Yaneng Bioscience, Co, Ltd, Shenzhen, China.
Department of Clinical Laboratory, Shenzhen Nanshan Maternity and Child Healthcare Hospital, Shenzhen, China.
Cancer Cytopathol. 2022 Dec;130(12):955-963. doi: 10.1002/cncy.22628. Epub 2022 Jul 19.
Most human papillomavirus (HPV)-positive women recover from infections and do not develop cervical intraepithelial neoplasia (CIN) and cervical cancer. Additional triage approaches are needed to reduce unnecessary colposcopy referrals. The aim of this study is to determine the high-risk HPV prevalence in a hospital-based population and to evaluate the performance of p16/Ki-67 dual-stain test for the triage of high-risk HPV-positive women to detect precursor lesions and cervical cancer compared with the ThinPrep cytologic test (TCT).
In a hospital-based population, 100,801 women were provided with a primary HPV DNA test and only women with high-risk HPV infections were triaged using TCT and p16/Ki-67 dual-stain test. CIN2 or worse (≥CIN2) or CIN3 or worse (≥CIN3) were defined as the clinical end points.
The p16/Ki-67 dual-stain indicated a statistically significant higher sensitivity (82.8% vs. 66.7%%), specificity (51.6% vs. 44.4%), positive predictive value (33.2% vs. 25.8%), negative predictive value (91.2% vs. 82.1%), and accuracy (58.6% vs. 49.4%) compared with TCT examination within ≥CIN2 cases. Similar patterns were observed for the ≥CIN3 end point.
Our study demonstrated that p16/Ki-67 dual-stain test could achieve better performance compared with TCT examination for ≥CIN2 or ≥ CIN3 detection, representing a promising approach as a specific and efficient triage strategy for high-risk HPV-positive women.
大多数人乳头瘤病毒（HPV）阳性的妇女可从感染中恢复，不会发展为宫颈上皮内瘤变（CIN）和宫颈癌。需要额外的分流方法来减少不必要的阴道镜转诊。本研究旨在确定基于医院人群的高危型 HPV 流行率，并评估 p16/Ki-67 双重染色试验在高危型 HPV 阳性妇女中的分流作用，以检测前驱病变和宫颈癌，与 ThinPrep 细胞学检查（TCT）相比。
在基于医院的人群中，为 100801 名妇女提供了初级 HPV DNA 检测，只有高危型 HPV 感染的妇女通过 TCT 和 p16/Ki-67 双重染色试验进行了分流。CIN2 或更高级别（≥CIN2）或 CIN3 或更高级别（≥CIN3）定义为临床终点。
p16/Ki-67 双重染色在统计学上显示出更高的敏感性（82.8%对 66.7%）、特异性（51.6%对 44.4%）、阳性预测值（33.2%对 25.8%）、阴性预测值（91.2%对 82.1%）和准确性（58.6%对 49.4%），与 TCT 检查≥CIN2 病例相比。对于≥CIN3 终点也观察到类似的模式。
我们的研究表明，p16/Ki-67 双重染色试验在检测≥CIN2 或≥CIN3 方面的性能优于 TCT 检查，代表了一种有前途的方法，可作为高危型 HPV 阳性妇女的一种特异性和有效的分流策略。
