以LDH为例来探讨具有溯源性和互换性的校准品在临床生化应用中的重要性

With Lactate Dehydrogenase as An Example to Evaluate the Importance of the Traceability and Commutability Calibration in Clinical Biochemical Detection

目的通过在临床实验室使用具有溯源性和互换性的校准品，寻求血清酶测定标准化的新途径。方法以乳酸脱氢酶（LDH）为例，收集混合血清，由4家酶学参考实验室联合赋值，制备具有溯源性和互换性的参考物质。参加试验的8个实验室先使用自己的校准品，在校准通过后，将高中低3个水平的血清样本和参考物质各测定3次，记录检验结果；再使用具有溯源性和互换性的参考物质作为校准品校准后，重复测定高中低3个水平的血清样本和参考物质各3次，记录检验结果。计算8家实验室在使用具有溯源性和互换性的参考物质作为校准品校准前后，参考物质检测结果与靶值的偏倚和高中低3个水平的血清样本LDH检测结果的变异系数（CV％）。结果使用具有溯源性和互换性的参考物质参后，参考物质检测结果与靶值的偏侍由6．80％降到1．40％；高中低3个水平的血清样本LDH检测结果的变异系数CV由11．41％，9．93％和9．87％降到了4．13％，3．55％和3．80％。结论在临床实验室使用具有溯源性和互换性的参考物质作校准品，能大大降低实验室间结果的正确度和精密度，提高检测结果的准确性，有利于各个实验室各设备间结果的标准化和一致性。

Objective With the use of traceability and commutability calibration in clinical laboratory,try to seek new way in the standardized of serum enzyme determination. Methods For example to the lactate dehydrogenase （LDH）, to collect mixed serum, which assigned by four enzymology reference laboratory, produced the traceability and commutability reference materials. Firstly, eight laboratories used their own calibration to calibrate their detection systems. After calibration, every la- boratory detected one enzyme calibrator and three patient samples and then recorded the results. Additionally reused the traceability and commutability reference materials to calibrate their detection systems. After calibration,every laboratory detected them again and recorded the results. Calculated the calibration products for the determination of the bias between the results of the overall mean and labeled values, determination of serum samples from the changes of the results of precision before and after calibration. Results After the use of thetraceability and commutabilityreference materials,the bias between results of reference materials test and the target was value from 6. 80% decline to 1.40%. The precision of three levels of se- rum samples were from 11.41%, 9.93% and 9.93% to 4.13%, 3.55% and 3.80%. Conclusion Using the traceability and commutability reference materials as calibration in clinical laboratory, can greatly reduce the accuracy and precision of the results among these laboratory and improve the accuracy of test results, and then is increase the standardization and consistency in clinical laboratory.