Evaluation of a Novel Single-Tube Method for Extended Genotyping of Human Papillomavirus.
Evaluation of a Novel Single-Tube Method for Extended Genotyping of Human Papillomavirus.
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DOI：
10.1128/jcm.01687-17
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发表时间：
2018-03
影响因子：
9.4
通讯作者：
Cuschieri K
中科院分区：
文献类型：
--
作者：
Bhatia R;Serrano I;Wennington H;Graham C;Cubie H;Boland E;Fu G;Cuschieri K
在全球范围内，使用高危人乳头瘤病毒（HPV）测试在全球范围内增加，并且对测试进行评估以确保适合此目的非常重要。在这项研究中，将新的HPV基因分型测试的性能，乳头状高风险HPV（HR-HPV）测试与两项公认的基因分型测试进行了比较。还确定了在富含疾病的回顾性队列中检测CIN2+的初步临床性能。通过乳头状HR-HPV检验测试了一组具有已知临床结果的500个具有颈液基细胞学样品。将分析的一致性与两个测定法进行了比较：线性阵列（LA）HPV基因分型测试和一个Optiplex HPV基因分型测试。进行了CIN2+样品检测的初始临床性能，并将其与两项经过临床验证的HPV测试的临床性能进行了比较：实时高危HPV测试（实时）和混合捕获2 HPV测试（HC2）。与LA和0.70和0.82相比，HPV16和HPV18的KAPPA值在HPV16和0.90和0.82之间观察到HR-HPV的高度一致性，与LA和0.82相比，HPV16和HPV18的KAPPA值分别为0.90和0.81，观察到HR-HPV的高度一致性（分别为97和95％），而HPV16和HPV18的KAPPA值分别为97和95％（分别为97和95％）。 。 Papilloplex测试对CIN2+检测的敏感性，特异性，正预测值和负预测值分别为92、54、33和96％，并且与实时和HC2观察到的值非常相似。乳头状HR-HPV测试显示出与HR-HPV水平和类型特异性水平的两个HPV基因分型测试相似的分析性能。尽管需要在筛查种群中进行进一步的纵向研究来确认这些发现，但有关临床表现的初步数据看起来令人鼓舞。
The use of high-risk human papillomavirus (HPV) testing for surveillance and clinical applications is increasing globally, and it is important that tests are evaluated to ensure they are fit for this purpose. In this study, the performance of a new HPV genotyping test, the Papilloplex high-risk HPV (HR-HPV) test, was compared to two well-established genotyping tests. Preliminary clinical performance was also ascertained for the detection of CIN2+ in a disease-enriched retrospective cohort. A panel of 500 cervical liquid-based cytology samples with known clinical outcomes were tested by the Papilloplex HR-HPV test. Analytical concordance was compared to two assays: a Linear Array (LA) HPV genotyping test and an Optiplex HPV genotyping test. The initial clinical performance for the detection for CIN2+ samples was performed and compared to that of two clinically validated HPV tests: a RealTime High-Risk HPV test (RealTime) and a Hybrid Capture 2 HPV test (HC2). High agreement for HR-HPV was observed between the Papilloplex and LA and Optiplex HPV tests (97 and 95%, respectively), with kappa values for HPV16 and HPV18 being 0.90 and 0.81 compared to the LA and 0.70 and 0.82 compared to the Optiplex test. The sensitivity, specificity, positive predictive value, and negative predictive value of the Papilloplex test for the detection of CIN2+ were 92, 54, 33, and 96%, respectively, and very similar to the values observed with RealTime and HC2. The Papilloplex HR-HPV test demonstrated a analytical performance similar to those of the two HPV genotyping tests at the HR-HPV level and the type-specific level. The preliminary data on clinical performance look encouraging, although further longitudinal studies within screening populations are required to confirm these findings.