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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