title: Accuracy of human papillomavirus testing on self-collected versus clinician-collected samples: a meta-analysis.
abstract: BACKGROUND
  Screening for human papillomavirus (HPV) infection is more effective in reducing the incidence of cervical cancer than screening using Pap smears. Moreover, HPV testing can be done on a vaginal sample self-taken by a woman, which offers an opportunity to improve screening coverage. However, the clinical accuracy of HPV testing on self-samples is not well-known. We assessed whether HPV testing on self-collected samples is equivalent to HPV testing on samples collected by clinicians.
  
  
  METHODS
  We identified relevant studies through a search of PubMed, Embase, and CENTRAL. Studies were eligible for inclusion if they fulfilled all of the following selection criteria: a cervical cell sample was self-collected by a woman followed by a sample taken by a clinician; a high-risk HPV test was done on the self-sample (index test) and HPV-testing or cytological interpretation was done on the specimen collected by the clinician (comparator tests); and the presence or absence of cervical intraepithelial neoplasia grade 2 (CIN2) or worse was verified by colposcopy and biopsy in all enrolled women or in women with one or more positive tests. The absolute accuracy for finding CIN2 or worse, or CIN grade 3 (CIN3) or worse of the index and comparator tests as well as the relative accuracy of the index versus the comparator tests were pooled using bivariate normal models and random effect models.
  
  
  RESULTS
  We included data from 36 studies, which altogether enrolled 154 556 women. The absolute accuracy varied by clinical setting. In the context of screening, HPV testing on self-samples detected, on average, 76% (95% CI 69-82) of CIN2 or worse and 84% (72-92) of CIN3 or worse. The pooled absolute specificity to exclude CIN2 or worse was 86% (83-89) and 87% (84-90) to exclude CIN3 or worse. The variation of the relative accuracy of HPV testing on self-samples compared with tests on clinician-taken samples was low across settings, enabling pooling of the relative accuracy over all studies. The pooled sensitivity of HPV testing on self-samples was lower than HPV testing on a clinician-taken sample (ratio 0·88 [95% CI 0·85-0·91] for CIN2 or worse and 0·89 [0·83-0·96] for CIN3 or worse). Also specificity was lower in self-samples versus clinician-taken samples (ratio 0·96 [0·95-0·97] for CIN2 or worse and 0·96 [0·93-0·99] for CIN3 or worse). HPV testing with signal-based assays on self-samples was less sensitive and specific than testing on clinician-based samples. By contrast, some PCR-based HPV tests generally showed similar sensitivity on both self-samples and clinician-based samples.
  
  
  CONCLUSIONS
  In screening programmes using signal-based assays, sampling by a clinician should be recommended. However, HPV testing on a self-sample can be suggested as an additional strategy to reach women not participating in the regular screening programme. Some PCR-based HPV tests could be considered for routine screening after careful piloting assessing feasibility, logistics, population compliance, and costs.
  
  
  BACKGROUND
  The 7th Framework Programme of the European Commission, the Belgian Foundation against Cancer, the International Agency for Research on Cancer, and the German Guideline Program in Oncology.
authors.affiliation: Unit of Cancer Epidemiology, Scientific Institute of Public Health, Brussels, Belgium. Electronic address: marc.arbyn@wiv-isp.be.
authors.forename: Marc
authors.initials: M
authors.lastname: Arbyn
authors.affiliation: Unit of Cancer Epidemiology, Scientific Institute of Public Health, Brussels, Belgium.
authors.forename: Freija
authors.initials: F
authors.lastname: Verdoodt
authors.affiliation: Department of Pathology, VU University Medical Center, Amsterdam, Netherlands.
authors.forename: Peter J F
authors.initials: PJ
authors.lastname: Snijders
authors.affiliation: Department of Pathology, VU University Medical Center, Amsterdam, Netherlands.
authors.forename: Viola M J
authors.initials: VM
authors.lastname: Verhoef
authors.affiliation: International Agency for Research on Cancer, Lyon, France.
authors.forename: Eero
authors.initials: E
authors.lastname: Suonio
authors.affiliation: Karolinska Institute, Stockholm, Sweden.
authors.forename: Lena
authors.initials: L
authors.lastname: Dillner
authors.affiliation: Unit of Cancer Epidemiology, Department of Oncology, Piedmont Centre for Cancer Prevention, S Giovanni University Hospital, Turin, Italy.
authors.forename: Silvia
authors.initials: S
authors.lastname: Minozzi
authors.affiliation: Unit of Cancer Epidemiology, Department of Oncology, Piedmont Centre for Cancer Prevention, S Giovanni University Hospital, Turin, Italy.
authors.forename: Cristina
authors.initials: C
authors.lastname: Bellisario
authors.affiliation: IRCCS-Istituto di Ricerche Farmacologiche Mario Negri, Milan, Italy.
authors.forename: Rita
authors.initials: R
authors.lastname: Banzi
authors.affiliation: Department of Cancer Epidemiology, Cancer Institute and Hospital, Chinese Academy of Medical Sciences, Beijing, China.
authors.forename: Fang-Hui
authors.initials: FH
authors.lastname: Zhao
authors.affiliation: Department of Gynaecology and Obstetrics, Hannover Medical School, Hannover, Germany.
authors.forename: Peter
authors.initials: P
authors.lastname: Hillemanns
authors.affiliation: Finnish Cancer Registry, Helsinki, Finland.
authors.forename: Ahti
authors.initials: A
authors.lastname: Anttila
mesh_terms: D001706:Biopsy; D003127:Colposcopy; D005260:Female; D006801:Humans; D008403:Mass Screening / Q000379:methods*; D027383:Papillomaviridae / Q000302:isolation & purification*; D030361:Papillomavirus Infections / Q000150:complications / Q000175:diagnosis* / Q000821:virology; D011237:Predictive Value of Tests; D015203:Reproducibility of Results; D012648:Self Care; D013048:Specimen Handling / Q000379:methods*; D002583:Uterine Cervical Neoplasms / Q000175:diagnosis* / Q000473:pathology / Q000821:virology; D002578:Uterine Cervical Dysplasia / Q000175:diagnosis* / Q000473:pathology / Q000821:virology