Food and drug administration - approved molecular methods for detecting human papillomavirus infection

Ginekol Pol. 2019;90(2):104-108. doi: 10.5603/GP.2019.0018.

Abstract

In the world, there are many tests that allow the detection of HPV infection. These tests are based on different operating principles and have different levels of sensitivity. The first test to detect HPV infection was approved by the Food and Drug Administration in 2003. Since then, the FDA has approved five more commercial tests for this purpose, the last one in 2018. This paper discusses the principles of molecular tests to detect HPV, which have been approved by the FDA, the main differences between them, as well as their advantages and disadvantages.

Keywords: Aptima; COBAS; Cervista; HPV detection; Hybrid Capture; Onclarity.

Publication types

  • Review

MeSH terms

  • Female
  • Humans
  • Molecular Diagnostic Techniques*
  • Papillomaviridae* / genetics
  • Papillomaviridae* / isolation & purification
  • Papillomavirus Infections / diagnosis*
  • United States
  • United States Food and Drug Administration
  • Uterine Cervical Neoplasms / prevention & control