Self-collected versus clinician-collected cervical samples for the detection of HPV infections by 14-type DNA and 7-type mRNA tests

Abstract

Background HPV self-sampling has been widely supported by the scientific community following a strong body of literature on the subject. Self-sampling is important in cervical cancer screening as it has been shown to improve participation. It is well documented that HPV-testing has proven superior to cytology with regards to sensitivity in detection of CIN and cancer. The value of self-collected samples is reliant on the quality of the molecular testing performed, as well as the patients’ preference in sampling procedure and compliance to follow up on positive test results. Due to the incompatibility of self-samples and cytology, triage of HPV-DNA positives by testing for molecular biomarkers is highly warranted. Methods Our objective was to compare the detection rate of genital Human Papillomavirus (HPV) infection in self- and clinician-collected samples by a 14-type HPV-DNA test and a 7-type mRNA E6/E7 test. Results Five hundred five women were recruited. Each study participant had two sample collection procedures performed upon the same visit, alternating order in execution of the self-collection or the clinician-taken procedure first or second, 1010 samples in total. HPV-DNA prevalence was 22.8% in self-collected versus 19.2% in clinician-collected samples (P = 0.19). Overexpression of mRNA E6/E7 from 7 HPV types was 7.1 and 6.3%, respectively (P = 0.71). The difference between HPV-DNA and HPV-mRNA positivity rates were statistically significant in both self-collected (22.8% versus 7.1%, P < 0.001) and clinician-collected samples (19.2% versus 6.3%, P < 0.001). Overall agreement between the two collection methods was fair, with a concordance rate of 78.2% (390/505), k = 0.34 (95% CI: 0.25–0.44), P < 0.001, for the HPV-DNA test and 92.5% (467/505), k = 0.40 (95% CI, 0.25–0.56), P < 0.001, for the mRNA test, respectively. 96.8% of the participants reported they felt confident carrying out the self-collection themselves, and 88.8% reported no discomfort at all performing the procedure. Conclusions This comparative study of two sampling methods reports fair agreement of HPV positivity rates between the self-collected and clinician-collected specimens using Abbott hrHPV and PreTect HPV-Proofer’7 tests. Only one third of HPV-DNA positive women had overexpression of mRNA E6/E7. Trial registration ISRCTN77337300.

Human Papillomavirus E6/E7 oncogene transcripts as biomarkers for the early detection of cervical cancer

“…Another important aspect is the higher rate of HPV DNA‐positive cases identified in our study compared to E6/E7 mRNA cases. An earlier study also showed that only one‐third of HPV‐DNA positive women had overexpression of mRNA E6/E7 40 . These may be transient cases that get spontaneously reverted and are not likely to progress to invasive cancer.…”

Genital HPV Prevalence, Follow-Up and Persistence in Males and HPV Concordance Between Heterosexual Couples in Wenzhou, China

“…HPV self-collecting is a new technique invented in recent years and has been widely supported because of the positive effect on the patients’ preference in sampling procedure and compliance to follow up on positive test results. 37 What’s more, male HPV self-collecting in genital area is much easier than females in vagina and cervix.…”

Shifting the power: scale-up of access to point-of-care and self-testing for sexually transmitted infections in low-income and middle-income settings

“…Women in LMICs have expressed a preference for providing vaginal swabs rather than urine for STI testing, and they prefer to self-collect their samples rather than having a healthcare provider doing so [2 ▪ ,29,30]. Crucially, multiple studies have shown strong agreement between results from self-collected versus clinician-collected samples [31,32].…”