International journal of gynecological cancer : official journal of the International Gynecological Cancer Society · 2023
Self- and physician-collected high-risk human papillomavirus (HPV) testing to detect high-grade cervical lesions among Thai women.
Многоцентровое исследованиеСтатьяПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод в очереди
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Phoolcharoen Natacha, Areeruk Wilasinee, Kantathavorn Nuttavut, Tiyayon Jitima, Chittithaworn Suwicha, Wetcho Thanita, Satitniramai Sikarn, Khomphaiboonkij Uraiwan, Pitakkarnkul Supakorn, Termrungruanglert Wichai, Srisomboon Jatupol, Tangjitgamol Siriwan, Research Group Thai Gynecologic Cancer Society
Аннотация
OBJECTIVE: We compared the performance of high-risk human papillomavirus (HPV) messenger RNA testing of physician- and self-collected specimens for detecting histological grade 2 or higher cervical intraepithelial neoplasia (CIN) among women who visited a colposcopy clinic in Thailand.
METHODS: From January 2022 to April 2022, 500 women participated in this cross-sectional multicenter study; 494 had complete data and valid specimen results. The participants were women who attended any one of the 10 participating institutes' colposcopy clinics due to abnormal cytology, positive high-risk HPV testing, or for follow-up. Participants used a self-sampling Aptima Multitest Swab specimen collection kit to self-collect vaginal samples before physicians biopsied the cervix during the colposcopic examination. The self- and physician-collected specimens were tested for high-risk HPV messenger RNA using Aptima nucleic acid amplification assays. Cervical tissues were collected during colposcopic-directed biopsy from the most severe lesion or a random biopsy and endocervical curettage specimen if no lesion was detected.
RESULTS: We detected high-risk HPV messenger RNA in 75.4% of self-collected specimens and 70.6% of physician-collected specimens. The prevalence of histological grade 2 or higher CIN from cervical histology was 25.1% (n=124). For self-collected specimens, the sensitivity and specificity of high-risk HPV messenger RNA for grade 2 or higher CIN were 87.0% (95% CI 79.7% to 92.4%; n=108) and 28.5% (95% CI 24.0% to 33.4%). For physician-collected specimens, the sensitivity and specificity of high-risk HPV messenger RNA for grade 2 or higher CIN were 90.2% (95% CI 83.6% to 94.9%; n=112) and 36.1% (95% CI 31.2% to 41.3%).
CONCLUSIONS: Self-collected specimens for high-risk HPV messenger RNA testing demonstrated good sensitivity and negative predictive value for detecting grade 2 or higher CIN in Thai women attending the participating institutes' colposcopy clinics. Self-collected samples performed similarly to physician-collected ones.
METHODS: From January 2022 to April 2022, 500 women participated in this cross-sectional multicenter study; 494 had complete data and valid specimen results. The participants were women who attended any one of the 10 participating institutes' colposcopy clinics due to abnormal cytology, positive high-risk HPV testing, or for follow-up. Participants used a self-sampling Aptima Multitest Swab specimen collection kit to self-collect vaginal samples before physicians biopsied the cervix during the colposcopic examination. The self- and physician-collected specimens were tested for high-risk HPV messenger RNA using Aptima nucleic acid amplification assays. Cervical tissues were collected during colposcopic-directed biopsy from the most severe lesion or a random biopsy and endocervical curettage specimen if no lesion was detected.
RESULTS: We detected high-risk HPV messenger RNA in 75.4% of self-collected specimens and 70.6% of physician-collected specimens. The prevalence of histological grade 2 or higher CIN from cervical histology was 25.1% (n=124). For self-collected specimens, the sensitivity and specificity of high-risk HPV messenger RNA for grade 2 or higher CIN were 87.0% (95% CI 79.7% to 92.4%; n=108) and 28.5% (95% CI 24.0% to 33.4%). For physician-collected specimens, the sensitivity and specificity of high-risk HPV messenger RNA for grade 2 or higher CIN were 90.2% (95% CI 83.6% to 94.9%; n=112) and 36.1% (95% CI 31.2% to 41.3%).
CONCLUSIONS: Self-collected specimens for high-risk HPV messenger RNA testing demonstrated good sensitivity and negative predictive value for detecting grade 2 or higher CIN in Thai women attending the participating institutes' colposcopy clinics. Self-collected samples performed similarly to physician-collected ones.