Faculty of Medicine, Ivane Javakhishvili Tbilisi State University, Tbilisi, Georgia.
National Screening Centre, Tbilisi, Georgia.
Cent Eur J Public Health. 2024 Sep;32(3):166-172. doi: 10.21101/cejph.a8014.
The objective of this study was to evaluate the effectiveness of human papillomavirus HPV test with HPV16/18 genotyping and liquid-based cytology (LBC) triage as a primary screening method for cervical cancer compared to conventional Pap test in women undergoing routine cervical cancer screening in Tbilisi.
Cross-sectional, prospective study was conducted, where 1,000 enrolled women aged 30-60 years during one visit underwent conventional Pap smear and Hr-HPV testing (Roche Cobas system). Women with any positive screening results were referred for further evaluation and remaining cells from the Cell Collection Medium vial were used for LBC. The study calculated sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) for each screening method and receiver-operating characteristic (ROC) curve to evaluate the accuracy of each diagnostic method in identifying people with CIN2+ diseases.
The HPV test with HPV16/18 genotyping and LBC triage demonstrated higher sensitivity (76.9%), specificity (71.6%), and PPV (34.5%) compared to conventional Pap tests (p < 0.05). NPV was also high with the HPV test (94.1%). The HPV test alone had the highest sensitivity (92.3%) and NPV (96.7%), but lower specificity (41.4%) and PPV (22.6%) than the HPV test with HPV16/18 genotyping and LBC triage (p < 0.05). Comparing the areas under the curve (AUCs), only the HPV with HPV16/18 genotyping and LBC triage showed a statistically significant difference when compared to conventional Pap (0.71 vs. 0.55, p = 0.03) and high figures of AUC 0.71 (95% CI: 0.58-0.85) suggesting that HPV test with HPV16/18 genotyping and LBC triage is a more reliable screening method for detecting CIN2+ disease and preventing cervical cancer, than other screening modality.
The results suggest that the HPV test with HPV16/18 genotyping and LBC triage is a more effective primary screening method compared to conventional Pap tests. This information should be the basis for transition from cytological screening to HPV testing in Georgia.
本研究旨在评估 HPV16/18 基因分型联合液基细胞学（LBC）分流的人乳头瘤病毒（HPV）检测作为一种主要的宫颈癌筛查方法，与传统巴氏涂片检查在第比利斯常规宫颈癌筛查中的效果相比。
这是一项横断面前瞻性研究，共纳入 1000 名年龄在 30-60 岁之间的女性，在一次就诊时进行传统巴氏涂片和人乳头状瘤病毒（HPV）检测（罗氏 Cobas 系统）。对任何阳性筛查结果的女性进行进一步评估，并对细胞采集管中的剩余细胞进行 LBC 检测。该研究计算了每种筛查方法的敏感性、特异性、阳性预测值（PPV）和阴性预测值（NPV），并绘制了受试者工作特征（ROC）曲线，以评估每种诊断方法在识别患有 CIN2+疾病的人群方面的准确性。
与传统巴氏涂片检查相比，HPV16/18 基因分型联合 LBC 分流的 HPV 检测具有更高的敏感性（76.9%）、特异性（71.6%）和 PPV（34.5%）（p<0.05）。HPV 检测的 NPV 也较高（94.1%）。HPV 检测单独具有最高的敏感性（92.3%）和 NPV（96.7%），但特异性（41.4%）和 PPV（22.6%）较低，低于 HPV16/18 基因分型联合 LBC 分流的 HPV 检测（p<0.05）。比较曲线下面积（AUCs），仅 HPV16/18 基因分型联合 LBC 分流的 HPV 检测与传统巴氏涂片（0.71 对 0.55，p=0.03）和较高的 AUC 值 0.71（95%CI：0.58-0.85）具有统计学差异，表明 HPV16/18 基因分型联合 LBC 分流的 HPV 检测是一种更可靠的筛查方法，用于检测 CIN2+疾病和预防宫颈癌，优于其他筛查方式。
结果表明，与传统巴氏涂片检查相比，HPV16/18 基因分型联合 LBC 分流的 HPV 检测是一种更有效的主要筛查方法。这些信息应该是格鲁吉亚从细胞学筛查向 HPV 检测过渡的基础。
