Performance of genotypic tropism testing in clinical practice using the enhanced sensitivity version of Trofile as reference assay: results from the OSCAR Study Group
Svicher, V.; D'Arrigo, R.; Alteri, C.; Andreoni, M.; Angarano, G.; Antinori, A.; Antonelli, G.; Bagnarelli, P.; Baldanti, F.; Bertoli, A.; Borderi, M.; Boeri, E.; Bonn, I.; Bruzzone, B.; Callegaro, A.Paola.; Cammarota, R.; Canducci, F.; Ceccherini-Silberstein, F.; Clementi, M.; Monforte, A.D'Arminio.; De Luca, A.; Di Biagio, A.; Di Gianbenedetto, S.; Di Perri, G.; Di Pietro, M.; Fabeni, L.; Fadda, G.; Galli, M.; Gennari, W.; Ghisetti, V.; Giacometti, A.; Gori, A.; Leoncini, F.; Maggiol
New Microbiologica 33(3): 195-206
2010
ISSN/ISBN: 1121-7138 PMID: 20954437 Document Number: 642881
The goal of the OSCAR programme is to evaluate the performances of genotypic HIV-1 tropism testing in clinical practice using the enhanced sensitivity version of Trofile (ESTA) as reference-assay. HIV-1 coreceptor-usage was assessed using plasma samples from 406 HIV-1 infected patients by ESTA and by gp120 V3 population-sequencing followed by Geno2pheno (set at a False Positive Rate [FPR] of 10% and 5%). ESTA was successful in 365 (89.9%) samples indicating R5 in 254 (69.6%), and DM/X4 in 111 (30.4% of samples (104 [28.5%] DM and 7 [1.9%] X4). Genotypic-testing successfully assessed viral tropism for all 406 samples, including the 41 with undetermined result by ESTA. Genotypic-tropism testing at a FPR of 5% and 10% was 81.1% and 78.4% concordant with ESTA, respectively. Despite a sensitivity of 48.7% and 55.9% at a FPR of 5% and 10%, respectively, a high concordance (specificity: 95.3% for FPR of 5% and 88.2% for FPR of 10%) between genotypic-tropism testing and ESTA was reached in the detection of R5-tropic viruses. Our results are in line with other European studies, and support the routine use of genotypic tropism testing in clinical-settings for monitoring of HIV-1 infected patients candidate to or failing CCR5-antagonists.