循环增强荧光免疫发光法检测肌酸激酶同工酶(CKMB)的试剂盒性能评估  

Performance evaluation of a kit for detecting creatine kinase isoenzyme MB(CKMB)using enhanced chemiluminescent immunoassay with cyclic enhancement

作　　者：杨羽菁 张磊 成方颖 李婷婷 Yang Yujing;Zhang Lei;Cheng Fangying;Li Tingting(National Children’s Medical Center,Children’s Hospital of Fudan University,Shanghai 201102,China)

机构地区：[1]国家儿童医学中心,复旦大学附属儿科医院,上海201102

出　　处：《首都食品与医药》2025年第7期77-80,共4页Capital Food Medicine

摘　　要：目的对新型发光法循环增强荧光免疫发光法检测肌酸激酶同工酶(CKMB)的试剂盒性能评估。方法对精密度、线性范围、抗干扰能力、正常人群参考区间、方法学比对进行评估。比较不同疾病与健康儿童的CKMB水平,以评估该方法的临床应用价值。结果该方法检测CKMB样本的重复精密度CV和中间精密度CV均小于6%,精密度较好。该方法检测CKMB的检测范围在1-292.667ng/mL,线性良好。检测20份健康儿童的CKMB水平,结果均在初始采纳的参考区间之内(星童正常人群99%分位值为5.8597ng/mL)。当样本出现溶血、脂血、黄疸的干扰时,该方法结果并不受影响。方法学比对实验使用贝克曼DxI 800全自动化学发光免疫分析仪检测,比对结果表明两种检测一致性好。在遗传代谢疾病、室间隔缺损、重症肺炎、恶性肿瘤、新生儿高胆红素血症疾病组中都观察到CKMB浓度增加。结论循环增强荧光免疫发光法检测肌酸激酶同工酶(CKMB)具有检测灵敏度高、准确性高、抗干扰能力强、重复性好等优势。此外,本研究还强调了在不同疾病背景下,对儿童患者CKMB水平进行常规监测的重要性。这不仅有助于及时发现潜在的心肌损伤或组织损伤,还可能为疾病的早期诊断、病情评估及治疗策略的制定提供有价值的参考信息。Objective To evaluate the performance of a new kit for detecting creatine kinase isoenzyme MB(CKMB)using enhanced chemiluminescent immunoassay with cyclic enhancement.Methods The precision,linear range,anti-interference ability,reference interval in the normal population,and methodological comparison were assessed.CKMB levels were compared between children with different diseases and healthy children to evaluate the clinical application value of this method.Results The within-run precision and between-run precision of CKMB detection using this method,as indicated by CV values,were both less than 6%,demonstrating good precision.The detection range for CKMB using this method was 1-292.667ng/mL,with good linearity.CKMB levels were measured in 20 healthy children,and all results fell within the initially adopted reference interval(the 99th percentile value for the normal pediatric population was 5.8597 ng/mL).The results were not affected by interference from hemolysis,lipemia,or icterus.Methodological comparison was conducted using the Beckman DxI 800 automatic chemiluminescent immunoassay analyzer,and the comparison showed good agreement between the two methods.Increased CKMB concentrations were observed in groups with inherited metabolic diseases,ventricular septal defects,severe pneumonia,malignant tumors,and neonatal hyperbilirubinemia.Conclusion The enhanced chemiluminescent immunoassay with cyclic enhancement for detecting CKMB offers advantages such as high sensitivity,high accuracy,strong anti-interference ability,and good reproducibility.Furthermore,this study emphasizes the importance of routine monitoring of CKMB levels in pediatric patients with different disease backgrounds.This not only helps to promptly identify potential myocardial or tissue damage but also provides valuable reference information for early disease diagnosis,condition assessment,and treatment strategy formulation.

关 键 词：CKMB 性能评估 心肌损伤 方法学比对 免疫发光法 

分 类 号：R446[医药卫生—诊断学]