我国心肌标志物检验项目性能规范的设定

Establishment of performance specifications for myocardial markers in China

目的制定我国心肌标志物———心肌肌钙蛋白I(cTnI)、心肌肌钙蛋白T(cTnT)、肌红蛋白(Myo)、同型半胱氨酸(Hcy)的性能规范,包括允许总误差(TEa)、允许不精密度(Ia)和允许偏倚(Ba)。方法根据米兰会议性能规范设定模式中的模式二(基于生物学变异)和模式三(基于当前技术水平)设定性能规范。结果基于生物学变异推荐cTnI的TEa、Ia和Ba分别为27.91%(适当)、10.54%(最低)、10.52%;基于生物学变异推荐cTnT的TEa和Ia分别为24.47%(最佳)、15.30%(适当);基于生物学变异推荐Myo的TEa、Ia和Ba分别为19.60%(适当)、10.43%(最低)、2.39%;基于当前技术水平推荐Hcy的TEa、Ia和Ba分别为20.00%、8.50%、5.98%。结论制定了符合我国临床实验室当前检测水平的心肌标志物性能规范。

Objective To establish the performance specifications of myocardial markers such as cardiac troponin I(cTnI),cardiac troponin T(cTnT),myoglobin(Myo)and homocysteine(Hcy)in China,including allowable total error(TEa),allowable imprecision(Ia)and allowable bias(Ba).Methods The performance specifications were set based on biological variation(BV)(Model 2)and the state of the art(Model 3)defined in the Milan Conference.Results The appropriate TEa,Ia and Ba of cTnI set by BV were 27.91%(desirable),10.54%(minimum)and 10.52%,respectively.The appropriate TEa and Ia of cTnT set by BV were 24.47%(optimal)and 15.30%(desirable),respectively.The appropriate TEa,Ia and Ba of Myo set by BV were 19.60%(desirable),10.43%(minimum)and 2.39%,respectively.The appropriate TEa,Ia and Ba of Hcy set by the state of the art were 20.00%,8.50%and 5.98%,respectively.Conclusion The performance specifications of myocardial markers conformed to the current detection level of clinical laboritories in China are established successfully.