Panpradist, NBeck, I.AVrana, JHiga, NMcIntyre, DRuth, P.SSo, IKline, E.SKanthula, RWong-On-Wing, ALim, JKo, DMilne, RRossouw, TFeucht, U.DMichael, CJourdain, GNgo-Giang-Huong, NLaomanit, LSoria, JLai, JKlavins, E.DFrenkel, L.MLutz, B.R2024-08-212024-08-212019-12-16Panpradist N, Beck IA, Vrana J, Higa N, McIntyre D, Ruth PS, So I, Kline EC, Kanthula R, Wong-On-Wing A, Lim J, Ko D, Milne R, Rossouw T, Feucht UD, Chung M, Jourdain G, Ngo-Giang-Huong N, Laomanit L, Soria J, Lai J, Klavins ED, Frenkel LM, Lutz BR. OLA-Simple: A software-guided HIV-1 drug resistance test for low-resource laboratories. EBioMedicine. 2019;50:34-44. DOI: https://doi.org/10.1016/j.ebiom.2019.11.002.https://doi.org/10.1016/j.ebiom.2019.11.002https://www.sciencedirect.com/science/article/pii/S2352396419307431https://hdl.handle.net/11288/597325Background HIV drug resistance (HIVDR) testing can assist clinicians in selecting treatments. However, high complexity and cost of genotyping assays limit routine testing in settings where HIVDR prevalence has reached high levels. Methods The oligonucleotide ligation assay (OLA)-Simple kit was developed for detection of HIVDR against first-line non-nucleoside/nucleoside reverse transcriptase inhibitors and validated on 672 codons (168 specimens) from subtypes A, B, C, D, and AE. The kit uses dry reagents to facilitate assay setup, lateral flow devices for visual HIVDR detections, and in-house software with an interface for guiding users and analyzing results. Findings HIVDR analysis of specimens by OLA-Simple compared to Sanger sequencing revealed 99.6 ± 0.3% specificity and 98.2 ± 0.9% sensitivity, and compared to high-sensitivity assays, 99.6 ± 0.6% specificity and 86.2 ± 2.5% sensitivity, with 2.6 ± 0.9% indeterminate results. OLA-Simple was performed more rapidly compared to Sanger sequencing (<4 h vs. 35–72 h). Forty-one untrained volunteers blindly tested two specimens each with 96.8 ± 0.8% accuracy. Interpretation OLA-Simple compares favorably with HIVDR genotyping by Sanger and sensitive comparators. Instructional software enabled inexperienced, first-time users to perform the assay with high accuracy. The reduced complexity, cost, and training requirements of OLA-Simple could improve access to HIVDR testing in low-resource settings and potentially allow same-day selection of appropriate antiretroviral therapy.enAttribution 3.0 United Stateshttp://creativecommons.org/licenses/by/3.0/us/HIV genotyping assayNNRTIResistanceRegimen switchingLow reseource laboratoriesArticleeBioMedicine