Pooled Source Plasma NAT for HIV-1 An Update from the Bayer HIV-1 IND Study Barbara Masecar Bayer Corporation Raleigh, NC Blood Products Advisory Committee.

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Presentation transcript:

Pooled Source Plasma NAT for HIV-1 An Update from the Bayer HIV-1 IND Study Barbara Masecar Bayer Corporation Raleigh, NC Blood Products Advisory Committee Meeting 67th Meeting September 14, 2000

Bayer HIV-1 IND Study: Background IND filed with FDA August, 1999 Shared filing with Roche Molecular Systems Roche Ampliscreen TM microwell plate method Testing initiated October sample minipools Nucleic acid extraction from minipools shared with HCV NAT screening 2

Bayer HIV-1 IND Study: Assay Performance Assay sensitivity: 95% positivity at 91 IU per mL Calculated detection limit at the unit level: 8,736 IU per mL in minipools of 96 donations 3

Bayer HIV-1 IND Study: IND Study Design Study-eligible HIV-1 NAT-reactive donors are categorized at the time of index donation: 4

Bayer HIV-1 IND Study: IND Study Design Donors positive for HIV-1 p24 antigen ONLY: Investigation of donors with possible false positive/false negative results is included in IND investigational plan No known donors in the category However, amending IND to ensure identification and further testing for these donors 5

Bayer HIV-1 IND Study: Update Since October, 1999: 2.1 million donations screened –11 Category A donors identified (NAT pos, ag/ab neg) –3 Category B donors identified (NAT/ag pos, ab neg) –10 Category C donors identified (NAT/ab pos, ag neg) 6

Bayer HIV-1 IND Study: Update Follow-up study results for Category A donors (NAT pos, ag/ab neg): Subsequent sample information available on 9 of 11 identified donors 7

Category A donors 8

Conclusions Reduction in Window Period: HIV-1 NAT relative to p24: 3-7 days HIV-1 NAT relative to HIV-1/2 antibody: 10.7 days No False Positive HIV-1 NAT results seen to date (all corroborated by some other HIV-1 test result) 9