET System. ARCHITECT c Systems Assays affected by Carbon Dioxide No affected assays. AEROSET Assays affected by Carbon Dioxide Configure Carbon Dioxide Rgt Probe SmartWash entries in the following assay files on the AEROSET System. Configure Reagent Wash Vol Mg 7D70 CO2C941 AlkW 345 Mg-U 7D70 CO2C941 AlkW 345 EXPECTED VALUES Reference Range Serum/Plasma 10 Range (meq/l) Cord 14 to 22 Newborn 13 to 22 Premature, 1 week 14 to 27 Infant 20 to 28 Child 20 to 28 Adult 22 to 29 > 60 years 23 to 31 For Carbon Dioxide, results expressed in meq/l are equivalent to mmol/l. It is recommended that each laboratory determine its own reference range based upon its particular locale and population characteristics. SPECIFIC PERFORMANCE CHARACTERISTICS Linearity Carbon Dioxide is linear from 5 meq/l (5 mmol/l) to 50 meq/l (50 mmol/l). Linearity was verified using Clinical and Laboratory Standards Institute (CLSI) protocol NCCLS EP6-A. 11 Limit of Detection (LOD) The LOD for Carbon Dioxide is 2 meq/l (2 mmol/l). The LOD is the lowest amount of analyte in a sample that can be detected with 95% probability. Limit of Quantitation (LOQ) The LOQ for Carbon Dioxide in serum and plasma specimens is 4 meq/l (4 mmol/l). The LOQ is the analyte concentration at which the CV = 20%. 3

4 SPECIFIC PERFORMANCE CHARACTERISTICS (Continued) Interfering Substances Interference effects were assessed by Dose Response method, at the medical decision levels of the analyte. Lower Decision Level Interfering Interferent Concentration N Target Observed* Substance (meq/l) (meq/l) % Bilirubin Hemoglobin Intralipid 30 mg/dl (513 µmol/l) mg/dl (1,026 µmol/l) ,000 mg/dl (10 g/l) ,000 mg/dl (20 g/l) ,000 mg/dl (10 g/l) ,000 mg/dl (20 g/l) Upper Decision Level Interfering Interferent Concentration N Target Observed* Substance (meq/l) (meq/l) % Bilirubin Hemoglobin Intralipid 30 mg/dl (513 µmol/l) mg/dl (1,026 µmol/l) ,000 mg/dl (10 g/l) ,000 mg/dl (20 g/l) ,000 mg/dl (10 g/l) ,000 mg/dl (20 g/l) *Percentages have been rounded to whole numbers. 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. Intralipid solutions at the above concentrations were prepared by addition of Intralipid to human serum pools. Interferences from medications or endogenous substances may affect results. 12 Precision The imprecision of the Carbon Dioxide assay is 5.5% Total CV or total SD 1 meq/l, whichever is greater. Representative data from studies using CLSI protocol NCCLS EP5-A 13 are summarized below. Control Level 1 Level 2 N Mean (meq/l) Within Run Between Run Between Day Total SD %CV SD %CV SD %CV SD %CV Accuracy The bias for Carbon Dioxide is 4.3% or ± 1 meq/l, whichever is greater, and the total error is 15.3%. Representative data from studies using NIST traceable standards and comparing results with the NIST certified concentration are summarized below. N 20 Concentration (meq/l) 20 Mean Bias (meq/l) -0.7 (%) -3.7 Total Error (%) 8.0% Method Comparison Correlation studies were performed using CLSI protocol NCCLS EP9-A2. 14 Serum results from the Carbon Dioxide assay on an ARCHITECT c System were compared with those from a commercially available PEP carboxylase methodology. Serum results from the Carbon Dioxide assay on an ARCHITECT c System were compared with those from the Carbon Dioxide assay on the AEROSET System. ARCHITECT vs. Comparative Method ARCHITECT vs. AEROSET N Y - Intercept Correlation Coefficient Slope Range (meq/l) 6 to 49 6 to 49 BIBLIOGRAPHY 1. Burtis CA, Ashwood ER, editors. Tietz Textbook of Clinical Chemistry, 3rd ed. Philadelphia, PA: WB Saunders; 1999: US Patent #5,801, US Department of Labor, Occupational Safety and Health Administration. 29 CFR Part Bloodborne Pathogens. 4. US Department of Health and Human Services. Biosafety in Microbiological and Biomedical Laboratories, 5th ed. Washington, DC: US Government Printing Office, January World Health Organization. Laboratory Biosafety Manual, 3rd ed. Geneva: World Health Organization, 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, 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 Tietz NW, editor. Fundamentals of Clinical Chemistry, 3rd ed. Philadelphia, PA: WB Saunders; 1987: 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: Burtis CA, Ashwood ER, editors. Tietz Textbook of Clinical Chemistry, 3rd ed. Philadelphia, PA: WB Saunders; 1999: Tholen DW, Kroll M, Astles JR, et al. Evaluation of the Linearity of Quantitative Measurement Procedures: A Statistical Approach; Approved Guideline (EP6-A). Wayne, PA: The National Committee for Clinical Laboratory Standards, Young DS, Effects of Drugs on Clinical Laboratory Tests, 5th ed. Washington, DC: AACC Press, 2000: 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, Kennedy JW, Tholen DW, Garber CC, et al. Method Comparison and Bias Estimation Using Patient Samples; Approved Guideline Second Edition (EP9-A2). Wayne, PA: The National Committee for Clinical Laboratory Standards, TRADEMARKS The ARCHITECT c System family of instruments consists of c 4000, c 8000, and c instruments. AEROSET, ARCHITECT, c 4000, c 8000, c 16000, c System, and SmartWash are trademarks of Abbott Laboratories in various jurisdictions. All other trademarks are property of their respective owners /R1 Abbott Laboratories Abbott Park, IL USA ABBOTT Max-Planck-Ring Wiesbaden Germany

5 ARCHITECT c SYSTEMS ASSAY PARAMETERS Carbon Dioxide Serum/Plasma Conventional and SI Units Configure assay parameters General General о Calibration о SmartWash о Results о Interpretation Assay: CO2C Type: Photometric Version: Number: 1067 Reaction definition о Reagent / Sample о Validity checks Reaction mode: End down Primary Secondary Read times Wavelength: 404 / 500 Main: Last required read: 20 Absorbance range: Color correction: Sample blank type: Self Blank: 3 5 о Reaction definition Reagent / Sample о Validity checks R1 Reagent: CO2C9 Reagent volume: 40 Diluent: Saline Water volume: 160 Diluent dispense mode: Type 0 Dispense mode: Type 0 Diluted Default Dilution name Sample sample Diluent Water Dilution factor dilution STANDARD : 2.0 = 1:1.00 1:2 : = 1:2.02 о : = о о Reaction definition о Reagent / Sample Validity checks Reaction check: None Configure assay parameters SmartWash о General о Calibration SmartWash о Results о Interpretation Assay: CO2C COMPONENT REAGENT / ASSAY WASH Volume Replicates R1 DIG00 Detergent A R1 AMIK9 Detergent A R1 VANCO Detergent A R1 GENT9 Detergent A R1 TOBRA Detergent A R1 DGT0B Detergent A Cuvette Trig 10% Detergent B 345 Carbon Dioxide Serum/Plasma Conventional Units Configure assay parameters Results о General о Calibration о SmartWash Results о Interpretation Assay: CO2C Assay number: 1067 Dilution default range: Result units: meq/l Low-Linearity: 5 High-Linearity: 50 Gender and age specific ranges: GENDER AGE (UNITS) NORMAL EXTREME Either (Y) Maximum absorbance variation: Configure assay parameters Calibration о General Calibration о SmartWash о Results о Interpretation Assay: CO2C Calibration method: Linear Calibrators о Volumes о Intervals о Validity checks Calibrator set: Calibrator level: Concentration: CO2C Blank: Water 0 Cal 1: CO2C1 Replicates: 3 [Range 1 3] Cal 2: CO2C2 о Calibrators Volumes о Intervals о Validity checks Calibrator: CO2C Diluted Calibrator level Sample sample Diluent Water Blank: Water 2.0 Cal 1: CO2C1 2.0 Cal 2: CO2C2 2.0 о Calibrators о Volumes Intervals о Validity checks Calibration intervals: Full interval: 336 (hours) Calibration type: Adjust type: None 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 Configure result units Assay: CO2C Version: Result units: meq/l Decimal places: 0 [Range 0 4] Correlation factor: Intercept: Carbon Dioxide Serum/Plasma SI Units Configure assay parameters Results о General о Calibration о SmartWash Results о Interpretation Assay: CO2C Assay number: 1067 Dilution default range: Result units: mmol/l Low-Linearity: 5 High-Linearity: 50 Gender and age specific ranges: GENDER AGE (UNITS) NORMAL EXTREME Either (Y) Configure result units Assay: CO2C Version: Result units: mmol/l Decimal places: 0 [Range 0 4] Correlation factor: Intercept: Due to differences in instrument systems and unit configurations, version numbers may vary. 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. 5

6 AEROSET SYSTEM ASSAY PARAMETERS Carbon Dioxide Serum/Plasma Conventional Units Assay Configuration: Outline Page Assay Name Assay # Line CO2C 67 B-Line Quantitative Ranges Min Text Min Panic-L L-Reference-H Panic-H Max Max Text * 0.0* * * 5 L-Linear Range-H 50 Reference Ranges* Age Male Female Qualitative Ranges N/A Carbon Dioxide Serum/Plasma SI Units Assay Configuration: Outline Page Assay Name Assay # Line CO2C 67 B-Line Quantitative Ranges Min Text Min Panic-L L-Reference-H Panic-H Max Max Text * 0.0* * * 5 L-Linear Range-H 50 Reference Ranges* Age Male Female Qualitative Ranges N/A Assay Configuration: Base Page Reaction Mode Wavelength-Prim/Sec Read time-main/flex AbsMaxVar END DOWN 404 / / Sample Blank Test Blank Read Time Abs Window Abs Limits CO2C ( 67 ) S.Vol DS.Vol D.Vol W.Vol Standard Rgt Name/Pos Dil Diluent: DILUENT D 18* Dil Type# 0 Rgt Name/Pos R.Vol W.Vol Type# Reagent 1 CO2C941 * Reaction Check Read Time A/B Range Minimum 1 1 / Factor/Intercept Decimal Places Units 1.0 / meq/l Assay Configuration: Base Page Reaction Mode Wavelength-Prim/Sec Read time-main/flex AbsMaxVar END DOWN 404 / / Sample Blank Test Blank Read Time Abs Window Abs Limits CO2C ( 67 ) S.Vol DS.Vol D.Vol W.Vol Standard Rgt Name/Pos Dil Diluent: DILUENT D 18* Dil Type# 0 Rgt Name/Pos R.Vol W.Vol Type# Reagent 1 CO2C941 * Reaction Check Read Time A/B Range Minimum 1 1 / Factor/Intercept Decimal Places Units 1.0 / mmol/l Assay Configuration: Calibration Page Calib Mode Interval (H) Linear 336 Blank/Calib Replicates Extrapolation % Span Span Abs Range 3 / 3 0 BLK Sample S.Vol DS.Vol D.Vol W.Vol Blk Abs Range BLK Water C1 CO2C Cal Deviation C2 CO2C FAC Limit (%) 10 Rgt Probe Assay Configuration: SmartWash Page Reagent Wash Vol DIG0051 AlkW 345 AMIK941 AlkW 345 VANCO51 AlkW 345 TOBRA41 AlkW 345 DGT0B11 AlkW 345 Cuvette Assay Name Wash Vol Sample Probe Wash Assay Configuration: Calibration Page Calib Mode Interval (H) Linear 336 Blank/Calib Replicates Extrapolation % Span Span Abs Range 3 / 3 0 BLK Sample S.Vol DS.Vol D.Vol W.Vol Blk Abs Range BLK Water C1 CO2C Cal Deviation C2 CO2C FAC Limit (%) 10 Rgt Probe Assay Configuration: SmartWash Page Reagent Wash Vol DIG0051 AlkW 345 AMIK941 AlkW 345 VANCO51 AlkW 345 TOBRA41 AlkW 345 DGT0B11 AlkW 345 Cuvette Assay Name Wash Vol Sample Probe Wash Refer to Assay Configuration in Section 2 of the AEROSET System Operations Manual for information regarding assay parameters. * User defined or instrument defined. Rgt Name listed is for 3L For 3L80-31, change Reagent 1 name to CO2C951. 6

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