Table_1_Comparison of multiplex PCR capillary electrophoresis assay and PCR-reverse dot blot assay for human papillomavirus DNA genotyping detection in cervical cancer tissue specimens.DOCX

BackgroundThe study aimed to evaluate the positivity rates and genotype distribution of the multiplex PCR capillary electrophoresis (MPCE) and PCR-Reverse Dot Blot (PCR-RDB) assays for human papillomavirus (HPV) detection in cervical cancer tissue specimens, and to explore their detection principles and applications in large-scale population screening.
MethodsThe MPCE and PCR-RDB assays were performed separately on 425 diagnosed cervical cancer tissue specimens. Subsequently, the results of both assays were compared based on the HPV infection positivity rates and genotype distribution.
ResultsThe overall positive rates of HPV genotypes for the MPCE and PCR-RDB assays were 97.9% and 92.9%, respectively. A p-value < 0.001 indicated a statistically significance difference in consistency between the two assays. The kappa value was 0.390, indicating that the consistency between both assays was fair. HPV16 was the most common single-genotype infection type, with infection rates detected via MPCE and PCR-RDB assays being 75.7% and 68.3%, respectively. In the age group >50 years, the HPV multiple-type infection rate detected via MPCE assay was significantly higher than that detected by the PCR-RDB assay, with a statistically significant difference (p = 0.002).
ConclusionTo reduce the false-negative rate and improve screening efficiency, the MPCE assay, which targets the oncogenic gene E6/E7 segments, can be extended to the general female population for the early detection, diagnosis, and treatment of cervical cancer.

背景 本研究旨在评估多重PCR毛细管电泳（multiplex PCR capillary electrophoresis, MPCE）与PCR反向斑点杂交（PCR-Reverse Dot Blot, PCR-RDB）两种检测方法在宫颈癌组织标本中人乳头瘤病毒（human papillomavirus, HPV）检测中的阳性率及基因型分布，并探讨其检测原理及在大规模人群筛查中的应用价值。
方法 本研究对425例经病理确诊的宫颈癌组织标本分别采用MPCE与PCR-RDB两种方法进行HPV检测，随后以HPV感染阳性率及基因型分布为指标，对比两种检测方法的检测结果。
结果 MPCE与PCR-RDB检测的HPV基因型总体阳性率分别为97.9%与92.9%。经统计学分析，p值<0.001，提示两种检测方法的一致性存在显著统计学差异；Kappa值为0.390，表明两种方法的检测一致性一般。HPV16为最常见的单一基因型感染类型，MPCE与PCR-RDB检测的HPV16感染率分别为75.7%与68.3%。在年龄>50岁的人群中，MPCE检测所得的HPV多重感染率显著高于PCR-RDB检测结果，差异具有统计学意义（p=0.002）。
结论 为降低假阴性率、提升宫颈癌筛查效率，靶向致癌基因E6/E7片段的MPCE检测方法可推广至普通女性人群，用于宫颈癌的早期筛查、诊断及治疗。