OLA-simple : a software-guided HIV-1 drug resistance test for low-resource laboratories

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dc.contributor.author Panpradist, Nuttada
dc.contributor.author BecK, Ingrid A.
dc.contributor.author Vrana, Justin
dc.contributor.author Higa, Nikki
dc.contributor.author McIntyre, David
dc.contributor.author Ruth, Parker S.
dc.contributor.author So, Isaac
dc.contributor.author Kline, Enos C.
dc.contributor.author Kanthula, Ruth
dc.contributor.author Wong-On-Wing, Annie
dc.contributor.author Lim, Jonathan
dc.contributor.author Ko, Daisy
dc.contributor.author Milne, Ross
dc.contributor.author Rossouw, Theresa M.
dc.contributor.author Feucht, Ute Dagmar
dc.contributor.author Chung, Michael
dc.contributor.author Jourdain, Gonzague
dc.contributor.author Ngo-Giang-Huong, Nicole
dc.contributor.author Laomanit, Laddawan
dc.contributor.author Soria, Jaime
dc.contributor.author Lai, James
dc.contributor.author Klavins, Eric D.
dc.contributor.author Frenkel, Lisa M.
dc.contributor.author Lutz, Barry R.
dc.date.accessioned 2020-07-31T13:05:58Z
dc.date.available 2020-07-31T13:05:58Z
dc.date.issued 2019-12
dc.description.abstract BACKGROUND : 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. FUND : USA National Institutes of Health R01; the Clinical and Retrovirology Research Core and the Molecular Profiling and Computational Biology Core of the UW CFAR; Seattle Children's Research Institute; UW Holloman Innovation Challenge Award; Pilcher Faculty Fellowship. en_ZA
dc.description.department Immunology en_ZA
dc.description.department Paediatrics and Child Health en_ZA
dc.description.librarian am2020 en_ZA
dc.description.sponsorship USA National Institutes of Health R01; the Clinical and Retrovirology Research Core and the Molecular Profiling and Computational Biology Core of the UW CFAR; Seattle Children's Research Institute; UW Holloman Innovation Challenge Award; Pilcher Faculty Fellowship. en_ZA
dc.description.uri http://www.elsevier.com/locate/ebiom en_ZA
dc.identifier.citation Panpradist, N., Beck, I.A., Vrana, J. et al. 2019, 'OLA-simple : a software-guided HIV-1 drug resistance test for low-resource laboratories', EBioMedicine, vol. 50, pp. 34-44. en_ZA
dc.identifier.issn 2352-3964 (online)
dc.identifier.other 10.1016/j.ebiom.2019.11.002
dc.identifier.uri http://hdl.handle.net/2263/75529
dc.language.iso en en_ZA
dc.publisher Elsevier en_ZA
dc.rights © 2019 The Author(s). Published by Elsevier B.V.. This is an open access article under the CCBY-NC-ND license. en_ZA
dc.subject HIV genotyping assay en_ZA
dc.subject Resistance en_ZA
dc.subject Regimen switching en_ZA
dc.subject Human immunodeficiency virus (HIV) en_ZA
dc.subject HIV drug resistance (HIVDR) en_ZA
dc.subject Oligonucleotide ligation assay (OLA) en_ZA
dc.subject Non-nucleoside reverse transcriptase inhibitors (NNRTI) en_ZA
dc.subject Nucleoside reverse transcriptase inhibitors (NRTI) en_ZA
dc.title OLA-simple : a software-guided HIV-1 drug resistance test for low-resource laboratories en_ZA
dc.type Article en_ZA


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