Confirmation Algorithm (visit = CFM)

Figure: Confirmation algorithm



Table 1. CFM Algorithm - Blinded and Unblinded Report Summary Comments
  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