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Blood Products Advisory Committee 67th Meeting – September 14, 2000

Blood Products Advisory Committee 67th Meeting – September 14, 2000. Detection of HIV-1 p24 antigen positive donor specimens by Chiron TMA HIV-1/HCV assay Analytical sensitivity of Chiron TMA HIV-1/HCV assay on different HIV-1 subtypes . RSA Blood Donation.

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Blood Products Advisory Committee 67th Meeting – September 14, 2000

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  1. Blood Products Advisory Committee67th Meeting – September 14, 2000 Detection of HIV-1 p24 antigen positive donor specimens by Chiron TMA HIV-1/HCV assay Analytical sensitivity of Chiron TMA HIV-1/HCV assay on different HIV-1 subtypes

  2. RSA Blood Donation • Approximately one million units collected annually – 57% by SABTS (Johannesburg), 18% by NBTS (Durban), 14% by WPBTS (Cape Town), 11% by four other Centers – 90% from “Low-Risk” donors, 10% from “High-Risk” donors • High HIV prevalence: overall 0.21% (1997-1998) – Repeat donors 8.7/10,000, first-time donors: 110/10,000 – “Low-Risk” donors: 1.6/10,000, “High-Risk” donors: 196/10,000 – Risk of transfusion-transmission estimated 0.22/10,000 (1994) • Donor selection and routine blood testing – Voluntary with self-exclusion questionnaire, face-to-face interview – HIV-1/2 Ab, HIV-1 p24, HCV Ab, HBsAg, syphilis serology – Double EIA testing strategy

  3. RSA Study: Study Design • All seven Centers collecting voluntary blood donations participated • 10,000 “Low-Risk” donors and 10,000 “High-Risk” donors • Sample contribution proportional to collection volume • Two EDTA plasma tubes shipped frozen to NAT laboratory at SABTS (Johannesburg) for individual TMA testing • Routine serology results and donor demographic information collected prior to linkage breaking and TMA testing • All positive samples shipped to BCP for additional testing

  4. RSA Study: Donor Population Total Repeat First time number donors donors “Low-Risk” 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%)

  5. RSA Study: Results TMARRRRRR RRNR NR p24 Ag NRRRRR NRNR NR Antibody NR NRRR RR RRNR “Low-Risk” 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

  6. RSA Study: Preliminary Conclusions • The number of HIV specimens identified in the RNA-window (1) and the p24-window (1) is lower than what was anticipated. • The role of routine HIV p24 antigen testing should be re-evaluated. • Automation and cost might be factors that will influence the decision on whether or not to do routine NAT testing. Nel TJ, et al. Abstract accepted by AABB 2000 for oral presentation

  7. 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 samples were confirmed by RT-PCR. b Included as positive controls. C Two contained HCV-pos samples, one with TMA-neg samples, one with QNSs. Allain JP, et al., abstract accepted by AABB 2000 for oral presentation

  8. HIV-1 p24 Antigen Positive Donations a,bAIBC (4/99 - 8/00) Sample DateTMA Multiplex TMA Disc 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 tested: approximate 600,000 donations. b Data provided by Dr. Richard Gammon, South Florida Blood Banks.

  9. 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

  10. 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

  11. 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

  12. 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

  13. 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

  14. 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 Chiron E < 50 Thailand 1/1 at 1:20 BBI WWRB301 Chiron

  15. Detection of HIV-1 Types F,G,H,O Specimens by TMA Assay Subtype Copies/ml Origin Detection Source Testing Site F 48000 2/2 Necker ARN 99 Lille, FR; Montpllier, FR F 5900 2/2 Necker ARN 99 Lille, FR; Montpllier, FR F 200 Argentina 2/2 BBI WWRB302 BBI/Chiron F 10000 Argentina 1/1 at 1:100 BBI WWRB301 Chiron F 9000 Argentina 1/1 at 1:100 BBI WWRB301 Chiron F < 50 Argentina 1/1 at 1:5 BBI WWRB301 Chiron G 48000 2/2 Necker ARN 99 Lille, FR; Montpllier, FR G 3100 2/2 Necker ARN 99 Lille, FR; Montpllier, FR G < 50 Ghana 1/1 at 1:10 BBI WWRB301 Chiron G < 50 Ghana 1/1 at 1:10 BBI WWRB301 Chiron H 9500 2/2 Necker ARN 99 Lille, FR; Montpllier, FR H 1400 2/2 Necker ARN 99 Lille, FR; Montpllier, FR O <150 2/2 Necker ARN 99 Lille, FR; Montpllier, FR O <150 2/2 Necker ARN 99 Lille, FR; Montpllier, FR O < 50 Spain 2/2 BBI WWRB302 BBI/Chiron O < 50 Cameroon 1/1 at 1:100 BBI WWRB301 Chiron

  16. Detection of Specimensa with Different HIV-1 Genotypes by TMA Assay (Montpellier, France) Genotypeb Origin Detection Genotypeb Origin Detection A/E/- Cambodia 1/1 -/A/AG Cameroon 1/1 A/E/- Cambodia 1/1 -/A/G Cameroon 1/1 A/E/- Cambodia 1/1 -/A/G Cameroon 1/1 A/E/- Cambodia 1/1 F1/F1/F1 Chad 1/1 -/D/F3 Cameroon 1/1 -/A/G RCA 1/1 -/A?/D Cameroon 1/1 C/C/- Djibouti 1/1 -/D/D Cameroon 1/1 C/C/- Djibouti 1/1 -/D/D Djibouti 1/1 -/O/O Cameroon 1/1 F3/F3/F3 Cameroon 1/1 -/O/O Cameroon 1/1 F2/F2/F2 Cameroon 1/1 -/B/- Montpellier 1/1 F2/F2/F2 Cameroon 1/1 -/A/AG Cameroon 1/1 -/G/G Cameroon 1/1 A/A/J Cameroon 1/1 C/C/- Djibouti 1/1 A/A/- Djibouti 1/1 C/C/- Djibouti 1/1 A/A/- Djibouti 1/1 -/A/AG Cameroon 1/1 A/A/- RCA 1/1 a ETSLR Panel, viral loads unknown b gag/pol/env

  17. CONCLUSIONS Of the three studies, all 17 HIV-1 p24 antigen positive specimens were also positive in Chiron TMA HIV-1/HCV assay Chiron TMA HIV-1/HCV assay has a  95% detectability at 100 copies/ml for all HIV-1 subtypes

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