Department of Medical Oncology, Lund University Faculty of Medicine, Lund, Sweden
Department of Microbiology, Immunology and Parasitology, Addis Ababa University, Addis Ababa, Ethiopia.
Int J Gynecol Cancer. 2024 Nov 4;34(11):1691-1697. doi: 10.1136/ijgc-2024-005694.
Most women who are high-risk human papilloma virus (hrHPV) positive in a cervical cancer screening test will spontaneously heal from their infection. Visual inspection with acetic acid (VIA) is recommended by the World Health Organization as a triage test for cervical screening, however its accuracy as a triage test has been questioned. In this study, we aimed to examine the sensitivity and specificity of VIA with and without Lugol's iodine as a triage test to detect cervical intraepithelial neoplasia (CIN2+) among women who tested positive for hrHPV after self-sampling.
This two-armed randomized controlled trial (RCT) took place in Adama, Ethiopia. The women who tested positive for vaginal hrHPV (Anyplex ΙΙ, Seegene) after self-sampling were randomized to VIA with or without iodine and appointed to a midwife-led clinic. The result of the triage test was categorized as positive, negative, suspicion of cancer or inconclusive, and treated accordingly. Cervical biopsies were collected from women who were hrHPV positive to serve as a gold standard.
22.4% (197/878) of women tested hrHPV positive. Sensitivity and specificity for VIA to detect CIN2+was 25.0% (95% CI 0.6 to 80.0) and 82.7% (95% CI 69.7 to 91.8), respectively. For VIA with iodine, the sensitivity was 50.0% (95% CI 0.7 to 93.2) and the specificity 86.3% (95% CI 71.4 to 93.0). The difference between the two methods was not statistically significant, p=0.5. The odds of detecting CIN2+ was 5.4 times higher if positive for VIA with iodine compared with a negative result. For VIA without iodine, the odds of detecting CIN2+ was 1.6 compared with a negative result. The odds of detecting CIN2+ was 6.4 times higher if the women were HIV positive than for those who were HIV negative.
VIA with iodine improved detection of CIN2+ in women who were hrHPV DNA positive but was not significantly better than VIA alone.
NCT05125380.
大多数人乳头状瘤病毒（HPV）高危阳性的宫颈癌筛查试验妇女会从其感染中自发痊愈。醋酸视觉检查（VIA）被世界卫生组织推荐为宫颈癌筛查的一种分诊试验，但其作为分诊试验的准确性受到质疑。在这项研究中，我们旨在检查 VIA 联合和不联合卢戈氏碘液作为 HPV 阳性的宫颈癌筛查试验的女性中筛查宫颈上皮内瘤变（CIN2+）的敏感性和特异性。
这项双臂随机对照试验（RCT）在埃塞俄比亚的阿达玛进行。通过自我采样检测到阴道人乳头瘤病毒（HPV）阳性的妇女被随机分配到 VIA 联合和不联合碘液组，并被分配到助产士主导的诊所。分诊试验的结果分为阳性、阴性、疑似癌症或不确定，并相应处理。对 HPV 阳性的妇女进行宫颈活检，作为金标准。
22.4%（197/878）的妇女 HPV 阳性。VIA 检测 CIN2+的敏感性和特异性分别为 25.0%（95% CI 0.6 至 80.0）和 82.7%（95% CI 69.7 至 91.8）。对于碘液联合 VIA，敏感性为 50.0%（95% CI 0.7 至 93.2），特异性为 86.3%（95% CI 71.4 至 93.0）。两种方法之间的差异无统计学意义，p=0.5。与 VIA 阴性相比，碘液联合 VIA 阳性检测 CIN2+的可能性高 5.4 倍。对于 VIA 不联合碘液，与阴性结果相比，检测 CIN2+的可能性高 1.6 倍。与 HIV 阴性的妇女相比，HIV 阳性的妇女检测 CIN2+的可能性高 6.4 倍。
碘液联合 VIA 提高了 HPV 阳性女性的 CIN2+检测率，但并不显著优于单独使用 VIA。
NCT05125380。
