Abstract

The International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) published the reference measurement procedure (RMP) for ALP measurement in 2011. However, the RMP is of high requirements for laboratories, complicated, time-consuming and high cost of reagents. Many manufacturers do not trace results to the higher procedure. And there is currently no designated comparison method (DCM) for ALP measurement. Thus, the standardization of ALP measurement is hindered. Automatic biochemical analyzers are easy to operate and widely used in clinical laboratories. Therefore, according to the RMP, establishing a DCM based on an automatic biochemical analyzer will be a practical way to establish traceability to the accuracy base and promote the standardization of ALP measurement. On the basis of conforming to the RMP recommended by IFCC as far as possible, the DCM was established based on a Thermo Indiko automatic biochemical analyzer. Performances of the method were validated. The DCM repeatability and within laboratory imprecision was <1% and <2.5%, respectively. For evaluation of trueness, the biases were within the equivalent limits. Measurement procedure comparisons and biases estimation were carried out between the DCM, the RMP, and the six routine methods using a panel of 40 individual human serum samples. The comparisons between the DCM and the RMP gave satisfying results. Compared with the DCM, the relative biases of some routine methods failed to meet the bias limit derived from biological variation.

摘要

国际临床化学与检验医学联合会（IFCC）于2011年公布了A​​LP测量的参考测量程序（RMP），但RMP对实验室要求高、复杂、耗时、试剂成本高。许多制造商不会将结果追溯到更高的程序。目前还没有指定的 ALP 测量比较方法 (DCM)。因此，阻碍了 ALP 测量的标准化。全自动生化分析仪操作简单，广泛应用于临床实验室。因此，根据RMP，建立基于全自动生化分析仪的DCM，将是建立对准确度基础的溯源，促进ALP测量标准化的切实可行途径。在尽可能符合IFCC推荐的RMP的基础上，建立了基于Thermo Indiko全自动生化分析仪的DCM。验证了该方法的性能。DCM 重复性和实验室内不精密度分别为 <1% 和 <2.5%。为了评估真实性，偏差在等效范围内。使用一组 40 个人血清样本在 DCM、RMP 和六种常规方法之间进行测量程序比较和偏差估计。DCM 和 RMP 之间的比较给出了令人满意的结果。与 DCM 相比，一些常规方法的相对偏差未能满足源自生物变异的偏差限制。验证了该方法的性能。DCM 重复性和实验室内不精密度分别为 <1% 和 <2.5%。为了评估真实性，偏差在等效范围内。使用一组 40 个人血清样本在 DCM、RMP 和六种常规方法之间进行测量程序比较和偏差估计。DCM 和 RMP 之间的比较给出了令人满意的结果。与 DCM 相比，一些常规方法的相对偏差未能满足源自生物变异的偏差限制。验证了该方法的性能。DCM 重复性和实验室内不精密度分别为 <1% 和 <2.5%。为了评估真实性，偏差在等效范围内。使用一组 40 个人血清样本在 DCM、RMP 和六种常规方法之间进行测量程序比较和偏差估计。DCM 和 RMP 之间的比较给出了令人满意的结果。与 DCM 相比，一些常规方法的相对偏差未能满足源自生物变异的偏差限制。使用一组 40 个人血清样本在 DCM、RMP 和六种常规方法之间进行测量程序比较和偏差估计。DCM 和 RMP 之间的比较给出了令人满意的结果。与 DCM 相比，一些常规方法的相对偏差未能满足源自生物变异的偏差限制。使用一组 40 个人血清样本在 DCM、RMP 和六种常规方法之间进行测量程序比较和偏差估计。DCM 和 RMP 之间的比较给出了令人满意的结果。与 DCM 相比，一些常规方法的相对偏差未能满足源自生物变异的偏差限制。