Minimal Post-Study Algorithm
Figure: Minimal Post-Study Algorithm
| 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 ECR | 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 | 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. |
| 3 | Reactive x1 or 2 or 3 |
HIV-1 Indeterminate or HIV-1 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. |
| 4 | Reactive x1 or 2 or 3 |
Negative or HIV-1 Indeterminate or HIV-1 Positive or HIV Positive, Untypable |
Detected | Not required | Not required | Not required | Infected, HIV-1 |
| 5 | 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 |
| 6a | Reactive x1 or 2 or 3 | HIV-2 Positive | Not detected | Not required |
Detected |
Not required | Infected, HIV-2 |
| 6b | Reactive x1 or 2 or 3 | HIV-2 Positive | Not detected | Not required | Not detected | Detected | Infected, HIV-2 |
| 7a | Reactive x1 or 2 or 3 | HIV-2 Indeterminate |
Not detected |
Not required |
Detected
|
Not required | Infected, HIV-2 |
| 7b | Reactive x1 or 2 or 3 | HIV-2 Indeterminate |
Not detected |
Not required | Not detected | Detected | Infected, HIV-2 |
| 8a | Reactive x1 or 2 or 3 | HIV Positive, Untypable | Not detected | Not detected | Detected | Not detected | Infected, HIV-2 |
| 8b | Reactive x1 or 2 or 3 | HIV Positive, Untypable | Not detected | Not detected | Not detected | Detected | Infected, HIV-2 |
| 9a | Reactive x1 or 2 or 3 | HIV Positive, Untypable |
Detected |
Not required |
Detected |
Not required | Infected, HIV-1 and HIV-2 |
| 9b | Reactive x1 or 2 or 3 | HIV Positive, Untypable | Not detected |
Detected |
Not detected | Detected | Infected, HIV-1 and HIV-2 |
| 10 | 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). |
| Criteria | Result |
|---|---|
| RNA is Detected | Standard redraw is triggered (SubmitRedraw, ReceiveRedraw, EIA, Geenius, RNA PCR) |
| EIA is Reactive | Geenius is triggered |
| EIA 2 or 3 are Reactive | Geenius is triggered |
| EIA is Non-reactive | EIA 2 and EIA 3 tests are triggered |
| RNA was positive and a redraw was triggered | HAWS will propose no result |
| All EIAs were Non-reactive | HAWS will propose Uninfected with no evidence of VISP |
| At least one EIA was Reactive | HAWS will propose Uninfected, likely VISP |