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OLA-Simple: A software-guided HIV-1 drug resistance test for low-resource laboratories.

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.

journal_name

EBioMedicine

journal_title

EBioMedicine

authors

Panpradist 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,Fr

doi

10.1016/j.ebiom.2019.11.002

subject

Has Abstract

pub_date

2019-12-01 00:00:00

pages

34-44

issn

2352-3964

pii

S2352-3964(19)30743-1

journal_volume

50

pub_type

杂志文章

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