Early Detection, Prevention and Infections Branch, International Agency for Research on Cancer (IARC/WHO), Lyon, France.
Department of Pathology, Amsterdam UMC location Vrije Universiteit Amsterdam, Amsterdam, The Netherlands.
Cancer Med. 2023 May;12(10):11828-11837. doi: 10.1002/cam4.5851. Epub 2023 Mar 31.
"REACH-Bhutan" aimed to evaluate the feasibility and clinical performance of a community-based screening program for cervical cancer in rural Bhutan using self-collected samples for high-risk human papillomavirus (HR-HPV) testing.
In April/May 2016, 2590 women aged 30-60 years were screened across rural Bhutan by providing a self-collected sample for careHPV testing. All careHPV-positive women, plus a random sample of careHPV-negative women, were recalled for colposcopy and biopsy. Self-samples also underwent GP5+/6+ polymerase chain reaction (PCR)-based HR-HPV DNA detection and genotyping. Cross-sectional screening indices were estimated against histological high-grade squamous intraepithelial lesions or worse (hHSIL+), including imputation of hHSIL+ in women without colposcopy.
HR-HPV positivity was 10.2% by careHPV and 14.8% by GP5+/6+ PCR. Twenty-two cases of hHSIL+ were histologically diagnosed, including one invasive cancer; an additional 7 hHSIL+ were imputed in women without colposcopy. HR-HPV testing by GP5+/6+ showed higher sensitivity for hHSIL+ (89.7%, 95% CI 72.6-97.8) than careHPV (75.9%, 95% CI 56.5-89.7). Negative predictive value was also slightly higher for GP5+/6+ (99.9%, 95% CI 99.6-100) than careHPV (99.7%, 95% CI 99.4-99.9). Specificity, however, was lower for GP5+/6+ (86.1%, 95% CI 84.6-87.4) than careHPV (90.6%, 95% CI 89.4-91.7), as was positive predictive value (6.9%, 95% CI 4.5-9.9 vs. 8.5%, 95% CI 5.4-12.6). Of 377 HR-HPV-positive women by GP5+/6+, 173 (45.9%) were careHPV-positive, including 54.7% HPV16-positive and 30.2% HPV18-positive women.
The final REACH-Bhutan results show that screening for cervical cancer with self-collection of samples and HR-HPV testing, in addition to our previous report of achieving high participation, can also perform well to detect women with hHSIL+.
“REACH-不丹”旨在评估在不丹农村地区使用自我采集样本进行高危型人乳头瘤病毒（HR-HPV）检测的基于社区的宫颈癌筛查计划的可行性和临床性能。
2016 年 4 月/ 5 月，通过提供自我采集样本进行 careHPV 检测，对不丹农村地区的 2590 名 30-60 岁的妇女进行了筛查。所有 careHPV 阳性的妇女，以及随机抽取的 careHPV 阴性的妇女，都被召回进行阴道镜检查和活检。自我样本还进行了 GP5+/6+聚合酶链反应（PCR）检测 HR-HPV DNA 检测和基因分型。对组织学高级别鳞状上皮内病变或更严重病变（hHSIL+）进行了横断面筛查指标评估，包括对未经阴道镜检查的妇女 hHSIL+的推断。
careHPV 检测 HR-HPV 阳性率为 10.2%，GP5+/6+PCR 检测 HR-HPV 阳性率为 14.8%。组织学诊断出 22 例 hHSIL+病例，包括 1 例浸润性癌；另外 7 例 hHSIL+在未经阴道镜检查的妇女中推断。GP5+/6+的 HR-HPV 检测对 hHSIL+的敏感性（89.7%，95%CI72.6-97.8）高于 careHPV（75.9%，95%CI56.5-89.7）。GP5+/6+的阴性预测值（99.9%，95%CI99.6-100）也略高于 careHPV（99.7%，95%CI99.4-99.9）。然而，GP5+/6+的特异性（86.1%，95%CI84.6-87.4）低于 careHPV（90.6%，95%CI89.4-91.7），阳性预测值（6.9%，95%CI4.5-9.9 与 8.5%，95%CI5.4-12.6）也较低。在 377 名 GP5+/6+ HR-HPV 阳性的妇女中，有 173 名（45.9%）careHPV 阳性，包括 54.7%HPV16 阳性和 30.2%HPV18 阳性的妇女。
最终的 REACH-不丹研究结果表明，通过自我采集样本和 HR-HPV 检测进行宫颈癌筛查，除了我们之前报告的高参与率外，还可以很好地检测出 hHSIL+的妇女。
