Objective To explore the possibility and reliability of mutual recognition of enzymatic determinations among 20 clinical laboratories entitled with state key clinical laboratory,and to supply reference for future national mutual recognition of laboratory examination results. Methods Determine the concentrations of ALT, AST, ALP,GGT,LDH ,CK with providing unifiedly Roche multiple calibrators and submit the results. The results were analyzed for robust Z score, percentage difference after calibration,bias at medical decision level to observe the possibility and reliability. Results A significant systematic bias was found in post-adjusted ALP and AST. ALT showed the lowest bias at medical decision level and also the lowest CV%. The bias of GGT,LDH and CK were in suitable bias level. Conclusion It remains immature in the mutual recognition of clinical enzymatic determinations and much work needs to be done in field of internal quality control of the laboratory. Standardization of enzymatic determination is a critical step to the mutual recognition among laboratories.%目的 通过在20家获批国家临床重点专科的检验科间开展酶学指标的实验室间比对,探讨临床化学酶学检测的实验室间结果互认的可行性与可靠性,为将来开展检验结果全国互认提供重要的参考依据.方法 各实验室在各自的检测系统上检测统一发放的罗氏临床化学复合校准品和血清标本的6项酶学指标(ALT,AST,ALP,GGT,LDH,CK)上报检测结果;统计各实验室检测结果,并比较以罗氏校准品对各实验室结果进行公式校准前后的结果,从而探讨实验室间酶学指标互认的可行性与可靠性.结果 汇总检测数据,从稳健Z比分数、校准前后百分差值、医学决定水平处的偏倚等指标反映检测结果.ALP,AST呈现显著的系统偏倚,公式校准前的结果显著高于靶值水平;ALT在医学决定水平处的偏倚最小,离散程度亦低;GGT,LDH和CK的偏倚在适合的偏倚水平内.结论 临床化学酶学指标在实验室间互认尚不成熟,需要保证实验室内部质量控制良好,努力实现酶学检测的标准化,才能实现检验结果实验室间互认的目标.
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