Fig. 2

Summary of the Deki Reader Laboratory and Clinical Concordance Evaluations. Two separate laboratory evaluations were performed. The first (n = 774 specimens) evaluated the Deki Reader v100, while the second (n = 474 specimens) evaluated the upgraded technology, the Deki Reader v200. The devices were evaluated using different RDT brands that were selected based on changing country algorithms (planned and implemented). Each evaluation included concordance between automated and visual analysis, and a precision analysis. The phase 2 (clinical concordance) field evaluation was performed using two different RDT algorithms. The first field evaluation (n = 2463 specimens) used the Advanced Quality™ Rapid HIV (1&2) RDT for screening and the HIV 1/2/0 TriLine RDT for confirmation of positive results (algorithm 1). The second field evaluation (n = 1997 specimens) was performed after a national HIV RDT algorithm change, and used the HIV 1/2/0 TriLine RDT for screening and the First Response® HIV 1–2-0 for confirmation of positive results (algorithm 2)