1. AEROSET® & ARCHITECT® c8000® OEM Reagent Training
MULTIGENT® Vancomycin
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2. 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
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3. 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.
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4. 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.
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5. 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.
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6. 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
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7. 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 – ug/mL (69.00 umol/L)
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8. 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.
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9. MULTIGENT ® Vancomycin c8000 Calibration Curve
Not for Customer Distribution

10. MULTIGENT ® Vancomycin AEROSET Calibration Curve
Not for Customer Distribution

11. 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
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12. 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
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13. MULTIGENT ® Vancomycin Performance Characteristics
Linearity
1.1 – ug/mL (0.76 – 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 ug/mL (1.81 to umol/L)
Recovery at the 5 levels ranged from to %
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14. MULTIGENT ® Vancomycin 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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15. MULTIGENT ® Vancomycin Performance Characteristics, con’d
Method Comparison
c c AEROSET
vs. PETIA vs. FPIA vs. c8000
__________________________________________________________ N
Slope
y-Intercept
Correlation Coefficient
Range (ug/mL) to to to 98.0
___________________________________________________________________
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16. 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
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17. 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.
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18. MULTIGENT ® Vancomycin Therapeutic and Toxic Ranges
Therapeutic Values:
Peak: 20 – 40 ug/mL (13.80 – 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
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19. Not for Customer Distribution
Questions and Answers
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20. 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
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