Performance characteristics of the point-of-care tests for HPV-based cervical cancer screening: a systematic review and meta-analysis

Abstract

Background We aimed to conduct an updated and comprehensive summary of the sensitivity and specificity of three human papillomavirus (HPV) point-of-care (POC) tests (careHPV™, oncoE6™ cervical test, Xpert® HPV) to guide resource-constrained countries for their implementation in cervical cancer screening. Methods Databases including Medline, Embase, Web of Science and cumulated index in nursing and allied health literature (CINAHL) were searched between January 2004 and October 2024. Observational studies analyzing the three tests for cervical cancer screening were included. Pooled estimates for the performance characteristics were calculated using random-effect models. Findings Of the 3976 records, 33 studies were included. The sensitivity and specificity of careHPV™ for detection of CIN2+ lesions in self-collected samples were 75.6% and 85.6% compared to 86.4% and 80.4% for physician-collected samples. The sensitivity and specificity of OncoE6™ cervical test were 54.5% and 98.4%, respectively, for physician-collected samples. Xpert® HPV had a sensitivity and specificity of 91.5% and 56.5% in self-collected vaginal samples (SCSs), 92.3% and 53.3%, respectively, in physician-collected cervical samples. Interpretation Both careHPV™ and Xpert® HPV have a good sensitivity and specificity as a POC cervical cancer screening method. These methods also hold potential for use on SCSs. Funding None.