1. Evaluation of new rapid fourth generation point of care test device for the early diagnosis of HIV infection AlereTM HIV Combo Yuko Tamanoue, Product Development Department

2. 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. Seroconversion Panels

4. Acute HIV infection * Both Ag/Ab positive

5. 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. Specificity

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