Many scientific societies have issued guidelines to introduce population-based cervical cancer screening with HPV testing. The Vitro HPV Screening assay is a fully automatic multiplex real-time PCR test targeting the L1 GP5+/GP6+ region of HPV genome. The assay detects 14 high risk (HR) HPV genotypes, identifying individual HPV16 and HPV18 genotypes, and the HPV-positive samples for the other 12 HR HPV types are subsequently genotyped with the HPV Direct Flow Chip test. Following international guidelines, the aim of this study was to validate the clinical accuracy of the Vitro HPV Screening test on ThinPrep-collected samples for its use as primary cervical cancer screening, using as comparator the validated cobas®4800 HPV test. The non-inferiority analysis showed that the clinical sensitivity and specificity of the Vitro HPV Screening assay for a diagnosis of cervical intraepithelial neoplasia of grade 2 or worse (CIN2+) were not inferior to those of cobas®4800 HPV (p= 0.0049 andp< 0.001 respectively). The assay has demonstrated a high intra- and inter-laboratory reproducibility, also among the individual genotypes. The Vitro HPV Screening assay is valid for cervical cancer screening and it provides genotyping information on HPV-positive samples without further sample processing in a fully automated workflow.
多个科学学会已发布指南，推荐采用基于人群的HPV检测进行宫颈癌筛查。Vitro HPV筛查检测是一种针对HPV基因组L1 GP5+/GP6+区域的全自动多重实时PCR检测方法。该检测可识别14种高危型HPV基因型，其中HPV16和HPV18单独分型，其余12种高危型HPV阳性样本则通过HPV Direct Flow Chip检测进行后续基因分型。遵循国际指南，本研究旨在验证Vitro HPV检测在ThinPrep采集样本中作为宫颈癌初级筛查方法的临床准确性，并以已验证的cobas®4800 HPV检测作为对照。非劣效性分析表明，Vitro HPV检测对于宫颈上皮内瘤变2级及以上病变诊断的临床敏感性和特异性均不劣于cobas®4800 HPV检测（p值分别为0.0049和<0.001）。该检测方法在实验室内及实验室间均表现出高度可重复性，各基因型检测结果亦保持稳定。Vitro HPV筛查检测适用于宫颈癌筛查，其全自动工作流程可在无需额外样本处理的情况下为HPV阳性样本提供基因分型信息。
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