荧光免疫层析法降钙素原检测试剂盒临床性能评估

郭莉娜; 杨启文; 伊洁; 谢秀丽; 王瑶; 王贺; 徐英春

doi:10.3969/j.issn.1674-9081.2016.03.010

荧光免疫层析法降钙素原检测试剂盒临床性能评估

Performance Evaluation of Fluorescence Immunochromatography Kit in Detection of Procalcitonin

摘要

摘要:
目的评估荧光免疫层析法试剂盒检测降钙素原的性能。
方法参照美国临床实验室标准化协会(Clinical and Laboratory Standards Institute, CLSI)EP5-A和EP6-A文件方法, 对荧光免疫层析法试剂盒(TEBSUN)检测降钙素原的精密度、线性、方法学比对、相对灵敏度和特异性进行评估。
结果荧光免疫层析法试剂盒检测降钙素原精密度较好, 低浓度和高浓度样本精密度的变异系数分别为8.3%和4.7%;线性验证试验结果显示, 在试剂盒标示的检测范围内具有良好的线性梯度关系(r=0.9989);方法学比对结果显示, 荧光免疫层析法试剂盒与梅里埃VIDAS酶联免疫荧光法分析系统的降钙素原试剂盒检测结果一致性良好(r=0.9770);在0.5和2.0 ng/ml两个浓度水平, 荧光免疫层析法试剂盒相对于酶联免疫荧光法试剂盒的灵敏度和特异性均大于86%, 与其测定结果的总体符合率为93.75%。
结论荧光免疫层析法试剂盒检测降钙素原的精密度、线性、方法学比对、相对灵敏度和相对特异性等性能评价较好, 适用于临床标本检测。

Abstract:
Objective To evaluate the performance of fluorescence immunochromatography kit in detecting procalcitonin.
Methods According to the Clinical and Laboratory Standards Institute(CLSI) EP5-A and EP6-A, the performance of fluorescence immunochromatography kit (TEBSUN) in detecting procalcitonin was evaluated in the aspects of precision, linearity, methodology comparison, relative sensitivity, and relative specificity.
Results The fluorescence immunochromatography kit showed high precision, the coefficients of variation (CV) of low and high concentration samples were 8.3% and 4.7%, respectively. Result of liner verification test showed good linear correlation within the indicated test range (r=0.9989).In methodology comparison tests, the fluorescence immunochromatography kit had good consistency with VIDAS enzyme-linked immunofluorescence kit (r=0.9770).The relative sensitivity and specificity of the fluorescence immunochromatography kit compared with the enzyme-linked immunofluorescence kit were both higher than 86% at 0.5 ng/ml and 2.0 ng/ml level. The total consistency of the two diagnostic kits was 93.75%.
Conclusion The fluorescence immunochromatography kit has good performance in precision, linearity, methodology comparison, relative sensitivity, and relative specificity, suggesting that it meets the requirements of clinical tests.

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