Analytical performance of HPV assays on vaginal self-collected vs practitioner-collected cervical samples: the SCoPE study

J Clin Virol. 2020 Jun:127:104375. doi: 10.1016/j.jcv.2020.104375. Epub 2020 Apr 18.

Abstract

Background: In the last decade, human papillomavirus (HPV) testing has been evaluated extensively for cervical screening, with studies finding increased sensitivity compared to cytology. Another advantage of HPV based-screening is the ability to test vaginal samples that can be collected by women themselves. Self-collection has the potential to extend cervical screening coverage by increasing participation rates, particularly among women who are under-screened or have never screened. This could have a significant impact on cervical cancer prevention, as the majority of invasive cervical cancer cases occur among under-screened women. Both the Netherlands and Australia have transitioned their national programs from cytology to HPV as the primary screening test and both countries include a pathway for self-collection.

Objectives: We evaluated the relative sensitivity for HPV detection of self-collection compared with practitioner-collected cervical specimens in the context of the Australian National Cervical Screening Program (NCSP).

Study design: 303 women aged ≥18 years attending a single tertiary referral centre took their own sample using a flocked-swab, and then had a practitioner-collected sample taken at colposcopy. All samples were tested at a single laboratory on the six PCR-based HPV assays which can be utilised in the NCSP; Roche cobas 4800 and cobas, Abbott RealTime, BD Onclarity, Cepheid Xpert, and Seegene Anyplex.

Results: HPV16/18 results had high observed agreement between self- and practitioner-collected samples on all assays (range: 0.94-0.99), with good agreement for non-HPV16/18 oncogenic HPV types (range: 0.64-0.73).

Conclusions: Self-collection for HPV-based cervical screening shows good concordance and relative sensitivity when compared to practitionercollected samples across assays in the NCSP.

Keywords: cervical cancer; diagnostic testing; human papillomavirus; screening; self-collection.

Publication types

  • Comparative Study

MeSH terms

  • Alphapapillomavirus / isolation & purification
  • Colposcopy / standards
  • DNA, Viral / isolation & purification
  • Early Detection of Cancer / methods*
  • Female
  • Humans
  • Netherlands
  • Papillomavirus Infections / diagnosis*
  • Physicians
  • Reagent Kits, Diagnostic
  • Sensitivity and Specificity
  • Specimen Handling / methods*
  • Tertiary Care Centers
  • Uterine Cervical Dysplasia / diagnosis
  • Uterine Cervical Dysplasia / virology
  • Vagina / virology*
  • Young Adult

Substances

  • DNA, Viral
  • Reagent Kits, Diagnostic