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Www.aids2014.org Alere TM HIV Combo Yuko Tamanoue, Product Development Department.

Published byKerry McLaughlin Modified over 9 years ago

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Presentation on theme: "Www.aids2014.org Alere TM HIV Combo Yuko Tamanoue, Product Development Department."— Presentation transcript:

1 www.aids2014.org Alere TM HIV Combo Yuko Tamanoue, Product Development Department

2 www.aids2014.org Alere™ HIV Combo- Rationale Acute infection accounts for 5-20% of all cases of HIV infection among person seeking testing. The seroconversion window period is associated with peak levels of viremia and high risk of transmission Earlier identification would: –Increase case finding –Facilitate earlier referral to care –Earlier Treatment –Partner Notification

3 www.aids2014.org Seroconversion Panels 19 panels3 rd generation rapid test (Ab) FDA- approved HIV 4 th generation (Ag/Ab) HIV EIA Ag (Ag) Alere HIV Combo (Ag/Ab) Earlier1602 Same3910 Later020 Total panels191112

4 www.aids2014.org Acute HIV infection RNA FDA- approved HIV 4 th generation (Ag/Ab) Alere HIV Combo No. of positive samples JudgeS/CO No. of positive JudgeAbAg% PN<13N17 NA P1~<518P1533.3% P5~<1010P0880.0% P10~<208P08100.0% P20~<5015P2*15100.0% P50~62115P3*15100.0% 69 Positive 66Positive5278.8% * Both Ag/Ab positive

5 www.aids2014.org Analytical sensitivity of HIV-1 p24 and subtype detection Analytical sensitivity of HIV-1 p24: 2 IU/ml HIV-1 antibody subtype panels: 100% (40/40), A, B, C, D, CRF01-AE, CRF02-AG, F, G, H, J, K, O HIV-1 virus subtype panel for antigen: 100% (31/31) A, B, C, D, CRF01-AE, CRF02-AG, F, G, H, O

6 www.aids2014.org Specificity Sample Sample No. Alere HIV Combo No. of positive AbAg HIV negative specimens (US)109901 HIV negative specimens (Africa) 15000 Disease state other than HIV and potentially interfering substances 34600 Total159501 Specificity 99.9%

7 www.aids2014.org Conclusions Alere™ HIV Combo shows comparable performance to FDA-approved 4 th generation laboratory assay Alere™ HIV Combo shows marked improvement in case finding over 3 rd generation poc test Alere™ HIV Combo could be a useful diagnostic tool in HIV screening programmes worldwide

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