新型量子点免疫荧光层析法检测降钙素原试剂盒临床应用评价

Clinical application and evaluation of a new quantum-dot immuno-fluorescence lateral flow assay in the detection of procalcitonin

目的探讨量子点免疫荧光层析法降钙素原检测试剂盒的临床应用价值。方法收集临床检测降钙素原标本150例,用量子点免疫荧光层析法和罗氏Roche电化学发光法进行降钙素原检测,分析其诊断符合率、Kappa一致性、ROC曲线和定量线性回归分析。结果当降钙素原截止值(cut-off值)为0.5 ng/ml时两者诊断符合率为98.67%,Kappa值为0.973;若以降钙素原2.0 ng/ml作为cut-off值,诊断符合率达98%,Kappa值为0.956。两组间线性回归系数r=0.998。结论在0.5 ng/ml和2.0 ng/ml的cut-off值下,量子点免疫荧光层析法和电化学发光法之间具有诊断一致性和相关性。

Objective To investigate the clinical value of quantum dots immunofluorescence assay for the detection of procalcitonin.Methods 150 specimens were collected to measure procalcitonin with quantum-dot immunofluorescence lateral flow assay and Roche electrochemical luminescence assay; consistency statistic,Kappa statistic and receiver operating characteristic curve and linear-regression analysis were employed to evaluate concordance between the two methods.Results When the Cut-off value was of proealcitonin 0.5 ng/ml,accuracy rate was 98.67%,Kappa consistence reached 0.973.If 2.0 ng/ml was selected as Cut-off value of proealcitonin,accuracy rate was 98.0%,Kappa consistence reached 0.956.Linear regression coefficient was r = 0.998.Conclusion There＇s consistency and correlation between quantum-dot immunofluorescence lateral flow assay and Roche electrochemical luminescence assay,when the Cut-off value was within 0.5 ng/ml-2.0 ng/ml.