一种检测宫颈拭子中HPV DNA的新方法：核酸提取与直接PCR的比较。

A new approach for detecting HPV DNA in cervical swabs: comparison of nucleic acid extraction with direct PCR.

作者信息

Çubuk Fatih, Yıldız Muhammet Çağrı, Balcı Fikrican, İrgin Ahmet, Aşkın Savaş, Sağtaş Ekrem, Kaygusuz Sedat

机构信息

National HPV Laboratory, Department of National Reference Laboratories and Biological Products, Public Health General Directorate, Ministry of Health, Ankara, Türkiye, Turkey.

Department of National Reference Laboratories and Biological Products, Public Health General Directorate, Ministry of Health, Ankara, Türkiye, Turkey.

出版信息

Virol J. 2025 Jan 11;22(1):8. doi: 10.1186/s12985-024-02601-w.

DOI:10.1186/s12985-024-02601-w

PMID:39794832

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11724592/

Abstract

BACKGROUND

Almost all cases of cervical cancer are associated with persistent high-risk HPV infection. WHO prioritizes primary HPV testing for cervical cancer screening. Cervical cancer screening programs require the ability to process a large number of samples in a simple and standardized manner and obtain reliable results. The workload, time, and cost associated with the number of samples to be processed encourage the development of alternative methods to the traditional nucleic acid extraction method for population-based screening. In this study, we aimed to compare the performance of a commercial pre-denaturation solution with nucleic acid extraction in HPV DNA detection by PCR in cervical swab samples.

METHODS

The study was designed in two phases: an experimental phase and a clinical phase. A total of 1200 cervical swabs were included in the clinical phase of the study. Positive results were obtained in 143 (11.9%) samples by nucleic acid extraction and 137 (11.4%) samples by PharmaDirect. Discordant results were detected in 28 (2.3%) samples.

RESULTS

PharmaDirect provided 88.1% sensitivity compared to nucleic acid extraction. PharmaDirect provided high sensitivity for HPV genotype 16 (92.3%) and relatively limited sensitivity for mixed genotype infections (73.7%).

CONCLUSION

This study demonstrates the potential of an alternative commercial pre-denaturation product that does not require nucleic acid extraction for HPV DNA detection in cervical swab samples. Such approaches may represent a useful alternative for population-based screening studies.

TRIAL REGISTRATION

Not applicable.

摘要

背景

几乎所有宫颈癌病例都与持续性高危型人乳头瘤病毒（HPV）感染相关。世界卫生组织将HPV初筛作为宫颈癌筛查的优先方法。宫颈癌筛查项目需要具备以简单、标准化方式处理大量样本并获得可靠结果的能力。与待处理样本数量相关的工作量、时间和成本促使人们开发替代传统核酸提取方法的技术，用于基于人群的筛查。在本研究中，我们旨在比较一种商用预变性溶液与核酸提取法在检测宫颈拭子样本中HPV DNA的PCR检测中的性能。