development of the vitros hiv combo assay of the vitros hiv combo assay patrick kilmartin product...
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Development of the VITROS HIV Combo assay
Patrick KilmartinProduct Development
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Development of the VITROS HIV Combo assay
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3© Ortho-Clinical Diagnostics, Inc.
Introduction
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Assay design and timing
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Antibody Sensitivity
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Seroconversion sensitivity
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HIV-1 p24 Ag sensitivity
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Detection of HIV-1 antigen genotypesdilutions of HIV-1 Group M & O virus
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Specificity
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Specificity
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Specificity- summary
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Other considerations
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Key focus of assay development activities at OCD is to ensure consistent results lot to lot and instrument to instrumentCalibrators - are optimized to consistently position cut off whilst
supporting 28 day calibration interval and excellent long term stability.Coated Wells - Coating methods optimized to ensure consistent
clinical and analytical performance lot-lot.Reagents - Formulations optimized to ensure consistent clinical and
technical performance, a high degree of protection against interference from “problem samples” such as anti-HRP activity, heterophilic antibodies, HAMA and RF. Excellent Sensitivity Excellent Specificity
Secure manufacturing processes with appropriate documentation aligned with J&J and FDA Quality Systems regulations—very successful FDA GMP inspections
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VITROS® Systems
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System features that benefit HIV testing
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Disposable tip sample metering Clot detection Bubble detection Short sample detection High/low viscosity detection
Sample + Reagent Verification Well Wash Dispense Verification Signal Reagent Dispense Verification
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IntelliReport
Reports the quality of each result
Lumino-meter
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AddReagent 2
AddReagent 1
Well Shuttle to Inner Ring
Incubation
4
Discard to waste
1
3
Microwell Dispense
1
Sample Metering
2
Reagent Metering
3
SignalReagent
7
Incubate4.5 mins
8Microwell
Wash
6
AddSample
10 5
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Intellicheck® Technology
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MicroSensor Technology – Sample Indices
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Conclusions
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