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

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.