Post-study Testing Service Algorithm (visit = SRV)
Figure: Post study testing service (SRV) algorithm
ECR (EIA/CMIA/Rapid) | Geenius (assay interpretation)** | HIV-1 RNA | HIV-1 TNA (or DNA) | HIV-2 RNA | HIV-2 TNA | Unblinded SRV result summary text | |
---|---|---|---|---|---|---|---|
1 |
Non-reactivex3 + 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-reactivex3 + 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).
|
3a PrEP yes | 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.
|
3b PrEP no |
Reactive x1 or 2 or 3 |
Negative
|
Not Detected | Not required | 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
|
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
|
Detected | Not required | Not required | Not required | Presumptive HIV-1 Infected, based on a single blood specimen. Recommend further testing for confirmation. Please draw a new sample per service testing requirements and submit using visit type “Confirmation/CFM”. |
6 | Reactive x1 or 2 or 3 |
Negative, or HIV1 indeterminate, or HIV1 positive |
Not Detected | Detected | Not required | Not required | Presumptive HIV-1 Infected, based on a single blood specimen. Recommend further testing for confirmation. Please draw a new sample per service testing requirements and submit using visit type “Confirmation/CFM”. |
7 | Reactive x1 or 2 or 3 | HIV2 Positive | Not detected | Not required | Not required | Not required | Presumptive HIV-2 Infected, based on a single blood specimen. Recommend further testing for confirmation. Please draw a new sample per service testing requirements and submit using visit type “Confirmation/CFM”. |
8 | Reactive x1 or 2 or 3 |
HIV Positive- Untypable
|
Not detected | Not detected | Detected | Not detected | Presumptive HIV-2 Infected, based on a single blood specimen. Recommend further testing for confirmation. Please draw a new sample per service testing requirements and submit using visit type “Confirmation/CFM”. |
9 | Reactive x1 or 2 or 3 |
HIV Positive- Untypable
|
Not detected | Not detected | Not detected | Detected | Presumptive HIV-2 Infected, based on a single blood specimen. Recommend further testing for confirmation. Please draw a new sample per service testing requirements and submit using visit type “Confirmation/CFM”. |
10 | Reactive x1 or 2 or 3 |
HIV Positive- Untypable
|
Detected
|
Not required |
Detected
|
Not required | Presumptive HIV-1 and HIV-2 Infected, based on a single blood specimen. Recommend further testing for confirmation. Please draw a new sample per service testing requirements and submit using visit type “Confirmation/CFM”. |
11 | Reactive x1 or 2 or 3 |
HIV Positive- Untypable
|
Not detected |
Detected
|
Not detected | Detected | Presumptive HIV-1 and HIV-2 Infected, based on a single blood specimen. Recommend further testing for confirmation. Please draw a new sample per service testing requirements and submit using visit type “Confirmation/CFM”. |
12 | 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). |