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

• Published in: Journal of clinical virology Vol. 159; p. 105349
• Main Authors: Garland, Suzanne M., Iftner, Thomas, Cuschieri, Kate, Kaufmann, Andreas M, Arbyn, Marc, de Sanjose, Silvia, Poljak, Mario, Dillner, Joakim, Unger, Elizabeth R., Garland, Suzanne M, Stanley, Margaret, Moscicki, Anna-Barbara, Woo, Yin Ling, Bhatla, Neerja, Chan, Karen L., Palefsky, Joel, Giuliano, Anna R, Brotherton, Julia M.L., Feldman, Sarah
• Format: Journal Article
• Language: English
• Published: Netherlands Elsevier B.V 01.02.2023
• Subjects: Cervical; Early Detection of Cancer; Female; HPV; Humans; Mass Screening; Medicin och hälsovetenskap; Nucleic Acids; Papillomaviridae - genetics; Papillomavirus Infections - diagnosis; Policy; Primary; Quality Control; Screening; Uterine Cervical Neoplasms - diagnosis; Uterine Cervical Neoplasms - prevention & control; Validation; Validation; Screening; Primary; Cervical; HPV
• ISSN: 1386-6532; 1873-5967; 1873-5967
• DOI: 10.1016/j.jcv.2022.105349

•Cervical screening with high precision assays utilizing nucleic acid testing [NAT] technology must be clinically validated to accurately predict underlying dysplasia.•There is a plethora of NAT assays available, but only a small number are clinically validated.•Self-collected samples are shown to be comparable to clinician collected for HPV DNA detection.•Self-collection of samples for NAT is a potential game changer for cervical screening in low middle income countries.•For self-collected samples, amplification NAT assays should be used. 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.