Field Evaluation of a Broadly Sensitive HIV-1 In-House Genotyping Assay for Use with both Plasma and Dried Blood Spot Specimens in a Resource-Limited Country

摘要: ABSTRACT HIV-1 drug resistance (HIVDR) assays are important tools in clinical management of HIV-infected patients on antiretroviral therapy (ART) and surveillance drug-resistant variants at population levels. The high cost associated with commercial hinders their use resource-limited settings. We adopted validated a low-cost in-house assay using 68 matched plasma dried blood spot (DBS) samples median viral load (VL) 58,187 copies/ml, ranging from 253 to 3,264,850 against the ViroSeq. Results indicated that not only had higher genotyping rate than did ViroSeq (94% versus 78%) but also was able genotype 89.5% (51/57) DBS VLs ≥1,000 copies/ml. sensitivity detecting DR mutations by 98.29% (95% confidence interval [CI], 97.86 98.72) 96.54 CI, 95.93 97.15) DBS, specificity 99.97% 99.91 100.00) for both sample types compared minor mutation differences detected result significance. In addition, analysis showed could reduce about 60% This field condition evaluation highlights potential utility cost-effective, subtype-independent, specimens HIVDR monitoring population-based