Development of the VITROS HIV Combo assay of the VITROS HIV Combo assay Patrick Kilmartin Product...
Transcript of Development of the VITROS HIV Combo assay of the VITROS HIV Combo assay Patrick Kilmartin Product...
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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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
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Discard to waste
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Microwell Dispense
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Sample Metering
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Reagent Metering
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SignalReagent
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Incubate4.5 mins
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Wash
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AddSample
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Intellicheck® Technology
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MicroSensor Technology – Sample Indices
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Conclusions
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