Self-sampling with HPV mRNA analyses from vagina and urine compared with cervical samples

J Clin Virol. 2018 Apr:101:69-73. doi: 10.1016/j.jcv.2018.02.002. Epub 2018 Feb 6.


Background: In order to increase coverage in the organized cervical screening program, self-sampling with HPV analyses has been suggested.

Objectives: The aim was to compare human papillomavirus (HPV) mRNA detection in vaginal and urine self-collected samples with clinician-taken cervical samples and the corresponding clinician-taken histological specimens.

Study design: Self-collected vaginal, urine and clinician-taken cervical samples were analyzed from 209 women with the Aptima mRNA assay (Hologic Inc, MA, USA). Cervical cytology, colposcopy, biopsy and/or the loop electrosurgical excision procedure (LEEP) were performed in every examination.

Results: The sensitivity of the HPV mRNA test in detecting high-grade squamous intraepithelial lesions (HSIL)/adenocarcinoma in situ (AIS)/cancer cases was as follows: for the vaginal self-samples 85.5% (95% CI; 75.0-92.8), the urinary samples 44.8% (95% CI; 32.6-57.4), and for routine cytology 81.7% (95% CI; 70.7-89.9). For the clinician-taken cervical HPV samples the sensitivity of the HPV mRNA test in detecting HSIL/AIS/cancer was 100.0% (95% CI; 94.9-100.0). The specificity of the HPV mRNA was similar for the clinician-taken cervical HPV samples and the self-samples: 49.0% vs. 48.1%. The urinary HPV samples had a specificity of 61.9% and cytology had a specificity of 93.3%.

Conclusion: The sensitivity of the Aptima HPV mRNA test in detecting HSIL/AIS/cancer from vaginal self-samples was similar to that of routine cytology. The Aptima HPV mRNA vaginal self-sampling analysis may serve as a complement in screening programs.

Keywords: HPV analyses; HPV mRNA; Self-collected vaginal smear; Urinary sample.

Publication types

  • Comparative Study
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Aged
  • Carcinoma in Situ / diagnosis*
  • Cervix Uteri / pathology
  • Cervix Uteri / virology
  • Early Detection of Cancer
  • Female
  • Humans
  • Mass Screening
  • Middle Aged
  • Papillomaviridae / genetics
  • Papillomaviridae / isolation & purification*
  • Papillomavirus Infections / diagnosis*
  • Predictive Value of Tests
  • RNA, Messenger / analysis*
  • RNA, Viral / analysis*
  • Sensitivity and Specificity
  • Specimen Handling / methods*
  • Urine / cytology
  • Urine / virology
  • Uterine Cervical Dysplasia / diagnosis*
  • Vagina / pathology
  • Vagina / virology
  • Young Adult


  • RNA, Messenger
  • RNA, Viral