Department of Epidemiology, Faculty of Public Health, Iran University of Medical Sciences, Tehran, Iran.
Reproductive Endocrinology Research Center, Research Institute for Endocrine Sciences, Shahid Beheshti University of Medical Sciences, Tehran, Iran.
BMC Infect Dis. 2024 Nov 16;24(1):1309. doi: 10.1186/s12879-024-10121-9.
Valid diagnostic tests for human papillomavirus (HPV) detection are crucial to identify individuals at high risk of cervical cancer. We assessed and compared the validity of Mehrviru HPV genotyping and Sacace (HPV Genotypes 14 Real-TM Quant) for molecular detection of 14 high-risk human papillomaviruses.
We used three HPV test results to identify HPV-positive individuals (14 high-risk genotypes) in a specialist gynecology clinic. The HPV test results were collected using Mehrviru, Sacace, and a third kit from the clinical diagnostic laboratory. We used Latent class analysis to determine the actual status of HPV infection in study participants. The sensitivity, specificity, positive and negative predictive values, positive and negative likelihood ratios, Youden, and area under the ROC curve indices of each diagnostic kit and their 95% confidence intervals were calculated. The agreement between the Mehrviru and Sacace kits was determined using the Kappa statistic.
We examined 117 women at high risk of HPV infection. The mean age (SD) was 37.2 (9.1). According to LCA, 28.6% of participants had an HPV infection. The sensitivity and specificity (95% CI) of the Mehrviru were 90.8% (73.7-97.2%) and 90.9% (82.1-95.6%), and corresponding figures for Sacace were 92.0% (72.3-98.1%) and 97.4% (90.2-99.3%). The kappa index between the Mehrviru and Sacace kits was 69.7% (55.6-83.9%). The area under the ROC curve for Mehrviru and Sacace test were 91.4% (85.7-97.1%) and 94.4% (89.3-99.5%).
There is an excellent agreement between Mehrviru and Sacace test results, and the diagnostic accuracy indices were similar.
有效的人乳头瘤病毒（HPV）检测诊断试验对于识别宫颈癌高危个体至关重要。我们评估并比较了 Mehrviru HPV 基因分型和 Sacace（HPV 基因型 14 Real-TM Quant）在分子检测 14 种高危人乳头瘤病毒中的有效性。
我们使用三种 HPV 检测结果在一家妇科专科诊所中确定 HPV 阳性个体（14 种高危基因型）。HPV 检测结果使用 Mehrviru、Sacace 和临床诊断实验室的第三种试剂盒收集。我们使用潜在类别分析来确定研究参与者的 HPV 感染实际状况。计算了每种诊断试剂盒及其 95%置信区间的灵敏度、特异性、阳性和阴性预测值、阳性和阴性似然比、Youden 和 ROC 曲线下面积指数。使用 Kappa 统计确定 Mehrviru 和 Sacace 试剂盒之间的一致性。
我们检查了 117 名 HPV 感染高危女性。平均年龄（SD）为 37.2（9.1）岁。根据 LCA，28.6%的参与者存在 HPV 感染。Mehrviru 的灵敏度和特异性（95%CI）分别为 90.8%（73.7-97.2%）和 90.9%（82.1-95.6%），Sacace 的相应数值分别为 92.0%（72.3-98.1%）和 97.4%（90.2-99.3%）。Mehrviru 和 Sacace 试剂盒之间的 Kappa 指数为 69.7%（55.6-83.9%）。Mehrviru 和 Sacace 检测的 ROC 曲线下面积分别为 91.4%（85.7-97.1%）和 94.4%（89.3-99.5%）。
Mehrviru 和 Sacace 检测结果之间存在极好的一致性，且诊断准确性指数相似。
