传染病诊断方法的验证

Validation of Diagnostic Assays for Infectious Diseases

诊断敏感性和特异性是诊断方法验证过程中的两个重要参数。本文通过分析和比较,详细阐述了诊断敏感性和特异性在动物检疫工作中的重要性,厘清了其与分析敏感性和特异性的区别。通过计算分析比较了不同流行率对检测结果可信度的影响,以及在同一流行率下,诊断敏感性和特异性变化对检测结果可信度的影响。结果显示,当流行率低时,诊断特异性对结果可信度的影响更大,诊断特异性的降低会导致阳性检测结果可信度显著下降。因此在进出境动物检疫工作中,不要一味强调分析特性,而要重视诊断特性;既要关注诊断敏感性,做到不漏检;也要关注诊断特异性,做到不误检。

Diagnostic sensitivity （Dse） and diagnostic specificity （Dsp） are two key parameters in validation of diagnostic assays for infectious diseases, showing the accuracy performance of a diagnostic assay. In this paper, the importance of Dse and Dsp in animal quarantine inspection was analyzed by comparing the differences between the analytical characters and diagnostic ones. The influence trends of reliability of detections were calculated with different prevalence rates. Results show that when the prevalence rate is low, the decrease of Dsp impacts reliability of positive results more greatly： a little reduction of Dsp will lead to a significant decrease in the reliability of the positive results. Therefore, in entry and exit animal quarantine inspection, the characteristics of the analysis should not be blindly emphasized, but attention should be paid to the diagnosis of characteristics. Compared with Dse, Dsp is equally important. We should not only focus on Dse to decrease the missing rate, but also pay attention to Dsp of diagnostic assay to reduce the false rate as possible as we can.