Replacement of HIV-1 p24 Antigen Screening with HIV-1 RNA Nucleic Acid Testing (NAT) for Whole Blood Donations

9/13/00


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Table of Contents

Replacement of HIV-1 p24 Antigen Screening with HIV-1 RNA Nucleic Acid Testing (NAT) for Whole Blood Donations

Background

HIV-1 p24 Antigen Testing Experience

Samples for Testing

Comparison of HIV-1 p24 Ag Positive Window-Case U.S. Blood Donors

Detection of HIV-1 p24 Ag and NAT Yield Samples by HIV-1 NAT (1:128 Dilution)

HIV Panel 6240 – Virologic/Serologic Profile

HIV Panel 6240 – Virologic/Serologic Profile

HIV Panel PRB932 – Virologic/Serologic Profile

HIV Panel PRB932 – Virologic/Serologic Profile

HIV Panel PRB943 – Virologic/Serologic Profile

HIV Panel PRB943 – Virologic/Serologic Profile

Clinical Sensitivity, HIV Panels, Gen-Probe

Clinical Sensitivity, HIV Panels, Gen-Probe

Effect of Dilution on NAT Reactivity (Gen-Probe HIV-1/HCV Assay)

Gen-Probe Linked Study – Phase I External Control Panel

PPT Slide

Conclusions

Linear Relationship Between HIV RNA Levels and p24 S/CO Ratios

95% Prediction Limits for Relationship of HIV RNA Levels and p24 S/CO Ratios

HIV-1 RNA Levels During “RNA Only” and “p24 Positive” Window Periods

Linear Relationship Between HIV-1 RNA Levels and p24 S/CO Ratios in 32 Cases