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C H I R O N Blood Testing

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


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


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


RSA Study: Donor Population

Total Repeat First timenumber donors donors

“Low-Risk” Male 6096 5465 631Female 3467 3038 429Total 9563 (46%) 8503 1060

“High-Risk” Male 6679 5720 959Female 4378 3334 1044Total 11057 (54%) 9054 2003

TOTAL Male 12775 (62%) 11185 1590Female 7845 (38%) 6372 1473Total 20620 (100%) 17557 (85%) 3063 (15%)


RSA Study: Results

TMA RR RR RR RR NR NRp24 Ag NR RR RR NR NR NRAntibody NR NR RR RR RR NR

“Low-Risk” Male 0 0 0 2 0 6094Female 0 0 0 1 0 3466Total 0 0 0 3 0 9560

“High-Risk” Male 0 1 5 58 0 6615Female 1 0 1 97 1 4278Total 1 1 6 155 1 10893

TOTAL Male 0 1 5 60 0 12709Female 1 0 1 98 1 7744Total 1 1 6 158 1 20453


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


Genomic Detection of HIV by TMA in High Prevalence Areas of Sub-Saharan Africa

Pool Pools Donors Pos. TMA p24 Absize 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


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

SF07989444 07/09/99 19.7 19.0 18.8 R/P R/NSF08012675 08/27/99 17.1 17.6 15.5 R/P R/PMM00124739 Sep 99 NT 17.0 18.6 R/P R/NSF08051578 12/17/99 21.5 22.4 21.7 R/P R/PSF08063998 02/01/00 19.6 20.2 20.0 R/P R/PSF08107307 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.


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 6000 Uganda 2/2 BBI WWRB302 BBI/Chiron



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 < 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


Detection of HIV-1 Type B Specimens by TMA Assay


B 30000 2/2 Necker ARN 99 Lille, FR; Montpllier, FR

B 20000 USA 2/2 BBI WWRB302 BBI/Chiron


B/D 5000 USA 2/2 BBI WWRB302 BBI/Chiron


B 2000 China 2/2 BBI WWRB302 BBI/Chiron


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 100 160/160 WHO Standard Gen-Probe

B 100 5/5 VQA 003ru Lille, FR

B 100 20/20 VQA Panel Hokkaido, JP


Detection of HIV-1 Type B Specimens by TMA Assay


B 9000 RSA 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 USA 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



Detection of HIV-1 Type C Specimens by TMA Assay


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 India 1/1 at 1:100 BBI WWRB301 Chiron



C 3000 India 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


Detection of HIV-1 Type D Specimens by TMA Assay


D 50000 Uganda 2/2 BBI WWRB302 BBI/Chiron


D 4800 2/2 Necker ARN 99 Lille, FR; Montpllier, FR



D 490 2/2 Necker ARN 99 Lille, FR; Montpllier, FR

D 7000 Uganda 1/1 at 1:100 BBI WWRB301 Chiron



D < 50 Uganda 1/1 at 1:5 BBI WWRB301 Chiron


Detection of HIV-1 Type E Specimens by TMA Assay


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 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


Detection of HIV-1 Types F,G,H,O Specimens by TMA Assay


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


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


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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