TY - JOUR
T1 - A rapid HPV typing assay to support global cervical cancer screening and risk-based management
T2 - A cross-sectional study
AU - Inturrisi, Federica
AU - de Sanjosé, Silvia
AU - Desai, Kanan T.
AU - Dagnall, Casey
AU - Egemen, Didem
AU - Befano, Brian
AU - Rodriguez, Ana Cecilia
AU - Jeronimo, Jose A.
AU - Zuna, Rosemary E.
AU - Hoffman, Amanda
AU - Farhat Nozzari, Sepideh
AU - Walker, Joan L.
AU - Perkins, Rebecca B.
AU - Wentzensen, Nicolas
AU - Palefsky, Joel M.
AU - Schiffman, Mark
N1 - Funding Information: The study was funded by the NCI Intramural Research Program. NCI chose the specimen collection and the two laboratories for the ScreenFire HPV testing (NCI‐CGR and UCSF). NCI invited UCSF to test half to rule out laboratory variability due to the NCI laboratory having previously tested these same specimens. The reported data were masked to prior results at NCI, and the half tested at UCSF were totally masked and previously unknown to that laboratory. UCSF was provided with equipment and reagents by Atila Biosystems for the sole purpose of this study. The authors declare no intellectual property or conflict of interest with regard to the manufacturer, whose scientists had no input into the masked testing, analysis, or reporting of the results. Funding Information: Joel M. Palefsky reports institutional grant support from Merck & Co., Roche Diagnostics, Antiva Biosciences, Vir Biotechnologies and Virion Therapeutics, as well as honoraria for attending meetings, giving lectures, presentations, consultations from Merck & Co., Roche Diagnostics, Antiva Biosciences, Vir Biotechnologies, Gilead Pharmaceuticals and Janssen Pharmaceuticals. He has stock or stock options in Virion Therapeutics and he has received resources/services from Atila Biosystems. All other authors declare no competing interests. Publisher Copyright: © 2023 The Authors. International Journal of Cancer published by John Wiley & Sons Ltd on behalf of UICC. This article has been contributed to by U.S. Government employees and their work is in the public domain in the USA.
PY - 2024/1/15
Y1 - 2024/1/15
N2 - The World Health Organization recommends human papillomavirus (HPV) testing for cervical screening. Extended genotyping can identify the highest-risk HPV-positive women. An inexpensive, rapid, mobile isothermal amplification assay (ScreenFire HPV RS test) was recently redesigned to yield four channels ordered by cancer risk (ie, hierarchical approach): HPV16, HPV18/45, HPV31/33/35/52/58 and HPV39/51/56/59/68. Stored specimens from 2076 women (mean age 30.9) enrolled in a colposcopy clinic, with high HPV prevalence, were tested with ScreenFire. We calculated hierarchical channel positivity and non-hierarchical channel and type positivity, according to histologic diagnosis (256 cancer, 350 cervical intraepithelial neoplasia [CIN]3, 409 CIN2, 1020 < CIN2) and known virologic reference results (Linear Array and TypeSeq). Additionally, we analyzed ScreenFire time-to-positive up to 60 min by channel and histology. Overall clinical sensitivity for CIN3+ was 94.7% (95% confidence interval 92.6-96.4), similar to Linear Array (92.3, 89.7-94.3) and TypeSeq (96.0, 93.9-97.6). Sensitivity was high for all types and channels. The hierarchical approach was well in line with HPV typing and histologic diagnosis, prioritizing higher risk women having HPV16 and precancer. For HPV16, time-to-positive was shorter in women with precancer. ScreenFire showed excellent agreement with research reference typing tests and detection of CIN2+. Risk-based type results could help guide clinical management of HPV-positive women. Time-to-positive combined with genotyping might be useful. ScreenFire is rapid, mobile, relatively inexpensive and designed for implementation of HPV-based screening and management, including in lower-resource settings. Further validation in screening by self-sampling and practical effectiveness merit evaluation.
AB - The World Health Organization recommends human papillomavirus (HPV) testing for cervical screening. Extended genotyping can identify the highest-risk HPV-positive women. An inexpensive, rapid, mobile isothermal amplification assay (ScreenFire HPV RS test) was recently redesigned to yield four channels ordered by cancer risk (ie, hierarchical approach): HPV16, HPV18/45, HPV31/33/35/52/58 and HPV39/51/56/59/68. Stored specimens from 2076 women (mean age 30.9) enrolled in a colposcopy clinic, with high HPV prevalence, were tested with ScreenFire. We calculated hierarchical channel positivity and non-hierarchical channel and type positivity, according to histologic diagnosis (256 cancer, 350 cervical intraepithelial neoplasia [CIN]3, 409 CIN2, 1020 < CIN2) and known virologic reference results (Linear Array and TypeSeq). Additionally, we analyzed ScreenFire time-to-positive up to 60 min by channel and histology. Overall clinical sensitivity for CIN3+ was 94.7% (95% confidence interval 92.6-96.4), similar to Linear Array (92.3, 89.7-94.3) and TypeSeq (96.0, 93.9-97.6). Sensitivity was high for all types and channels. The hierarchical approach was well in line with HPV typing and histologic diagnosis, prioritizing higher risk women having HPV16 and precancer. For HPV16, time-to-positive was shorter in women with precancer. ScreenFire showed excellent agreement with research reference typing tests and detection of CIN2+. Risk-based type results could help guide clinical management of HPV-positive women. Time-to-positive combined with genotyping might be useful. ScreenFire is rapid, mobile, relatively inexpensive and designed for implementation of HPV-based screening and management, including in lower-resource settings. Further validation in screening by self-sampling and practical effectiveness merit evaluation.
KW - HPV genotyping
KW - HPV testing
KW - LMIC
KW - cervical cancer screening
KW - risk-stratification
UR - http://www.scopus.com/inward/record.url?scp=85173442583&partnerID=8YFLogxK
U2 - https://doi.org/10.1002/ijc.34698
DO - https://doi.org/10.1002/ijc.34698
M3 - Article
C2 - 37772799
SN - 0020-7136
VL - 154
SP - 241
EP - 250
JO - International journal of cancer
JF - International journal of cancer
IS - 2
ER -