Chen Yanlin, Li Ye, Xue Lifang, Xu Mu, Wang Liying, Dong Binhua, Cai Liangzhi
Department of Gynecology, Laboratory of Gynecologic Oncology, Fujian Maternity and Child Health Hospital, Fuzhou, Fujian, PR China.
College of Clinical Medicine for Obstetrics & Gynecology and Pediatrics, Fujian Medical University, Fuzhou 350001, Fujian, PR China.
J Med Microbiol. 2024 Dec;73(12). doi: 10.1099/jmm.0.001938.
Human papillomavirus (HPV), the predominant viral infection affecting the anogenital tract, is closely linked to the development of intraepithelial neoplasia and malignancies in the cervix and other anal regions. Currently, 15 high-risk HPVs (HR-HPVs) and 3 potential HR-HPV types have been recognized as contributors to cervical cancer. Consequently, it is imperative to conduct HR-HPV screening using suitable tests in order to identify precancerous lesions and prevent the development of cancer. The Human papillomavirus genotyping (type 23) detection kit (PCR-reverse point hybridization method) is reliable for clinical testing. The objective of this research was to assess the concordance between the Human papillomavirus genotyping (type 23) detection kit (PCR-reverse point hybridization method) and the approved HPV test. A sample of 781 women who received HPV genotype testing during cervical cancer screening consultations at the Department of Gynecology, Fujian Maternity and Child Health Hospital, was examined. Thirty-two cases were excluded for lacking histological results or showing signs of vulvar intraepithelial rheology, leaving 749 valid histological samples. Only 181 valid pathological specimens were available after excluding those without cervical biopsy or total hysterectomy. The consistency of the test results was assessed using the kappa () statistic, with CIN2+ serving as the benchmark for determining sensitivity and specificity. Statistical significance was defined as differences with values <0.05 (two-tailed). The human papillomavirus genotyping (type 23) detection kit (PCR-reverse point hybridization method) and the approved HPV test demonstrated a high level of concordance with a total kappa value of 0.969 (<0.05). The overall concordance rate was found to be 98.720%. Using cervical intraepithelial neoplasia grade 2+ (CIN2+) as the reference standard, the human papillomavirus genotyping (type 23) detection kit (PCR-reverse point hybridization method) and the approved HPV test both showed 89.655% sensitivity (>0.05), while the specificity values were 40.590 and 40.309%, respectively (>0.05). The evaluated HPV test demonstrates comparable performance to other assays available during the same time frame and exhibits strong concordance in detecting the majority of HPV genotypes.
人乳头瘤病毒（HPV）是影响肛门生殖道的主要病毒感染，与子宫颈及其他肛门区域上皮内瘤变和恶性肿瘤的发生密切相关。目前，15种高危型HPV（HR-HPV）和3种潜在的高危型HPV已被确认为宫颈癌的致病因素。因此，必须使用合适的检测方法进行HR-HPV筛查，以识别癌前病变并预防癌症的发生。人乳头瘤病毒基因分型（23型）检测试剂盒（PCR-反向点杂交法）用于临床检测是可靠的。本研究的目的是评估人乳头瘤病毒基因分型（23型）检测试剂盒（PCR-反向点杂交法）与已获批准的HPV检测方法之间的一致性。对在福建省妇幼保健院妇科进行宫颈癌筛查咨询期间接受HPV基因分型检测的781名女性样本进行了检查。32例因缺乏组织学结果或显示外阴上皮内流变学迹象而被排除，留下749份有效的组织学样本。排除那些未进行宫颈活检或全子宫切除术的样本后，仅获得181份有效的病理标本。使用kappa（κ）统计量评估检测结果的一致性，以CIN2+作为确定敏感性和特异性的基准。统计学显著性定义为κ值<0.05（双侧）的差异。人乳头瘤病毒基因分型（23型）检测试剂盒（PCR-反向点杂交法）与已获批准的HPV检测方法显示出高度一致性，总kappa值为0.969（P<0.05）。总体一致性率为98.720%。以宫颈上皮内瘤变2级及以上（CIN2+）为参考标准，人乳头瘤病毒基因分型（23型）检测试剂盒（PCR-反向点杂交法）和已获批准的HPV检测方法的敏感性均为89.655%（P>0.05），而特异性值分别为40.590%和40.309%（P>0.05）。所评估的HPV检测方法与同一时期可用的其他检测方法表现相当，并且在检测大多数HPV基因型方面表现出很强的一致性。
