IPVS POLICY STATEMENT ON HPV NUCLEIC ACID TESTING guidance for those utilising/considering HPV as primary precancer screening: Quality Assurance and Quality Control issues

Details

• Alternative Title:
  J Clin Virol
• Personal Author:
  Garland, Suzanne M. ; Iftner, Thomas ; Cuschieri, Kate ; Kaufmann, Andreas M ; Arbyn, Marc ; de Sanjose, Silvia ; Poljak, Mario ; Dillner, Joakim ; Unger, Elizabeth R.
• Corporate Authors:
  IPVS Policy Committee GarlandSuzanne MabcStanleyMargaretmMoscickiAnna-BarbaranWooYin LingoBhatlaNeerjapChanKaren L.qPalefskyJoelrGiulianoAnna RsKaufmannAndreasgde SanjoseSilviaiBrothertonJulia M.L.tuFeldmanSarahv
• Description:
  We advise that only clinically validated HPV assays which have fulfilled internationally accepted performance criteria be used for primary cervical screening. Further, assays should be demonstrated to be fit for purpose in the laboratory in which they will ultimately be performed, and quality materials manuals and frameworks will be helpful in this endeavor. Importantly, there is a fundamental shortage of well validated, low-cost, low complexity HPV tests that have demonstrated utility in a near-patient setting; representing a significant challenge and focus for future development in order to reach the WHO's goal of eliminating cervical cancer.
• Subjects:
  • Female
  • Humans
  • Uterine Cervical Neoplasms
  • Mass Screening
  • Papillomavirus Infections
  • Early Detection of Cancer
  • Papillomaviridae
  • Quality Control
  • Nucleic Acids
  • Policy
• Keywords:
  • HPV
  • primary
  • cervical
  • screening
  • validation
• Source:
  J Clin Virol. 159:105349
• Pubmed ID:
  36584621
• Pubmed Central ID:
  PMC11391586
• Document Type:
  Journal Article
• Funding:
  CC999999/ImCDC/Intramural CDC HHSUnited States/
• Volume:
  159
• Download URL:
  https://stacks.cdc.gov/view/cdc/162398/cdc_162398_DS1.pdf
• File Type:
  [PDF - 327.79 KB]
• Collection(s):
  CDC Public Access
• Main Document Checksum:
  urn:sha-512:7406302e56b6a49a39af0832a8d68f24d709d72d2ecada71968c036d8f596ad9e87e801dde0f187519b66a193b67dfaa1871b856579fb038c4e3e9845d898d95