CRP VARIO 6K26-30 and 6K26-41

NOTE: This package insert must be read carefully prior to product use. REAGENT HANDLING AND STORAGE (Continued) Package insert instructions must be followed accordingly. Reliability of assay results cannot be guaranteed if there are any deviations from the Reagent Storage instructions in this package insert. • Unopened reagents are stable until the expiration date when stored NOTE: Changes Highlighted at 2 to 8°C. • Reagent stability is 60 days if the reagent is uncapped and onboard. INTENDED USE Indications of Deterioration The MULTIGENT CRP Vario assay [CRPVa] is intended for the Instability or deterioration should be suspected if there are visible quantitative immunoturbidimetric determination of C-reactive protein in signs of leakage, extreme turbidity, microbial growth, if calibration does human serum and plasma with variable assay ranges [CRP16, CRP32, not meet the appropriate package insert and/or ARCHITECT System CRP48] using the ARCHITECT c Systems. Operations Manual criteria, or if controls do not meet the appropriate criteria. SUMMARY AND EXPLANATION OF TEST C-reactive protein (CRP) is an acute phase protein whose concentration WARNINGS AND PRECAUTIONS rises non-specifically in response to inflammation. CRP is seen to Precautions for Users increase as a result of the inflammatory process, most notably in response to pneumococcal (bacterial) infection, histolytic disease, and • For in vitro diagnostic use. a variety of other disease states. Intraindividual variation is a major • Do not use components beyond the expiration date. limitation of the assay when the assay is used for directing therapies. • Do not mix materials from different kit lot numbers. • CAUTION: This product requires the handling of human specimens. Intraindividual variations of the CRP levels are from 30% to 60%. Serial It is recommended that all human sourced materials be considered measurement may be required to estimate true mean of CRP depending potentially infectious and be handled in accordance with the OSHA on the intended use in any specific individual. CRP is used as a marker Standard on Bloodborne Pathogens.1 Biosafety Level 22 or other or general diagnostic indicator of infections and inflammation, in addition appropriate biosafety practices3,4 should be used for materials that to serving as a monitor of patient response to pharmacological therapy contain or are suspected of containing infectious agents. and surgery. • This product contains sodium azide; for a specific listing, refer to the REAGENTS section of this package insert. Contact with acids PRINCIPLES OF PROCEDURE liberates very toxic gas. This material and its container must be MULTIGENT CRP Vario is a latex immunoassay developed to accurately disposed of in a safe way. and reproducibly measure blood CRP levels in serum and plasma. NOTE: Refer to Section 8 of the ARCHITECT System Operations When an antigen-antibody reaction occurs between CRP in a sample Manual for proper handling and disposal of reagents containing and anti-CRP antibody, which has been adsorbed to latex particles, sodium azide. agglutination results. This agglutination is detected as an absorbance change (572 nm), with the rate of change being proportional to the SPECIMEN COLLECTION AND HANDLING quantity of CRP in the sample. Three different methods (High Sensitivity [CRP16], Standard [CRP32], and Wide Range [CRP48]) are available to Suitable Specimens cover a wide analytical measurement range. • Serum: Use serum collected by standard venipuncture techniques Methodology: Turbidimetric/Immunoturbidimetric into plastic tubes with or without gel barriers. Ensure complete clot formation has taken place prior to centrifugation. When processing REAGENTS samples, separate serum from blood cells or gel according to the specimen collection tube manufacturer’s instructions. Reagent Kit Some specimens, especially those from patients receiving 6K26-30 MULTIGENT CRP Vario is supplied as a two-reagent kit, anticoagulant or thrombolytic therapy, may take longer to complete which contains: their clotting processes. Fibrin clots may subsequently form in these sera and the clots could cause erroneous test results. 2 x 37 mL SYMBOLS IN PRODUCT LABELING CRP VARIO 2 x 37 mL • Plasma: Use plasma collected by standard venipuncture techniques into plastic tubes. Acceptable anticoagulants are lithium heparin 6K26-30 and 6K26-41 Calibrator 6K26-41 MULTIGENT CRP Vario is supplied as a two-reagent kit, (with or without gel barrier), sodium heparin, and EDTA. Ensure centrifugation is adequate to remove platelets. When processing Concentration which contains: samples, separate plasma from blood cells or gel according to the 3 x 86 mL specimen collection tube manufacturer’s instructions. Contents of kit 3 x 86 mL NOTE: Glass tubes were not tested. Contains sodium azide. Contact with acids Method Estimated Tests per Kit* For total sample volume requirements, refer to the ASSAY PARAMETERS liberates very toxic gas. section of this package insert and Section 5 of the ARCHITECT System For product questions contact Abbott Laboratories Customer Support 6K26-30 6K26-41 Operations Manual. High sensitivity 600 2,192 Control United States: 1-877-4ABBOTT Canada: 1-800-387-8378 (English speaking customers) Standard 600 2,192 Specimen Storage Wide range 500 1,836 1-800-465-2675 (French speaking customers) Maximum Bibliographic Identifies products to be used together Temperature International: Call your local Abbott representative *Calculation is based on the minimum reagent fill volume per kit. Storage Reference Ingredients Reactive Ingredients Concentration 20 to 25°C 15 days 5 2 to 8°C 2 months 5, 6 In vitro diagnostic medical device Glycine buffer (pH 7.0) 1.28% -20°C 3 years 5 Anti-CRP polyclonal antibodies (rabbit) 0.2% Batch code/Lot number adsorbed on latex particles Guder et al.5 suggest storage of frozen specimens at -20°C for no longer Nonreactive Ingredients: than the time interval cited above. However, limitations of laboratory Reagent 1 SENTINEL CH. SpA contains bovine albumin (≤ 1%) and sodium azide (< 0.1%). equipment make it necessary in practice for clinical laboratories to Via Robert Koch, 2 contains bovine albumin (≤ 0.1%) and sodium azide (< 0.1%). establish a range around -20°C for specimen storage. This temperature Reagent 2 Milan 20152 Italy range may be established from either the freezer manufacturer’s Catalog number/List number REAGENT HANDLING AND STORAGE specifications or your laboratory standard operating procedure(s) for specimen storage. Serial number Reagent Handling NOTE: Stored specimens must be inspected for particulates. If present, • Ready for use. mix and centrifuge the specimen to remove particulates prior to testing. Consult instructions for use • Ready for use. • Distributed by Remove air bubbles, if present in the reagent cartridge, with a Use by/Expiration date new applicator stick. Alternatively, allow the reagent to sit at the Abbott Laboratories Inc. Abbott Park, IL 60064 USA appropriate storage temperature to allow the bubbles to dissipate. Manufacturer and To minimize volume depletion, do not use a transfer pipette to remove ABBOTT the bubbles. 65205 Wiesbaden, Germany Temperature limitation CAUTION: Reagent bubbles may interfere with proper detection of July 2010 reagent level in the cartridge, causing insufficient reagent aspiration 6K263041_IFU_01_EN that could impact results.

8 / 8 1 / 8 PROCEDURE RESULTS Materials Provided Refer to Appendix C of the ARCHITECT System Operations Manual for information on results calculations. 6K26-30 MULTIGENT CRP Vario Kit 6K26-41 MULTIGENT CRP Vario Kit To convert results from mg/dL to mg/L, multiply mg/dL by 10. 7 Representative performance data are given in the EXPECTED VALUES Materials Required but not Provided and SPECIFIC PERFORMANCE CHARACTERISTICS sections of this • 6K26-10 MULTIGENT CRP Calibrator Set package insert. Results obtained in individual laboratories may vary. • 6K26-14 MULTIGENT CRP Calibrator HS • 6K26-12 MULTIGENT CRP Calibrator WR LIMITATIONS OF THE PROCEDURE • 6K26-21 MULTIGENT CRP Control HS The following are limitations on the use of the High Sensitivity CRP per 8 • 6K32-20 Immuno Control 1 (Not available in the US) CDC/AHA recommendations. • 6K32-21 Immuno Control 2 (Not available in the US) • Screening the entire adult population is not recommended. • Saline (0.85% to 0.90% NaCl) for specimens that require dilution • CRP is not a substitute for traditional cardiovascular risk factors. • Acute coronary syndrome management should not depend on Assay Procedure CRP measurements. For a detailed description of how to run an assay on the ARCHITECT • Patients with persistently unexplained CRP levels above 1.0 mg/dL c Systems, refer to Section 5 of the ARCHITECT System Operations (10 mg/L) should be evaluated for noncardiovascular etiologies. Manual. • Secondary prevention measures should not depend on CRP. Specimen Dilution Procedure • Serial measurements of CRP should not be used to monitor The ARCHITECT c Systems have automatic dilution features; refer to treatment. Section 2 of the ARCHITECT System Operations Manual for additional • The average of two CRP results, repeated optimally two weeks apart, information. should be used on metabolically stable patients. Serum and Plasma: Specimens with CRP values exceeding the linearity In very rare cases gammopathy, particularly of the monoclonal IgM are flagged and may be diluted by following either the Automated type (e.g., Waldenström macroglobulinemia), may cause unreliable Dilution Protocol or the Manual Dilution Procedure. results. Automated Dilution Protocol Refer to the SPECIMEN COLLECTION AND HANDLING and SPECIFIC PERFORMANCE CHARACTERISTICS sections of this package insert. If using the Automated Dilution Protocol, the system performs a dilution of the specimen and automatically corrects the concentration by EXPECTED VALUES multiplying the result by the appropriate dilution factor. The dilution for each method is listed below. Reference Range Range (mg/dL) Range (mg/L) Method Dilution 9 High sensitivity 1:10 Serum and plasma ≤ 0.5 ≤ 5 Standard 1:5 Schlebusch et al.10 have published pediatric reference ranges. Wide range 1:5 CRP is an acute phase protein whose concentration rises Manual Dilution Procedure non-specifically in response to inflammation. CRP values should not • Use saline (0.85% to 0.90% NaCl) to dilute the sample. be interpreted without a complete clinical evaluation. Follow-up testing • The operator must enter the dilution factor in the patient or control of patients with elevated values is recommended in order to help rule order screen. The system uses this dilution factor to automatically out a recent response to undetected infection or tissue injury. It is THIS PAGE INTENTIONALLY LEFT BLANK correct the concentration by multiplying the result by the entered recommended that each laboratory establish its own expected range. For factor. diagnostic purposes, the patient’s medical history and all other clinical • If the operator does not enter the dilution factor, the result must be findings should be considered when evaluating CRP results. multiplied by the appropriate dilution factor before reporting the result. NOTE: If a diluted sample result is flagged indicating it is less than the SPECIFIC PERFORMANCE CHARACTISTICS linear low limit, do not report the result. Rerun using an appropriate Reportable Range dilution. The reportable range for MULTIGENT CRP Vario is: For detailed information on ordering dilutions, refer to Section 5 of the ARCHITECT System Operations Manual. High Sensitivity Method 0.01 to 16.00 mg/dL (0.1 to 160 mg/L} Standard Method 0.02 to 32.00 mg/dL (0.2 to 320 mg/L) CALIBRATION Wide Range 0.02 to 48.00 mg/dL (0.2 to 480 mg/L) NOTE: The MULTIGENT CRP Vario assay must be calibrated using All three methods were tested for prozone up to a CRP concentration the individual levels listed in the ASSAY PARAMETERS. Refer to the of 100 mg/dL (1,000 mg/L). No prozone effect was observed within parameters for the High Sensitivity [CRP16], Standard [CRP32], and the linear range of the assay. At 100 mg/dL (1,000 mg/L) the observed Wide Range [CRP48] methods and the MULTIGENT CRP Calibrator result was correctly flagged as above the linearity of the assay. package insert specific for the method used in your laboratory. Limit of Quantitation (LOQ) Calibration is stable for approximately 15 days (360 hours) and is The LOQ is the analyte concentration at which the CV = 20%. The limit required with each change in reagent lot number. Verify calibration curve of quantification for MULTIGENT CRP Vario is: with at least two levels of controls according to the established quality High Sensitivity Method 0.01 mg/dL (0.1 mg/L) control requirements for your laboratory. If control results fall outside Standard and Wide Range Methods 0.02 mg/dL (0.2 mg/L) acceptable ranges, recalibration may be necessary. For a detailed description of how to calibrate an assay, refer to Section 6 Interfering Substances of the ARCHITECT System Operations Manual. Interference studies were conducted using an acceptance criteria of Standardization ± 5% deviation from the target value. No interference was observed at For information on calibrator standardization, refer to the MULTIGENT the concentrations below. CRP Calibrator package insert specific for the method used in your Interfering Substance Interferent Concentration laboratory. Bilirubin, conjugated and fetal 30 mg/dL (513 μmol/L) QUALITY CONTROL Hemoglobin 500 mg/dL (5 g/L) As appropriate, refer to your laboratory standard operating procedure(s) Intralipid 1,500 mg/dL (15 g/L) and/or quality assurance plan for additional quality control requirements Rheumatoid factor 550 IU/mL (550 kU/L) 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. 2 / 8 7 / 8 SPECIFIC PERFORMANCE CHARACTISTICS (Continued) Method Comparison (Continued) c Systems Assay Parameters Precision AEROSET vs. ARCHITECT vs. CRP Standard Method CRP Vario (Wide Range Method) Serum/Plasma: The precision of the MULTIGENT CRP Vario assay is ≤ 6% Total Nephelometer AEROSET Conventional and SI Units CV. Studies were performed using CLSI protocol NCCLS EP5-A.11 N5454 Representative results in mg/L are summarized below. Y - Intercept (95% CI*) -0.68 to 0.50 -0.64 to 0.46 Configure assay parameters — General Configure assay parameters — SmartWash Correlation Coefficient 0.9996 0.9997 CRP High Sensitivity Method Slope (95% CI*) 1.004 to 1.020 0.977 to 0.991 ● General о Calibration о SmartWash о Results о Interpretation о General о Calibration ● SmartWashо Results о Interpretation Assay: CRP48 Type: Photometric Version: †Assay: CRP48 Level 1 Level 2 Level 3 Level 4 Standard Error of the Estimate 1.64 1.58 Number: 2975 COMPONENT REAGENT / ASSAY WASH Volume Replicates N 40404040 Range (mg/L) 1.0 to 219.0 0.6 to 223 Run controls for onboard reagents by:* Lot Cuvette Trig** 10% Detergent B 345 Mean (mg/L) 0.462 4.92 11.35 45.88 * CI = Confidence Interval Within Run SD 0.019 0.035 0.148 0.298 ● Reaction definition о Reagent / Sample о Validity checks %CV 4.00 0.72 1.30 0.65 AEROSET vs. ARCHITECT vs. ** Not required for ARCHITECT software version 7.00 and above. CRP Wide Range Method Reaction mode: Rate up Between Run SD 0.011 0.024 0.109 0.120 Nephelometer AEROSET Primary Secondary Read times %CV 2.38 0.49 0.96 0.26 Wavelength: 572 / None Main: 20 – 26 SD 0.022 0.043 0.183 0.389 N5959 Last required read: 26 Flex: ___ – ___ Total %CV 4.66 0.87 1.62 0.85 Y - Intercept (95% CI*) -1.26 to 1.53 -1.44 to 2.04 Absorbance range: 0.7000 – 3.2000 Color correction: ___ – ___ Correlation Coefficient 0.9989 0.9982 Sample blank type: None NOTE: % CV was calculated prior to rounding Mean and SD. Slope (95% CI*) 1.023 to 1.051 0.968 to 0.999 CRP Vario (Wide Range Method) Serum/Plasma: Standard Error of the Estimate 4.10 5.28 CRP Standard Method Conventional Units Range (mg/L) 1.0 to 286.0 0.7 to 301.2 Level 1 Level 2 Level 3 Level 4 * CI = Confidence Interval о Reaction definition ● Reagent / Sample о Validity checks Configure assay parameters — Results N 40404040 R1 R2 о General о Calibration о SmartWash ● Results о Interpretation Mean (mg/L) 5.10 18.30 73.30 319.40 Reagent: CRP0S Reagent volume: 120 120 BIBLIOGRAPHY Assay: CRP48 Assay number: 2975 Within Run SD 0.10 0.11 0.37 2.08 Diluent: Saline Water volume: ______Dilution default range: Result units: mg/dL %CV 1.97 0.59 0.50 0.65 1. US Department of Labor, Occupational Safety and Health Diluent dispense mode: Type 0 Dispense mode: Type 0 Type 0 Low-Linearity: 0.02 SD 0.04 0.12 0.14 1.12 Administration. 29 CFR Part 1910.1030. Bloodborne Pathogens. Diluted Default High-Linearity: 48.00 Between Run Dilution name Sample sample Diluent Water Dilution factor dilution %CV 0.78 0.65 0.19 0.35 2. US Department of Health and Human Services. Biosafety in Gender and age specific ranges: SD 0.11 0.19 0.40 2.70 STANDARD : 2.0 ______= 1:1.00 GENDER AGE (UNITS) NORMAL EXTREME Total Microbiological and Biomedical Laboratories, 5th ed. Washington, Either 0 – 130 (Y) 0.00 – 0.50 %CV 2.15 1.04 0.54 0.85 DC: US Government Printing Office, January 2007. ● NOTE: % CV was calculated prior to rounding Mean and SD. 3. World Health Organization. Laboratory Biosafety Manual, 3rd ed. DIL 1 : 20.0 2.0 80 ___ = 1:5.00о Geneva: World Health Organization, 2004. ______: ______= ___ CRP Wide Range Method о 4. Sewell DL, Bove KE, Callihan DR, et al. Protection of Laboratory Level 1 Level 2 Level 3 Level 4 Workers from Occupationally Acquired Infections; Approved о Reaction definition о Reagent / Sample ● Validity checks N 40404040 Guideline—Third Edition (M29-A3). Wayne, PA: Clinical and Reaction check: None Mean (mg/L) 5.20 18.40 90.20 268.00 Laboratory Standards Institute, 2005. Configure result units Within Run SD 0.06 0.18 0.69 3.32 5. Guder WG, da Fonseca-Wollheim F, Heil W, et al. The Quality of Assay: CRP48 %CV 1.16 0.99 0.77 1.24 Diagnostic Samples. Darmstadt, Germany: GIT Verlag; 2001:24–5. Rate linearity %: ___ Version: † Between Run SD 0.05 0.08 0.76 3.35 6. US Pharmacopeial Convention, Inc. General notices. In: US Result units: mg/dL %CV 0.98 0.44 0.84 1.25 Pharmacopeia National Formulary, 1995 ed (USP 23/NF 18). Decimal places: 2 [Range 0 – 4] Total SD 0.1 0.22 1.25 4.92 Rockville, MD: The US Pharmacopeial Convention, Inc; 1994:11. Correlation factor: 1.0000 %CV 1.91 1.17 1.39 1.83 Configure assay parameters — Calibration Intercept: 0.0000 7. Burtis CA, Ashwood ER, Bruns DE, editors. Tietz Textbook of Clinical Chemistry and Molecular Diagnostics, 4th ed. St Louis, MO: Elsevier о General ● Calibration о SmartWashо Results о Interpretation Method Comparison Assay: CRP48 Calibration method: Spline Saunders; 2006:2263. Serum results from the MULTIGENT CRP Vario methods on the 8. Pearson TA, Mensah GA, Alexander RW, et al. Markers of AEROSET System were compared with the results from a commercially inflammation and cardiovascular disease: application to clinical and ● Calibrators о Volumes о Intervals о Validity checks available nephelometric methodology. public health practice: A statement for healthcare professionals from Concentration:‡ Calibrator set: Calibrator level: (Short name)‡‡ (mg/dL) (mg/L) Serum results from the MULTIGENT CRP Vario methods on an the Centers for Disease Control and Prevention and the American 48CRP Blank: Water 0.00 0.0 ARCHITECT c System were compared with the results on the AEROSET Heart Association. Circulation 2003;107(3):499–511. Cal 1: 48CRP1 CRP Vario (Wide Range Method) Serum/Plasma: System. 9. Dati F, Johnson AM, Whicher JT. The existing interim consensus (CRP05) 0.50 5.0 SI Units Replicates: 2 [Range 1 - 3] Cal 2: 48CRP2 (CRP10) 1.00 10.0 For the MULTIGENT CRP High Sensitivity method only, serum results reference ranges and the future approach. Clin Chem Lab Med 2001;39(11):1134–6. Cal 3: 48CRP3 (CRP20) 2.00 20.0 from an ARCHITECT c System and the AEROSET System were also Configure assay parameters — Results 10. Schlebusch H, Liappis N, Kalina E, et al. High sensitive CRP and Cal 4: 48CRP4 (CRP40) 4.00 40.0 compared with the results from a commercially available turbidimetric Cal 5: 48CRP5 о General о Calibration о SmartWash ● Results о Interpretation methodology. creatinine: reference intervals from infancy to childhood. J Lab Med (CRP160) 16.00 160.0 Assay: CRP48 Assay number: 2975 2002;26(5/6):341–6. Cal 6: 48CRP6 Method comparison data are presented in mg/L. (CRPWR) 48.00 480.0 Dilution default range: Result units: mg/L 11. Kennedy JW, Carey RN, Coolen RB, et al. Evaluation of Precision Low-Linearity: 0.2 AEROSET vs. ARCHITECT vs. Performance of Clinical Chemistry Devices; Approved Guideline High-Linearity: 480.0 CRP High Sensitivity Method о Calibrators ● Volumes о Intervals о Validity Genderchecks and age specific ranges: Nephelometer AEROSET (EP5-A). Wayne, PA: The National Committee for Clinical Laboratory Calibrator: 48CRP Diluted GENDER AGE (UNITS) NORMAL EXTREME N4545Standards, 1999. Calibrator level Sample sample DiluentEither Water 0 – 130 (Y) 0.0 – 5.0 Y - Intercept (95% CI*) -0.24 to 0.54 -0.33 to 0.45 Blank: Water 2.0 ______Correlation Coefficient 0.9994 0.9994 TRADEMARKS Cal 1: 48CRP1 2.0 ______Slope (95% CI*) 0.985 to 1.006 0.975 to 0.996 CRP Vario is a trademark of Sentinel CH. SpA in various jurisdictions. Cal 2: 48CRP2 4.0 Standard Error of the Estimate 0.96 0.96 Cal 3: 48CRP3 5.0 ______The ARCHITECT c System family of instruments consists of c 4000, Range (mg/L) 1.0 to 104.0 1.1 to 103.3 Cal 4: 48CRP4 5.0 ______c 8000, and c 16000 Systems. Cal 5: 48CRP5 3.0 ______* CI = Confidence Interval Cal 6: 48CRP6 2.0 ______AEROSET, ARCHITECT, c 4000, c 8000, c 16000, c System, MULTIGENT, Configure result units AEROSET vs. ARCHITECT vs. and SmartWash are trademarks of Abbott Laboratories in various jurisdictions. Assay: CRP48 CRP High Sensitivity Method Turbidimetric Turbidimetric Version: † Method Method All trademarks are property of their respective owners. Result units: mg/L N5555 о Calibrators о Volumes ● Intervals о Validity checks US Patent: 6,248,597 / 6,828,158 and equivalent patents in other Calibration intervals: Decimal places: 1 [Range 0 – 4] Y - Intercept (95% CI*) -0.01 to 0.07 -0.02 to 0.10 countries. Full interval: 360 (hours) Correlation factor: 1.0000 Correlation Coefficient 0.9995 0.9990 Calibration type: Intercept: 0.0000 Slope (95% CI*) 0.992 to 1.009 1.001 to 1.035 Adjust type: None Standard Error of the Estimate 0.10 0.14 6K263041_IFU_01_EN Range (mg/L) 0.2 to 13.6 0.2 to 13.6 * CI = Confidence Interval о Calibrators о Volumes о Intervals ● Validity checks Blank absorbance range: -0.0500 – 0.0500 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. * Parameter is available in ARCHITECT software version 7.00 and above. ‡ Displays the number of decimal places defined in the decimal place field. In ARCHITECT software version 5.00 and above, these values are defined on the Configure calibrator set screen. ‡‡ Short name does not display on instrument screen. 6 / 8 3 / 8 c Systems Assay Parameters c Systems Assay Parameters CRP Vario (High Sensitivity Method) Serum/Plasma: CRP Vario (Standard Method) Serum/Plasma: Conventional and SI Units Conventional and SI Units Configure assay parameters — General Configure assay parameters — SmartWash Configure assay parameters — General Configure assay parameters — SmartWash ● General о Calibration о SmartWash о Results о Interpretation о General о Calibration ● SmartWashо Results о Interpretation ● General о Calibration о SmartWash о Results о Interpretation о General о Calibration ● SmartWashо Results о Interpretation Assay: CRP16 Type: Photometric Version: †Assay: CRP16 Assay: CRP32 Type: Photometric Version: †Assay: CRP32 Number: 2974 COMPONENT REAGENT / ASSAY WASH Volume Replicates Number: 2973 COMPONENT REAGENT / ASSAY WASH Volume Replicates Run controls for onboard reagents by:* Lot CuvetteTrig** 10% Detergent B 345 Run controls for onboard reagents by:* Lot CuvetteTrig** 10% Detergent B 345

● Reaction definition о Reagent / Sample о Validity checks ● Reaction definition о Reagent / Sample о Validity checks Reaction mode: Rate up ** Not required for ARCHITECT software version 7.00 and above. Reaction mode: Rate up ** Not required for ARCHITECT software version 7.00 and above. Primary Secondary Read times Primary Secondary Read times Wavelength: 572 / None Main: 20 – 26 Wavelength: 572 / None Main: 20 – 26 Last required read: 26 Flex: ___ – ___ Last required read: 26 Flex: ___ – ___ Absorbance range: 0.7000 – 3.2000 Color correction: ___ – ___ Absorbance range: 0.7000 – 3.2000 Color correction: ___ – ___ Sample blank type: None Sample blank type: None CRP Vario (High Sensitivity Method) Serum/Plasma: CRP Vario (Standard Method) Serum/Plasma: Conventional Units Conventional Units

о Reaction definition ● Reagent / Sample о Validity checks Configure assay parameters — Results о Reaction definition ● Reagent / Sample о Validity checks Configure assay parameters — Results R1 R2 о General о Calibration о SmartWash ● Results о Interpretation R1 R2 о General о Calibration о SmartWash ● Results о Interpretation Reagent: CRP0S Reagent volume: 100 100 Assay: CRP16 Assay number: 2974 Reagent: CRP0S Reagent volume: 100 100 Assay: CRP32 Assay number: 2973 Diluent: Saline Water volume: ______Dilution default range: Result units: mg/dL Diluent: Saline Water volume: ______Dilution default range: Result units: mg/dL Diluent dispense mode: Type 0 Dispense mode: Type 0 Type 0 Low-Linearity: 0.01 Diluent dispense mode: Type 0 Dispense mode: Type 0 Type 0 Low-Linearity: 0.02 Diluted Default High-Linearity: 16.00 Diluted Default High-Linearity: 32.00 Dilution name Sample sample Diluent Water Dilution factorGender dilution and age specific ranges: Dilution name Sample sample Diluent Water Dilution factorGender dilution and age specific ranges: STANDARD : 4.0 ______= 1:1.00 GENDER AGE (UNITS) NORMAL EXTREME STANDARD : 2.0 ______= 1:1.00 GENDER AGE (UNITS) NORMAL EXTREME Eithe●r 0 – 130 (Y) 0.00 – 0.50 Eithe●r 0 – 130 (Y) 0.00 – 0.50 DIL 1 : 10.0 4.0 90 ___ = 1:10.00о DIL 1 : 20.0 2.0 80 ___ = 1:5.00о ______: ______= ___о ______: ______= ___о

о Reaction definition о Reagent / Sample ● Validity checks о Reaction definition о Reagent / Sample ● Validity checks Reaction check: None Reaction check: None Configure result units Configure result units Assay: CRP16 Assay: CRP32 Rate linearity %: ___ Version: † Rate linearity %: ___ Version: † Result units: mg/dL Result units: mg/dL Decimal places: 2 [Range 0 – 4] Decimal places: 2 [Range 0 – 4] Configure assay parameters — Calibration Correlation factor: 1.0000 Correlation factor: 1.0000 Intercept: 0.0000 Configure assay parameters — Calibration Intercept: 0.0000 о General ● Calibration о SmartWashо Results о Interpretation о General ● Calibration о SmartWashо Results о Interpretation Assay: CRP16 Calibration method: Spline Assay: CRP32 Calibration method: Spline

● Calibrators о Volumes о Intervals о Validity checks ● Calibrators о Volumes о Intervals о Validity checks Concentration:‡ Calibrator set: Calibrator level: (mg/dL) (mg/L) Concentration:‡ (Short name)‡‡ Calibrator set: Calibrator level: (Short name)‡‡ (mg/dL) (mg/L) 16CRP Blank: Water 0.00 0.00 32CRP Blank: Water 0.00 0.0 Cal 1: 16CRP1 CRP Vario (High Sensitivity Method) Serum/Plasma: CRP Vario (Standard Method) Serum/Plasma: (CRPHS) 0.25 2.50 Cal 1: 32CR(CRP05)P1 0.50 5.0 Replicates: 2 [Range 1 - 3] Cal 2: 16CRP2 SI Units SI Units (CRP05) 0.50 5.00 Replicates: 2 [Range 1 - 3] Cal 2: 32CRP2 (CRP10) 1.00 10.0 Cal 3: 16CRP3 (CRP10) 1.00 10.00 Configure assay parameters — Results Cal 3: 32CRP3 (CRP20) 2.00 20.0 Configure assay parameters — Results Cal 4: 16CRP4 (CRP20) 2.00 20.00 Cal 4: 32CRP4 (CRP40) 4.00 40.0 Cal 5: 16CRP5 о General о Calibration о SmartWash ● Results о Interpretation о General о Calibration о SmartWash ● Results о Interpretation (CRP80) 8.00 80.00 Cal 5: 32CRP5 (CRP160) 16.00 160.0 Cal 6: 16CRP6 Assay: CRP16 Assay number: 2974 Assay: CRP32 Assay number: 2973 (CRP160) 16.00 160.00 Dilution default range: Result units: mg/L Cal 6: 32CRP6 (CRP320) 32.00 320.0 Dilution default range: Result units: mg/L Low-Linearity: 0.10 Low-Linearity: 0.2 High-Linearity: 160.00 High-Linearity: 320.0 о Calibrators ● Volumes о Intervals о Validity Genderchecks and age specific ranges: о Calibrators ● Volumes о Intervals о Validity checksGender and age specific ranges: Calibrator: 16CRP Diluted GENDER AGE (UNITS) NORMAL EXTREME Calibrator: 32CRP Diluted GENDER AGE (UNITS) NORMAL EXTREME Calibrator level Sample sample DiluentEi Waterther 0 – 130 (Y) 0.00 – 5.00 Calibrator level Sample sample DiluentEi Waterther 0 – 130 (Y) 0.0 – 5.0 Blank: Water 4.0 ______Blank: Water 2.0 ______Cal 1: 16CRP1 4.0 ______Cal 1: 32CRP1 2.0 ______Cal 2: 16CRP2 4.0 ______Cal 2: 32CRP2 2.0 ______Cal 3: 16CRP3 4.0 ______Cal 3: 32CRP3 2.0 ______Cal 4: 16CRP4 4.0 ______Cal 4: 32CRP4 2.0 ______Cal 5: 16CRP5 4.0 ______Cal 5: 32CRP5 2.0 ______Cal 6: 16CRP6 4.0 ______Cal 6: 32CRP6 2.0 ______Configure result units Configure result units Assay: CRP16 Assay: CRP32 Version: † Version: † о Calibrators о Volumes ● Intervals о Validity checks Result units: mg/L Result units: mg/L Decimal places: 2 [Range 0 – 4] о Calibrators о Volumes ● Intervals о Validity checks Calibration intervals: Calibration intervals: Decimal places: 1 [Range 0 – 4] Correlation factor: 1.0000 Full interval: 360 (hours) Full interval: 360 (hours) Correlation factor: 1.0000 Intercept: 0.0000 Calibration type: Calibration type: Intercept: 0.0000 Adjust type: None Adjust type: None

о Calibrators о Volumes о Intervals ● Validity checks о Calibrators о Volumes о Intervals ● Validity checks Blank absorbance range: -0.0500 – 0.0500 Blank absorbance range: -0.0500 – 0.0500 Span: Blank – Blank Span: Blank – Blank Span absorbance range: _____ – _____ Span absorbance range: _____ – _____ Expected cal factor: 0.00 Expected cal factor: 0.00 Expected cal factor tolerance %: 0 † Expected cal factor tolerance %: 0

† Due to differences in instrument systems and unit configurations, version numbers may vary. Due to differences in instrument systems and unit configurations, version numbers may vary. * Parameter is available in ARCHITECT software version 7.00 and above. * Parameter is available in ARCHITECT software version 7.00 and above. ‡ Displays the number of decimal places defined in the decimal place field. In ARCHITECT software version 5.00 and above, these values are defined ‡ Displays the number of decimal places defined in the decimal place field. In ARCHITECT software version 5.00 and above, these values are defined on the Configure calibrator set screen. on the Configure calibrator set screen. ‡‡ Short name does not display on instrument screen. ‡‡ Short name does not display on instrument screen. 4 / 8 5 / 8