Fatih Çubuk, Muhammet Çağrı Yıldız, Fikrican Balcı, Ahmet İrgin, Savaş Aşkın, Ekrem Sağtaş, Sedat Kaygusuz
{"title":"一种检测宫颈拭子HPV DNA的新方法：核酸提取与直接PCR的比较。","authors":"Fatih Çubuk, Muhammet Çağrı Yıldız, Fikrican Balcı, Ahmet İrgin, Savaş Aşkın, Ekrem Sağtaş, Sedat Kaygusuz","doi":"10.1186/s12985-024-02601-w","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>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.</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>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%).</p><p><strong>Conclusion: </strong>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.</p><p><strong>Trial registration: </strong>Not applicable.</p>","PeriodicalId":23616,"journal":{"name":"Virology Journal","volume":"22 1","pages":"8"},"PeriodicalIF":4.0000,"publicationDate":"2025-01-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11724592/pdf/","citationCount":"0","resultStr":"{\"title\":\"A new approach for detecting HPV DNA in cervical swabs: comparison of nucleic acid extraction with direct PCR.\",\"authors\":\"Fatih Çubuk, Muhammet Çağrı Yıldız, Fikrican Balcı, Ahmet İrgin, Savaş Aşkın, Ekrem Sağtaş, Sedat Kaygusuz\",\"doi\":\"10.1186/s12985-024-02601-w\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>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.</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>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%).</p><p><strong>Conclusion: </strong>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.</p><p><strong>Trial registration: </strong>Not applicable.</p>\",\"PeriodicalId\":23616,\"journal\":{\"name\":\"Virology Journal\",\"volume\":\"22 1\",\"pages\":\"8\"},\"PeriodicalIF\":4.0000,\"publicationDate\":\"2025-01-11\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11724592/pdf/\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Virology Journal\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1186/s12985-024-02601-w\",\"RegionNum\":3,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q2\",\"JCRName\":\"VIROLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Virology Journal","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1186/s12985-024-02601-w","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q2","JCRName":"VIROLOGY","Score":null,"Total":0}
A new approach for detecting HPV DNA in cervical swabs: comparison of nucleic acid extraction with direct PCR.
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.
期刊介绍：
Virology Journal is an open access, peer reviewed journal that considers articles on all aspects of virology, including research on the viruses of animals, plants and microbes. The journal welcomes basic research as well as pre-clinical and clinical studies of novel diagnostic tools, vaccines and anti-viral therapies.
The Editorial policy of Virology Journal is to publish all research which is assessed by peer reviewers to be a coherent and sound addition to the scientific literature, and puts less emphasis on interest levels or perceived impact.
求助内容：
应助结果提醒方式：
京公网安备 11010802042870号
