Evaluation of Sero-Reactivity Recent Exposure Algorithm (visit = EOX)
Figure: Evaluation of Sero-Reactivity Recent Exposure (EOX) algorithm
| ECR (EIA/CMIA/Rapid) | Geenius (assay interpretation)** | HIV-1 RNA | HIV-1 TNA (or DNA) | HIV-2 RNA | HIV-2 TNA | Unblinded EOX 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). |