肌酸激酶和乳酸脱氢酶测定结果正确性比对分析

Analysis on the assay result between Creatine kinase and lactate dehydrogenase detection

目的不同医院间检验结果的互认，避免重复检验，是降低就医成本的一项重要举措。实验采用CK和LDH有证标准物质作为校准，对各个参加实验室校准前后结果的正确性进行比对分析，从而为医院间结果互认奠定技术基础。方法在上海市闵行区内选取7家一级医院，发放1支酶标准品，2个血清样品，各实验室采用现行的方法测定标准品和血清样品，记录检验结果；再采用另一水平酶标准品校准仪器后，同样测定上述酶标准品和血清样本，记录检验结果，计算校准前后酶标准品均值与标示值之间的偏倚和校准前后血清样品测定结果精密度的变化。结果酶标准品校准前准确性（CK偏倚0．5％，LDH偏倚-6．2％）和变异系数（CK变异系数5．2％，LDH变异系数6．1％）；校准后准确性（CK偏倚0．1％，LDH偏倚-1．0％）和变异系数（CK变异系数2．2％，LDH变异系数3．5％）；血清样品的变异系数CK下降到2％，LDH下降到3％。结论无论封闭还是开放系统，选择正确的方法和质量好的试剂，并采用CK和LDH用有证标准物质为检测项目的校准，可以缩小各实验室室间结果变异系数，提高结果正确性。

Objective An important measureThe core effort of State Health Care Reform is reducing the burden of patient. Clinical diagnostic result mutual recognition between different hospital is the major way toward this target. Use the Certificate Reference Material（CRM） as the calibrator is possible to achieve the ultimate goal of standardization at different hospital. Methods 7 laboratories were involved in this program. One CRM and two patient samples were send to each participate lab. The three samples was tested using routine method and record the results. The three samples were analyzed before and after calibration used the other level CRM. Record the resultsl all lab data was processed with computer. Results Compare with the target values,the bias of creatine kinase（CK） and lactate dehydrogenase（LDH） were 0. 5% and --6.2%. the variable coefficient of CK and LDH were 5. 2% and 6.1% . After the calibration, the bias of CK and LDH were 0. 1% and - 1.0 %. the variable coefficient of CK and LDH were 2.2% and 3.5 %. the variable coefficient of CK was depressed to 2% ,LDH was 3%. Conclusion Use CRM as the calibrator can decrease the CV of the labs. This way could obtain the comparable analytic results from different laboratories.