Correlation between P16/Ki67 in cervical cytology and diagnosis of cervical intraepithelial neoplasia 2-3 in Thai women infected with high-risk types of human papillomavirus.

OBJECTIVES: The addition of p16/Ki-67 dual immunostaining to human papilloma virus (HPV) screening tests has been shown to increase the detection rate of high-grade cervical intraepithelial neoplasia. Thus, the aim of this study was to evaluate the accuracy of p16/Ki67 dual staining in the detection of cervical intraepithelial neoplasia 2 (CIN2+) in women with high-risk HPV infection. MATERIALS AND METHODS: A cross-sectional study was conducted between August 2017 and August 2019 at the Chulabhorn Hospital in Bangkok, Thailand. Women aged 20-70 years who underwent co-testing and tested positive for high-risk (HR) HPV (N = 215) were invited to participate in the study. P16/Ki67 testing was performed on residual cytological materials. Colposcopic biopsies were performed on all patients, and the results were correlated with positive or negative p16/Ki-67 test results. RESULTS: The sensitivity and specificity of p16/Ki-67 dual staining in the detection of CIN2+ in the women with HR HPV infection were 74.4 % and 63.4 %, respectively. Compared with liquid-based cytology (LBC), p16/Ki67 cytology had similar sensitivity (p = 1.000) and specificity (p = 0.561) to LBC for detecting CIN2+. CONCLUSION: In this study, p16/Ki67 dual staining in HPV triage demonstrated a test performance similar to that of LBC.

Self- and physician-collected high-risk human papillomavirus (HPV) testing to detect high-grade cervical lesions among Thai women.

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.

Quality of tissue from punch biopsy forceps vs. round loop electrode in colposcopically directed biopsy: a randomized controlled trial.

OBJECTIVE: To compare the quality of tissue from punch biopsy forceps (PB group) with round loop electrode (LE group) in colposcopically directed biopsy along with the evaluation of pain associated with each procedure. METHODS: Patients with abnormal cervical cytologic results and abnormal colposcopic findings were enrolled into a randomized trial into either a PB group or LE group. The quality of tissue was evaluated in regards to the size of tissue, site of tissue, and tissue damage. Each quality had 1 to 3 points and the sum of each quality contributed to the total tissue score that ranged from 3 to 9. Pain associated with each procedure was assessed by a visual analog scale (VAS). This was a clinical trial study and was registered at www.clinicaltrials.in.th (Identifier: TCTR20160404001). RESULTS: Ninety-six women who met all eligibility requirements were enrolled in the study. Forty-eight patients were randomly assigned to the PB group and 48 patients were randomized into the LE group. The characteristics of the patients were similar between the 2 groups with the exception of the median age. The median total tissue score was 8 points in the LE group which was more than the median of 7 points in the PB group with a statistically significant difference (p=0.014). However, the median VAS pain score in both groups was 3.4 (p=0.82). CONCLUSION: The quality of cervical tissues obtained from biopsy with a round loop electrode was better than the punch biopsy forceps with no difference in the level of pain.