中国N末端B型利钠肽原、B型利钠肽和同型半胱氨酸参考区间来源及决定限的分布

Survey and analysis on sources of reference intervals and distribution of medical decision levels in NT-proBNP, BNP and homocysteine

目的统计2014年中国参加室间质量评价计划实验的血N末端B型利钠肽原（NT-proBNP）、B型利钠肽（BNP）和同型半胱氨酸（homocysteine，Hcy）参考区间来源，并描述决定限的分布。 方法提取卫生部临床检验中心2014年全国NT-proBNP、BNP和Hcy第1次室间质量评价回报结果中参考区间和决定限的相关信息。剔除异常值和错误数据。使用Microsoft Excel 2007和SPSS 13.0软件对剩余数据进行分析，包括参考区间来源及决定限分布。并按检测系统对NT-proBNP和BNP进行分组统计，按试剂厂家对Hcy进行分组统计，分析组间差异。 结果有330、119和339个实验室分别上报了血NT-proBNP、BNP和Hcy数据，但其中只有133、54和102家实验室回报了决定限的相关信息。3个项目参考区间来源比例最高的均为试剂厂家说明书[NT-proBNP 76.97%（254/330），BNP 89.08%（106/119），Hcy 83.19%（282/339）]。本调查中NT-proBNP、BNP和Hcy分别只有36.53%（122/334）、45.38%（54/119）和47.95%（164/342）的实验室对直接引用的参考区间进行了验证。3个项目决定限的均值和中位数并不接近（NT-proBNP 507.99 ng/L和300.00 ng/L，BNP 342.72 ng/L和100.00 ng/L，Hcy 17.34 μmol/L和15.00 μmol/L），P2.5～P97.5范围广（NT-proBNP 125.00～1 800.00 ng/L，BNP 87.50～4 562.50 ng/L，Hcy 4.15～50.00 μmol/L）。决定限范围，NT-proBNP为60.00～7 000.00 ng/L，BNP为80.00～7 000.00 ng/L，Hcy为1.5～52.00 μmol/L。秩和检验示NT-proBNP、BNP和Hcy的P值分别为0.449、0.208和0.754，显示3个项目各组间总体差异均无统计学意义。结论各实验室血NT-proBNP、BNP和Hcy决定限分布变异性很大，参考区间来源不统一，应尽快建立适应中国人群的参考区间，推进全国参考区间的一致化和标准化。

ObjectiveTo analyze the sources of reference intervals and distribution of medical decision levels in NT-proBNP, BNP and homocysteine （Hcy） based on the feedback of laboratories which participated in the 2014 External Quality Assessment （EQA） program in China. MethodsInformation of reference intervals and medical decision levels was collected from the 2014 EQA programs in NT-proBNP, BNP and Hcy.All the abnormal values and errors were eliminated.Data were analyzed by SPSS 13.0 and Microsoft Excel 2007 in terms of referring to sources of reference intervals and distribution of medical decision levels.Values were further grouped based on instrument system for NT-proBNP and BNP, reagent manufacturers for Hcy. ResultsThere were 330, 119 and 339 laboratories submitting the data on the reference intervals of NT-proBNP, BNP and Hcy.Only 133, 54 and 102 laboratories provided information about medical decision levels.Most reference sources were derived from reagent manufactures （NT-proBNP 76.97%（254/330）, BNP 89.08%（106/119）, Hcy 83.19%（282/339））. Approximately, 36.53%（122/334）, 45.38%（54/119） and 47.95%（164/342） of the laboratories validated the reference intervals of NT-proBNP, BNP and Hcy.According to the surveys, the mean and median values were not close to each other （NT-proBNP 507.99 ng/L and 300.00 ng/L, BNP 342.72 ng/L and 100.00 ng/L, Hcy 17.34 μmol/L and 15.00 μmol/L）. Variation of P2.5 and P97.5 was as follows： （NT-proBNP 125.00-1 800.00 ng/L, BNP 87.50-4562.50 ng/L, Hcy 4.15-50.00 μmol/L）. The ranges were NT-proBNP 60.00-7 000.00 ng/L, and BNP 80.00-7 000.00 ng/L, and Hcy 1.5-52.00 μmol/L.P values of rank sum test for NT-proBNP, BNP and Hcy were 0.449, 0.208 and 0.754. ConclusionsMedical decision levels of NT-proBNP, Hcy and BNP showed large variation among laboratories and the sources of reference interval were not unified.Thus, urgent efforts should be made to establish appropriate reference intervals for Chinese people and promote harmonization and standardization of reference intervals and medical decision levels on BNP, NT-proBNP and Hcy.