Division of Cancer Epidemiology and Genetics, National Cancer Institute, Bethesda, MD 20892-7234, USA.
Am J Clin Pathol. 2010 Aug;134(2):193-9. doi: 10.1309/AJCPRI8XPQUEAA3K.
Human papillomavirus (HPV) testing is more sensitive for the detection of cervical precancer and cancer than cervical cytology. The increased sensitivity of HPV testing and cytology combined ("cotesting") compared to cytology alone permitted professional societies to recommend 3-year screening intervals among the cotest-negative results. However, there is an increasing recognition that both clinical sensitivity and specificity of cervical cancer screening are important to patient safety and must be considered in the context of using current and future HPV DNA tests. Exquisite analytic sensitivity for HPV does not increase clinical sensitivity of an HPV test but does result in excessive test positivity and decreased clinical specificity. A recent US Food and Drug Administration (FDA)-approved HPV test, Cervista (Hologic, Bedford, MA), demonstrated excessive test positivity-2 to 4 times more positive than the other FDA-approved HPV test-from its premarketing approval trial. The poor specificity of Cervista raises questions about the safety and applicability of using this test in routine cervical cancer screening. These data provide a didactic example of the potential dangers of mistaking excellent analytic sensitivity and even clinical sensitivity for good clinical performance.
人乳头瘤病毒（HPV）检测比宫颈细胞学检查更敏感，可检测出宫颈癌前病变和癌症。HPV 检测与细胞学联合检测（“联合检测”）比单独细胞学检测的敏感性更高，这使得专业协会建议在联合检测阴性结果中，筛查间隔为 3 年。然而，人们越来越认识到，宫颈癌筛查的临床敏感性和特异性对于患者安全都很重要，必须在使用当前和未来 HPV DNA 检测的情况下考虑到这些因素。HPV 检测的分析敏感性极高，但并不会增加 HPV 检测的临床敏感性，反而会导致检测阳性率过高，临床特异性降低。最近美国食品和药物管理局（FDA）批准的 HPV 检测 Cervista（Hologic，马萨诸塞州贝德福德），与其他获得 FDA 批准的 HPV 检测相比，其阳性率过高——高出 2 至 4 倍——来自其上市前批准试验。Cervista 的特异性较差，引发了人们对该检测在常规宫颈癌筛查中的安全性和适用性的质疑。这些数据为将极好的分析敏感性甚至临床敏感性误认为良好的临床性能的潜在危险提供了一个教学示例。
