ARCHITECT cSystems only Multigent C-Reactive Protein (CRP) Harmonization 6K26-30, 6K26-41 Worldwide Launch: September 2010 REF Not for customer distribution For information only unless accompanied by the Lotus Notes form that contains electronic signatures. c8000 Project Notebook, 3.6.21, version 5 © 2010 Abbott

Assay Disk Information Clinical Utility Reaction & Methodology Agenda Launch Strategy Assay Disk Information Clinical Utility Reaction & Methodology Sample Handling Reagent Handling Calibration Quality Control Performance Data Interference Precision Method Comparison Product Summary Q&A Not for customer distribution For information only unless accompanied by the Lotus Notes form that contains electronic signatures. c8000 Project Notebook, 3.6.21, version 5 © 2010 Abbott Multigent CRP Harmonization September 2010

Multigent CRP Launch Strategy The Multigent assays are available for use on the ARCHITECT cSystems. Complaint handling: Abbott has responsibility for initial complaint registration. Sentinel (the vendor) will investigate Level II complaints. Not for customer distribution For information only unless accompanied by the Lotus Notes form that contains electronic signatures. c8000 Project Notebook, 3.6.21, version 5 © 2010 Abbott Multigent CRP Harmonization September 2010

Multigent CRP Launch Strategy Key updates to CRP assays MULTIGENT CRP Vario (6K26) Enhancements… convert from Sentinel orange cartridges to Abbott reagent cartridges convert from Sentinel cartons / boxes to Abbott cartons convert to a global Abbott branded labeling have a size code change to reflect the change New smaller kit size Discontinue duplicate products…. Abbott CRP (8G65-21) Abbott CRP Calibrator (8G68-02) Not for customer distribution For information only unless accompanied by the Lotus Notes form that contains electronic signatures. c8000 Project Notebook, 3.6.21, version 5 © 2010 Abbott Multigent CRP Harmonization September 2010

Multigent CRP Launch Strategy Activities and Timeline September 2010 Customer Launch Letter – Release in September for distribution to customers. Customers convert to the enhanced CRP Vario Reagents, Cals & QC within 7 months of availability. Current sizecodes will be discontinued. CRP Vario Reagent CRP Cal Set CRP Cal WR CRP Cal HS CRP Control HS Discontinue Abbott CRP (8G65) Not for customer distribution For information only unless accompanied by the Lotus Notes form that contains electronic signatures. c8000 Project Notebook, 3.6.21, version 5 © 2010 Abbott Multigent CRP Harmonization September 2010

Assay Disk Information Multigent CRP parameters Standard CRP, Assay 2973, High Sensitivity CRP Assay 2974, and Wide Range CRP, Assay 2975 are available on the following recently released ARCHITECT cSystems assay disks. Assay Disks List Number ARCHITECT c Systems MULTIGENT Assay Disk Conventional Units / Alternate Units 8K50-04 SI Units / Alternate Units 8K51-04 ARCHITECT c Systems Special Chemistry Assay Disk Conventional Units / Alternate Units 2P10-03 Disk SI Units / Alternate Units 2P11-03 Assay configuration is provided in the assay specific application sheets. Not for customer distribution For information only unless accompanied by the Lotus Notes form that contains electronic signatures. c8000 Project Notebook, 3.6.21, version 5 © 2010 Abbott Multigent CRP Harmonization September 2010

Clinical Utility CRP Vario assay is intended for the quantitative immunoturbidimetric determination of C-reactive protein in human serum and plasma with variable assay ranges covering a wide analytical measurement range. Three different applications of the assay are available for use: CRP Standard CRP32 –measures normal to high levels of CRP. CRP HS (High Sensitivity) CRP16 – identifies extremely low levels of CRP. CRP WR (Wide Range) CRP48 – measures within the standard range but with an extended linearity allowing for higher measurement and reduced dilutions. Not for customer distribution For information only unless accompanied by the Lotus Notes form that contains electronic signatures. c8000 Project Notebook, 3.6.21, version 5 © 2010 Abbott Multigent CRP Harmonization September 2010

Clinical Utility CRP testing is used as: A marker or general diagnostic indicator of infections and inflammation.¹ One of the fastest reacting acute phase protein² Levels may rise more than 1000-fold during an acute phase response² Prognosis and extent of coronary atherosclerosis - elevated levels are linked to the occurrence.³ Progression of both stable and unstable angina.³ Monitoring disease activity & response.³ Example: Monitor CRP following surgery Source: 1. Multigent CRP Vario 6K26 Package Insert. 2. FBR Guide 3. Jacobs and Demott, Editors, Laboratory Test Handbook 5th Edition, 2001, Lexi-comp, Inc, Hudson, OH Not for customer distribution For information only unless accompanied by the Lotus Notes form that contains electronic signatures. c8000 Project Notebook, 3.6.21, version 5 © 2010 Abbott Multigent CRP Harmonization September 2010

Clinical Utility Increased CRP values are associated with: Injury/Trauma Infection Stress Myocardial Infarction Surgery Inflammation Tumor growth Decreased CRP values are associated with: Normal (absence of disease state) NOTE: MULTIGENT CRP Vario does not have the right to claim cardiac risk screening as a function of clinical utility and/or intended use. High sensitivity CRP is not specific for cardiovascular disease. Source: Jacobs and Demott, Editors, Laboratory Test Handbook 5th Edition, 2001, Lexi-comp, Inc, Hudson, OH, FBR Guide Not for customer distribution For information only unless accompanied by the Lotus Notes form that contains electronic signatures. c8000 Project Notebook, 3.6.21, version 5 © 2010 Abbott Multigent CRP Harmonization September 2010

Multigent CRP Reaction & Methodology Step 1: Sample containing CRP is added to Reagent 1 (Glycine Buffer). Step 2: Reagent 2 containing Antibody (anti-human CRP rabbit serum) is added to the sample/Reagent 1 mix. Sample/ Reagent 1 Reagent 2 Y Y Y Y Y Y Y + ↑ CRP ↑ CRP Specific Antibody Step 3: When sample containing CRP is added to R1 and mixed with the antibody in Reagent 2 insoluble aggregates form. The degree of agglutination is directly proportional to the concentration of CRP in the sample. This is determined by measuring the decrease of transmitted light caused by the aggregates at a wavelength of 572 nm. Y Y Y Y Y Y Y Y Y Not for customer distribution For information only unless accompanied by the Lotus Notes form that contains electronic signatures. c8000 Project Notebook, 3.6.21, version 5 © 2010 Abbott Multigent CRP Harmonization September 2010

Multigent CRP methodology Turbidimetric/Immunoturbidimetric Available in the CAP Diagnostic Immunology Survey Contact CAP for the current coding. Not for customer distribution For information only unless accompanied by the Lotus Notes form that contains electronic signatures. c8000 Project Notebook, 3.6.21, version 5 © 2010 Abbott Multigent CRP Harmonization September 2010

Multigent CRP Sample Handling Specimen Requirements: Serum Plastic tubes With or without gel barrier Plasma Lithium Heparin (With or without gel barrier) or Sodium Heparin or EDTA Not for customer distribution For information only unless accompanied by the Lotus Notes form that contains electronic signatures. c8000 Project Notebook, 3.6.21, version 5 © 2010 Abbott Multigent CRP Harmonization September 2010

Multigent CRP Sample Handling Specimen storage: * Guder WG, da Fonseca-Wollheim F, Heil W, et al. The Quality of Diagnostic Samples. Darmstadt, Germany: GIT Verlag; 2001:24-5. Repeated freeze/thaw cycles should be avoided to minimize potential protein degradation. Stored specimens must be inspected for particulates. If present, mix and centrifuge to remove particulates prior to testing. Temperature Maximum Storage * Serum/Plasma 20 to 25°C 2 to 8°C -20°C 15 days 2 months 3 years Not for customer distribution For information only unless accompanied by the Lotus Notes form that contains electronic signatures. c8000 Project Notebook, 3.6.21, version 5 © 2010 Abbott Multigent CRP Harmonization September 2010

Multigent CRP Reagent Handling 2 Reagent Kit Configurations Tests/kit Estimated calculation is based on the minimum reagent fill volume per kit. Reagent is liquid, ready-to-use, 2 reagent kit Storage 2 to 8°C. Unopened kit stable to expiration date Remove any air bubbles, if present, with an applicator stick Reagent onboard stability – 60 days (1440 hours) 6K26-30 R1 2 x 37 mL R2 6K26-41 3 x 86 mL 3 x 88 mL Method 6K26-30 (# of tests) 6K26-41 High Sensitivity 600 2,192 Standard Wide Range 500 1,836 Not for customer distribution For information only unless accompanied by the Lotus Notes form that contains electronic signatures. c8000 Project Notebook, 3.6.21, version 5 © 2010 Abbott Multigent CRP Harmonization September 2010

Multigent CRP Calibration Standard Method Calibration interval is 15 days (360 hours) Use the Multigent CRP Calibrator 6K26 –10 Calibration: Standard method uses six levels of CRP Calibrator. REF Standard Method Size CRP 05 1 x 2 mL CRP 10 CRP 20 CRP 40 CRP 160 CRP 320 Not for customer distribution For information only unless accompanied by the Lotus Notes form that contains electronic signatures. c8000 Project Notebook, 3.6.21, version 5 © 2010 Abbott Multigent CRP Harmonization September 2010

Multigent CRP Calibration Wide Range Method Calibration interval is 15 days (360 hours) Use the Multigent CRP Calibrator 6K26 –10 substituting CRP 320 with CRP WR 6K26-12 Calibration: Wide Range method uses six levels of CRP Calibrator. REF REF Wide Range Method Size CRP 05 1 x 2 mL CRP 10 CRP 20 CRP 40 CRP 160 CRP WR (6K26-12) Not for customer distribution For information only unless accompanied by the Lotus Notes form that contains electronic signatures. c8000 Project Notebook, 3.6.21, version 5 © 2010 Abbott Multigent CRP Harmonization September 2010

Multigent CRP Calibration High Sensitivity Method Calibration interval is 15 days (360 hours) Use the Multigent CRP Calibrator 6K26 –10 substituting CRP 320 with CRP HS 6K26-14 and adding CRP 80 from 6K26 –10 Calibration: High Sensitivity method uses six levels of CRP Calibrator. REF REF High Sensitivity Method Size CRP HS (6K26-14) 1 x 2 mL CRP 05 CRP 10 CRP 20 CRP 80 CRP 160 Not for customer distribution For information only unless accompanied by the Lotus Notes form that contains electronic signatures. c8000 Project Notebook, 3.6.21, version 5 © 2010 Abbott Multigent CRP Harmonization September 2010

Multigent CRP Calibration Do not freeze calibrators. Calibrators are liquid ready to use. The calibrators are prepared by diluting CRP with human serum. Calibrator values are verified using ERM-DA472/IFCC (European Reference Material/International Federation Clinical Chemistry) from IRMM(Institute for Reference Materials and Measurements). The concentration of the calibrators are indicated in each respective Multigent CRP Calibrator package insert and on the vial labels. Unopened calibrators are stable until the expiration date indicated on the package when stored at 2-8 °C. Opened calibrators are stable for 3 months at 2 to 8°C if contamination is avoided and vials are recapped immediately after use. Not for customer distribution For information only unless accompanied by the Lotus Notes form that contains electronic signatures. c8000 Project Notebook, 3.6.21, version 5 © 2010 Abbott Multigent CRP Harmonization September 2010

Multigent CRP Calibration Curve – ARCHITECT cSystems CRP High Sensitivity (CRP16) Not for customer distribution For information only unless accompanied by the Lotus Notes form that contains electronic signatures. c8000 Project Notebook, 3.6.21, version 5 © 2010 Abbott Multigent CRP Harmonization September 2010

Multigent CRP Calibration Curve – ARCHITECT cSystems CRP Standard (CRP32) Not for customer distribution For information only unless accompanied by the Lotus Notes form that contains electronic signatures. c8000 Project Notebook, 3.6.21, version 5 © 2010 Abbott Multigent CRP Harmonization September 2010

Multigent CRP Calibration Curve – ARCHITECT cSystems CRP Wide Range (CRP48) Not for customer distribution For information only unless accompanied by the Lotus Notes form that contains electronic signatures. c8000 Project Notebook, 3.6.21, version 5 © 2010 Abbott Multigent CRP Harmonization September 2010

Multigent CRP Quality Control The High Sensitivity method uses the Multigent CRP Control HS, 6K26-21 Multigent CRP Control HS, List No. 6K26-21 contains: Other acceptable controls are : Immuno Control 1 6K32-20 (Not available in the US) Immuno Control 2 6K32-21 (Not available in the US) These are the only controls approved for use with this assay. REF Control Product Name Configuration CRP Control HS 3 x 2 mL REF REF Not for customer distribution For information only unless accompanied by the Lotus Notes form that contains electronic signatures. c8000 Project Notebook, 3.6.21, version 5 © 2010 Abbott Multigent CRP Harmonization September 2010

Multigent CRP Performance Data Serum and Plasma Normal Expected Range (adults): < 0.5 mg/dL (< 5 mg/L) Reportable Range: 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) Wide Range method 0.02 to 48.00 mg/dL (0.2 to 480 mg/L) Limit of Quantitation (LOQ) = High sensitivity method 0.01 mg/dL (0.1 mg/L) Standard and Wide Range methods 0.02 mg/dL (0.2 mg/L) LOQ represents the lowest measurable concentration at which the CV < 20% and the recovery is within +/- 20% of expected value. Note: SI units are mg/L. To convert results from mg/dL to mg/L, multiply by 10. Not for customer distribution For information only unless accompanied by the Lotus Notes form that contains electronic signatures. c8000 Project Notebook, 3.6.21, version 5 © 2010 Abbott Multigent CRP Harmonization September 2010

Multigent CRP Interference Interference studies were conducted using an acceptance criteria of +/- 5% deviation from the target value. No interference was observed at the concentrations below. Interfering Substance Interferent Concentration Bilirubin, conjugated and fetal 30 mg/dL (513 μmol/L) Hemoglobin 500 mg/dL (5.0 g/L) Intralipid 1,500 mg/dL (15 g/L) Rheumatoid factor 550 IU/mL (650 kU/L) Not for customer distribution For information only unless accompanied by the Lotus Notes form that contains electronic signatures. c8000 Project Notebook, 3.6.21, version 5 © 2010 Abbott Multigent CRP Harmonization September 2010

Multigent CRP Precision Representative data from precision study are summarized below. The precision acceptance criteria for the CRP assay is ≤6% Total CV. CRP High Sensitivity Method: Representative Data LEVEL N Concentration Mean (mg/L) CV (%) Within Run Total Control Level 1 40 0.462 4.0 4.66 Control Level 2 4.92 0.72 0.87 Control Level 3 11.35 1.30 1.62 Control Level 4 45.88 0.65 0.85 Not for customer distribution For information only unless accompanied by the Lotus Notes form that contains electronic signatures. c8000 Project Notebook, 3.6.21, version 5 © 2010 Abbott Multigent CRP Harmonization September 2010

Multigent CRP Precision The precision acceptance criteria for the CRP assay is ≤6% Total CV. CRP Standard Method: Representative Data LEVEL N Concentration Mean (mg/L) CV (%) Within Run Total Control Level 1 40 5.10 1.97 2.15 Control Level 2 18.30 0.59 1.04 Control Level 3 73.30 0.50 0.54 Control Level 4 319.40 0.65 0.85 Not for customer distribution For information only unless accompanied by the Lotus Notes form that contains electronic signatures. c8000 Project Notebook, 3.6.21, version 5 © 2010 Abbott Multigent CRP Harmonization September 2010

Multigent CRP Precision The precision acceptance criteria for the CRP assay is ≤6% Total CV. CRP Wide Range Method: Representative Data LEVEL N Concentration Mean (mg/L) CV (%) Within Run Total Control Level 1 40 5.20 1.16 1.91 Control Level 2 18.40 0.99 1.17 Control Level 3 90.20 0.77 1.39 Control Level 4 268.0 1.24 1.83 Not for customer distribution For information only unless accompanied by the Lotus Notes form that contains electronic signatures. c8000 Project Notebook, 3.6.21, version 5 © 2010 Abbott Multigent CRP Harmonization September 2010

Method Comparison CRP Vario (6K26) vs. Abbott CRP (8G65) Method Comparison testing was performed on ARCHITECT c16000 Least Squares Passing-Bablok Bias / Total Error N Corr Coef Slope Intercept %95 CI 95% CI Mean Bias Mean % Bias 119 0.9996 1.01 (1.00, 1.01) -0.06 (-0.09, -0.03) 0.98 (0.97, 0.99) -0.00 (-0.01, 0.01) -0.03 -1.8 Not for customer distribution For information only unless accompanied by the Lotus Notes form that contains electronic signatures. c8000 Project Notebook, 3.6.21, version 5 © 2010 Abbott Multigent CRP Harmonization September 2010

Multigent CRP Method Comparison Serum results from the Multigent CRP High Sensitivity assay on an ARCHITECT cSystem were compared with the results on the AEROSET system. Serum results from the Multigent CRP assay on an AEROSET system were compared with results on the Beckman Image. CRP High Sensitivity Method ARCHITECT cSystem vs. AEROSET (1.1 to 103.3 mg/L) AEROSET vs. Comparative Method (1.0 to 104.0 mg/L) N 45 Y – Intercept -0.33 to 0.45 -0.24 to 0.54 Correlation Coefficient 0.9994 Slope 0.975 to 0.996 0.985 to 1.006 Not for customer distribution For information only unless accompanied by the Lotus Notes form that contains electronic signatures. c8000 Project Notebook, 3.6.21, version 5 © 2010 Abbott Multigent CRP Harmonization September 2010

Multigent CRP Method Comparison For the MULTIGENT CRP High Sensitivity method only, serum results from an ARCHITECT cSystem and the AEROSET System were also compared with the results from a commercially available turbidimetric methodology. CRP High Sensitivity Method ARCHITECT vs. Turbidimetric (0.2 to 13.6 mg/L) AEROSET vs. N 55 Y – Intercept -0.02 to 0.10 -0.01 to 0.07 Correlation Coefficient 0.9990 0.9995 Slope 1.001 to 1.035 0.992 to 1.009 Not for customer distribution For information only unless accompanied by the Lotus Notes form that contains electronic signatures. c8000 Project Notebook, 3.6.21, version 5 © 2010 Abbott Multigent CRP Harmonization September 2010

Multigent CRP Method Comparison Serum results from the Multigent CRP Standard assay on an ARCHITECT cSystem were compared with the results on the AEROSET system. Serum results from the Multigent CRP assay on an AEROSET system were compared with results on the Beckman Image. CRP Standard Method ARCHITECT cSystem vs. AEROSET (0.6 to 223 mg/L) AEROSET vs. Comparative Method (1.0 to 219.0 mg/L) N 54 Y – Intercept -0.64 to 0.46 -0.68 to 0.50 Correlation Coefficient 0.9997 0.9996 Slope 0.977 to 0.991 1.004 to 1.020 Not for customer distribution For information only unless accompanied by the Lotus Notes form that contains electronic signatures. c8000 Project Notebook, 3.6.21, version 5 © 2010 Abbott Multigent CRP Harmonization September 2010

Multigent CRP Method Comparison Serum results from the Multigent CRP Wide Range assay on an ARCHITECT cSystem were compared with the results on the AEROSET system. Serum results from the Multigent CRP assay on an AEROSET system were compared with results on the Beckman Image. CRP Wide Range Method ARCHITECT cSystem vs. AEROSET (0.7 to 301.2 mg/L) AEROSET vs. Comparative Method (1.0 to 286.0 mg/L) N 59 Y – Intercept -1.44 to 2.04 -1.26 to 1.53 Correlation Coefficient 0.9982 0.9989 Slope 0.968 to 0.999 1.023 to 1.051 Not for customer distribution For information only unless accompanied by the Lotus Notes form that contains electronic signatures. c8000 Project Notebook, 3.6.21, version 5 © 2010 Abbott Multigent CRP Harmonization September 2010

Multigent CRP Product Summary Assay Stability: Onboard stability = 60 days Calibration stability = 15 days Precision: Total CV < 6% Reportable Range: CRP High sensitivity method 0.01 to 16.0 mg/dL (Conv) 0.1 to 160 mg/L (SI) CRP Standard method 0.02 to 32.0 mg/dL (Conv) 0.2 to 320 mg/L (SI) CRP Wide Range method 0.02 to 48.0 mg/dL (Conv) 0.2 to 480 mg/L (SI) LOQ: 0.01 mg/dL (Conv) 0.1 mg/L (SI) CRP Standard and Wide Range methods 0.02 mg/dL (Conv) 0.2 mg/L (SI) Assay Method: Turbidimetric / Immunoturbidimetric Reagent LN: 6K26-30/6K26-41 Reaction Mode: Rate-Up Calibration: Spline Multigent CRP Calibrator Set 6K26-10 Multigent CRP Calibrator HS 6K26-14 Multigent CRP Calibrator WR 6K26-12 cSystems Reagent Volumes: CRP High sensitivity and Standard method R1 Reagent: 100 L R2 Reagent: 100 L CRP Wide range method R1 Reagent: 120 L R2 Reagent: 120 L Sample Volume: CRP Wide range and Standard method: 2.0 L CRP High Sensitivity method: 4.0 L Acceptable specimen: Serum, plasma REF REF REF REF Not for customer distribution For information only unless accompanied by the Lotus Notes form that contains electronic signatures. c8000 Project Notebook, 3.6.21, version 5 © 2010 Abbott Multigent CRP Harmonization September 2010

Multigent CRP Product Summary SmartWash: Assay parameters for ARCHITECT cSystems The only SmartWash required for CRP16, CRP32 and CRP48 is a 10% Detergent B cuvette wash for Triglyceride. This wash is not required on systems with ARCHITECT software version 7.00 and above. Not for customer distribution For information only unless accompanied by the Lotus Notes form that contains electronic signatures. c8000 Project Notebook, 3.6.21, version 5 © 2010 Abbott Multigent CRP Harmonization September 2010

Q&A Question: How will existing AEROSET CRP customers be managed since this product is not available for use on AEROSET? Answer: Inventory of the existing MULTIGENT and Abbott CRP products which are labeled for AEROSET use will be managed to support AEROSET customers until retirement of the system 12/31/10. Not for customer distribution For information only unless accompanied by the Lotus Notes form that contains electronic signatures. c8000 Project Notebook, 3.6.21, version 5 © 2010 Abbott Multigent CRP Harmonization September 2010

Q&A Question: Do we have the cardiac risk assessment claim for the high sensitivity application CRP HS? Answer: No, We cannot promote use outside of labeling. Refer to “Limitations of the Procedure” in the package insert. However, we do offer the application for high sensitivity and we are extremely competitive with other CRP applications currently available. CRP HS, according to the FDA website, can be used for evaluation of conditions thought to be associated with inflammation, in otherwise healthy individuals. END OF DOCUMENT Not for customer distribution For information only unless accompanied by the Lotus Notes form that contains electronic signatures. c8000 Project Notebook, 3.6.21, version 5 © 2010 Abbott Multigent CRP Harmonization September 2010