Department of Pathology, Cliniques universitaires St Luc, UCL, Brussels.
Clin Microbiol Infect. 2010 Jun;16(6):671-5. doi: 10.1111/j.1469-0691.2009.02943.x. Epub 2009 Aug 18.
The present study aimed to validate ThermoFisher's (Thermo Fisher Scientific, Runcorn, Cheshire, UK) Papspin (PS) for human papillomavirus (HPV) testing by in-house PCR and by the Hybrid Capture II (HC2) assay and to compare the results with those obtained using Specimen Transport Medium (STM) (Digene Diagnostics, Gaithersburg, MD, USA). Forty-five patients underwent conization for known lesions ranging from atypical squamous cells of undetermined significance (ASC-US) with high-risk HPV (hr-HPV) to high-grade squamous intraepithelial lesion (H-SIL/CIN2+) or adenocarcinoma. Two negative controls were included: one patient with post-menopausal bleeding and another from whom an inflammatory cervical sample was taken without conization. Prior to conization, a gynaecologist collected two cervical samples, fixed in PS or STM, from each patient. All but four cases were tested for panHPV (GP5+/GP6+) and specific hr-HPV subtypes (HPV16, 18, 31,33) by PCR using both media and all were processed for HC2. This study demonstrates that both HPV detection techniques work with PS, showing a specificity of 78.3% for HC2 and 92.8% for PCR compared to 83.8% for HC2 and 92% for PCR using STM. The efficacy of detecting HPV in PS-preserved H-SIL/CIN2+ was very high (96% for PCR using PS and 86% for HC2 using PS), which was in the same range as for PCR using STM, and which was only slightly lower than for HC2 using STM (96% and 89%, respectively). The differences were not statistically significant. It is concluded that ThermoFisher's PS is a valid liquid-based cytology medium for cervical samples, convenient for HPV testing by PCR with GP5+/GP6+ primers and by the HC2 assay.
本研究旨在通过内部聚合酶链反应（PCR）和杂交捕获 II（HC2）检测法验证 ThermoFisher（Thermo Fisher Scientific，英国 Runcorn）的 Papspin（PS）用于人乳头瘤病毒（HPV）检测，并将结果与使用 Specimen Transport Medium（STM）（Digene Diagnostics，美国马里兰州盖瑟斯堡）获得的结果进行比较。45 名患者因已知病变而行锥形切除术，病变范围从非典型鳞状细胞意义不明确（ASC-US）伴高危 HPV（hr-HPV）到高级别鳞状上皮内病变（H-SIL/CIN2+）或腺癌。纳入了两个阴性对照：一名绝经后出血患者和另一名未行锥形切除术的宫颈炎症患者。在锥形切除术前，妇科医生从每位患者收集两个宫颈样本，分别固定于 PS 或 STM 中。除了四个病例外，所有病例均通过两种方法的 PCR 检测了 panHPV（GP5+/GP6+）和特定的 hr-HPV 亚型（HPV16、18、31、33），并且所有病例均进行了 HC2 处理。本研究表明，两种 HPV 检测技术均可与 PS 配合使用，与 STM 相比，HC2 的特异性为 78.3%，PCR 为 92.8%，而 STM 的 HC2 和 PCR 分别为 83.8%和 92%。PS 保存的 H-SIL/CIN2+中 HPV 的检测效果非常高（PS 保存的 PCR 为 96%，PS 保存的 HC2 为 86%），与 STM 保存的 PCR 相当，略低于 STM 保存的 HC2（分别为 96%和 89%）。差异无统计学意义。结论认为，ThermoFisher 的 PS 是一种有效的宫颈样本液基细胞学介质，方便使用 GP5+/GP6+引物的 PCR 和 HC2 检测进行 HPV 检测。
