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

Saville M 1 , Hawkes D 2 , Keung M 3 , Ip E 3 , Silvers J 4 , Sultana F 5 Show all authors , Malloy MJ 5 , Velentzis LS 6 , Canfel L K 7 , Wrede CD 8 , Brotherton J 9

Affiliations 

  • 1 VCS Foundation, Carlton South, Victoria, Australia; VCS Pathology, Carlton South, Victoria, Australia; Department of Obstetrics and Gynaecology, University of Melbourne, Parkville, Victoria, Australia; Department of Obstetrics and Gynaecology, University of Malaya, Kuala Lumpur, Malaysia
  • 2 VCS Foundation, Carlton South, Victoria, Australia; VCS Pathology, Carlton South, Victoria, Australia; Department of Pharmacology and Therapeutics, University of Melbourne, Parkville, Victoria, Australia; Department of Pathology, University of Malaya, Kuala Lumpur, Malaysia. Electronic address: dhawkes@vcs.org.au
  • 3 VCS Foundation, Carlton South, Victoria, Australia; VCS Pathology, Carlton South, Victoria, Australia
  • 4 Department of Oncology and Dysplasia, Royal Women's Hospital, Melbourne, Victoria, Australia
  • 5 VCS Foundation, Carlton South, Victoria, Australia; Melbourne School of Population and Global Health, University of Melbourne, Parkville, Victoria, Australia
  • 6 Melbourne School of Population and Global Health, University of Melbourne, Parkville, Victoria, Australia; Cancer Research Division, Cancer Council NSW, Woolloomooloo, NSW, Australia
  • 7 Cancer Research Division, Cancer Council NSW, Woolloomooloo, NSW, Australia; School of Public Health, Sydney Medical School, University of Sydney, NSW, Australia
  • 8 Department of Obstetrics and Gynaecology, University of Melbourne, Parkville, Victoria, Australia; Department of Oncology and Dysplasia, Royal Women's Hospital, Melbourne, Victoria, Australia
  • 9 VCS Foundation, Carlton South, Victoria, Australia; Department of Obstetrics and Gynaecology, University of Malaya, Kuala Lumpur, Malaysia; Melbourne School of Population and Global Health, University of Melbourne, Parkville, Victoria, Australia
J Clin Virol, 2020 06;127:104375.
PMID: 32361328 DOI: 10.1016/j.jcv.2020.104375

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.

* Title and MeSH Headings from MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine.

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