Zuna R E, Moore W, Dunn S T
Department of Pathology, University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma 73190, USA.
Mod Pathol. 2001 Mar;14(3):147-51. doi: 10.1038/modpathol.3880271.
HPV DNA testing of the residual sample volume of liquid-based Pap tests has been recommended as a way to determine the appropriate follow-up for women who have equivocal results in routine clinical screening. A major aspect of quality assurance in the cytopathology laboratory consists of correlation of smear interpretation with biopsy or conization results as mandated by CLIA '88. However, the use of histology as the gold standard suffers from similar problems of subjectivity and sampling as the Pap smear. In this study we explore the potential use of HPV DNA testing of the residual volume from the ThinPrep Pap Test (Cytyc Corporation, Boxborough, Massachusetts) as a substitute gold standard in quality assurance monitoring of a cervical cytology screening program. The residual samples from 397 ThinPrep Pap cases were retrospectively analyzed for high-risk HPV DNA using the Hybrid Capture II technique. Sensitivity (71.8%), specificity (86.5%), predictive value of positive (77.1%) and negative (82.9%) ThinPrep Pap interpretations were calculated on the basis of HPV DNA results for 266 cases classed as either squamous intraepithelial lesion (SIL) or negative. Overall, there was agreement between the two tests in 80.8% of cases (Cohen's kappa =.59). The percentage of HPV DNA-positive cases interpreted as atypical squamous cells of uncertain significance (ASCUS) was 43.7%, and the percentage of negative cases was 17.1%. We believe that this approach is an objective adjunct to the traditional quality assurance protocol, with the added benefit that it includes cases interpreted as negative, as well as abnormal cases that do not come to biopsy.
对于液基巴氏试验剩余样本进行人乳头瘤病毒（HPV）DNA检测，已被推荐作为一种方法，用于确定在常规临床筛查中结果不明确的女性的适当后续检查。细胞病理学实验室质量保证的一个主要方面包括按照1988年临床实验室改进修正案（CLIA '88）的要求，将涂片解读结果与活检或锥切结果进行关联。然而，将组织学作为金标准与巴氏涂片一样，存在主观性和取样方面的类似问题。在本研究中，我们探索了对ThinPrep巴氏试验（Cytyc公司，马萨诸塞州博克斯伯勒）剩余样本进行HPV DNA检测作为宫颈细胞学筛查项目质量保证监测替代金标准的潜在用途。使用杂交捕获II技术对397例ThinPrep巴氏病例的剩余样本进行回顾性分析，以检测高危HPV DNA。根据266例分类为鳞状上皮内病变（SIL）或阴性病例的HPV DNA结果，计算出ThinPrep巴氏解读的敏感性（71.8%）、特异性（86.5%）、阳性预测值（77.1%）和阴性预测值（82.9%）。总体而言，80.8%的病例两种检测结果一致（科恩kappa系数=0.59）。HPV DNA阳性病例中被解释为意义不明确的非典型鳞状细胞（ASCUS）的比例为43.7%，阴性病例的比例为17.1%。我们认为这种方法是传统质量保证方案的客观辅助手段，其额外好处是它包括被解释为阴性的病例以及未进行活检的异常病例。
