再说说精密度

Talking about precision again

全世界临床实验室对每份患者标本中需要检测的每个分析物都只做一次检测就发出检测报告。这是临床实验室相对于其他分析领域实验室最大的特点,但也是最大的缺陷!如果临床医生和患者对检测报告有怀疑,那么就需要实验室重新做一次检测。重新检测的结果与先前的检测报告一致,这是最理想的结果。为了满足临床和患者的需求,临床实验室定量检验项目的首要分析性能一定是精密度。可惜,国内大多数临床实验室和体外诊断产品的厂商没有对精密度性能予以充分重视。本文呼吁认真学习美国临床实验室标准化协会(CLSI)的EP5文件,并按照文件的实验方案进行完整的精密度实验,以真实、可靠的实验数据建立或验证精密度性能,这才是确保向临床和患者提供有质量的报告的基础。本文也介绍了在验证厂商精密度性能时,比较标准差大小使用卡方检验的含义。

Clinical laboratories around the world reporting determination results deeply depend on only once determining for each analyte for each specimen. This approach only occurs in clinical laboratories in the world,it is the main characteristic of clinical laboratory,however,there also are disadvantages. Relative determinations should be performed again when clinicians and patients have doubts about the reports. The re-determination results are consistent with previous reports,which is the best result. To ensure the quality of determination results and meet the requirements of clinic and patients,clinical laboratories must pay full attention to the precision performance of measurement system,as the primary analytical performance of quantitative analysis. Unfortunately,today＇ s clinical laboratories and in vitro diagnostic manufacturers have not done well precision experiments. This paper calls for the careful study of the Clinical and Laboratory Standards Institute（ CLSI） EP5 document,and establishes or verifies the precision performance of each analyte measurement system for determining patient specimen,and this is the key to ensure the quality of determination results for clinic and patients. This paper describes the use of chi-square test for standard deviation when verifying the precision performance from manufacturers as well.