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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

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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