Mossoro-Kpinde Christian Diamant, Mboumba Bouassa Ralph-Sydney, Jenabian Mohammad-Ali, Wolyec Serge Tonen, Robin Leman, Matta Mathieu, Longo Jean de Dieu, Grésenguet Gérard, Andreoletti Laurent, Bélec Laurent
Laboratoire National de Biologie Clinique et de Santé Publique, Bangui, Central African Republic; Faculté des Sciences de la Santé, Université de Bangui, Bangui, Central African Republic.
Laboratoire de Virologie, Hôpital Européen Georges Pompidou, Paris, France; Université Paris Descartes, Paris Sorbonne Cité, Paris, France.
AIDS Res Treat. 2016;2016:7954810. doi: 10.1155/2016/7954810. Epub 2016 Dec 5.
. We evaluated the performances of Amplix real-time PCR platform developed by Biosynex (Strasbourg, France), combining automated station extraction (Amplix station 16 Dx) and real-time PCR (Amplix NG), for quantifying plasma HIV-1 RNA by lyophilized HIV-1 RNA-based Amplix reagents targeting and , using samples from HIV-1-infected adults from Central African Republic. . Amplix real-time PCR assay showed low limit of detection (28 copies/mL), across wide dynamic range (1.4-10 log copies/mL), 100% sensitivity and 99% specificity, high reproducibility, and accuracy with mean bias < 5%. The assay showed excellent correlations and concordance of 95.3% with the reference HIV-1 RNA load assay (Roche), with mean absolute bias of +0.097 log copies/mL by Bland-Altman analysis. The assay was able to detect and quantify the most prevalent HIV-1 subtype strains and the majority of non-B subtypes, CRFs of HIV-1 group M, and HIV-1 groups N and O circulating in Central Africa. The Amplix assay showed 100% sensitivity and 99.6% specificity to diagnose virological failure in clinical samples from antiretroviral drug-experienced patients. . The HIV-1 RNA-based Amplix real-time PCR platform constitutes sensitive and reliable system for clinical monitoring of HIV-1 RNA load in HIV-1-infected children and adults, particularly adapted to intermediate laboratory facilities in sub-Saharan Africa.
我们评估了由法国斯特拉斯堡的Biosynex公司开发的Amplix实时PCR平台的性能，该平台结合了自动化提取工作站（Amplix 16 Dx工作站）和实时PCR（Amplix NG），使用基于冻干HIV-1 RNA的Amplix试剂，针对[具体靶点1]和[具体靶点2]，对来自中非共和国的HIV-1感染成人的血浆HIV-1 RNA进行定量。Amplix实时PCR检测显示出低检测限（28拷贝/毫升），动态范围宽（1.4 - 10 log拷贝/毫升），灵敏度为100%，特异性为99%，具有高重现性，且平均偏差<5%，准确性高。该检测与参考HIV-1 RNA载量检测方法（罗氏）具有良好的相关性，一致性为95.3%，通过Bland-Altman分析，平均绝对偏差为+0.097 log拷贝/毫升。该检测能够检测和定量中非地区最流行的HIV-1亚型毒株以及大多数非B亚型、HIV-1 M组的CRF毒株，以及HIV-1 N组和O组毒株。Amplix检测在诊断抗逆转录病毒治疗经验丰富的患者临床样本中的病毒学失败方面显示出100%的灵敏度和99.6%的特异性。基于HIV-1 RNA的Amplix实时PCR平台构成了一个敏感且可靠的系统，用于对HIV-1感染儿童和成人的HIV-1 RNA载量进行临床监测，特别适用于撒哈拉以南非洲的中级实验室设施。
