Johnson Lawrence R, Starkey Cindi R, Palmer James, Taylor James, Stout Spencer, Holt Stephanie, Hendren Ryan, Bock Brian, Waibel Elizabeth, Tyree Gale, Miller Gerald C
Hematopathology and Flow Cytometry, Regional Medical Laboratory, Tulsa, OK 74104, USA.
Am J Clin Pathol. 2008 Sep;130(3):401-8. doi: 10.1309/4DXEAFG2JXYF34N3.
Clinical tests for human papillomavirus (HPV) DNA require clinical validation before being offered for use by laboratories. To determine the clinical viability of a laboratory-developed test using the Invader HPV reagents (Third Wave Technologies, Madison, WI), a retrospective study was designed using 213 patient cervical cytologic samples. The results of the Invader assay were directly compared with the results obtained using the Hybrid Capture 2 High-Risk HPV assay (Digene, Gaithersburg, MD). The results of both assays were also compared with cytologic evaluation. In addition, clinical performance was evaluated using a standard-of-care approach in which colposcopically guided biopsies were done in cases where standard of care dictated, and the histologic features of the biopsy specimens were noted. The Invader-based test demonstrated a clinical sensitivity in atypical squamous cells of undetermined significance cases of 98% for cervical intraepithelial neoplasia (CIN) 2 or worse and 100% for CIN 3 or worse and a negative predictive value of 96.9% (confidence interval, 89.3%-99.6%) using data generated mostly from the use of an earlier version of reagents. These findings support the clinical and laboratory benefits of the Invader method.
人乳头瘤病毒（HPV）DNA的临床检测在实验室使用前需要进行临床验证。为了确定使用Invader HPV试剂（Third Wave Technologies，麦迪逊，威斯康星州）的实验室自行开发检测方法的临床可行性，设计了一项回顾性研究，使用213例患者的宫颈细胞学样本。将Invader检测结果直接与使用杂交捕获2高危型HPV检测法（Digene，盖瑟斯堡，马里兰州）获得的结果进行比较。两种检测方法的结果也与细胞学评估结果进行比较。此外，采用标准治疗方法评估临床性能，即在标准治疗要求的情况下进行阴道镜引导下活检，并记录活检标本的组织学特征。基于Invader的检测方法在意义不明确的非典型鳞状细胞病例中，对宫颈上皮内瘤变（CIN）2级或更严重病变的临床敏感性为98%，对CIN 3级或更严重病变的临床敏感性为100%，使用主要由早期版本试剂产生的数据得出的阴性预测值为96.9%（置信区间，89.3%-99.6%）。这些发现支持了Invader方法在临床和实验室方面的优势。
