Department of Pathology, Istanbul Medeniyet University Göztepe Prof. Dr. Süleyman Yalçın City Hospital, Istanbul, Turkey.
Department of Obstetrics and Gynecology, Istanbul Medeniyet University Göztepe Prof. Dr. Süleyman Yalçın City Hospital, Istanbul, Turkey.
Acta Cytol. 2023;67(4):395-402. doi: 10.1159/000530347. Epub 2023 Mar 28.
According to the current 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 abnormalities. 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 the Cobas 4800 platform among women with normal cytology.
Between September 2017 and October 2022, we retrospectively identified 2,919 patients who had normal cytology and hrHPV positivity and 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.
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 low-grade squamous intraepithelial lesions (LSILs), and 18 (36.7%) patients had ≥high-grade squamous intraepithelial lesions (HSILs) biopsy results. The false-positivity rate and PPV of Aptima were 63.3% (31/49) and 36.7% (95% confidence interval [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.
We recommend analyzing the performances of hrHPV platforms in future, larger studies in patients with normal cytology rather than only in cases with abnormal cytology.
根据当前美国阴道镜和宫颈病理学会（ASCCP）的指南，细胞学结果正常的患者可以根据其高危型人乳头瘤病毒（hrHPV）检测结果转介行阴道镜检查。hrHPV 的阳性预测值（PPV）更高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 检测法和 Cobas 4800 平台在具有轻微细胞学异常的患者中的表现。然而，在我们的英文文献检索中，我们没有发现其他比较这两种方法在细胞学正常的患者中的性能的研究。因此，我们旨在比较 Aptima 检测法和 Cobas 4800 平台在细胞学正常的患者中的 PPV。
在 2017 年 9 月至 2022 年 10 月期间，我们回顾性地确定了 2919 名细胞学正常且 hrHPV 阳性并转介行阴道镜检查的患者。其中，882 名患者同意进行阴道镜检查；在检查中，发现 134 名患者有目标病变并进行了阴道镜下活检。
在进行阴道镜下活检的患者中，49 名（38.9%）接受了 Aptima 检测，77 名（61.1%）接受了 Cobas 检测。在 Aptima 组中，29 名（59.2%）患者的组织学表现为良性，2 名（4.1%）患者为低度鳞状上皮内病变（LSIL），18 名（36.7%）患者为≥高级别鳞状上皮内病变（HSIL）活检结果。Aptima 的假阳性率和 PPV 分别为 63.3%（31/49）和 36.7%（95%置信区间[CI]：0.232-0.502），用于≥HSIL 的组织病理学诊断。在 Cobas 组中，48 名（62.3%）活检为良性，11 名（14.3%）报告 LSIL，18 名（23.4%）活检为≥HSIL。Cobas 的假阳性率和 PPV 分别为 76.6%（59/77）和 23.4%（95% CI：0.139-0.328），用于≥HSIL 的组织学诊断。Aptima HPV 16 阳性的假阳性率为 40%（4/10）。Cobas HPV 16 阳性的假阳性率为 61.1%（11/18）。Aptima 和 Cobas 的 HPV 16 阳性的 PPV 分别为 60%（95% CI：0.296-0.903）和 38.9%（95% CI：0.163-0.614），用于≥HSIL 的组织学诊断。
我们建议在未来的研究中分析 hrHPV 平台的性能，而不是仅在细胞学异常的情况下进行，要在细胞学正常的患者中进行更大规模的研究。
