丙氨酸氨基转移酶37℃参考方法评价临床常用方法探讨

Approach on using the reference method of catalytic concentration of alanine aminotransferase(37℃) to evaluate the routine methods

目的通过建立37℃丙氨酸氨基转移酶(ALT)参考方法,评价干化学和湿化学五种检测组合的临床常用方法 ,探讨ALT测定结果的准确性与可比性。方法依据国际临床化学与检验医学联合会(IFCC)推荐的参考测量程序建立ALT参考方法,测定ERMR○-AD 454 ALT参考品,验证参考方法的准确性。并对其精密度进行评估。同时用参考方法为冰冻新鲜血清定值,校准非配套湿化学常用方法。干化学采用Vitros配套系统。按照NCCLS EP9-A方案分别比较40份人血清干湿化学五种检测组合的常用方法和参考方法ALT结果。结果用参考方法测定ERMR○-AD 454ALT参考品结果186.4 U/L,在其给定的186±4 U/L范围内。建立的37℃ALT参考方法总CV0.89%-1.12%。Vit-ros干化学配套系统;Olympus仪器和Roche试剂及校准品组成的湿化学非配套系统;Olympus仪器和Roche试剂及参考方法定值的冰冻血清作校准品组成的湿化学非配套系统;Olympus湿化学配套系统以及Olympus仪器试剂和Roche校准品组成的湿化学非配套系统ALT 5种检测结果和参考方法进行比较,相关均良好(r2分别为0.994,0.998 6,1,0.997,0.99。)。前3种检测系统ALT检测结果与参考方法相对偏倚均在±20%之内,符合CLIA’88的20%的判定标准。后两种检测系统结果与参考方法相对偏倚在ALT低水平高达60%。结论通过ALT参考方法可以评价加入磷酸吡哆醛的临床常用方法,提高血清ALT测定结果的准确性和可比性。不适合评价不加磷酸吡哆醛的临床常用方法。

Objective To investigate the efficacy of estimating the clinical routine the accuracy and comparability of alanine aminotransferase（ALT） using the reference method to evaluating clinical routine methods of five measuring panels about dry and wet chemistry.Methods To establish the reference method to measure catalytic concentration of ALT at 37℃ according to IFCC primary procedure..In order to verify the accuracy of the reference method,we measured ERM -AD 454 ALT by using the reference method and the precision was analyzed.At the same time,A calibrator was prepared and its value for ALT was assigned with the reference method.we calibrated no-integration wet chemistry by the calibrator.Dry chemistry used support Vitros.the five routine methods of dry chemistry and wet chemistry compared to the reference method by EP9-A of NCCLS.Results The reference method was established elementarily to measure catalytic concentration of ALT at 37℃.The result of measuring ERM -AD 454 ALT was 186.4 U/L and the value of ERM -AD 454 ALT was 186±4 U/L.We got the total coefficients of variation（CV） were 0.89-1.12 %.There were five routine systems：Vitros dry chemistry;no-support wet chemistry panel including Olympus instrument adding reagent and calibrator about Roche;no-support wet chemistry panel including Olympus instrument adding Roche reagent and the calibrator produced from the reference method;wet chemistry supportting panel and wet chemistry no-supporting which Olympus instrument adding reagent and a Roche calibrator.The correlations of the five routine method and the reference method were well respectively（r^2=0.994,0.996,1,0.997,0.998）.And the relative biases of the results of the former three compared to the reference method were in±20 %.So it did not surpass the standard of CLIA＇ 88.the relative biases of the results of the latter two compared to the referrence method were about 60% when the concentration of ALT was low.Conclusion The reference method of ALT（37℃）has been already established.Accuracy and comparability of ALT measurements can be improved by reference method to appreciating the routine methods adding the pyridoxal-5-phosphoric acid（PLP） into the reagent.But the reference method of ALT（37℃）could not evaluate the routine methods not adding the pyridoxal-5-phosphoric acid（PLP） into the reagent.