论文部分内容阅读
目的对厦门万泰凯瑞生物技术有限公司的细胞角蛋白19片段非小细胞肺原相关抗原21-1(CYFRA21-1)化学发光定量检测试剂盒进行分析性能评估。方法依据《体外诊断试剂分析性能评估系列指导原则》等文件对试剂盒的敏感性、线性范围、可报告范围、准确度、精密度、交叉反应等性能进行评估,同时与电化学发光法平行比对,检测配对血清/血浆结果的一致性。结果该试剂盒检测最低限为0.1ng/mL;线性范围为0.1~1 000.0ng/mL;可报告范围达0.1~2 000.0ng/mL;批内精密度为6.15%~9.46%,批间精密度为7.57%~11.00%;回收率达99.60%;与多种常见肿瘤抗原无交叉反应;轻度溶血、胆红素小于或等于340μmol/L、三酰甘油小于或等于18.1μmol/L及类风湿因子小于或等于400U/mL时,对试剂无显著干扰;与电化学发光法检测总符合率为98.56%,一致性良好(P<0.05,Kappa=0.965);血清、血浆标本检测一致性良好(P<0.05,Kappa=0.936)。结论厦门万泰凯瑞生物技术有限公司生产的细胞角蛋白19片段CYFRA21-1化学发光定量检测试剂盒各项性能评估良好,可满足临床检测要求。
Objective To evaluate the analytical performance of chemiluminescence quantitative detection kit for cytokeratin 19 fragment non-small cell lung antigen-associated antigen 21-1 (CYFRA21-1) of Xiamen Wantekai Biotechnology Co., Ltd. Methods The sensitivity, linear range, reportable range, accuracy, precision and cross-reaction performance of the kit were evaluated according to the “Guidelines for Performance Evaluation of In Vitro Diagnostic Reagents” and other documents. In parallel with the electrochemical luminescence method Yes, check for consistency of paired serum / plasma results. Results The detection limit of this kit was 0.1 ng / mL. The linear range was 0.1-1 000.0 ng / mL. The reportable range was 0.1-2 000.0 ng / mL. The intra-assay precision was 6.15% -9.46% Degree of 7.57% ~ 11.00%; recovery rate of 99.60%; with a variety of common tumor antigens no cross-reaction; mild hemolysis, bilirubin less than or equal to 340μmol / L, triglyceride less than or equal to 18.1μmol / L and class Rheumatoid factor less than or equal to 400U / mL, no significant interference with the reagent; Electrochemiluminescence detection with a total compliance rate of 98.56%, good consistency (P <0.05, Kappa = 0.965); serum, plasma samples consistent detection of good (P <0.05, Kappa = 0.936). Conclusion The performance of CYFRA21-1 chemiluminescence quantitative detection kit of Cytokeratin 19 produced by Xiamen Wan Tai Kairui Biotech Co., Ltd. was evaluated well, which can meet the clinical testing requirements.