Svicher Valentina, D'Arrigo Roberta, Alteri Claudia, Andreoni Massimo, Angarano Gioacchino, Antinori Andrea, Antonelli Guido, Bagnarelli Patrizia, Baldanti Fausto, Bertoli Ada, Borderi Marco, Boeri Enzo, Bonn Isabella, Bruzzone Bianca, Callegaro Anna Paola, Cammarota Roberta, Canducci Filippo, Ceccherini-Silberstein Francesca, Clementi Massimo, Monforte Antonella D'Arminio, De Luca Andrea, Di Biagio Antonio, Di Gianbenedetto Simona, Di Perri Giovanni, Di Pietro Massimo, Fabeni Lavinia, Fadda Giovanni, Galli Massimo, Gennari William, Ghisetti Valeria, Giacometti Andrea, Gori Andrea, Leoncini Francesco, Maggiolo Franco, Maserati Renato, Mazzotta Francesco, Micheli Valeria, Meini Genny, Monno Laura, Mussini Cristina, Nozza Silvia, Paolucci Stefania, Parisi Saverio, Pecorari Monica, Pizzi Daniele, Quirino Tiziana, Re Maria Carla, Rizzardini Giuliano, Santangelo Rosaria, Soria Alessandro, Stazi Francesca, Sterrantino Gaetana, Turriziani Ombretta, Viscoli Claudio, Vullo Vincenzo, Lazzarin Adriano, Perno Carlo Federico
University of Rome Tor Vergata, Department of Experimental Medicine, Roma, Italy.
New Microbiol. 2010 Jul;33(3):195-206.
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.
OSCAR项目的目标是使用Trofile增强灵敏度版本（ESTA）作为参考检测方法，评估临床实践中基因型HIV-1嗜性检测的性能。
通过ESTA以及gp120 V3群体测序随后进行Geno2pheno（设定假阳性率[FPR]为10%和5%），使用406例HIV-1感染患者的血浆样本评估HIV-1共受体使用情况。
ESTA在365份样本（89.9%）中检测成功，其中254份（69.6%）显示为R5，111份（样本的30.4%，其中104份[28.5%]为双嗜性和7份[1.9%]为X4）显示为双嗜性/ X4。基因分型检测成功评估了所有406份样本的病毒嗜性，包括ESTA检测结果未确定的41份样本。FPR为5%和10%时，基因分型嗜性检测与ESTA的一致性分别为81.1%和78.4%。尽管在FPR为5%和10%时灵敏度分别为48.7%和55.9%，但在检测R5嗜性病毒时，基因分型嗜性检测与ESTA之间仍达到了较高的一致性（特异性：FPR为5%时为95.3%，FPR为10%时为88.2%）。
我们的结果与其他欧洲研究一致，并支持在临床环境中常规使用基因型嗜性检测来监测接受CCR5拮抗剂治疗或治疗失败的HIV-1感染患者。
