N末端B型钠尿肽荧光层析法定量检测试剂盒评价

目的：对N末端B型钠尿肽（NT—proBNP）荧光层析法定量检测试剂盒进行评价。方法：随机选取24例高值样本（〉5000ng／L）、18例中值样本（2000～5000ng／L）、49例低值样本（〈2000ng／L）,总计91例样本分别由对照化学发光法试剂盒及待评价的荧光层析法试剂盒进行检测。结果：待评价试剂盒与对照试剂盒检测结果阳性符合率、阴性符合率及总符合率100％;相关系数r=0．97,P〈0．05;待评价试剂盒检测高、中、低值标本的精密度分别是4．2％、4．6％及3．2％,均小于15％。结论：待评价的荧光层析法试剂盒性能达到预定要求,可考虑用于临床标本的NT—proBNP项目的检测。

Quality evaluation of reagent pack for quantitative chromatography-fluorescence determination of N-terminal pro-B-type natriuretic peptide

Objective： To evaluate the quality of a reagent pack for quantitative chromatography-fluorescence determination of N-terminal pro-B-type natriuretic peptide （NT-proBNP）. Methods：A total of 91 samples ,including 24 with high-level （ 〉 5000 rig/L）, 18 with medium-level （2000 ~ 5000 ng/L） and 49 with low-level （ 〈 2000 ng/L） NT-prnBNP, were randomly selected. All samples were tested using both chemical luminescent kit for control and fluorescent chromatography kit for test. Results： The rates of positive coincidence, negative coincidence and overall coincidence between these two reagent kits were 100%. The correlation coefficient was 0.97 （ P 〈 0.05 ）. The precision of test for high-, medium- and low-level samples using the evaluated reagent pack was 4. 2% , 4. 6% and 3.2% respectively, all below 15%. Conclusion： The performance of reagent pack for chromatography-fluorescence determination is qualified for desired requirements, and may be used for detection of NT- proBNP in clinical samples.