C-Papers


LWMC
国产细胞角蛋白19片段CYFRA21-1化学发光定量检测试剂盒的性能评估
Title
Author
方宜臻;叶辉铭;刘江武;金宏伟;林永志;颜水堤;于洋;高磊;徐飞海;张忠英
Institution
厦门大学附属中山医院检验科;厦门万泰凯瑞生物技术有限公司
QKMC
国际检验医学杂志
CN
50-1176/R
ISSN
1673-4130
FBNY
2016-11-30
Volume
v.37
Issue
22
YM
90-93
GJZ
细胞角蛋白19片段;试剂;化学发光免疫分析法;方法学评价
Keywords
LWZY
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。
Abstract
Ref
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Fund_Code
厦门市重点实验室基金资助项目(3502Z20130006);; 福建省科技计划项目(2011D018)
FileName
GWSQ201622034

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