Laboratory audit as part of the quality assessment of a primary HPV-screening program

J Clin Virol. 2016 Feb;75:33-6. doi: 10.1016/j.jcv.2015.12.007. Epub 2015 Dec 24.


Background: As primary HPV screening programs are rolled out, methods are needed for routine quality assurance of HPV laboratory analyzes.

Objective: To explore the use of similar design for audit as currently used in cytology-based screening, to estimate the clinical sensitivity to identify women at risk for CIN 3 or worse (CIN3+).

Study design: Population-based cohort study conducted within the cervical screening program in Stockholm, Sweden, in 2011-2012. All women with histopathologically confirmed CIN3+ in the following two years were identified by registry analysis. Primary HPV and cytology screening results were collected. For women who had not been HPV tested, biobanked cytology samples were HPV-tested. If the original HPV result had been negative, the sample and subsequent biopsies were analyzed with broad HPV typing (general primer PCR and Luminex).

Results: 154 women had a biobanked prediagnostic cytology sample taken up to 2 years before a histopathologically confirmed CIN3+. The high-risk HPV-positivity was 97% (148/154 women), whereas 143/154 (94%) women had had a cytological abnormality. Among the six HPV-negative samples, one sample was HPV 33 positive in repeat testing whereas the other five cases were HPV-negative also on repeat testing, but HPV-positive in the subsequent tumor tissue.

Conclusions: A sensitivity of the HPV test that is higher than the sensitivity of cytology suggests adequate quality of the testing. Regular audits of clinical sensitivity, similar to those of cytology-based screening, should be used also in HPV-based screening programs, in order to continuously monitor the performance of the analyzes.

Keywords: Audit; HPV; Primary screening; Sensitivity.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Clinical Audit*
  • Cytogenetic Analysis
  • Early Detection of Cancer
  • Female
  • Humans
  • Mass Screening / standards
  • Papillomaviridae* / isolation & purification
  • Papillomavirus Infections / diagnosis
  • Papillomavirus Infections / virology*
  • Sensitivity and Specificity
  • Sweden
  • Uterine Cervical Neoplasms / diagnosis
  • Uterine Cervical Neoplasms / prevention & control*
  • Uterine Cervical Neoplasms / virology
  • Vaginal Smears