实验室认可的国际标准ISO15189(医学实验室一质量和能力的专用要求)对检验结果的溯源性和可比性提出了明确要求,强调方法学比较试验(比对试验)是实现准确度溯源和患者标本检验结果可比性的重要途径~([1])。对于拥有多个不同生化检测系统的实验室,应参考美国临床实验室标准化委员会NCCLS EP9-A文件,对不同检测系统进行方法比对和偏差评估,并判断其临床可接受性,为实现不同检测系统 Laboratory accreditation of international standards ISO15189 (medical laboratory quality and ability of a dedicated requirement) on the traceability and comparability of test results made clear requirements, emphasizing the methodological comparison test (comparison test) is to achieve the accuracy of traceability and patient An important way for comparability of specimen test results ~ ([1]). For laboratories with multiple biochemical detection systems, reference should be made to the NCCLS EP9-A file to assess the methodological alignment and bias of different detection systems and to determine their clinical acceptability. To achieve different assays system