Clinical validation of REALQUALITY RQ-HPV Screen according to the international guidelines for human papillomavirus DNA test requirements for cervical screening

Virol J. 2018 Mar 20;15(1):48. doi: 10.1186/s12985-018-0965-z.

Abstract

Background: According to international guidelines, HPV DNA tests represent a valid alternative to Pap Test for primary cervical cancer screening, provided that they guarantee balanced clinical sensitivity and specificity for cervical intraepithelial neoplasia grade 2 or more severe lesions. The aim of this study was to assess whether REALQUALITY RQ-HPV Screen, a new assay based on real time PCR that targets the E6-E7 region of 14 high-risk human papillomaviruses, meets the criteria for primary cervical cancer screening.

Methods: As required by guidelines, a non-inferiority test was conducted to compare the clinical performance of the test under evaluation with that of a clinically validated reference test (Hybrid Capture 2, HC2). The reproducibility of the device was assessed as well. The clinical samples used to test the hypothesis of non-inferiority and to asses reproducibility comprised 910 and 536 cervical specimens respectively. All specimens were originating from a population-based screening cohort.

Results: The study demonstrates that both the clinical sensitivity and specificity of REALQUALITY RQ-HPV Screen are non-inferior to those of HC2. In addition, an adequate intra- and inter-laboratory reproducibility has been reached by the test.

Conclusions: REALQUALITY RQ-HPV Screen fulfils all the requirements of the international guidelines and can be considered clinically validated for primary cervical cancer screening purposes.

Keywords: DNA testing; HPV; International guidelines; Primary cervical cancer screening.

MeSH terms

  • Adult
  • Case-Control Studies
  • DNA, Viral
  • Early Detection of Cancer
  • Female
  • Genotype
  • Human Papillomavirus DNA Tests* / methods
  • Human Papillomavirus DNA Tests* / standards
  • Humans
  • Middle Aged
  • Papillomaviridae / genetics*
  • Papillomavirus Infections / complications
  • Papillomavirus Infections / diagnosis*
  • Papillomavirus Infections / virology*
  • Practice Guidelines as Topic
  • Reproducibility of Results
  • Uterine Cervical Neoplasms / etiology*
  • Young Adult

Substances

  • DNA, Viral