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

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...

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Main Authors: Fatih Çubuk, Muhammet Çağrı Yıldız, Fikrican Balcı, Ahmet İrgin, Savaş Aşkın, Ekrem Sağtaş, Sedat kaygusuz
Format: Article
Language:English
Published: BMC 2025-01-01
Series:Virology Journal
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Online Access:https://doi.org/10.1186/s12985-024-02601-w
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author Fatih Çubuk
Muhammet Çağrı Yıldız
Fikrican Balcı
Ahmet İrgin
Savaş Aşkın
Ekrem Sağtaş
Sedat kaygusuz
author_facet Fatih Çubuk
Muhammet Çağrı Yıldız
Fikrican Balcı
Ahmet İrgin
Savaş Aşkın
Ekrem Sağtaş
Sedat kaygusuz
author_sort Fatih Çubuk
collection DOAJ
description 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.
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institution Kabale University
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spelling doaj-art-bb5af6b1c15a4521928e40f06a4491e32025-01-12T12:08:09ZengBMCVirology Journal1743-422X2025-01-012211710.1186/s12985-024-02601-wA new approach for detecting HPV DNA in cervical swabs: comparison of nucleic acid extraction with direct PCRFatih Çubuk0Muhammet Çağrı Yıldız1Fikrican Balcı2Ahmet İrgin3Savaş Aşkın4Ekrem Sağtaş5Sedat kaygusuz6National HPV Laboratory, Department of National Reference Laboratories and Biological Products, Public Health General Directorate, Ministry of HealthNational HPV Laboratory, Department of National Reference Laboratories and Biological Products, Public Health General Directorate, Ministry of HealthPharmaline Sağlık Hizmetleri San. Tic. A.ŞNational HPV Laboratory, Department of National Reference Laboratories and Biological Products, Public Health General Directorate, Ministry of HealthNational HPV Laboratory, Department of National Reference Laboratories and Biological Products, Public Health General Directorate, Ministry of HealthDepartment of National Reference Laboratories and Biological Products, Public Health General Directorate, Ministry of HealthPublic Health General Directorate, Ministry of HealthAbstract 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.https://doi.org/10.1186/s12985-024-02601-wHPVHPV DNAPCRPre-denaturationSensitivityCervical cancer screening
spellingShingle Fatih Çubuk
Muhammet Çağrı Yıldız
Fikrican Balcı
Ahmet İrgin
Savaş Aşkın
Ekrem Sağtaş
Sedat kaygusuz
A new approach for detecting HPV DNA in cervical swabs: comparison of nucleic acid extraction with direct PCR
Virology Journal
HPV
HPV DNA
PCR
Pre-denaturation
Sensitivity
Cervical cancer screening
title A new approach for detecting HPV DNA in cervical swabs: comparison of nucleic acid extraction with direct PCR
title_full A new approach for detecting HPV DNA in cervical swabs: comparison of nucleic acid extraction with direct PCR
title_fullStr A new approach for detecting HPV DNA in cervical swabs: comparison of nucleic acid extraction with direct PCR
title_full_unstemmed A new approach for detecting HPV DNA in cervical swabs: comparison of nucleic acid extraction with direct PCR
title_short A new approach for detecting HPV DNA in cervical swabs: comparison of nucleic acid extraction with direct PCR
title_sort new approach for detecting hpv dna in cervical swabs comparison of nucleic acid extraction with direct pcr
topic HPV
HPV DNA
PCR
Pre-denaturation
Sensitivity
Cervical cancer screening
url https://doi.org/10.1186/s12985-024-02601-w
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