Joshi Smita, Kumar B Kishore, Ramshankar Vijayalakshmi, Maitra Nandita, Palit Sayantani Pramanik, Ravindran Soundharya, Shyam Twinkle Sara
Department of Preventive Oncology, Prayas, Amrita Clinic, Pune, India.
Consilx Digital, India.
Asian Pac J Cancer Prev. 2024 Dec 1;25(12):4211-4216. doi: 10.31557/APJCP.2024.25.12.4211.
We are reporting the performance of HPV self-sample collected by a novel kit in comparison with clinician collected cervical sample for HPV testing for cervical cancer screening.
Consenting, eligible women aged 25 to 60, with a positive cervical cancer screening test report in the past one year but without any prior treatment for cervical abnormalities were enrolled in the study. Each woman provided 2 samples for the HPV test (vaginal self-sample collected with the CERVICHECKTM, an indigenous kit from India and cervical sample collected by the clinician). These samples were analysed using cobas HPV test on 4800 platform and for liquid-based cytology.
We enrolled 156 eligible, consenting participants at 2 study sites. The agreement for the sample collected by CERVICHECKTM and clinician collected sample for any high-risk HPV was 95.1% (k= 0.90, SE 0.036, 95% CI 0.83-0.97). The agreement for HPV 16 or 18 only was 95.1%, (k=0.88, SE 0.045, 95% CI 0.79-0.97). The overall acceptability of the kit was good, participants expressed that self-sampling was easy and > 90% women were willing to recommend it to their friends.
There was almost perfect or perfect agreement between the HPV self-sample collected by CERVICHECKTM and clinician collected cervical sample. Self-sampling was highly acceptable to the participating women.
我们报告了一种新型试剂盒采集的人乳头瘤病毒（HPV）自我样本与临床医生采集的宫颈样本在宫颈癌筛查HPV检测中的表现。
研究纳入了年龄在25至60岁之间、同意参与且符合条件的女性，这些女性在过去一年内宫颈癌筛查检测报告呈阳性，但之前未接受过任何宫颈异常治疗。每位女性提供2份样本用于HPV检测（一份是使用印度本土试剂盒CERVICHECKTM采集的阴道自我样本，另一份是临床医生采集的宫颈样本）。这些样本在4800平台上使用cobas HPV检测进行分析，并进行液基细胞学检查。
我们在2个研究地点招募了156名符合条件且同意参与的参与者。CERVICHECKTM采集的样本与临床医生采集的样本在任何高危型HPV检测结果上的一致性为95.1%（κ = 0.90，标准误0.036，95%置信区间0.83 - 0.97）。仅针对HPV 16或18的一致性为95.1%（κ = 0.88，标准误0.045，95%置信区间0.79 - 0.97）。该试剂盒的总体可接受性良好，参与者表示自我采样很容易，超过90%的女性愿意向朋友推荐。
CERVICHECKTM采集的HPV自我样本与临床医生采集的宫颈样本之间几乎完全一致或完全一致。自我采样在参与的女性中高度可接受。
