Post-study Algorithm (visit = POS)

Figure: Post-study (POS) algorithm



Table 1. POS Algorithm – Blinded and Unblinded Report Summary Comments
  ECR (EIA/CMIA/Rapid) Geenius (assay interpretation)** HIV-1 RNA HIV-1 TNA (or DNA) HIV-2 RNA HIV-2 TNA Unblinded POS result summary text
1 Non-reactive x3 + NR Abbott Prism Not required Not detected Not required Not required Not required No evidence of infection with HIV-1 or HIV-2. No evidence of vaccine-induced sero-reactivity or non-specific serological cross-reactivity. If any previous HVTN HIV diagnostic test results showed evidence of vaccine-induced sero-reactivity, it is recommended that HIV diagnostic testing continue through the HVTN until no evidence of sero-reactivity is repeatedly demonstrated.
2 Non-reactive x3 + Reactive Abbott Prism Not required

Not

detected

Not required Not required Not required No evidence of infection with HIV-1 or HIV-2. No evidence of non-specific sero-reactivity or vaccine-induced sero-reactivity (if participant received vaccine product) by most recent methods available. Evidence of non-specific or possible vaccine-induced sero-reactivity by a less specific method (Abbott Prism HIV-1/2/O Plus).
3 Reactive x1 or 2 or 3

Negative

Not Detected Not detected Not required Not required

No evidence of infection with HIV-1 or HIV-2. These results are consistent with vaccine-induced sero-reactivity, if participant received vaccine product, or these results may be due to non-specific serological cross-reactivity.

4 Reactive x1 or 2 or 3

HIV1 indeterminate or HIV1 positive

(consistent with product)

Not Detected Not detected Not required Not required

No evidence of infection with HIV-1 or HIV-2. These results are consistent with vaccine-induced sero-reactivity, if participant received vaccine product, or these results may be due to non-specific serological cross-reactivity.

5 Reactive x1 or 2 or 3

Negative or

HIV1 indeterminate or HIV1 positive or

HIV Positive, Untypable

Detected Not required Not required Not required Infected, HIV-1
6 Reactive x1 or 2 or 3

Negative or HIV-1 indeterminate or HIV-1 positive or

HIV Positive, Untypable

Not detected Detected Not required Not required Infected, HIV-1
7a Reactive x1 or 2 or 3 HIV2 Positive Not detected Not required

Detected

Not required Infected, HIV-2
7b Reactive x1 or 2 or 3 HIV2 Positive Not detected Not required Not detected Detected Infected, HIV-2
8a Reactive x1 or 2 or 3 HIV2 indeterminate

Not detected

Not required

Detected

Not required Infected, HIV-2
8b Reactive x1 or 2 or 3 HIV2 indeterminate

Not detected

Not required Not detected Detected Infected, HIV-2
9a Reactive x1 or 2 or 3 HIV Positive, Untypable Not detected Not detected Detected Not detected Infected, HIV-2
9b Reactive x1 or 2 or 3 HIV Positive, Untypable Not detected Not detected Not detected Detected Infected, HIV-2
10a Reactive x1 or 2 or 3 HIV Positive, Untypable

Detected

Not required

Detected

Not required Infected, HIV-1 and HIV-2
10b Reactive x1 or 2 or 3 HIV Positive, Untypable Not detected

Detected

Not detected Detected Infected, HIV-1 and HIV-2
11 Non-reactive x2 + Antigen reactive Abbott Determine Negative Not Detected Not required Not required Not required No evidence of infection with HIV-1/2 and no evidence of vaccine-induced seropositivity/reactivity (VISP/R). These results (antigen reactivity with non-detectable RNA results) are consistent with non-specific cross-reactivity (false reactive, not VISP/R).