High sensitivity and specificity rates of cobas® HPV test as a primary screening test for cervical intraepithelial lesions in a real-world setting

PLoS One. 2023 Feb 6;18(2):e0279728. doi: 10.1371/journal.pone.0279728. eCollection 2023.

Abstract

Cervical carcinoma (CC) is the fourth most common malignancy among women. Screening with Papanicolau smear is linked to a reduction in CC incidence rates when screening programs have been developed. However, this technique has several limitations, including moderate sensitivity rates for detection of cervical preneoplastic HPV-related lesions. In this real-world study, we proposed to evaluate the sensitivity and specificity rates of cobas® test, which amplifies target DNA fragments by polymerase chain reaction and hybridization of nucleic acids for the detection of 14 HR-HPV types in a single analysis) used as primary screening test for CC and preneoplastic lesions in women aged 25-65 years in a large University Hospital in Buenos Aires. A total of 1044 patients were included in the sample (median age: 46 years); sensitivity and specificity rates for the HR-HPV test used as primary screening test were 98.66% (95% confidence interval [95CI]: 97.67-99.3%) and 87.15% (95CI: 84.93-89.15%), respectively. The positive predictive value was 88.47% (95CI: 86.54%-90.42%) and the negative predictive value was 98.48% (95CI: 97.75%-99.23%). The cobas® HR-HPV testing was highly sensitive and specific for the detection of CC and preneoplastic lesions in real practice.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Carcinoma*
  • DNA, Viral / analysis
  • DNA, Viral / genetics
  • Early Detection of Cancer / methods
  • Female
  • Humans
  • Mass Screening / methods
  • Middle Aged
  • Papillomaviridae / genetics
  • Papillomavirus Infections* / epidemiology
  • Sensitivity and Specificity
  • Uterine Cervical Dysplasia* / diagnosis
  • Uterine Cervical Neoplasms*
  • Vaginal Smears / methods

Substances

  • DNA, Viral

Grants and funding

Assistance for the writing of this manuscript was provided by Agencia Médica (Buenos Aires, Argentina) and funded by Roche. Roche also supported for the purchase of collection kits and consumables for Cobas 4800® tests. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.