Analytical performance of HPV assays on vaginal self-collected vs practitioner-collected cervical samples: the SCoPE study.
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
Vagina
/ virology
Young Adult
Uterine Cervical Dysplasia
/ diagnosis
cervical cancer
diagnostic testing
human papillomavirus
screening
self-collection
Journal
Journal of clinical virology : the official publication of the Pan American Society for Clinical Virology
ISSN: 1873-5967
Titre abrégé: J Clin Virol
Pays: Netherlands
ID NLM: 9815671
Informations de publication
Date de publication:
06 2020
06 2020
Historique:
received:
11
12
2019
revised:
14
04
2020
accepted:
15
04
2020
pubmed:
4
5
2020
medline:
2
7
2021
entrez:
4
5
2020
Statut:
ppublish
Résumé
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. 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). 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. 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). Self-collection for HPV-based cervical screening shows good concordance and relative sensitivity when compared to practitionercollected samples across assays in the NCSP.
Sections du résumé
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.
Identifiants
pubmed: 32361328
pii: S1386-6532(20)30117-7
doi: 10.1016/j.jcv.2020.104375
pii:
doi:
Substances chimiques
DNA, Viral
0
Reagent Kits, Diagnostic
0
Types de publication
Comparative Study
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
104375Informations de copyright
Copyright © 2020 Elsevier B.V. All rights reserved.
Déclaration de conflit d'intérêts
Declaration of Competing Interest The test kits for this study were supplied free of charge from Abbott, BD, Roche, Seegene and Cepheid. None of the manufacturers had any influence on the study design, analysis or production of this manuscript. KC is a co-PI of an investigator-initiated trial of cervical cytology and primary HPV screening in Australia (`Compass'), which is conducted and funded by the VCS foundation, a government-funded health promotion charity. DH, MS, JMLB, ELOI, MHTK, MM, FS were employed by VCS Foundation. The VCS foundation have received equipment and a funding contribution for the Compass trial from Roche Molecular Systems and Ventana Inc USA. However neither I nor my institution on my behalf (Cancer Council NSW) receives direct funding from industry for this trial or any other project. DH has received travel funding to attend conferences and meetings from Roche, Abbott and Seegene but has had no personal gain from any diagnostics manufacturer.