Confirmation Algorithm (visit = CFM)
Figure: Confirmation algorithm
| ECR (EIA/CMIA/Rapid) | Geenius (assay interpretation)** | HIV-1 RNA | HIV-1 TNA | HIV-2 RNA | HIV-2 TNA | Unblinded CFM result summary text | |
|---|---|---|---|---|---|---|---|
| 1 |
Non-reactivex3
|
Not required | Not detected |
Not detected
|
Not required | Not required | Further testing required. Draw a new 10mL EDTA whole blood sample using visit type “Follow-up” (FUP). |
| 2 | Reactive x1 or 2 or 3 |
Negative
|
Not detected | Not detected | Not required | Not required | Further testing required. Draw a new 10mL EDTA whole blood sample using visit type “Follow-up” (FUP). |
| 3 | Reactive x1 or 2 or 3 |
HIV1 indeterminate or HIV1 positive
|
Not detected | Not detected | Not required | Not required | Further testing required. Draw a new 10mL EDTA whole blood sample using visit type “Follow-up” (FUP). |
| 4 | Reactive x1 or 2 or 3 |
Negative, or HIV1 indeterminate, or HIV1 positive
|
Detected | Not required | Not required | Not required | HIV-1 Infected |
| 5 | Reactive x1 or 2 or 3 |
Negative, or HIV1 indeterminate, or HIV1 positive
|
Not detected | Detected | Not required | Not required | HIV-1 Infected |
| 6 | Reactive x1 or 2 or 3 | HIV2 Positive | Not detected | Not required | Not required | Not required | HIV-2 Infected |
| 7 | Reactive x1 or 2 or 3 | HIV Positive- Untypable | Not detected | Not detected | Detected | Not detected | HIV-2 Infected |
| 8 | Reactive x1 or 2 or 3 | HIV Positive- Untypable | Not detected | Not detected | Not detected | Detected | HIV-2 Infected |
| 9 | Reactive x1 or 2 or 3 | HIV Positive- Untypable |
Detected
|
Not required |
Detected
|
Not required | HIV-1 and HIV-2 Infected |
| 10 | Reactive x1 or 2 or 3 | HIV Positive- Untypable | Not detected |
Detected
|
Not detected | Detected | HIV-1 and HIV-2 Infected |