Validation of serological assays for diagnosis of infectious diseases
Validation of serological assays for diagnosis of infectious diseases
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DOI：
10.20506/rst.17.2.1119
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发表时间：
1998-08-01
影响因子：
0.6
通讯作者：
Jacobson, RH
中科院分区：
文献类型：
--
作者：
Jacobson, RH
检测方法验证是一系列以下相互关联的过程：实验过程：通过实验优化试剂和方案，以准确度和精密度检测分析物，并确保检测方法的重复性和再现性相对过程：相对于从已知感染/暴露状态的参考动物群体获得的检测结果计算其诊断灵敏度和诊断特异性条件过程：将目标群体中的动物分类为感染或未感染取决于用于验证检测试剂盒的参考动物群体代表检测试剂盒将应用的群体的程度（根据试验结果准确预测动物感染状况以及阳性和阴性试验结果的预测值取决于疾病的估计流行率。目标人群中的感染）的增量过程：当使用证实其具有耐用性（如准确度和精密度结果所示）时，检测有效性的置信度随时间推移而增加（随着通过添加已知感染状态的参考人群进行升级和扩展，该检测也可实现有效性水平的提高）连续过程：只有在通过统计学验证证明该检测方法继续提供准确和精确的结果的情况下，该检测方法才有效。因此，传染病诊断检测方法的验证不会以基于少数参考样品的一系列有时间限制的实验结束。相反，这是一个过程，也需要不断的警惕和维护，沿着重新评估其性能特点，为每一个种群的动物，它是applied.It是肯定的，目前的运动，制定和实施的认可标准，兽医诊断实验室可能是没有什么价值，除非有一些保证，在这些实验室进行的测定是适当的验证。完全认可的实验室可能会产生高度可重复的检测结果，但由于检测方法验证过程不当，结果仍可能对动物的感染状态进行错误分类。因此，检测方法验证是兽医诊断实验室核心产品-检测结果及其解释的基础。
Assay validation is a series of the following interrelated processes:an experimental process: reagents and protocols are optimised by experimentation to detect the analyte with accuracy and precision, and to ensure repeatability and reproducibility in the assaya relative process: its diagnostic sensitivity and diagnostic specificity are calculated relative to test results obtained from reference animal populations of known infection/exposure statusa conditional process: classification of animals in the target population as infected or uninfected is conditional upon how well the reference animal population used to validate the assay represents the population to which the assay will be applied (accurate predictions of the infection status of animals from test results and predictive values of positive and negative test results are conditional upon the estimated prevalence of disease/infection in the target population)an incremental process: confidence in the validity of an assay increases over time when use confirms that it is robust as demonstrated by accurate and precise results (the assay may also achieve increasing levels of validity as it is upgraded and extended by adding reference populations of known infection status)a continuous process: the assay remains valid only insofar as the assay continues to provide accurate and precise results as proved through statistical verification.Therefore, validation of diagnostic assays for infectious diseases does not end with a time-limited series of experiments based on a few reference samples. Rather, it is a process that also requires constant vigilance and maintenance, along with reassessment of its performance characteristics for each population of animals to which it is applied.It is certain that the current movement to develop and implement accreditation criteria for veterinary diagnostic laboratories may be of little worth unless there is some assurance that the assays conducted in such laboratories are properly validated. Fully accredited laboratories may generate highly reproducible test results, but the results may still misclassify animals as to their infection status due to an improper assay validation process. Therefore, assay validation is foundational to the core product of veterinary diagnostic laboratories - test results and their interpretation.