title: Human papillomavirus viral load on careHPV testing of self-collected vaginal samples vs. clinician-collected cervical samples.
abstract: OBJECTIVE
  To compare viral load on careHPV DNA testing in self-collected vaginal (VHPC) and clinician-collected cervical (CHPC) samples for the detection of high-grade cervical intra-epithelial neoplasia (CIN).
  
  
  METHODS
  Cross-sectional study. Ever-married women aged 30-59 years were targeted for cervical screening. On attendance for screening, vaginal self-sampling was performed by the woman, and an auxiliary nurse midwife subsequently performed a per-speculum examination, collected a CHPV sample and a Pap smear, and made a visual inspection of the cervix with acetic acid. The ratio of viral load expressed in relative light units to positive controls set at a cut-off of 1pg/ml was used for careHPV quantitative assessment. The median viral load was compared using non-parametric tests. Receiver operating characteristic (ROC) curves were constructed for the detection of CINII+ and CINIII+ in CHPV and VHPV samples.
  
  
  RESULTS
  Overall, the median viral load in the 4658 women screened was higher in CHPV samples compared with VHPV samples (9.8-fold higher in cases of high-grade CIN). The median viral load was significantly higher among Pap-positive women compared with Pap-negative women in both CHPV and VHPV samples (p<0.01). Assessment by ROC analysis for the detection of high-grade CIN did not differ significantly between CHPV and VHPV samples.
  
  
  CONCLUSIONS
  Viral load on careHPV testing was comparable between self- and clinician-collected samples for the detection of high-grade CIN. The self-sampling approach may be an option for screening in low-resource countries.
authors.affiliation: Division of Epidemiology and Biostatistics, Institute of Cytology and Preventive Oncology, Indian Council of Medical Research, Department of Health Research, Noida, Uttar Pradesh, India. Electronic address: satyanarayanalabani@yahoo.com.
authors.forename: S
authors.initials: S
authors.lastname: Labani
authors.affiliation: Division of Epidemiology and Biostatistics, Institute of Cytology and Preventive Oncology, Indian Council of Medical Research, Department of Health Research, Noida, Uttar Pradesh, India.
authors.forename: S
authors.initials: S
authors.lastname: Asthana
mesh_terms: D000328:Adult; D002584:Cervix Uteri / Q000821:virology*; D003430:Cross-Sectional Studies; D004279:DNA, Viral / Q000032:analysis*; D055088:Early Detection of Cancer / Q000379:methods; D005260:Female; D006801:Humans; D007194:India; D008875:Middle Aged; D027383:Papillomaviridae / Q000235:genetics; D012372:ROC Curve; D012424:Rural Population; D012648:Self Care; D013048:Specimen Handling / Q000379:methods*; D002583:Uterine Cervical Neoplasms / Q000175:diagnosis* / Q000821:virology; D014621:Vagina / Q000821:virology*; D019562:Viral Load; D002578:Uterine Cervical Dysplasia / Q000175:diagnosis* / Q000821:virology
chemical_list: D004279:DNA, Viral
keywords: CareHPV screening; Cervical cancer; Low-resource countries; Rural community; Viral load