Comparative analysis of diagnostic methods for high-risk HPV detection: A scoping review and meta-analysis

Abstract

Introduction: High-risk (HR) human papillomavirus (HPV) is the main cause of cervical cancer and a substantial proportion of oropharyngeal cancers, making early and accurate detection critical for effective screening and prevention, particularly in low-resource settings

Objective: This study aims to compare the diagnostic accuracy of point-of-care and rapid testing methods for HR-HPV detection.

Methods: We conducted a scoping review and meta-analysis in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews framework. PubMed/MEDLINE, ScienceDirect, and Scopus were searched for English-language studies published from 2010 through July 2025. Fifteen studies met the inclusion criteria, with eight included in the meta-analysis.

Results: Recombinase polymerase amplification combined with clustered regularly interspaced short palindromic repeats/Cas12a achieved the highest pooled diagnostic performance, with a sensitivity of 0.94 and specificity of 0.97. Polymerase chain reaction-based analyses also showed high accuracy (sensitivity = 0.85; specificity = 0.97) but exhibited considerable heterogeneity across platforms and sample types. Loop-mediated isothermal amplification demonstrated moderate performance (sensitivity = 0.60; specificity = 0.91), while p16 immunohistochemistry offered good sensitivity (0.91) but lower specificity (0.73), supporting its use as a confirmatory rather than primary screening tool. In situ hybridization and next-generation sequencing provided broader genotyping capability but were limited by higher cost and technical complexity.

Conclusion: Polymerase chain reaction remains the clinical gold standard for HR-HPV detection, whereas recombinase polymerase amplification/clustered regularly interspaced short palindromic repeats–Cas12a emerges as a promising alternative for decentralized, low-resource screening. Future multi-center studies should standardize reporting, expand genotype coverage beyond HPV-16 and HPV-18, and assess cost, turnaround time, and operational feasibility to ensure that advances in

Keywords

Diagnostic / Human papillomavirus / Point of care / Rapid diagnostic

Acknowledgements

None.

Funding

This study was funded by the Research Grant “Program Hibah Penelitian Fundamental” (0070/C3/AL.04/2025 23, 1014/LL3/ AL.04/2025, and 479/A/LPPM/USAKTI/VI/2025) from the Directorate General of Higher Education, Research, and Technology, under the Ministry of Education, Culture, Research, and Technology of Indonesia.

Conflict of interest

The authors have no conflicts of interest associated with the material presented in this paper.

Author contributions

Conceptualization:Rahmi Amtha, Monica Dwi Hartanti, Indrayadi Gunardi

Data curation: Nadira Putri Fedin, Christopher Andrew Teguh, Ilham Hizbulloh

Formal analysis: Indrayadi Gunardi

Methodology: Rahmi Amtha, Monica Dwi Hartanti, Indrayadi Gunardi, Muhammad Ihsan Rizal

Project administration: Nadira Putri Fedin

Visualization: Indrayadi Gunardi, Christopher Andrew Teguh, Ilham Hizbulloh

Writing–original draft: Nadira Putri Fedin, Rahmi Amtha, Indrayadi Gunardi

Writing–review & editing: Yani Kurniawan, Didik Tulus Subekti, Christina Safira Whinie Lestari

Ethics approval and consent to participate

Not applicable.

Consent for publication

Not applicable.

Availability of data

Data is available from the corresponding author upon reasonable request.

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