Blood Products Advisory Committee 67th Meeting September 14, 2000

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Blood Products Advisory Committee 67th Meeting – September 14, 2000 Detection of HIV-1 p24 antigen positive giver examples by Chiron TMA HIV-1/HCV test Analytical affectability of Chiron TMA HIV-1/HCV test on various HIV-1 subtypes

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RSA Blood Donation Approximately one million units gathered annually – 57% by SABTS (Johannesburg), 18% by NBTS (Durban), 14% by WPBTS (Cape Town), 11% by four different Centers – 90% from "Okay" contributors, 10% from "High-Risk" benefactors High HIV predominance: general 0.21% (1997-1998) – Repeat givers 8.7/10,000, first-time givers: 110/10,000 – "Generally safe" givers: 1.6/10,000, "High-Risk" givers: 196/10,000 – Risk of transfusion-transmission assessed 0.22/10,000 (1994) Donor choice and routine blood testing – Voluntary with self-avoidance survey, up close and personal meeting – HIV-1/2 Ab, HIV-1 p24, HCV Ab, HBsAg, syphilis serology – Double EIA testing procedure

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RSA Study: Study Design All seven Centers gathering willful blood gifts took an interest 10,000 "Okay" givers and 10,000 "High-Risk" givers Sample commitment relative to accumulation volume Two EDTA plasma tubes transported solidified to NAT lab at SABTS (Johannesburg) for individual TMA testing Routine serology results and contributor demographic data gathered preceding linkage breaking and TMA testing All constructive examples delivered to BCP for extra testing

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RSA Study: Donor Population Total Repeat First time number donors donors "Generally safe" Male 6096 5465 631 Female 3467 3038 429 Total 9563 (46%) 8503 1060 "High-Risk" Male 6679 5720 959 Female 4378 3334 1044 Total 11057 (54%) 9054 2003 TOTAL Male 12775 (62%) 11185 1590 Female 7845 (38%) 6372 1473 Total 20620 (100%) 17557 (85%) 3063 (15%)

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RSA Study: Results TMA RR RR RR NR NR p24 Ag NR RR RR NR NR NR Antibody NR NR RR RR RR NR "Generally safe" Male 0 0 0 2 0 6094 Female 0 0 0 1 0 3466 Total 0 0 0 3 0 9560 "High-Risk" Male 0 1 5 58 0 6615 Female 1 0 1 97 1 4278 Total 1 1 6 155 1 10893 TOTAL Male 0 1 5 60 0 12709 Female 1 0 1 98 1 7744 Total 1 1 6 158 1 20453

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RSA Study: Preliminary Conclusions The quantity of HIV examples recognized in the RNA-window (1) and the p24-window (1) is lower than what was foreseen. The part of routine HIV p24 antigen testing ought to be re-assessed. Computerization and cost may be components that will impact the choice on regardless of whether to do routine NAT testing. Nel TJ, et al. Theoretical acknowledged by AABB 2000 for oral presentation

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Genomic Detection of HIV by TMA in High Prevalence Areas of Sub-Saharan Africa Pool Pools Donors Pos. TMA p24 Ab size tested tested pools pos. pos. pos. S. Africa 24 126 3024 4 4 4 b 0 Ghana 11-25 140 2578 10 c 8 a 0 6 b a Two TMA-positive/seronegative specimens were affirmed by RT-PCR. b Included as positive controls. C Two contained HCV-pos tests, one with TMA-neg tests, one with QNSs. Allain JP, et al., conceptual acknowledged by AABB 2000 for oral presentation

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HIV-1 p24 Antigen Positive Donations a,b AIBC (4/99 - 8/00) Sample Date TMA Multiplex TMA Disk HIV Serology ID Received Pool Single HIV-1 p24/Neut Ab/WB SF07989444 07/09/99 19.7 19.0 18.8 R/P R/N SF08012675 08/27/99 17.1 17.6 15.5 R/P R/P MM00124739 Sep 99 NT 17.0 18.6 R/P R/N SF08051578 12/17/99 21.5 22.4 21.7 R/P R/P SF08063998 02/01/00 19.6 20.2 20.0 R/P R/P SF08107307 04/04/00 18.6 21.1 20.1 R/P R/P a Total tried: estimated 600,000 gifts. b Data gave by Dr. Richard Gammon, South Florida Blood Banks.

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Detection of HIV-1 Type A Specimens by TMA Assay Subtype Copies/ml Origin Detection Source Testing Site A 29000 2/2 Necker ARN 99 Lille, FR; Montpllier, FR A 15000 2/2 Necker ARN 99 Lille, FR; Montpllier, FR A 7200 2/2 Necker ARN 99 Lille, FR; Montpllier, FR A 6000 Uganda 2/2 BBI WWRB302 BBI/Chiron A 4600 2/2 Necker ARN 99 Lille, FR; Montpllier, FR A 2300 2/2 Necker ARN 99 Lille, FR; Montpllier, FR A 600 Ghana 2/2 BBI WWRB302 BBI/Chiron A 500 Ghana 2/2 BBI WWRB302 BBI/Chiron A 200 Ivory Coast 2/2 BBI WWRB302 BBI/Chiron A 600 Uganda 1/1 at 1:5 BBI WWRB301 Chiron A 1000 Uganda 1/1 at 1:100 BBI WWRB301 Chiron A 1000 Ghana 1/1 at 1:100 BBI WWRB301 Chiron A 1000 Ghana 1/1 at 1:100 BBI WWRB301 Chiron A 600 Ghana 1/1 at 1:100 BBI WWRB301 Chiron A < 400 Ghana 1/1 at 1:100 BBI WWRB301 Chiron A < 50 Uganda 1/1 at 1:5 BBI WWRB301 Chiron A < 50 Ghana 1/1 at 1:100 BBI WWRB301 Chiron

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Detection of HIV-1 Type B Specimens by TMA Assay Subtype Copies/ml Origin Detection Source Testing Site B 30000 2/2 Necker ARN 99 Lille, FR; Montpllier, FR B 20000 USA 2/2 BBI WWRB302 BBI/Chiron B 8200 2/2 Necker ARN 99 Lille, FR; Montpllier, FR B/D 5000 USA 2/2 BBI WWRB302 BBI/Chiron B 3700 2/2 Necker ARN 99 Lille, FR; Montpllier, FR B 2000 China 2/2 BBI WWRB302 BBI/Chiron B 1800 2/2 Necker ARN 99 Lille, FR; Montpllier, FR B 900 Argentina 2/2 BBI WWRB302 BBI/Chiron B 40000 Egypt 1/1 at 1:100 BBI WWRB301 Chiron B 20000 China 1/1 at 1:100 BBI WWRB301 Chiron B 20000 China 1/1 at 1:100 BBI WWRB301 Chiron B 100 160/160 WHO Standard Gen-Probe B 100 5/5 VQA 003ru Lille, FR B 100 20/20 VQA Panel Hokkaido, JP

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Detection of HIV-1 Type B Specimens by TMA Assay Subtype Copies/ml Origin Detection Source Testing Site B 9000 RSA 1/1 at 1:100 BBI WWRB301 Chiron B 6000 China 1/1 at 1:100 BBI WWRB301 Chiron B 50 6/6 VQA 003ru Lille, FR B 50 19/20 VQA Panel Hokkaido, JP B 5000 China 1/1 at 1:100 BBI WWRB301 Chiron B 5000 USA 1/1 at 1:100 BBI WWRB301 Chiron B 4000 China 1/1 at 1:100 BBI WWRB301 Chiron B 30 155/160 WHO Standard Gen-Probe B 25 2/2 Pelicheck S2091 Lyon, FR B 20 20/20 JRC Standard Panel Hokkaido, JP B 10 20/20 JRC Standard Panel Hokkaido, JP B 8 2/2 Pelicheck S2091 Lyon, FR B 200 China 1/1 at 1:100 BBI WWRB301 Chiron

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Detection of HIV-1 Type C Specimens by TMA Assay Subtype Copies/ml Origin Detection Source Testing Site C 70000 Mozanbique 2/2 BBI WWRB302 BBI/Chiron C 20000 Uganda 2/2 BBI WWRB302 BBI/Chiron C 9300 2/2 Necker ARN 99 Lille, FR; Montpllier, FR C 80000 Zimbabwe 1/1 at 1:100 BBI WWRB301 Chiron C 700 Zimbabwe 2/2 BBI WWRB302 BBI/Chiron C 390 2/2 Necker ARN 99 Lille, FR; Montpllier, FR C 300 Zimbabwe 2/2 BBI WWRB302 BBI/Chiron C 30000 RSA 1/1 at 1:100 BBI WWRB301 Chiron C 30000 RSA 1/1 at 1:100 BBI WWRB301 Chiron C 30000 India 1/1 at 1:100 BBI WWRB301 Chiron C 700 RSA 1/1 at 1:5 BBI WWRB301 Chiron C 4000 Zimbabwe 1/1 at 1:100 BBI WWRB301 Chiron C 3000 India 1/1 at 1:100 BBI WWRB301 Chiron C 2000 Zimbabwe 1/1 at 1:100 BBI WWRB301 Chiron C < 50 RSA 1/1 at 1:100 BBI WWRB301 Chiron C < 50 Zimbabwe 1/1 at 1:100 BBI WWRB301 Chiron

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Detection of HIV-1 Type D Specimens by TMA Assay Subtype Copies/ml Origin Detection Source Testing Site D 50000 Uganda 2/2 BBI WWRB302 BBI/Chiron D 10000 Uganda 2/2 BBI WWRB302 BBI/Chiron D 4800 2/2 Necker ARN 99 Lille, FR; Montpllier, FR D 3000 Uganda 2/2 BBI WWRB302 BBI/Chiron D 800 Uganda 2/2 BBI WWRB302 BBI/Chiron D 490 2/2 Necker ARN 99 Lille, FR; Montpllier, FR D 7000 Uganda 1/1 at 1:100 BBI WWRB301 Chiron D 3000 Uganda 1/1 at 1:100 BBI WWRB301 Chiron D 1000 Uganda 1/1 at 1:100 BBI WWRB301 Chiron D < 50 Uganda 1/1 at 1:5 BBI WWRB301 Chiron

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Detection of HIV-1 Type E Specimens by TMA Assay Subtype Copies/ml Origin Detection Source Testing Site E 7700 2/2 Necker ARN 99 Lille, FR; Montpllier, FR E 3000 Thailand 2/2 BBI WWRB302 BBI/Chiron E 1500 2/2 Necker ARN 99 Lille, FR; Montpllier, FR E 300 Thailand 2/2 BBI WWRB302 BBI/Chiron E 100 20/20 VQA Panel Hokkaido, JP E 10000 Thailand 1/1 at 1:100 BBI WWRB301 Chiron E 50 20/20 VQA Panel Hokkaido, JP E 20 19/20 VQA Panel Hokkaido, JP E < 50 Thailand 2/2 BBI WWRB302 BBI/Chiron E < 50 Thailand 1/1 at 1:5 BBI WWRB301

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