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www.aids2014.org
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
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
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Seroconversion Panels19 panels 3rd generation
rapid test (Ab)
FDA- approved HIV 4th generation
(Ag/Ab)
HIV EIA Ag (Ag)
Alere HIV Combo (Ag/Ab)
Earlier 16 0 2
Same 3 9 10
Later 0 2 0
Total panels 19 11 12
PCR
↓ ↓ ↓
Day -5.3 -0.6 0↑ ↑ Ag EIA
Alere HIVCombo
3rdgeneration
FDA approved4th generation
+6.7+0.6
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Acute HIV infection
RNAFDA- approved
HIV 4th generation (Ag/Ab)
Alere HIV ComboNo. of positive samples
Judge S/CO No. of positive Judge Ab Ag %
P N <1 3 N 17 17 NA
P 1~<5 18 P 1 5 33.3%
P 5~<10 10 P 0 8 80.0%
P 10~<20 8 P 0 8 100.0%
P 20~<50 15 P 2* 15 100.0%
P 50~621 15 P 3* 15 100.0%
69 Positive 66 Positive 52 78.8%* Both Ag/Ab positive
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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
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Specificity
SampleSample
No.
Alere HIV ComboNo. of positive
Ab Ag
HIV negative specimens (US) 1099 0 1
HIV negative specimens (Africa) 150 0 0
Disease state other than HIV and potentially interfering substances 346 0 0
Total 1595 0 1
Specificity 99.9%
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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