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Alere TM HIV Combo

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

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Alere TM HIV Combo

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  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

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