Evaluation of the concordance in HPV type between self- and physician-collected samples using a brush-based device and a PCR-based HPV DNA test in Japanese referred patients with abnormal cytology or HPV infection

Abstract

Background To adopt HPV self-sampling in Japan, we assessed the concordance between self- and physician-collected human papillomavirus (HPV) samples from Japanese patients and examined the performance of HPV self-sampling for cervical intraepithelial neoplasia grade 2 or worse (CIN2+). Methods Patients who had previously tested negative for intraepithelial lesions or malignancy/HPV-positive, and patients with atypical squamous cells of undetermined significance or worse (ASCUS+) cytology were eligible for this cross-sectional study. Participants performed HPV self-sampling using an Evalyn brush, which was submitted at the Fukui Prefectural Health Care Association. The Evalyn brush heads were stored in ThinPrep vials. The physician, however, performed HPV and cell sampling using an endocervical brush and immediately stored the brush heads in ThinPrep vials. All participants underwent colposcopy and biopsy. Histopathological diagnoses were made by pathologists at Fukui University Hospital. HPV infection was confirmed using a PCR-based Cobas 4800 HPV DNA test. Cytological analysis was performed at Fukui Prefectural Health Care Association. Results HPV-positive rates for physician-collected samples and self-collected samples were 51 and 50%, respectively. The perfect match rate of HPV type between the groups was 88% (κ = 0.76). HPV16/18 showed higher agreement rates than other HPVs (99%, kappa 0.96 and 89% kappa 0.77, respectively). Both groups showed 100% sensitivity to CIN2+, but specificity was 57.0 and 58.1%, respectively. Conclusion For HPV typing, a good concordance rate was seen between self- and physician-collected samples. Self-sampling showed high sensitivity for CIN2+. Self-sampling using the Evalyn brush and Cobas 4800 may be feasible for screening Japanese individuals.

Evaluation of ILEX SelfCerv for Detection of High-Risk Human Papillomavirus Infection in Gynecology Clinic Attendees at a Tertiary Hospital in South Africa

“…In our study, the sensitivity of self-collected samples for HPV-16 (85.5%) was higher than 75%, and the specificity (97.9%) was comparable to the 100% reported in a previous study [ 13 ]. The sensitivity and specificity for the other 12 hr-HPVs in the current study were similar to that previously reported in Japan [ 27 ].…”

High-risk human papillomavirus detection in self-collected vaginal samples compared with healthcare worker collected cervical samples among women attending gynecology clinics at a tertiary hospital in Pretoria, South Africa

“…However, studies comparing the detection rate of HPV between healthcare worker-collected-and self-collected samples in LMICs are limited. Moreover, the majority of studies have focused on comparing healthcare workercollected and self-collected samples for HPV DNA detection [7,8,[24][25][26] than HPV mRNA detection. This study aimed to compare the positivity of hrHPV DNA and hrHPV mRNA between healthcare workercollected and self-collected samples and investigate the accuracy of the applicator-tampon-based self-collected samples in detecting hrHPV DNA and hrHPV mRNA.…”

Comparison between Urine and Cervical High-Risk HPV Tests for Japanese Women with ASC-US

“…The shortage of gynecologists would be one of the causes impairing the participation rate, particularly in rural areas [13]. Though self-sampling kits demonstrated highly acceptable performance in usage and sensitivity, these were not widely accepted due to the need to use special equipment and the resistance of women to put the equipment into the vagina themselves in Japan [8,9]. The urine hrHPV-DNA test could be a substitute for the cervical test and is expected to increase receiving rate in the uterine cervical cancer screening because that does not need a special sampling kit, examination chair, or gynecologist examination.…”

“…The HPV-DNA test using a urine sample is expected to substitute the cervical test by including self-sampling because it is easier for examinees to Diagnostics 2021, 11, 1895 2 of 9 collect specimens themselves, there is no need to prepare examination beds and expensive collection kits, and it has an advantage in preventing coronavirus transmission by reducing contact with the medical staff during the recent COVID-19 pandemic. Several reports have shown the good concordance between urine and cervical sampling to detect HPV infection in women with cervical intraepithelial neoplasia (CIN) [5][6][7][8][9]. Daponte et al reviewed the literature and introduced a urine HPV test as a most promising tool to change cervical cancer prevention strategies [10].…”