Introduction: According to current the American Society for Colposcopy and Cervical Pathology (ASCCP) guidelines, patients with normal cytology results may be referred for colposcopy according to their high-risk human papillomavirus (hrHPV) test results. A higher positive predictive value (PPV) of hrHPV has significance for preventing unnecessary colposcopic examinations. Several studies have compared the performance of the Aptima assay and the Cobas 4800 platform among patients who had minor cytologic abnormality. However, in our English literature search, we found no other study that had been conducted to compare these two methods in patients with normal cytology. We thus aimed to compare the PPV of the Aptima assay and Cobas 4800 platform among women with normal cytology. Methods: Between September 2017 and October 2022, we retrospectively identified 2,919 patients who had normal cytology and hrHPV positivity who had been referred for a colposcopy. Among them, 882 agreed to undergo a colposcopy; on examination, 134 had target lesions revealed and underwent a colposcopic punch biopsy. Results: Among the patients who underwent a colposcopic punch biopsy, 49 (38.9%) were tested with Aptima, and 77 (61.1%) were tested with Cobas. In the Aptima group, 29 (59.2%) patients showed benign histology, 2 (4.1%) patients had an low-grade squamous intraepithelial lesions (LSIL), and 18 (36.7%) patients had ≥ high-grade squamous intraepithelial lesion (HSIL) biopsy results. The false positivity rate and PPV of Aptima were 63.3% (31/49) and 36.7% (95% CI:0.232-0.502), respectively, for a histopathologic diagnosis of ≥ HSIL. In the Cobas group, 48 (62.3%) biopsies were benign, 11 (14.3%) reported an LSIL, and 18 (23.4%) biopsies were ≥HSIL. The false positivity rate and PPV of Cobas were 76.6% (59/77) and 23.4% (95% CI:0.139-0.328), respectively, concerning a ≥HSIL tissue diagnosis. The false positivity rate of Aptima HPV 16 positivity was 40% (4/10). The false positivity rate of Cobas HPV 16 positivity was 61.1% (11/18). The PPVs of HPV 16 positivity for Aptima and Cobas were 60% (95% CI:0.296-0.903), and 38.9% (95% CI:0.163-0.614), respectively, concerning ≥HSIL tissue diagnosis. Discussion/Conclusion: We recommend analyzing the performances of hrHPV platforms in future larger studies in patients with normal cytology, rather than only cases with abnormal cytology.


中文翻译：

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Aptima HPV 检测和 Cobas 4800 平台在细胞学正常且高危 HPV 阳性女性中的临床表现比较

简介：根据现行美国阴道镜和宫颈病理学会（ASCCP）指南，细胞学结果正常的患者可根据高危人乳头瘤病毒（hrHPV）检测结果转诊进行阴道镜检查。hrHPV较高的阳性预测值（PPV）对于预防不必要的阴道镜检查具有重要意义。几项研究比较了 Aptima 检测和 Cobas 4800 平台在有轻微细胞学异常的患者中的性能。然而，在我们的英文文献检索中，我们没有发现其他研究在细胞学正常的患者中比较这两种方法。因此，我们的目的是在细胞学正常的女性中比较 Aptima 检测和 Cobas 4800 平台的 PPV。方法：2017 年 9 月至 2022 年 10 月期间，我们回顾性鉴定了 2,919 名细胞学正常且 hrHPV 阳性且转诊接受阴道镜检查的患者。其中，882人同意接受阴道镜检查；检查后，134 名患者发现了目标病变，并接受了阴道镜穿刺活检。结果：在接受阴道镜穿刺活检的患者中，49 例（38.9%）接受了 Aptima 测试，77 例（61.1%）接受了 Cobas 测试。在 Aptima 组中，29 例（59.2%）患者显示良性组织学，2 例（4.1%）患者具有低度鳞状上皮内病变（LSIL），18 例（36.7%）患者具有≥高度鳞状上皮内病变（HSIL） ) 活检结果。对于≥ HSIL 的组织病理学诊断，Aptima 的假阳性率和 PPV 分别为 63.3% (31/49) 和 36.7% (95% CI:0.232-0.502)。在 Cobas 组中，48 例 (62.3%) 活检结果为良性，11 例 (14.3%) 报告存在 LSIL，18 例 (23.4%) 活检结果≥HSIL。对于 ≥ HSIL 组织诊断，Cobas 的假阳性率和 PPV 分别为 76.6%（59/77）和 23.4%（95% CI：0.139-0.328）。Aptima HPV 16 阳性的假阳性率为 40% (4/10)。Cobas HPV 16阳性假阳性率为61.1%（11/18）。对于 ≥ HSIL 组织诊断，Aptima 和 Cobas 的 HPV 16 阳性 PPV 分别为 60% (95% CI:0.296-0.903) 和 38.9% (95% CI:0.163-0.614)。讨论/结论：我们建议在未来更大规模的研究中，在细胞学正常的患者中分析 hrHPV 平台的性能，而不仅仅是细胞学异常的病例。