HPV-DNA testing from self-sampled menstrual blood using M-strip: A proof-of-concept study on feasibility & acceptance of a novel biosampling method.

Abstract

Background & objectives Screening for cervical cancer by self-sampling appears more acceptable to women and has the potential to boost screening uptake, which is dismal at present in India. Studies have shown that menstrual blood (MB) provides equivalent results to cervical smear for Human Papillomavirus (HPV)-Deoxyribonucleic acid (DNA) testing, but sample collection needs standardization. This study explored the feasibility and acceptance of self-sampling using 'M-strip' for high-risk HPV DNA (hr-HPV DNA) testing from MB. Methods One hundred and eleven women aged 30-50 yr without a previous diagnosis of pre-cancer or cancer used the M-strip to collect the MB sample. The strip was peeled off the sanitary pad after use, sent in a zip-lock pouch, and tested for high-risk human papillomavirus (hr-HPV) DNA by real-time polymerase chain reaction (rt-PCR). Instructions were provided verbally, in video illustration, and print. Feedback from participants regarding acceptance and comfort in sampling was documented, and from women who refused to participate. Results Seventy-seven women provided MB samples, all of which were evaluable. Six tested positive for hr-HPV DNA, and all six had direct cervical smears obtained subsequently. Randomly selected HPV DNA-negative MB samples were also tested by direct cervical smear. Positive and negative MB samples were 100 per cent in concordance with the findings from direct cervical smears. Participants expressed a high level of acceptance and preference for this method. Interpretation & conclusions Women could successfully collect adequate samples with the M-strip for hr-HPV DNA testing. Using M-strip with their sanitary pads was preferred by and highly acceptable to women in this study.