title: Clinical evaluation of high-risk HPV detection on self-samples using the indicating FTA-elute solid-carrier cartridge.
abstract: BACKGROUND
  High-risk human papillomavirus (hrHPV) testing in cervical screening is usually performed on physician-taken cervical smears in liquid-based medium. However, solid-state specimen carriers allow easy, non-hazardous storage and transportation and might be suitable for self-collection by non-responders in screening and in low-resource settings.
  
  
  OBJECTIVE
  We evaluated the adequacy of self-collected cervicovaginal (c/v) samples using a Viba-brush stored on an Indicating FTA-elute cartridge (FTA-based self-sampling) for hrHPV testing in women referred to a gynecology clinic due to an abnormal smear.
  
  
  METHODS
  182 women accepted to self-collect a c/v sample. After self-sampling, a physician obtained a conventional liquid-based cervical smear. Finally, women were examined by colposcopy and a biopsy was taken when clinically indicated. Self-samples required only simple DNA elution, and DNA was extracted from physician-obtained samples. Both samples were tested for 14 hrHPVs by GP5+/6+-EIA-LQ Test and SPF(10)-DEIA-LiPA(25).
  
  
  RESULTS
  Both assays detected significantly more hrHPV in physician-collected specimens than in self-collected samples (75.3% and 67.6% by SPF(10); 63.3% and 53.3% by GP5+/6+, respectively). The combination of physician-collected specimen and GP5+/6+ testing demonstrated the optimal balance in sensitivity (98.0%) and specificity (48.1%) for CIN2+ detection in this referral population. A test system of FTA-based self-collection and SPF(10) hrHPV detection approached this sensitivity (95.9%) and specificity (42.9%).
  
  
  CONCLUSIONS
  These results show that the clinical performance of hrHPV detection is determined by both the sample collection system and the test method. FTA-based self-collection with SPF(10) testing might be valuable when a liquid-based medium cannot be used, but requires further investigation in screening populations.
authors.affiliation: DDL Diagnostic Laboratory, Visseringlaan 25, 2288ER Rijswijk, The Netherlands. daan.geraets@ddl.nl
authors.forename: D T
authors.initials: DT
authors.lastname: Geraets
authors.forename: R
authors.initials: R
authors.lastname: van Baars
authors.forename: I
authors.initials: I
authors.lastname: Alonso
authors.forename: J
authors.initials: J
authors.lastname: Ordi
authors.forename: A
authors.initials: A
authors.lastname: Torné
authors.forename: W J G
authors.initials: WJ
authors.lastname: Melchers
authors.forename: C J L M
authors.initials: CJ
authors.lastname: Meijer
authors.forename: W G V
authors.initials: WG
authors.lastname: Quint
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D002584:Cervix Uteri / Q000821:virology*; D004279:DNA, Viral / Q000235:genetics; D005260:Female; D005838:Genotype; D006801:Humans; D008875:Middle Aged; D027383:Papillomaviridae / Q000235:genetics / Q000302:isolation & purification*; D030361:Papillomavirus Infections / Q000175:diagnosis* / Q000821:virology; D016133:Polymerase Chain Reaction; D012646:Self Administration; D012680:Sensitivity and Specificity; D013048:Specimen Handling / Q000295:instrumentation* / Q000379:methods; D002583:Uterine Cervical Neoplasms / Q000175:diagnosis / Q000821:virology; D014626:Vaginal Smears / Q000295:instrumentation / Q000379:methods*; D055815:Young Adult; D002578:Uterine Cervical Dysplasia / Q000175:diagnosis / Q000821:virology
chemical_list: D004279:DNA, Viral