Silvina Masciotra1, Krystin A Price2, Patrick Sprinkle2, Laura Wesolowski2, S Michele Owen2. 1. Division of HIV/AIDS Prevention, Centers for Disease Control and Prevention, Atlanta, GA, United States. Electronic address: svm6@cdc.gov. 2. Division of HIV/AIDS Prevention, Centers for Disease Control and Prevention, Atlanta, GA, United States.
Abstract
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. Published by Elsevier B.V.
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. Published by Elsevier B.V.
Authors: S R Leon; L B Ramos; S K Vargas; N Kojima; D G Perez; C F Caceres; J D Klausner Journal: J Clin Microbiol Date: 2015-12-09 Impact factor: 5.948
Authors: Joanne D Stekler; Lauren R Violette; Hollie A Clark; Sarah J McDougal; Lisa A Niemann; David A Katz; Pollyanna R Chavez; Laura G Wesolowski; Steven F Ethridge; Vanessa M McMahan; Andy Cornelius-Hudson; Kevin P Delaney Journal: JMIR Res Protoc Date: 2020-01-27