免疫抑制法检测肌酸激酶同工酶MB临床应用评价

目的对选定的肌酸激酶同工酶MB(CK-MB)检测试剂盒进行性能验证及对异常CK-MB结果的临床标本进行回顾性分析。方法对CK-MB检测试剂盒的正确度、精密度、线性范围、最大稀释比以及参考区间进行验证;随机选取50例表观健康体检者作为健康人对照组,50例临床确诊心血管疾病患者作为心血管疾病组并用于临床应用的验证;收集28例临床检测报告为“CK结果倒置”的患者血清标本,对试剂盒纠正“CK结果倒置”结果的能力进行评估。结果选定的CK-MB检测试剂盒各项检测性能符合要求,在临床应用上能较好地纠正由巨CK-Ⅱ(线粒体型CK)引起的“CK倒置”结果,从而能更好地为临床提供参考。结论该试剂盒各项检测性能良好,其添加的线粒体型CK抑制抗体能较好地纠正巨CK-Ⅱ(线粒体型CK)引起的“CK结果倒置”结果,但其他类型的“CK结果倒置”结果,仍需通过同工酶电泳等方法进行确认。

Clinical application evaluation of immunosuppressive assay for detection of creatine kinase MB

Objective To verify the performance of a given detection kit for creatine kinase isoenzyme MB(CK-MB)and analyze the abnormal results of CK-MB in clinical samples retrospectively.Methods Firstly,the accuracy,precision,linear range,maximum dilution ratio and reference interval of the CK-MB detection kit were verified.Then the clinical application performance was verified by randomly selected 50 healthy individuals as the normal control group and 50 patients with clinical diagnosis of cardiovascular disease.Finally,the clinical test reports of“inversion of CK results”from 28 patients were collected,and the ability of the kit to correct“inversion of CK results”was evaluated.Results The test performance of the given CK-MB test kit met the requirements of clinical application and may correct the“inversion of CK results”caused by giant CK-Ⅱ(mitochondrial CK),so as to provide better reference for clinical practice.Conclusion The detection performance of the given kit should be fine.The addition of inhibitory antibody to mitochondrial CK in the kit could correct the“inversion of CK results”caused by giant CK-Ⅱ(mitochondrial CK),but the other types of“inversion of CK results”still need to be confirmed by isozyme electrophoresis or other methods.