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

Last updated: April 19, 2018
Project Number: RC0981-000
Product Line: Rapid Response
Research Type: Other Diagnostics
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

There is evidence to show that self-sampled human papilloma virus (HPV) tests can achieve similar diagnostic test accuracy as clinician-sampled HPV tests with certain combinations of HPV tests and sampling devices for the detection of CIN2 (cervical intra-epithelial neoplasia) or severe diagnosis. For example, GP5+/6+ PCR HPV tests based on cervix specimens sampled with brushes or lavage have similar sensitivities and specificities as clinician-sampled HPV tests. Signal-based HPV tests including Hybrid Capture (HC2), one of the most widely tested HPV tests, are less sensitive and less specific with self-sampled specimens. There are individual studies showing high concordance or fair to high agreement between self- and clinician-sampled HPV tests. However, self-sampled HPV tests are less sensitive and specific than cytology at the threshold of ASCUS (atypical squamous cells of undetermined significance) or more severe dysplasia. The advantages of self-sampled HPV tests included better acceptance by those eligible for routine screening programs. Self-sampled HPV tests detected more cases with findings of CIN2 or more severe than cytology or co-testing with clinician-sampled HPV tests and cytology. The limitations of this review include considerable heterogeneity between studies, relatively few studies on the agreement between self- and clinician-sampled HPV tests, and the applicability of the existing evidence to vaccinated populations.