混合血清校准品的制备及其在肝、肾功能检验结果互认中的意义

目的探讨利用混合血清制备校准品的可能性，观察实验室间检测结果校准的效果。方法分别检测单份血清和由这些单份血清制备的混合血清的生化指标，检测项目包括丙氨酸氨基转移酶（ALT）、天门冬氨酸氨基转移酶（AST）、碱性磷酸酶（ALP）、γ-谷氨酰基转移酶（GGT）、白蛋白（Alb）、总蛋白（TP）、总胆红素（TBil）、尿素（Urea）和肌酐（Cr）。比较单份血清各项目检测值的均数与混合血清检测值的接近程度。将100份正常人血清（40岁以下成人，男女各半）等量混合为自制校准血清与1例患者血清同时送11家临床实验室检测，检测项目同前。依照同一实验室检测的自制校准血清检测值和《全国临床检验操作规程》（第3版）给定的各项目的参考值对患者血清检测值进行校准，观察校准效果。结果混合血清各项目检测值与单份血清测定值的均数十分接近。患者血清送11家临床实验室检测，ALT、AST、ALP、GGT、Alb、TP、TBil、Urea、Cr检测结果的变异系数（CV）分别为11．65％、3．76％、12．86％、4．71％、3．00％、2．75％、15．35％、5．92％、10．33％，校准后分别为7．47％、5．84％、8．87％、5．00％、2．40％、1．87％、4．71％、3．02％、4．94％。结论肝、肾功能评价常用指标，混合血清具有较好的单份血清可加平均性；依照自制校准血清检测值和约定真值对待检血清检测值进行校准效果明显。

Improving comparability of the results in different laboratories on liver function and renal function with the pooled serum as calibrator

Objective To investigate the possibility of using pooled serum as calibrator and observe the effects of the results in different laboratories on the determination of liver function and renal function. Methods 9 biochemical items including alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP), γ-glutamyltransferase (GGT), albumin (Alb), total protein (TP), total bilirubin (TBil), urea and creatinine (Cr) were detected in the individual serum and the pooled serum from the individual serum. The mean value of each item of individual serum was compared with the value of the pooled serum. A self made calibrator was prepared with equal volume pooled serum from 100 healthy individuals (adults under 40 years-old, male∶ female=1∶ 1). This calibrator and one patient′ s serum being randomly selected were sent to 11 laboratories for the determination with different determination systems. The results of patient′ s sample were adjusted to the results of calibrator in the same laboratory according to National Guide to Laboratory Procedures (Third Edition). Results The means of the value from individual serum were closed to the value from the pooled serum. The coefficients of variation (CV) of 9 items including ALT, AST, ALP, GGT, Alb, TP, TBil, urea and Cr from patient′s sample in 11 laboratories were 11.65%, 3.76%, 12.86%, 4.71%, 3.00%, 2.75%, 15.35%, 5.92% and 10.33% respectively and these were 7.47%, 5.84%, 8.87%, 5.00%, 2.40%, 1.87%, 4.71%, 3.02% and 4.94% respectively after adjustment. Conclusions The measured value of pooled serum is closed to the means of the value from individual serum. The comparability of the results in different laboratories on liver function and renal function can be improved by the pooled serum as calibrator to adjust.