A multicenter performance evaluation of the DPP® HIV-1/2 assay for the detection of HIV antibodies in various HIV testing algorithms

Abstract

Background: Multicenter studies were conducted to evaluate the DPP® HIV 1/2 Assay using oral fluid (OF) and fingerstick (FS) specimens in two different countries at the point of care (POC). Objective: To evaluate the DPP® HIV 1/2 Assay using OF and FS specimens when compared to various worldwide algorithms for the detection of HIV. Methods: At each testing center, each participant was tested using the DPP HIV 1/2 Assay using OF and FS specimens. Each sample was dispersed into a premeasured buffer in a dropper bottle (DPP® SampleTainer™ bottle) and added to the sample well of the device followed by the addition of running buffer to the buffer well of the device. Reference testing was performed according to the National testing algorithm of each Country. Results: Assay sensitivity resulted in ranges of 98.9-100% for OF specimens and 99.8-100% for FS specimens. Assay specificity resulted in ranges of 99.9-100% for OF specimens and 99.5-100% for FS specimens. Conclusions: Assay sensitivity and specificity obtained for both FS and OF were similar. The DPP HIV 1/2 Assay is highly accurate in detecting antibodies to HIV-1/2 with OF and FS specimens when compared to nationally accepted algorithms. The assay is especially advantageous in that the original sample is collected in a closed vial, eliminating the need for recollection of samples at the POC in the event of an invalid result or assay error upon testing. © 2013 Elsevier B.V.