北京市临床实验室GGT、CK、LDH及α-AMY测量结果的正确度调查

A regional survey for trueness of measurement results of GGT,CK,LDH and α-AMY in clinical laboratories of Beijing area

目的了解北京市各临床实验室γ-谷氨酰基转移酶(GGT)、肌酸激酶(CK)、乳酸脱氢酶(LDH)及α-淀粉酶(α-AMY)常规测量系统测量结果的正确度。方法用北京市12家大型临床实验室GGT、CK、LDH及α-AMY常规测量系统分别测量2个活性水平的人血清基质国家二级标准物质,以标准物质"认定值±不确定度"及En值为标准评价测量结果的正确度。结果2个活性水平的标准物质,GGT测量结果范围分别为89.5～119.3 U/L、169.6～214.3 U/L;CK测量结果范围分别为197.0～224.7 U/L、372.0～446.7 U/L;LDH测量结果范围分别为169.0～225.7 U/L、260.7～372.0 U/L;α-AMY测量结果范围分别为40.0～69.3 U/L、162.3～271.0 U/L;GGT、CK、LDH及α-AMY常规测量系统测量结果满足正确度标准要求的实验室比例分别为8%(1/12)、33%(4/12)、18%(2/11)和10%(1/9)。结论北京市临床实验室大部分GGT、CK、LDH及α-AMY常规测量系统测量结果的正确度不能满足量值溯源要求。

Objective To survey the trueness of the measurement results of γ-glutamyl transferase （ GGT）, creatine kinase （ CK）, lactate dehydrogenase （LDH） and α-amylase （α-AMY） measured by routine measurement system in the clinical laboratories of Beijing area. Methods The national secondary standard reference materials prepared with human serum matrix of two active levels were measured in 12 different clinical laboratories by using routine measurement system respectively. The trueness of measurement results was evaluated by both of uncertainty on certified value of standard materials and En value. Results For the two active levels of national standard materials, the measurement results were as follows. GGT： 89.5 to 119.3 U/L and 169.6 to 214.3 U/L, CK： 197.0 to 224.7 U/L and 372.0 to 446.7 U/L, LDH： 169.0 to 225.7 U/L and 260.7 to 372.0 U/L, α-AMY： 40.0 to 69.3 U/L and 162.3 to 271.0 U/L. The percentages of laboratories in which the trueness of measued results met the requirement of criterions for GGT, CK, LDH and α-AMY were 8% （1/12）, 33% （4/12）, 18% （2/11） and 10% （1/9） respectively. Conclusion In Beijing area, the trueness of measured results of GGT, CK, LDH and α-Amy in most laboratories can not meet the requirements of measurement traceability.