Lin Zhi-Yuan, Fang Yi-Zhen, Jin Hong-Wei, Lin Hua-Yue, Dai Zhang, Luo Qing, Li Hong-Wei, Lin Yan-Ling, Huang Shui-Zhen, Gao Lei, Xu Fei-Hai, Zhang Zhong-Ying
Center for Clinical Laboratory, Xiamen University Affiliated Zhongshan Hospital, Xiamen, China.
Fujian Medical University Union Hospital, Fuzhou, China.
J Clin Lab Anal. 2018 Jul;32(6):e22426. doi: 10.1002/jcla.22426. Epub 2018 Mar 31.
To verify and evaluate the performance characteristics of a creatine kinase phosphokinase isoenzymes MB (CK-MB) assay kit, which produced by Xiamen Innodx Biotech Co. Ltd.
Evaluation was carried out according to "Guidelines for principle of analysis performance evaluation of in vitro diagnostic reagent." The performance parameters included detection limit, linearity range, reportable range, recovery test, precision verification, interference test, cross-reactivity, matrix effect, and method comparison.
The detection limit was 0.1 ng/mL. The assay had clinical linearity over range of 0.1 ng/mL-500 ng/mL. Reportable range was from 0.1 ng/mL to 1000 ng/mL. The average percent of recovery was 99.66%. The coefficient of variation (CV) for within-run and between-run of low CK-MB sample was 5.55% and 6.16%, respectively. As for high-level sample, it was 7.88% and 7.80%. In medical decision level, the relative deviation (Bias) of all interference tests was lower than 15%. When the sample had mild-hemolysis; hemoglobin ≤15 g/L; triglyceride ≤17 mmol/L; bilirubin ≤427.5 μmol/L; rheumatoid factor ≤206U/mL, there was no significant interference to be found. Moreover, assay kit had no cross-reaction with CK-MM and CK-BB. At last, total diagnostic accuracy of kit was 93.24%, when compared with refer kit.
Overall the results of the verification study indicated the performance of kit is met the requirements of the clinical test.
验证并评估厦门艾德克斯生物科技有限公司生产的肌酸激酶同工酶MB（CK-MB）检测试剂盒的性能特征。
依据“体外诊断试剂分析性能评估原则指南”进行评估。性能参数包括检测限、线性范围、报告范围、回收试验、精密度验证、干扰试验、交叉反应性、基质效应及方法比较。
检测限为0.1 ng/mL。该检测在0.1 ng/mL至500 ng/mL范围内具有临床线性。报告范围为0.1 ng/mL至1000 ng/mL。平均回收率为99.66%。低浓度CK-MB样本批内和批间变异系数（CV）分别为5.55%和6.16%。高浓度样本批内和批间变异系数分别为7.88%和7.80%。在医学决定水平，所有干扰试验的相对偏差（偏倚）均低于15%。当样本轻度溶血；血红蛋白≤15 g/L；甘油三酯≤17 mmol/L；胆红素≤427.5 μmol/L；类风湿因子≤206 U/mL时，未发现明显干扰。此外，该检测试剂盒与CK-MM和CK-BB无交叉反应。最后，与参考试剂盒相比，该试剂盒的总诊断准确率为93.24%。
总体而言，验证研究结果表明该试剂盒的性能符合临床试验要求。
