Shih Yu-Hsiang, Sun Lou, Hsu Shih-Tien, Chen Ming-Jer, Lu Chien-Hsing
Department of Obstetrics and Gynecology, Taichung Veterans General Hospital, Taichung, Taiwan.
Int J Womens Health. 2023 Sep 11;15:1421-1429. doi: 10.2147/IJWH.S416520. eCollection 2023.
This study investigated whether random urine (RU) samples can be used to accurately identify human papillomavirus (HPV) and whether these samples can replace self-collected vaginal samples in HPV tests.
A total of 167 patients with abnormal Pap smears were recruited. The patients provided self-collected vaginal and RU samples for HPV testing. Clinicians obtained cervical samples from the patients. Colposcopy examination and cervical biopsy were performed. Hybrid Capture II (HC II) and Cervista tests were used to detect HPV in the RU samples.
The results of tests on clinician-collected cervical samples were used as the benchmark. The sensitivities of the Cervista tests on vaginal samples and the HC II and Cervista tests on RU samples were 75.00%, 49.07%, and 44.44%, respectively. After we adjusted the HPV detection cutoff value for urine samples based on values in the receiver operating characteristic curve, the sensitivities of the HC II and Cervista tests increased to 63.89% and 58.33%, respectively. In 167 patients, 59 had cervix biopsies showing CIN2 or worse (CIN2+). For CIN2+, the sensitivity was 47.5% and 50.8% in the HC II and Cervista tests on RU samples, respectively.
HPV tests on RU samples had approximately 60% sensitivity to HPV tests on clinician-collected cervical samples after the cutoff values were adjusted. For CIN2+, the sensitivity was only approximately 50%. Further studies and improvements in urine-based HPV testing are needed to establish it as a more convenient and accessible method for detecting HPV and cervical dysplasia in patients.
本研究调查随机尿（RU）样本是否可用于准确鉴定人乳头瘤病毒（HPV），以及这些样本能否在HPV检测中替代自行采集的阴道样本。
共招募了167例巴氏涂片异常的患者。患者提供自行采集的阴道和RU样本用于HPV检测。临床医生从患者处获取宫颈样本。进行了阴道镜检查和宫颈活检。使用杂交捕获二代（HC II）和Cervista检测法检测RU样本中的HPV。
以临床医生采集的宫颈样本检测结果作为基准。Cervista检测法对阴道样本的敏感度以及HC II和Cervista检测法对RU样本的敏感度分别为75.00%、49.07%和44.44%。根据受试者工作特征曲线中的数值调整尿液样本的HPV检测临界值后，HC II和Cervista检测法的敏感度分别提高到63.89%和58.33%。在167例患者中，59例宫颈活检显示为CIN2或更严重病变（CIN2+）。对于CIN2+，RU样本的HC II和Cervista检测法的敏感度分别为47.5%和50.8%。
调整临界值后，RU样本的HPV检测对临床医生采集的宫颈样本的HPV检测敏感度约为60%。对于CIN2+，敏感度仅约为50%。需要进一步研究和改进基于尿液的HPV检测，以使其成为检测患者HPV和宫颈发育异常的更便捷、更易获取的方法。
