Accuracy of point-of-care HIV and CD4 field testing by lay healthcare workers in the Botswana Combination Prevention Project.

Accurate HIV and CD4 testing are critical in program implementation, with HIV misdiagnosis having serious consequences at both the client and/or community level. We implemented a comprehensive training and Quality Assurance (QA) program to ensure accuracy of point-of-care HIV and CD4 count testing by lay counsellors during the Botswana Combination Prevention Project (BCPP). We compared the performance of field testing by lay counsellors to results from an accredited laboratory to ascertain accuracy of testing. All trained lay counsellors passed competency assessments and performed satisfactorily in proficiency testing panel evaluations in 2013, 2014, and 2015. There was excellent agreement (99.6 %) between field and laboratory-based HIV test results; of the 3002 samples tested, 960 and 2030 were concordantly positive and negative respectively, with 12 misclassifications (kappa score 0.99, p < 0.0001). Of the 149 HIV-positive samples enumerated for CD4 count in the field using PIMA at a threshold of ≤ 350 cells/µl; there was 86 % agreement with laboratory testing, with only 21 misclassified. The mean difference between field and lab CD4 testing was - 16.16 cells/µl (95 % CI -5.4 to 26.9). Overall, there was excellent agreement between field and laboratory results for both HIV rapid test and PIMA CD4 results. A standard training package to train lay counsellors to accurately perform HIV and CD4 point-of-care testing in field settings was feasible, with point-of-care results obtained by lay counsellors comparable to laboratory-based testing.

Performance of drug-resistance genotypic assays among HIV-1 infected patients with predominantly CRF02_AG strains of HIV-1 in Abidjan, Cote d'Ivoire.

OBJECTIVE: We evaluated the performance of three genotypic assays to detect resistant mutations among HIV-1 infected patients with known antiretroviral drug resistance profile in Abidjan, Cote d'Ivoire, most of whom had the circulating recombinant form (CRF02_A/G) of HIV-1. METHODS: The 56 patients analyzed in this study were enrolled in a pilot program to make available antiretroviral therapy (ART) to HIV-infected patients in Abidjan through the UNAIDS Drug Access Initiative (DAI). These patients had failed ART, as demonstrated by rebound in RNA viral load. Their plasma samples had been previously analyzed for ART genotypic drug-resistance by VircoGEN (Mechelen, Belgium) and were known to have primary and secondary resistance mutations, and also had phenotypic drug-resistance by a recombinant virus assay technology (Mechelen, Belgium). The two assays we evaluated were: VircoGEN, TruGene HIV-1, and ViroSEQ HIV-1 assays. RESULTS: For the reverse transcriptase gene, all 27 samples that had the T215Y/F mutation were detected by VircoGEN , ViroSEQ, and TrueGene. All 19 (100%) samples that had the K70R/E mutation detected by VircoGEN were detected by ViroSEQ, and 18 (94.7%) by TrueGene. All ten samples with the M184V mutation, three with the K65R, two with the G190A mutation, one with the K103N mutation, and one with the V75T mutation were detected similarly by all three assays. For the protease gene, all three assays detected the I84V (n = 1), M46I (n = 1), and L90M (n = 1) mutations. CONCLUSION: These results suggest that any of these assays should be considered for monitoring the occurrence of drug resistance among HIV-infected patients receiving antiretroviral therapy in West Africa.