AEROSET® & ARCHITECT® c8000® OEM Reagent Training MULTIGENT® Amikacin MULTIGENT® Quinidine 30-3616/R1 Not for Customer Distribution

MULTIGENT ® Amikacin and Quinidine Assay Amikacin (Seradyn) AEROSET and c8000 Quinidine (Seradyn) Target Launch Date January 2006 Assays in Development for OEM launch Assay Vancomycin (Seradyn) Gentamicin (Seradyn) Tobramycin (Seradyn) Target Launch Date June 2006 TBD September 2006 30-3616/R1 Not for Customer Distribution

Not for Customer Distribution MULTIGENT ® Amikacin and Quinidine Reagent packaging will say: Manufactured by Seradyn Distributed by Abbott Laboratories Package insert contains AEROSET/c8000 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. 30-3616/R1 Not for Customer Distribution

Not for Customer Distribution MULTIGENT® Amikacin 30-3616/R1 Not for Customer Distribution

Amikacin Clinical Utility Amikacin is a semi-synthetic aminoglycoside that exhibits bactericidal activity against a wide range of pathogens, including many organisms resistant to other aminoglycosides. It is active against gram-negative organisms, penicillinase, and non-penicillinase producing staphylococci. Strength of the drug is due to resistance to aminoglycoside-inactivating enzymes. 30-3616/R1 Not for Customer Distribution

MULTIGENT ® Amikacin Reagent Methodology - Homogeneous particle-enhanced turbidimetric immunoassay (PETIA) CAP Code – 0010 (Other method, specify on result form) List Number 6L35-20 Reagent - 2 x 70 Test kit R1 = 2 x 21 mL (ready to use) R2 = 2 x 8 mL (ready to use) Storage 2-8°C Kit is stable to the expiration date On board stability is 54 days Do not Freeze or expose to temperatures above 32°C. 30-3616/R1 Not for Customer Distribution

MULTIGENT ® Amikacin Reaction Mechanism Amikacin + Antibody to Amikacin/BIS TRIS buffer (R1) + Amikacin Coated Microparticles (R2) Competition Amikacin:Antibody complex + Amikacin-coated Microparticle:Antibody complex 30-3616/R1 Not for Customer Distribution

MULTIGENT ® Amikacin Calibrators List Number – 6L35-01 6 levels – 1 x 1 mL - Liquid ready to use Cal 1 – 0.0 ug/mL Cal 2 – 3.0 ug/mL Cal 3 – 10.0 ug/mL Cal 4 – 20.0 ug/mL Cal 5 – 35.0 ug/mL Cal 6 – 50.0 ug/mL 30-3616/R1 Not for Customer Distribution

MULTIGENT ® Amikacin Calibrators Calibrator stability is to the expiration date on the carton. Cal curve stablity is 54 days. Storage is 2-8° C Cal 1 (Zero Cal ) is the calibration blank. Do not freeze or expose to temperatures above 32°C. Improper storage can affect assay performance. 30-3616/R1 Not for Customer Distribution

MULTIGENT ® Amikacin 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 30-3616/R1 Not for Customer Distribution

MULTIGENT ® Amikacin 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. Sample Storage 7 days at 2-8 °C 14 days at < -10°C 30-3616/R1 Not for Customer Distribution

MULTIGENT ® Amikacin Performance Characteristics Linearity 0.6 – 50.0 ug/mL 50.0 is the highest level calibrator value Accuracy by Recovery Recovered concentrations ranged from 1.55 to 42.84 ug/mL Recovery at the 5 levels ranged from 97.7 to 104% 30-3616/R1 Not for Customer Distribution

MULTIGENT ® Amikacin 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) 4.62 15.50 30.71 Total sd 0.17 0.37 1.03 Total %CV 3.68 2.3 3.36 30-3616/R1 Not for Customer Distribution

MULTIGENT ® Amikacin Reagent Cross Contamination SmartWash™ information is included in the ASSAY PARAMETERS. Note: Amikacin has a sample probe Acid wash for both AEROSET and c8000. See the Amikacin package insert, LIMITATIONS OF THE PROCEDURE, for assays that are affected by the Amikacin reagent. Amikacin must be configured on a separate line from Microalbumin (LN 2K98-20) on the AEROSET System. 30-3616/R1 Not for Customer Distribution

MULTIGENT ® Amikacin Interfering Substances Interference results for bilirubin, HAMA, hemolysis, RF, Total Protein and lipids are listed in the package insert. See package insert for cross reactivity due to other drugs and amikacin metabolites. 30-3616/R1 Not for Customer Distribution

MULTIGENT ® Amikacin Therapeutic and Toxic Ranges Therapeutic Values: Peak: 20 – 25 ug/mL Trough: 5 – 10 ug/mL Toxic Values: Peak: >35 ug/mL Trough: >10 ug/mL 30-3616/R1 Not for Customer Distribution

Not for Customer Distribution MULTIGENT® Quinidine 30-3616/R1 Not for Customer Distribution

Quinidine Clinical Utility Quinidine is used in the prevention and treatment of ventricular arrhythmias, junctional (nodal) arrhythmias, and supraventricular (atrial) arrhythmias. 30-3616/R1 Not for Customer Distribution

MULTIGENT ® Quinidine Reagent Methodology - Homogeneous particle-enhanced turbidimetric immunoassay (PETIA) CAP Code – 0010 (Other method, specify on result form) List Number – 6L31-20 Reagent – 2 x 70 Test kit R1 = 2 x 21 mL (ready to use) R2 = 2 x 8 mL (ready to use) Storage 2-8°C Kit is stable to the expiration date On board stability is 54 days Do not Freeze or expose to temperatures above 32°C. 30-3616/R1 Not for Customer Distribution

MULTIGENT ® Quinidine Reaction Mechanism Quinidine + Antibody to Quinidine/BIS-TRIS buffer (R1) + Quinidine-coated Microparticles (R2) Competition Quinidine:Antibody complex + Quinidine-coated Microparticle:Antibody complex 30-3616/R1 Not for Customer Distribution

MULTIGENT ® Quinidine Calibrators List Number – 6L31-01 6 levels – 1 x 1 mL - Liquid ready to use Cal 1 – 0.0 ug/mL Cal 2 – 0.5 ug/mL Cal 3 – 1.0 ug/mL Cal 4 – 2.0 ug/mL Cal 5 – 4.0 ug/mL Cal 6 – 8.0 ug/mL 30-3616/R1 Not for Customer Distribution

MULTIGENT ® Quinidine Calibrators Cal 1 (not Water) is the calibration blank. Calibrator stability is to the expiration date on the carton. Cal curve stability is 17 days. Storage is 2-8° C Do not freeze or expose to temperatures above 32°C. Improper storage can affect assay performance. 30-3616/R1 Not for Customer Distribution

MULTIGENT ® Quinidine 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 30-3616/R1 Not for Customer Distribution

MULTIGENT ® Quinidine 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. Sample Storage 7 day at 2-8 °C 14 days at < -10°C 30-3616/R1 Not for Customer Distribution

MULTIGENT ® Quinidine Performance Characteristics Linearity 0.2 – 8.0 ug/mL 8.0 ug/mL is the highest level calibrator value Accuracy by Recovery Concentrations ranged from 0.25 ug/mL to 6.06 ug/mL Recovery at the 5 levels ranged from 97 to 101% 30-3616/R1 Not for Customer Distribution

MULTIGENT ® Quinidine Performance Characteristics, cont’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) 1.04 3.03 5.26 Total sd 0.05 0.09 0.16 Total %CV 4.81 2.97 3.04 30-3616/R1 Not for Customer Distribution

MULTIGENT ® Quinidine Reagent Cross Contamination SmartWash™ information is included in the ASSAY PARAMETERS. Only wash required is Trig cuvette wash on c8000. See the Quinidine package insert, LIMITATIONS OF THE PROCEDURE, for assays that are affected by the Quinidine reagent. Quinidine must be configured on a separate line from Microalbumin (LN 2K98-20) on the AEROSET System. 30-3616/R1 Not for Customer Distribution

MULTIGENT ® Quinidine Interfering Substances Interference results for bilirubin, HAMA, hemolysis, RF, Total Protein and lipids are listed in the package insert. See package insert for cross reactivity due to other drugs and quinidine metabolites. 30-3616/R1 Not for Customer Distribution

MULTIGENT ® Quinidine Therapeutic Ranges Therapeutic Values: 1.5 – 5 ug/mL (based on non-specific methods that measure quinidine metabolites as well as quinidine) Toxic Values: Concentrations greater or equal to 6 ug/mL are considered toxic 30-3616/R1 Not for Customer Distribution

Not for Customer Distribution Questions and Answers 30-3616/R1 Not for Customer Distribution

Not for Customer Distribution Why does the Amikacin package insert list the Limit of Quantitation (LOQ) as 0.52 u/mL but the assay linear range is 0.6 to 50.0 ug/ml ? Calibrators are made and standardized to 1 decimal place. We cannot claim 0.5 because testing wasn’t done at that level and we cannot claim accuracy beyond 1 decimal place. SI conversion mathematics allows 2 decimal places for the SI units. 30-3616/R1 Not for Customer Distribution

Why did we correlate to TDx®? AxSYM® installation at the vendor’s site was tentative at the time of verification testing. As a backup, method correlation testing would be done against TDx until the AxSYM was available. A scheduled date has now been determined for Method correlation testing to be done against the AxSYM in January 2006. Method correlation testing was also done against Hitachi. End of Document 30-3616/R1 Not for Customer Distribution