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A systematic review and meta-analysis of studies evaluating the performance of point-of-care tests for human papillomavirus screening
  1. Helen Kelly1,
  2. Philippe Mayaud1,
  3. Michel Segondy2,
  4. Nitika Pant Pai3,
  5. Rosanna W Peeling1
  1. 1 London School of Hygiene and Tropical Medicine, London, UK
  2. 2 INSERM U1058 and University Hospital (CHRU), Montpellier, France
  3. 3 Department of Epidemiology, McGill University, Montreal, Canada
  1. Correspondence to Dr Helen Kelly, Department of Clinical Research, Faculty of Infectious and Tropical Diseases, London School of Hygiene and Tropical Medicine, London WC1E7HT, UK; helen.kelly{at}lshtm.ac.uk

Abstract

Background High-risk human papillomavirus (HPV) is a necessary cause of high-grade cervical intraepithelial neoplasia (grade 2 or higher, CIN2+). Simplified and rapid HPV DNA assays designed for use in resource-limited settings have recently become available.

Methods We performed a systematic review and meta-analysis by searching Medline, Embase, Global Health and CINAHL databases for studies from 1 January 2004 to 25 February 2017 that reported the performance of careHPV or OncoE6 for the detection of histological CIN2+ in cervical cancer screening. We used bivariate models to estimate pooled sensitivity and specificity for CIN2+ and CIN3+.

Results A total of 29 657 women were included from seven studies evaluating the performance of careHPV for the detection of CIN2+ and four studies among 27 845 women for the detection of CIN3+. The pooled prevalence for CIN2+ and CIN3+ was 2.3% and 1.1%, respectively. careHPV had sensitivity and specificity of 88.1% (95% CI 81.4 to 92.7) and 83.7% (95% CI 74.9 to 89.8), respectively, for CIN2+ and 90.3% (95% CI 83.4 to 94.5) and 85.3% (95% CI 73.1 to 92.5), respectively, for CIN3+, using clinician-collected cervical specimen. The corresponding pooled estimates using self-collected vaginal swabs were 73.6% (95% CI 64.9 to 80.8) and 88.0% (95% CI 79.1 to 93.5) for CIN2+ and 75.2% (95% CI 66.8 to 82.0) and 90.6% (95% CI 83.4 to 94.9) for CIN3+. Two studies using OncoE6 reported sensitivity and specificity ranging from 31.3% to 42.4% and 99.1%–99.4% for CIN2+, and 53.5% and 98.9% for CIN3+ for one study.

Conclusion CareHPV has good sensitivity and specificity for the detection of CIN2+ and CIN3+, but sensitivity was lower using self-collected vaginal samples. The specificity is lower in high HPV prevalence populations such as women living with HIV. OncoE6 assay warrants further evaluation.

  • high-risk human papillomavirus (HPV)
  • cervical intraepithelial neoplasia (CIN)
  • rapid tests
  • HIV

This is an Open Access article distributed in accordance with the terms of the Creative Commons Attribution (CC BY 4.0) license, which permits others to distribute, remix, adapt and build upon this work, for commercial use, provided the original work is properly cited. See: http://creativecommons.org/licenses/by/4.0/

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Footnotes

  • Handling editor Jackie A Cassell

  • Contributors HK, PM and RWP conceptualised the study and developed the research protocol. HK and PM identified articles for full-text review. HK extracted data from studies that matched inclusion criteria. HK and NPP did the statistical analyses. All contributed to the writing of the manuscript.

  • Funding The authors of this manuscript received funding support from the UK Medical Research Council (MRC) PHINDS scheme (PH01/14-39).

  • Competing interests None declared.

  • Provenance and peer review Commissioned; externally peer reviewed.