Begin main content

HPV Self-Sampling for Primary Cervical Cancer Screening: A Review of Diagnostic Test Accuracy and Clinical Evidence – An Update

Last updated: May 30, 2019
Project Number: RC1124-000
Product Line: Rapid Response
Research Type: Devices and Systems
Report Type: Summary with Critical Appraisal
Result type: Report

Question

  1. What is the diagnostic test accuracy of self-sampled HPV tests compared with clinician-sampled HPV tests or cytology for asymptomatic cervical cancer screening?
  2. What is the clinical evidence regarding the agreement or concordance of self-sampled HPV tests and clinician-sampled HPV tests or cytology for asymptomatic cervical cancer screening?

Key Message

Similar to the meta-analysis reviewed in in the previous CADTH report, Arbyn et al. confirmed the difference in diagnostic test accuracy between self- and clinician-collected samples remained significant for signal amplification-based HPV tests. Since the publication of the CADTH report, there were new studies that have examined self- and clinician-sampled HPV tests.Two systematic reviews, two randomized controlled trials (RCTs), and ten non-randomized studies were identified. In the updated meta-analysis by Arbyn et al., human papillomavirus (HPV) tests were categorized into polymerase chain reaction (PCR) and signal amplification-based tests. Self-sampled HPV tests based on PCR for the detection of cervical intraepithelial neoplasia (CIN) grade 2 or more severe were shown to not have statistically different sensitivity or specificity compared with clinician-sampled tests. However, self-sampled HPV tests based on signal amplification were not as accurate for the detection of CIN2+. Moderate to excellent agreement between self- and clinician-sampled HPV tests was reported in primary studies. Various HPV tests were tested in different healthcare settings. However, it was unclear whether the differences in the agreement were associated with the types of HPV tests. There was heterogeneity between the included studies and the impact on the diagnostic accuracy or agreement of self- and clinician-sampled HPV tests was unclear.Further research on the diagnostic test accuracy and agreement between self- and clinician-sampled HPV tests in target populations could reduce the uncertainties in the application of self-sampled HPV tests.