IPVS policy statement on HPV nucleic acid testing guidance for those utilising/considering HPV as primary precancer screening: Quality assurance and quality control issues

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.

Automated summary

It is advised to use only clinically validated HPV assays that have met internationally accepted performance criteria for primary cervical screening. Furthermore, the assays should be demonstrated to be suitable for use in the specific laboratory where they will be performed, and the availability of quality materials manuals and frameworks can be helpful in this process. Importantly, there is a fundamental shortage of well-validated, low-cost, low-complexity HPV tests that have demonstrated utility in a near-patient setting, posing a significant challenge and emphasizing the need for future development to achieve the WHO's goal of cervical cancer elimination.