采用 VALGENT 框架评估 PapilloCheck HPV-Screening 检测的临床和分析性能。
Clinical and analytical performance of the PapilloCheck HPV-Screening assay using the VALGENT framework.
机构信息
French Human papilomavirus Reference Laboratory, Institut Pasteur, France; Department of Endocrinology and Reproductive Medicine, IE3M, Groupe Hospitalier Pitié-Salpêtrière, Assistance Publique, Hôpitaux de Paris (AP-HP), Paris, France.
Scottish HPV Reference Laboratory, Royal Infirmary of Edinburgh, 51 Little France Crescent, EH16 4SA, United Kingdom.
出版信息
J Clin Virol. 2016 Aug;81:6-11. doi: 10.1016/j.jcv.2016.05.004. Epub 2016 May 19.
BACKGROUND
The benefit of HPV testing for cervical cancer screening and disease management has been shown in many recent studies and is part of several new evidence-based guidelines. Assessment of emerging HPV tests in this context is essential, using well-annotated samples, such as those generated via the Validation of Genotyping Tests-HPV (VALGENT) framework.
OBJECTIVE
Our aim was to assess the PapilloCheck HPV assay in terms of absolute and relative accuracy for primary cervical cancer screening, using a standard comparator test (GP5+/6+EIA)already validated in randomised trials.
STUDY DESIGN
Type-specific HPV prevalence was stratified by age and cytology grade and compared with the luminex typing assay incorporating a GP5+6+ PCR (GP5+/6+ LMNX Assay). Clinical outcomes were compared with GP5+/6+EIA.
RESULTS
Prevalence of hrHPV types (high-risk HPV) increased with severity of cytology. The concordance between PapilloCheck and the GP5+/6+ LMNX Assay was excellent when assessed at the qualitative hrHPV presence/absence level also at the type-specific level in the whole population and in women over 30 years of age. Absolute clinical sensitivity and specificity of the PapilloCheck was high and ranged between 95.5% and 98.2% for sensitivity and between 82.7% and 91.6% for specificity, depending on the outcome and population.
CONCLUSION
The sensitivity and specificity of this assay for the outcomes of CIN2+ were similar to those of the standard comparator assay, GP5+/6+ EIA.
背景
HPV 检测在宫颈癌筛查和疾病管理中的益处已在许多近期研究中得到证实，并且是几个新的基于证据的指南的一部分。在这种情况下，评估新兴 HPV 检测至关重要，需要使用经过良好注释的样本，例如通过 Validation of Genotyping Tests-HPV (VALGENT) 框架生成的样本。
目的
我们旨在使用已在随机试验中验证的标准比较试验（GP5+/6+EIA）评估 PapilloCheck HPV 检测在原发性宫颈癌筛查方面的绝对和相对准确性。
研究设计
根据年龄和细胞学分级对 HPV 型别进行分层，并与包含 GP5+6+PCR 的 Luminex 型别测定法（GP5+/6+LMNX 测定法）进行比较。将临床结果与 GP5+/6+EIA 进行比较。
结果
高危型 HPV（hrHPV）的流行率随细胞学严重程度的增加而增加。在整个人群中和 30 岁以上的女性中，PapilloCheck 与 GP5+/6+LMNX 测定法在定性的 hrHPV 存在/缺失水平上以及在型别特异性水平上的一致性非常好。PapilloCheck 的绝对临床敏感性和特异性均很高，在不同的结果和人群中，敏感性范围为 95.5%至 98.2%，特异性范围为 82.7%至 91.6%。
结论
对于 CIN2+等结果，该检测的敏感性和特异性与标准比较检测（GP5+/6+EIA）相似。
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