摘要
目的：对新产业MAGLUMI全自动化学发光免疫分析仪检测肝纤维化指标的方法学性能进行验证。方法：按照美国临床实验室标准化协会（CLSI）推荐方法测定的生物参考区间指标,采用MAGLUMI4000化学发光免疫分析仪对检测肝纤维化指标透明质酸（HA）、层粘连蛋白（LN）、Ⅲ型前胶原氨基端肽（PⅢNP）、Ⅳ型胶原（CⅣ）的批内和日间精密度、准确度、线性范围及灵敏度等进行验证。结果：MAGLUMI分析仪测定HA、LN、PⅢNP、CⅣ批内和日间精密度变异系数（CV）分别为3.01%~4.82%和3.77%~4.69%;相对偏倚（%）为-5.3%~0.2%;测定线性范围与厂商要求相近;HA、LN、PⅢN-P和CⅣ的测定数值与厂商提供的参考区间符合,检测的灵敏度分别为1.30 ng/ml、0.9 ng/ml、0.49 ng/ml和0.54 ng/ml。结论：MAGLUMI化学发光免疫分析仪可直接用于对人血清中肝纤维化指标HA、LN、PⅢNP及CⅣ的含量进行定量分析,批内精密度、日间精密度、准确度、线性范围、灵敏度以及参考区间均较好,报告结果准确可靠。MAGLUMI分析仪是一种较理想的适用于判断肝纤维化程度的检测仪,值得推广应用。
Objective： To detect hepatic fibrosis parameter methodology performance for validation of Snibe MAGLUMI automatic chemiluminescence immunoassay analyzer. Methods： Recommended by the American association of clinical laboratory standardization（CLSI） method, we detected the determination of hyaluronic acid（HA）, Laminin（LN）, Ⅲ procollagen N-terminal peptide（PⅢ PN-P）, Ⅳcollagen（C Ⅳ）, and the precision, accuracy, linear range, sensitivity and biological reference range by MAGLUMI analyzer. Results： MAGLUMI determination of HA, LN, PⅢ PN-P, C Ⅳ and precision, and the daytime in this batch variation coefficient were 3.01~4.82% and 3.77~4.69%. Relative bias must lean between -5.3% and 0.2%. The scope of determination of linear range and the manufacturer were similar. The value of HA, LN, PⅢ PN-P, C Ⅳ and reference interval coincidence rate provided by manufacturers were all 100%. And the sensitivities were 1.30ng/ml, 0.9ng/ml, 0.49ng/ml and 0.54ng/ml. Conclusion： MAGLUMI can be used in quantitative analysis of the content of HA, LN, PⅢ PN-P and C Ⅳ directly, which are indicators of liver fibrosis in human serum. Precision, accuracy, linear range, sensitivity and biological reference range show good performance in this methodology. The results of report are accurate and reliable. MAGLUMI is an ideal way to determine the degree of liver fibrosis.
出处
《中国医学装备》
2016年第11期43-46,共4页
China Medical Equipment
关键词
化学发光免疫分析仪
肝纤维化指标
性能评价
Chemiluminescence immunoassay analyzer
Hepatic fibrosis indicators
Performance evaluation
