Abstract
BackgroundRapid diagnostic tests (RDTs) are a cornerstone of HIV diagnosis and rely on good quality processing and interpretation, particularly in the era of test and treat. The Deki Reader (Fio Corporation®, Toronto, Ontario, Canada) is a portable device designed specifically for analysing RDTs and was selected for evaluation in South Africa in the context of HIV RDT analysis.MethodsThis study consisted of a laboratory evaluation and two-part field evaluation of the Deki Reader v100, covering two RDT testing algorithms, and an evaluation of the continuous quality monitoring through the Fionet™ web portal. Based on user feedback from the field evaluation, the device underwent hardware and software redesign, and the Deki Reader v200 was evaluated in the laboratory. Ethics approval for this evaluation was obtained from the University of the Witwatersrand Human Research Ethics Committee: M150160.ResultsThe intra- and inter-device laboratory precision of the Deki Reader v100 were 98.3 and 99.2% respectively, and 99.3 and 100% for the Deki Reader v200. The laboratory concordances compared to standard-of-care reporting were 99.5 and 98.0% for the two respective models, while sensitivity and specificity were 99.5 and 99.4% for the Deki Reader V100 and 100 and 93.1% for the Deki Reader V200 respectively. Screening and confirmatory concordances in the field were 99.3 and 96.5% under algorithm 1 and 99.7 and 100% under algorithm 2. Sensitivity and specificity for the field evaluation were 99.8 and 97.7%. Overall robustness of the device was acceptable and continuous quality monitoring through Fionet™ was feasible.ConclusionsThe Deki Reader provides an option for improved and reliable quality assessment for rapid diagnosis of HIV using RDTs to enhance the quality of healthcare at the point-of-care. However, the introduction of new RDTs and modification of current algorithms necessitates ongoing and agile RDT reader adjustments, which will require cost modelling to ensure sustainability of devices implemented into national HIV programs.
Highlights
Rapid diagnostic tests (RDTs) are a cornerstone of Human Immunodeficiency Virus (HIV) diagnosis and rely on good quality processing and interpretation, in the era of test and treat
A recent audit of selected South African clinics showed that RDT testing practices were poor, with algorithm nonadherence, a lack of external quality control, and a lack of understanding when results were discordant, all of which may compromise the quality of the results [13]
Laboratory evaluation The laboratory evaluations of both the Deki Reader v100 and the Deki Reader v200 showed that automated RDT analysis was comparable with Standard of care (SOC)
Summary
Rapid diagnostic tests (RDTs) are a cornerstone of HIV diagnosis and rely on good quality processing and interpretation, in the era of test and treat. In many resource-limited settings, HIV diagnosis is achieved using only RDTs, allowing for rapid scale-up of HIV testing services (HTS) [1], in an effort to meet the 90–90-90 [2] and 95– 95-95 [3] goals Linked to this are the gamechanging studies showing the value of early antiretroviral therapy (ART) initiation [4,5,6], which led the World Health Organisation (WHO) to recommend a universal test and treat (UTT) program for HIV [7]. A recent systematic review [1] showed that suboptimal testing strategies, failure to follow algorithms, human error and inadequate supply chain management, amongst others, contribute to misdiagnosis globally This analysis of 25 studies showed that users frequently perform or interpret the RDTs incorrectly, with some studies describing the use of expired RDTs [1]. A recent audit of selected South African clinics showed that RDT testing practices were poor, with algorithm nonadherence, a lack of external quality control, and a lack of understanding when results were discordant, all of which may compromise the quality of the results [13]
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