C H I R O N Blood Testing Blood Products Advisory Committee 67th Meeting – September 14, 2000 Detection of HIV-1 p24 antigen positive donor specimens by.

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C H I R O N Blood Testing 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

C H I R O N Blood Testing 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% ( ) – 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

C H I R O N Blood Testing 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

C H I R O N Blood Testing RSA Study: Donor Population TotalRepeatFirst time numberdonorsdonors “Low-Risk” Male Female Total 9563 (46%) “High-Risk” Male Female Total11057 (54%) TOTALMale12775 (62%) Female 7845 (38%) Total20620 (100%)17557 (85%)3063 (15%)

C H I R O N Blood Testing RSA Study: Results TMARRRRRRRRNRNR p24 AgNRRRRRNRNRNR AntibodyNRNRRRRRRRNR “Low-Risk” Male Female Total “High-Risk” Male Female Total TOTALMale Female Total

C H I R O N Blood Testing 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

C H I R O N Blood Testing Genomic Detection of HIV by TMA in High Prevalence Areas of Sub-Saharan Africa PoolPoolsDonors Pos. TMA p24Ab sizetestedtested pools pos. pos. pos. S. Africa b 0 Ghana 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

C H I R O N Blood Testing HIV-1 p24 Antigen Positive Donations a,b AIBC (4/99 - 8/00) Sample Date TMA Multiplex TMA Disc HIV Serology ID Received Pool Single HIV-1 p24/Neut Ab/WB SF /09/ R/P R/N SF /27/ R/P R/P MM Sep 99 NT R/P R/N SF /17/ R/P R/P SF /01/ R/P R/P SF /04/ R/P R/P a Total tested: approximate 600,000 donations. b Data provided by Dr. Richard Gammon, South Florida Blood Banks.

C H I R O N Blood Testing Detection of HIV-1 Type A Specimens by TMA Assay SubtypeCopies/ml Origin DetectionSourceTesting Site A /2Necker ARN 99Lille, FR; Montpllier, FR A /2Necker ARN 99Lille, FR; Montpllier, FR A7200 2/2Necker ARN 99Lille, FR; Montpllier, FR A6000 Uganda 2/2BBI WWRB302 BBI/Chiron A4600 2/2Necker ARN 99Lille, FR; Montpllier, FR A2300 2/2Necker ARN 99Lille, FR; Montpllier, FR A600 Ghana 2/2BBI WWRB302BBI/Chiron A500 Ghana 2/2BBI WWRB302 BBI/Chiron A200 Ivory Coast 2/2BBI WWRB302 BBI/Chiron A600 Uganda 1/1 at 1:5BBI WWRB301 Chiron A1000 Uganda 1/1 at 1:100BBI WWRB301 Chiron A1000 Ghana 1/1 at 1:100BBI WWRB301 Chiron A600 Ghana 1/1 at 1:100BBI WWRB301 Chiron A< 400 Ghana 1/1 at 1:100BBI WWRB301 Chiron A< 50 Uganda 1/1 at 1:5BBI WWRB301 Chiron A< 50 Ghana 1/1 at 1:100BBI WWRB301 Chiron

C H I R O N Blood Testing Detection of HIV-1 Type B Specimens by TMA Assay SubtypeCopies/ml Origin Detection Source Testing Site B /2 Necker ARN 99 Lille, FR; Montpllier, FR B20000 USA 2/2 BBI WWRB302 BBI/Chiron B8200 2/2 Necker ARN 99Lille, FR; Montpllier, FR B/D5000 USA 2/2 BBI WWRB302 BBI/Chiron B3700 2/2 Necker ARN 99Lille, FR; Montpllier, FR B2000 China 2/2 BBI WWRB302 BBI/Chiron B1800 2/2 Necker ARN 99Lille, FR; Montpllier, FR B900 Argentina 2/2 BBI WWRB302 BBI/Chiron B40000 Egypt 1/1 at 1:100 BBI WWRB301 Chiron B20000 China 1/1 at 1:100 BBI WWRB301 Chiron B /160 WHO StandardGen-Probe B100 5/5 VQA 003ruLille, FR B100 20/20 VQA PanelHokkaido, JP

C H I R O N Blood Testing Detection of HIV-1 Type B Specimens by TMA Assay SubtypeCopies/ml Origin DetectionSource Testing Site B9000 RSA 1/1 at 1:100BBI WWRB301 Chiron B6000 China 1/1 at 1:100BBI WWRB301 Chiron B50 6/6VQA 003ru Lille, FR B50 19/20VQA Panel Hokkaido, JP B5000 China 1/1 at 1:100BBI WWRB301 Chiron B5000 USA 1/1 at 1:100BBI WWRB301 Chiron B4000 China 1/1 at 1:100BBI WWRB301 Chiron B30 155/160WHO Standard Gen-Probe B25 2/2Pelicheck S2091 Lyon, FR B20 20/20JRC Standard Panel Hokkaido, JP B10 20/20JRC Standard Panel Hokkaido, JP B8 2/2Pelicheck S2091 Lyon, FR B200 China 1/1 at 1:100BBI WWRB301 Chiron

C H I R O N Blood Testing Detection of HIV-1 Type C Specimens by TMA Assay SubtypeCopies/ml Origin Detection Source Testing Site C70000 Mozanbique 2/2 BBI WWRB302 BBI/Chiron C20000 Uganda 2/2 BBI WWRB302 BBI/Chiron C9300 2/2 Necker ARN 99 Lille, FR; Montpllier, FR C80000 Zimbabwe 1/1 at 1:100 BBI WWRB301 Chiron C 700 Zimbabwe 2/2 BBI WWRB302 BBI/Chiron C390 2/2 Necker ARN 99 Lille, FR; Montpllier, FR C300 Zimbabwe 2/2 BBI WWRB302 BBI/Chiron C30000 RSA 1/1 at 1:100 BBI WWRB301 Chiron C30000 India 1/1 at 1:100 BBI WWRB301 Chiron C700 RSA 1/1 at 1:5 BBI WWRB301 Chiron C4000 Zimbabwe 1/1 at 1:100 BBI WWRB301 Chiron C3000 India 1/1 at 1:100 BBI WWRB301 Chiron C2000 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

C H I R O N Blood Testing Detection of HIV-1 Type D Specimens by TMA Assay SubtypeCopies/ml Origin DetectionSourceTesting Site D50000 Uganda 2/2BBI WWRB302 BBI/Chiron D10000 Uganda 2/2BBI WWRB302 BBI/Chiron D4800 2/2Necker ARN 99Lille, FR; Montpllier, FR D3000 Uganda 2/2BBI WWRB302 BBI/Chiron D800 Uganda 2/2BBI WWRB302 BBI/Chiron D490 2/2Necker ARN 99Lille, FR; Montpllier, FR D7000 Uganda 1/1 at 1:100BBI WWRB301 Chiron D3000 Uganda 1/1 at 1:100BBI WWRB301 Chiron D1000 Uganda 1/1 at 1:100BBI WWRB301 Chiron D< 50 Uganda 1/1 at 1:5BBI WWRB301 Chiron

C H I R O N Blood Testing Detection of HIV-1 Type E Specimens by TMA Assay SubtypeCopies/ml Origin DetectionSourceTesting Site E7700 2/2Necker ARN 99Lille, FR; Montpllier, FR E3000 Thailand 2/2BBI WWRB302 BBI/Chiron E1500 2/2Necker ARN 99Lille, FR; Montpllier, FR E300 Thailand 2/2BBI WWRB302 BBI/Chiron E100 20/20VQA PanelHokkaido, JP E10000 Thailand 1/1 at 1:100BBI WWRB301 Chiron E50 20/20VQA PanelHokkaido, JP E20 19/20VQA PanelHokkaido, JP E< 50 Thailand 2/2BBI WWRB302 BBI/Chiron E< 50 Thailand 1/1 at 1:5BBI WWRB301 Chiron E< 50 Thailand 1/1 at 1:20BBI WWRB301Chiron

C H I R O N Blood Testing Detection of HIV-1 Types F,G,H,O Specimens by TMA Assay SubtypeCopies/ml Origin DetectionSourceTesting Site F /2Necker ARN 99Lille, FR; Montpllier, FR F5900 2/2Necker ARN 99Lille, FR; Montpllier, FR F200 Argentina 2/2BBI WWRB302 BBI/Chiron F10000 Argentina 1/1 at 1:100BBI WWRB301 Chiron F9000 Argentina 1/1 at 1:100BBI WWRB301Chiron F< 50 Argentina 1/1 at 1:5BBI WWRB301Chiron G /2Necker ARN 99Lille, FR; Montpllier, FR G3100 2/2Necker ARN 99Lille, FR; Montpllier, FR G< 50 Ghana 1/1 at 1:10BBI WWRB301 Chiron H9500 2/2Necker ARN 99Lille, FR; Montpllier, FR H1400 2/2Necker ARN 99Lille, FR; Montpllier, FR O<150 2/2Necker ARN 99Lille, FR; Montpllier, FR O< 50 Spain 2/2BBI WWRB302 BBI/Chiron O< 50 Cameroon 1/1 at 1:100BBI WWRB301 Chiron

C H I R O N Blood Testing Detection of Specimens a with Different HIV-1 Genotypes by TMA Assay (Montpellier, France) Genotype b OriginDetectionGenotype b OriginDetection A/E/- Cambodia1/1-/A/AG Cameroon1/1 A/E/- Cambodia1/1-/A/G Cameroon1/1 A/E/- Cambodia1/1F1/F1/F1 Chad1/1 -/D/F3 Cameroon1/1-/A/G RCA1/1 -/A?/D Cameroon1/1C/C/- Djibouti1/1 -/D/D Cameroon1/1C/C/- Djibouti1/1 -/D/D Djibouti1/1-/O/O Cameroon1/1 F3/F3/F3 Cameroon1/1-/O/O Cameroon1/1 F2/F2/F2 Cameroon1/1-/B/- Montpellier1/1 F2/F2/F2 Cameroon1/1-/A/AG Cameroon1/1 -/G/G Cameroon1/1A/A/J Cameroon1/1 C/C/- Djibouti1/1A/A/- Djibouti1/1 -/A/AG Cameroon1/1A/A/- RCA1/1 a ETSLR Panel, viral loads unknown b gag/pol/env

C H I R O N Blood Testing 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