Validation of a New Low-Cost, Methanol-Based Fixative for Cervical Cytology and Human Papillomavirus Detection

Acta Cytol. 2018;62(5-6):393-396. doi: 10.1159/000489873. Epub 2018 Jun 18.

Abstract

Objective: To test the performance of a new fixative for pap smear collection for liquid-based cervical cytology, CellPreserv® and compare it with the commercially available, PreservCyt® used in the diagnosis and detection of human papillomavirus (HPV).

Methods: Seven hundred twenty five women participated in this study after signing an informed consent. The specimens were collected using a traditional device, agitated in PBS, and equally divided in both fixatives. The slides were prepared routinely, stained by Papanicolaou, examined blindly by 2 cytologists, and reviewed by one cytopathologist. To search for HPV, 1,000 μL from each fixative was taken and processed by polymerase chain reaction.

Results: Considering the adequacy of samples, both fixatives had similar results - 0.33 and 0.32% of the cases unsatisfactory for PreservCyt® and CellPreserv®, respectively. Considering the 701 satisfactory cases and comparing the new fixative to the traditional fixative, there was 99.3% concordance between both. The results regarding the HPV detection was 100% concordant between the 2 fixatives.

Conclusion: The new methanol-based fixative, CellPreserv®, is cheaper and equally efficient for treating cervical cancer screening and for HPV detection, and can be safely used by the health system prevailing in low-income countries.

Keywords: CellPreserv; Cervical intraepithelial neoplasia; Human papillomavirus; Liquid-based cytology; ThinPrep.

Publication types

  • Comparative Study
  • Validation Study

MeSH terms

  • Adolescent
  • Adult
  • Aged
  • Brazil
  • Cost Savings
  • Cost-Benefit Analysis
  • Cytodiagnosis / economics
  • Cytodiagnosis / methods*
  • Female
  • Fixatives* / economics
  • Health Care Costs
  • Human Papillomavirus DNA Tests* / economics
  • Humans
  • Liquid Biopsy
  • Methanol* / economics
  • Middle Aged
  • Papanicolaou Test
  • Papillomavirus Infections / economics
  • Papillomavirus Infections / pathology*
  • Papillomavirus Infections / virology
  • Predictive Value of Tests
  • Reproducibility of Results
  • Tissue Fixation / economics
  • Tissue Fixation / methods*
  • Uterine Cervical Neoplasms / economics
  • Uterine Cervical Neoplasms / pathology*
  • Uterine Cervical Neoplasms / virology
  • Vaginal Smears
  • Young Adult

Substances

  • Fixatives
  • Methanol