Advances in HPV Diagnostic Testing—Improving Access and Accuracy

A special issue of Pathogens (ISSN 2076-0817). This special issue belongs to the section "Viral Pathogens".

Deadline for manuscript submissions: 31 January 2025 | Viewed by 2276

Special Issue Editor


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Guest Editor
School of Health Sciences, Massey University, Auckland 0632, New Zealand
Interests: molecular diagnostics; infectious disease; sexually transmitted infections; viral haemorrhagic fevers; point of care diagnostics; human papillomavirus; cervical cancer screening; capacity building; antimicrobial stewardship
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Special Issue Information

Dear Colleagues,

Oncogenic types of HPV were first identified as the cause of cervical cancer in the 1980s. This lead to the development of highly effective prophylactic HPV vaccines and the eventual implementation of primary screening programmes based on viral nucleic acid detection and partial typing. Diagnostic methods for HPV have evolved considerably in recent years, with the development of more sensitive, specific and/or accessible tests. Methods including extended genotyping, analysis of methylation signatures, viral loads, and other proteomic and bioinformatic approaches continue to be reported.  However, various challenges remain.

There is yet to be an ideal test or algorithm that optimally reduces both the risk of missing relevant disease and over-treatment. Whilst HPV primary cervical cancer screening is well developed, the use and interpretation of those same HPV tests in anal cancer screening or oropharyngeal disease is still being investigated. Additionally, in resource-limited settings, a variety of molecular diagnostic tools have been developed for point of care testing (POCT), but their dependence on expensive equipment, a reliable power supply and other technical requirements limit their applications. Early detection of HPV infection and any resulting abnormalities remains essential for the effective management of HPV-related diseases.

This Special Issue aims to present the latest research on all aspects of HPV diagnostics, from improving the accuracy of disease prediction and detection through to improvements in reliability and acceptability of access and achieving timely testing.  We invite you to share research that contributes new knowledge to this field and that will aid in reducing the morbidity and mortality associated with this globally important virus.

Dr. Collette Bromhead
Guest Editor

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Keywords

  • human papillomavirus
  • molecular diagnostics
  • self-testing
  • point of care testing
  • biomarkers
  • cervical intraepithelial neoplasia (CIN)
  • anal intraepithelial neoplasia (AIN)
  • oropharyngeal cancer
  • primary screening
  • methylation
  • viral load
  • mass spectrometry
  • CRISPR

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Published Papers (2 papers)

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Research

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12 pages, 762 KiB  
Article
Preliminary Results of Feasibility and Acceptability of Self-Collection for Cervical Screening in Italian Women
by Illari Sechi, Narcisa Muresu, Mariangela V. Puci, Laura Saderi, Arcadia Del Rio, Andrea Cossu, Maria R. Muroni, Santina Castriciano, Marianna Martinelli, Clementina E. Cocuzza, Giovanni Sotgiu and Andrea Piana
Pathogens 2023, 12(9), 1169; https://doi.org/10.3390/pathogens12091169 - 17 Sep 2023
Cited by 6 | Viewed by 1322
Abstract
Background: Given the diagnostic accuracy of HPV-DNA tests in terms of self-collected samples, in order to implement self-sampling in cervical screening programs, the standardization of the pre-analytical phase, including decisions concerning the choice of medium, the volume of elution, and storage conditions, are [...] Read more.
Background: Given the diagnostic accuracy of HPV-DNA tests in terms of self-collected samples, in order to implement self-sampling in cervical screening programs, the standardization of the pre-analytical phase, including decisions concerning the choice of medium, the volume of elution, and storage conditions, are necessary, in addition to understanding the potential factors involved in acceptability by women. On this basis, we carried out a cross-sectional study to assess (i) the stability of dry vaginal self-collected samples stored at room temperature for up to 4 weeks after elution in 2 mL of eNat® (Copan) medium, and (ii) the acceptability of self-collection in enrolled women. Methods: 185 women were enrolled in the LILT (Italian League Against Tumors) regional project. A self-sampling kit, including a dry FLOQSwab® (Copan), instructions for use, and a satisfaction questionnaire, were supplied for each woman and sent by mail to the laboratory. The HPV-DNA test was carried out using the Anyplex™ II HPV HR (Seegene) kit. To evaluate the specimen’s stability, 185 dry vaginal swabs were eluted in eNat®, a lyses-based molecular medium and tested for HPV detection at two different time points (<6 days and 1 month after elution). The Cohen’s Kappa coefficients and McNemar test were used to assess the agreement of HPV-DNA at different times. Results: We found high agreement in terms of HPV-DNA results among the samples tested at two different time points (Cohen K = 0.98; p < 0.0001). Moreover, most of the women found it easy to use self-collection devices and the pictorial instructions clear to understand. Approximately half of the enrolled women declared preferring self-sampling to clinician-collected methods. Conclusion: Our results display the high reliability and accuracy of HPV-DNA tests using dry vaginal self-collection FLOQSwabs® devices eluted in 2 mL of molecular medium. The analysis of the questionnaire showed a high acceptability of self-collection among women, although a high percentage preferred standard collection devices. Overall, our preliminary results support the adoption of self-collection in screening programs, even though further analyses should be performed to optimize and standardize protocols for HPV tests on self-samples, and educational campaigns are needed to adequately inform and increase responsiveness in a target population. Full article
(This article belongs to the Special Issue Advances in HPV Diagnostic Testing—Improving Access and Accuracy)
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Review

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28 pages, 2311 KiB  
Review
Isothermal Technologies for HPV Detection: Current Trends and Future Perspectives
by Elda A. Flores-Contreras, Everardo González-González, Gerardo de Jesús Trujillo-Rodríguez, Iram P. Rodríguez-Sánchez, Jesús Ancer-Rodríguez, Antonio Alí Pérez-Maya, Salomon Alvarez-Cuevas, Margarita L. Martinez-Fierro, Iván A. Marino-Martínez and Idalia Garza-Veloz
Pathogens 2024, 13(8), 653; https://doi.org/10.3390/pathogens13080653 - 2 Aug 2024
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Abstract
The human papillomavirus (HPV) is a non-enveloped DNA virus transmitted through skin-to-skin contact that infects epithelial and mucosal tissue. It has over 200 known genotypes, classified by their pathogenicity as high-risk and low-risk categories. High-risk HPV genotypes are associated with the development of [...] Read more.
The human papillomavirus (HPV) is a non-enveloped DNA virus transmitted through skin-to-skin contact that infects epithelial and mucosal tissue. It has over 200 known genotypes, classified by their pathogenicity as high-risk and low-risk categories. High-risk HPV genotypes are associated with the development of different types of cancers, including cervical cancer, which is a leading cause of mortality in women. In clinical practice and the market, the principal tests used to detect HPV are based on cytology, hybrid detection, and qPCR. However, these methodologies may not be ideal for the required timely diagnosis. Tests have been developed based on isothermal nucleic acid amplification tests (INAATs) as alternatives. These tests offer multiple advantages over the qPCR, such as not requiring specialized laboratories, highly trained personnel, or expensive equipment like thermocyclers. This review analyzes the different INAATs applied for the detection of HPV, considering the specific characteristics of each test, including the HPV genotypes, gene target, the limit of detection (LOD), detection methods, and detection time. Additionally, we discuss the tests available on the market that are approved by the Food and Drug Administration (FDA). Finally, we address the challenges and potential solutions for the large-scale implementation of INAATs, particularly in rural or underserved areas. Full article
(This article belongs to the Special Issue Advances in HPV Diagnostic Testing—Improving Access and Accuracy)
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