Performance of the Alinity m HR HPV assay on self-collected vaginal samples compared to clinician-collected cervical samples

Authors

Adino Tesfahun Tsegaye, Division of Cancer Epidemiology & Genetics, National Cancer Institute, Rockville, MD, United States. Electronic address: adino.tsegaye@nih.gov.
Megan A. Clarke, Division of Cancer Epidemiology & Genetics, National Cancer Institute, Rockville, MD, United States.
Beverly Long, Kolschowsky Research and Education Institute at Sarasota Memorial Health Care System, Sarasota, FL, United States.
Nicole P. Chappell, Division Directory, Gynecologic Oncology, George Washington University, Washington DC, United States.
Sarah A. Phillips, Division of Cancer Epidemiology & Genetics, National Cancer Institute, Rockville, MD, United States.
Megan A. Swiger, Kolschowsky Research and Education Institute at Sarasota Memorial Health Care System, Sarasota, FL, United States.
Anna BuAbbud, Inova Health System Fairfax, VA, United States.
Priya Sathyanarayan, Division Directory, Gynecologic Oncology, George Washington University, Washington DC, United States.
Nicolas Wentzensen, Division of Cancer Epidemiology & Genetics, National Cancer Institute, Rockville, MD, United States.

Document Type

Journal Article

Publication Date

12-1-2025

Journal

Journal of clinical virology : the official publication of the Pan American Society for Clinical Virology

Volume

181

DOI

10.1016/j.jcv.2025.105883

Keywords

Alinity m HR-HPV assay; Cervical cancer; Extended-genotyping; Screening; Self-collection

Abstract

BACKGROUND: Human papillomavirus (HPV) testing using self-collected samples could increase cervical cancer screening among never screened or underscreened populations. This study aimed to evaluate the concordance between self-collected and clinician-collected samples using the Alinity m high risk (HR) HPV extended genotyping assay. METHODS: Self-collected vaginal samples and clinician-collected cervical samples were obtained from 25 to 69-year-old women who had visits for cervical cancer screening, colposcopy, follow up pap test, and/or treatment of cervical dysplasia at the George Washington University Hospital in Washington DC and Sarasota Memorial Health Care System and their affiliates in Florida. Extended genotyping based on the Alinity m HR HPV assay was performed on stored residual samples and the agreement between clinician- and self-collected HPV test results was assessed using positive percent agreement and Cohen's kappa values. RESULTS: There were 294 participants who provided paired self and clinician-collected samples. The overall prevalence of any HR-HPV was 26 %(76/293) for clinician-collected samples and 27 %(79/291) for self-collected samples. The positive percent agreement between clinician- and self-collected samples for any HR-HPV was 78 %, and the Cohen's Kappa value was 0.83(95 %CI:0.76,0.91). For specific HPV genotypes, the positive percent agreement ranged from 72 % for HPV16-79 % for other HR-HPV group A (HPV31/33/52/58); and the Kappa value ranged from 0.83(95 %CI:0.68,0.98) for HPV16-0.87(95 %CI:0.77,0.97) for other HR-HPV group A. CONCLUSION: There was a strong test concordance between self-collected and clinician-collected samples using the Alinity m HR HPV assay. Self-collected samples tested with the Alinity m HR HPV assays can be considered an alternative to clinician-collected primary HPV testing.

APA Citation

Tsegaye, Adino Tesfahun; Clarke, Megan A.; Long, Beverly; Chappell, Nicole P.; Phillips, Sarah A.; Swiger, Megan A.; BuAbbud, Anna; Sathyanarayan, Priya; and Wentzensen, Nicolas, "Performance of the Alinity m HR HPV assay on self-collected vaginal samples compared to clinician-collected cervical samples" (2025). GW Authored Works. Paper 8485.
https://hsrc.himmelfarb.gwu.edu/gwhpubs/8485

Department

School of Medicine and Health Sciences Student Works