1. AEROSET® & ARCHITECT® c8000® OEM Reagent Training
MULTIGENT® Amikacin
MULTIGENT® Quinidine
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Not for Customer Distribution

2. 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
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Not for Customer Distribution

3. 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.
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Not for Customer Distribution

4. Not for Customer Distribution
MULTIGENT® Amikacin
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Not for Customer Distribution

5. 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.
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Not for Customer Distribution

6. 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.
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Not for Customer Distribution

7. 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
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Not for Customer Distribution

8. 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
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Not for Customer Distribution

9. 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.
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Not for Customer Distribution

10. 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
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Not for Customer Distribution

11. 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
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Not for Customer Distribution

12. 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 ug/mL
Recovery at the 5 levels ranged from 97.7 to 104%
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Not for Customer Distribution

13. MULTIGENT ® Amikacin Performance Characteristics, con’d
Precision
Acceptable Criteria is <10% Total CV
Representative data for total run precision is shown below:
Level Level 2 Level 3
Mean (ug/mL)
Total sd
Total %CV
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Not for Customer Distribution

14. 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.
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Not for Customer Distribution

15. 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.
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Not for Customer Distribution

16. 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
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Not for Customer Distribution

17. Not for Customer Distribution
MULTIGENT® Quinidine
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Not for Customer Distribution

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

19. 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.
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Not for Customer Distribution

20. 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
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Not for Customer Distribution

21. 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
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Not for Customer Distribution

22. 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.
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Not for Customer Distribution

23. 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
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Not for Customer Distribution

24. 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
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Not for Customer Distribution

25. 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%
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Not for Customer Distribution

26. 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)
Total sd
Total %CV
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Not for Customer Distribution

27. 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.
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Not for Customer Distribution

28. 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.
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Not for Customer Distribution

29. 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
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30. Not for Customer Distribution
Questions and Answers
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31. 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.
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32. 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
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