自我采集与临床医生采集的宫颈样本用于检测 HPV 感染的 14 型 DNA 和 7 型 mRNA 测试。
Self-collected versus clinician-collected cervical samples for the detection of HPV infections by 14-type DNA and 7-type mRNA tests.
机构信息
Oncology Department, Hospital General de México "Eduardo Liceaga", Mexico City, Mexico.
Department of Colposcopy, Hospital General de Mexico "Eduardo Liceaga", Mexico City, Mexico.
出版信息
BMC Infect Dis. 2021 May 31;21(1):504. doi: 10.1186/s12879-021-06189-2.
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 .
背景
HPV 自我采样在大量相关文献的支持下，已得到科学界的广泛认可。自我采样在宫颈癌筛查中很重要，因为它已被证明可以提高参与度。HPV 检测在检测 CIN 和癌症方面的灵敏度优于细胞学检测，这一点已得到充分证明。自我采集样本的价值取决于分子检测的质量，以及患者对采样过程的偏好和对阳性检测结果的随访依从性。由于自我样本与细胞学检查不兼容，因此强烈需要通过检测分子生物标志物来对 HPV-DNA 阳性进行分流。
方法
我们的目的是比较使用 14 型 HPV-DNA 检测和 7 型 mRNA E6/E7 检测，对自我和临床医生采集样本中生殖器人乳头瘤病毒（HPV）感染的检出率。
结果
共招募了 505 名女性。每位研究参与者在同一就诊时进行了两种样本采集程序，自我采集或临床医生采集程序的执行顺序先或后交替，总共采集了 1010 个样本。自我采集样本中 HPV-DNA 的流行率为 22.8%，而临床医生采集样本中 HPV-DNA 的流行率为 19.2%（P=0.19）。7 种 HPV 类型的 mRNA E6/E7 过表达率分别为 7.1%和 6.3%（P=0.71）。在自我采集样本（22.8%与 7.1%，P<0.001）和临床医生采集样本（19.2%与 6.3%，P<0.001）中，HPV-DNA 和 HPV-mRNA 阳性率之间的差异均具有统计学意义。两种采集方法的总体一致性为中等，HPV-DNA 检测的一致性率为 78.2%（390/505），κ=0.34（95%CI：0.25-0.44），P<0.001，mRNA 检测的一致性率为 92.5%（467/505），κ=0.40（95%CI，0.25-0.56），P<0.001。96.8%的参与者表示他们对自己进行自我采集有信心，88.8%的参与者表示在进行该程序时没有任何不适。
结论
本研究比较了两种采样方法，使用 Abbott hrHPV 和 PreTect HPV-Proofer'7 检测报告，自我采集和临床医生采集样本的 HPV 阳性率之间的一致性为中等。只有三分之一的 HPV-DNA 阳性女性存在 mRNA E6/E7 的过表达。
试验注册
ISRCTN77337300。
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