AEROSET® & ARCHITECT® c8000® OEM Reagent Training MULTIGENT® Vancomycin 30-3735/R1 Not for Customer Distribution

MULTIGENT ® Vancomycin Assay Vancomycin (Seradyn) AEROSET and c8000 Target Launch Date May 2006 Assays in Development for OEM launch Assay Gentamicin (Seradyn) Tobramycin (Seradyn) Target Launch Date July 2006 September 2006 30-3735/R1 Not for Customer Distribution

MULTIGENT ® Vancomycin Reagent packaging will say: Manufactured by Seradyn Distributed by Abbott Laboratories Package insert contains c8000/AEROSET Assay configuration parameters that must be entered manually. No disk will be available at launch. Abbott list number on labeling. Abbott Laboratories Customer Support phone number on package insert. Reagent cross contamination, high sample carryover and required flagging were evaluated. Assay support is provided by Abbott. 30-3735/R1 Not for Customer Distribution

MULTIGENT ® Vancomycin Clinical Utility Vancomycin is commonly used in the treatment of methicillin-resistant Staphylococcus aureus infections. This aminoglycoside inhibits the growth of the bacterium by intervening in the cell wall synthesis, thereby killing the bacterium. 30-3735/R1 Not for Customer Distribution

MULTIGENT ® Vancomycin Reagent Methodology - Homogeneous particle-enhanced turbidimetric immunoassay (PETIA) CAP Code – 0010 (Other method, specify on result form) List Number 6E44-20 Reagent - 2 x 200 Test kit R1 = 2 x 36 mL (ready to use) R2 = 2 x 36 mL (ready to use) Storage 2-8°C Kit is stable to the expiration date On board stability is 45 days Do not Freeze or expose to temperatures above 32°C. 30-3735/R1 Not for Customer Distribution

MULTIGENT ® Vancomycin Reaction Mechanism Vancomycin + Antibody to Vancomycin /BIS TRIS buffer (R1) + Vancomycin Coated Microparticles (R2) Competition Vancomycin: Antibody complex + Vancomycin-coated Microparticle: Antibody complex 30-3735/R1 Not for Customer Distribution

MULTIGENT ® Vancomycin Calibrators List Number – 6E44-01 6 levels – 1 x 1 mL - Liquid ready to use Cal 1 – 0.0 ug/mL (0.00 umol/L) Cal 2 – 5.0 ug/mL (3.45 umol/L) Cal 3 – 10.0 ug/mL (6.90 umol/L) Cal 4 – 25.0 ug/mL (17.25 umol/L) Cal 5 – 50.0 ug/mL (34.50 umol/L) Cal 6 – 100.0 ug/mL (69.00 umol/L) 30-3735/R1 Not for Customer Distribution

MULTIGENT ® Vancomycin Calibrators Calibrator stability is to the expiration date on the carton. Cal curve stability is 45 days. Cal 1 (Zero Cal) is the calibration blank. Calibrators must be stored frozen (≤ -10C°) until the first use. After first use, store calibrators tightly capped at 2 to 8°C for six weeks. Do not refreeze or expose to temperatures above 32°C. Improper storage can affect assay performance. 30-3735/R1 Not for Customer Distribution

MULTIGENT ® Vancomycin c8000 Calibration Curve Not for Customer Distribution

MULTIGENT ® Vancomycin AEROSET Calibration Curve Not for Customer Distribution

MULTIGENT ® Vancomycin Specimen Collection and Handling Serum, in glass or silicone-coated plastic tubes with or without a gel barrier and with or without clot activators Some gel separation tubes may not be suitable for use with TDM assays. Refer to the tube manufacturer’s labeling. B-D gel barrier tubes equivalent to serum 30-3735/R1 Not for Customer Distribution

MULTIGENT ® Vancomycin Specimen Collection and Handling Lithium Heparin, sodium heparin, K2-EDTA, and K3-EDTA in glass or silicone-coated plastic tubes with or without a gel barrier are acceptable plasma sample types. Separated Sample Storage 7 days at 2-8 °C 14 days at <-10°C 30-3735/R1 Not for Customer Distribution

MULTIGENT ® Vancomycin Performance Characteristics Linearity 1.1 – 100.0 ug/mL (0.76 – 69.00 umol/L) 100.0 ug/mL (69.00 umol/L) is the highest level calibrator value Accuracy by Recovery Recovered concentrations ranged from 2.63 to 74.47 ug/mL (1.81 to 51.38 umol/L) Recovery at the 5 levels ranged from 99.29 to 105.20% 30-3735/R1 Not for Customer Distribution

MULTIGENT ® Vancomycin Performance Characteristics, con’d Precision Acceptable Criteria is <10% Total CV Representative data for total run precision is shown below: Level 1 Level 2 Level 3 Mean (ug/mL) 6.40 22.26 36.08 Total sd 0.42 0.49 0.87 Total %CV 6.56 2.20 2.41 30-3735/R1 Not for Customer Distribution

MULTIGENT ® Vancomycin Performance Characteristics, con’d Method Comparison c8000 c8000 AEROSET vs. PETIA vs. FPIA vs. c8000 __________________________________________________________ N 56 141 145 Slope 0.995 1.105 1.022 y-Intercept -1.38 0.95 -0.09 Correlation Coefficient 0.994 0.993 0.995 Range (ug/mL) 3.4 to 98.4 2.1 to 85.3 1.4 to 98.0 ___________________________________________________________________ 30-3735/R1 Not for Customer Distribution

MULTIGENT ® Vancomycin Reagent Cross Contamination SmartWash™ information is included in the ASSAY PARAMETERS. See the Vancomycin package insert, LIMITATIONS OF THE PROCEDURE, for assays that are affected by the Vancomycin reagent. Vancomycin has a sample probe Acid wash for both AEROSET and c8000. Vancomycin must be configured on a separate line from the following on the AEROSET System: Microalbumin (LN 2K98-20) Total Bilirubin (LN 6L45-20 and 6L45-40) Ceruloplasmin LN 6K9140 30-3735/R1 Not for Customer Distribution

MULTIGENT ® Vancomycin Interfering Substances Interference results for bilirubin, HAMA, hemolysis, RF, IgG, Albumin and lipids are listed in the package insert. See package insert for cross reactivity due to other drugs and vancomycin metabolites. 30-3735/R1 Not for Customer Distribution

MULTIGENT ® Vancomycin Therapeutic and Toxic Ranges Therapeutic Values: Peak: 20 – 40 ug/mL (13.80 – 27.60 umol/L) Trough: 5 – 10 ug/mL (3.45 – 6.90 umol/L) Toxic Values: Greater than 40 ug/mL (27.60 umol/L) Side effects include deafness and renal failure 30-3735/R1 Not for Customer Distribution

Not for Customer Distribution Questions and Answers 30-3735/R1 Not for Customer Distribution

Not for Customer Distribution Why does this package insert show Architect c8000 information before the AEROSET? The package inserts are currently being changed to present the Architect data and information before the AEROSET information. This is due to phasing out AEROSET. Method Correlation is shown comparing c8000 to Hitachi and to the AxSYM® and AEROSET to the c8000. End of Document 30-3735/R1 Not for Customer Distribution