自建系统谷草／谷丙转氨酶量值溯源性研究

目的确保患者标本在日立自建系统与罗氏配套检测系统上谷草／谷丙转氨酶的检测结果可溯源到同一测量基准。方法通过日立自建系统与罗氏配套系统对新鲜混合血清测定结果进行对比分析，找出日立自建系统存在的系统偏差，井对日立系统校准值进行修订，修订后对日立系统进行二次校准，然后进一步进行两系统对比分析。结果第一次对比两系统偏差超过1／2CLIA’88规定的最大允许误差范围，第二次两系统偏差小于1／4CLIA’88规定的最大允许误差范围。结论通过对比分析从而对自建系统校准血清的校准值重新赋值，是实现自建系统检测结果准确性和可溯源的有效途径。

Study on the traceability of AST/ALT value of self-building system

Objective To ensure the same measuring basis of alanine aminotransferase （ALT）/aspartate aminotransferase （AST） testing by HITACHI self - building system and Roche detection system. Methods A comparison analysis was used to determine the results of the freshly pooled sera testing by HITACHI self- building system and Roche detection system. The systematic deviation of self- bnilding system was found, revised the calibration value and the secondary calibration was performed after revision; then the comparison analysis was done in two systems. Results In the first comparison analysis, the deviation of two systems exceeded the maximum allowable error range of the half of Clinical Laboratury Improvement Amendment 88 （CLIA＇88） standard; in the secondary comparison analysis, the deviation of two systems was less than the quarter of CLIA＇88 standard. Conclusion Through the comparison analysis, the calibration value of self- building system is reassigned, that is the effective method to achieve the accuracy and traceability of testing results of self- building system.