Performance evaluation of the CHEMBIO DPP® (dual path platform) HIV-1/2 assay in early and established infections.

BACKGROUND

The availability of more accurate point-of-care technology could increase the number of persons aware of their HIV status. The DPP(®) HIV-1/2 assay is the first dual path platform rapid test (RT) approved in the U.S. that also received the Clinical Laboratory Improvement Amendments (CLIA) waiver for use with oral fluid and fingerstick and venous whole blood.

OBJECTIVE

To evaluate the performance of the DPP(®) HIV-1/2 assay with plasma specimens.

STUDY DESIGN

Sensitivity and specificity of the assay were calculated from 696 HIV-1 groups M (B and non-B subtypes) and O and HIV-2 (groups A and B) specimens and 505 HIV-negative specimens, respectively. Analysis of the assay performance in HIV-1 early infections was assessed by estimating the relative sensitivity of the RT before the Western blot (WB) becomes positive using a 50% cumulative frequency analysis and by comparing the reactivity with other Food and Drug Administration (FDA)-approved RTs.

RESULTS

The sensitivity for established infection was 100% for HIV-1 and 100% for HIV-2. The specificity was 100%. The DPP(®) HIV-1/2 assay performs similarly to most antibody-based RT approved by FDA in early HIV-1 infections.

CONCLUSIONS

The DPP(®) technology showed no significant improvement for detecting early infections over other lateral-flow RTs used in the U.S. Without more data on the DPP(®) HIV-1/2 assay, especially from whole blood and oral fluid specimens collected during the early phase of infection, its performance as point-of-care technology remains to be assessed.