摘要
目的验证非均相免疫法（HIA）测定氨基端前B型钠尿肽（NT-proBNP）的各项性能参数及参考范围并初步应用于临床。方法连续测定10次NT-proBNP的0水平校准品和3次低水平血浆,计算功能灵敏度。采用美国临床实验室标准化委员会（NCCLS）EP6-A、EP15-A、EP7-P提供的方案对该方法的线性范围、精密度、干扰进行验证,并与电化学发光法进行比对及偏差评估。测定345名表面健康人及无相关疾病人群的NT-proB-NP,对参考范围进行验证。测定63例慢性心力衰竭患者及急性冠状动脉综合征患者的NT-proBNP水平并评价其分布。结果本方法功能灵敏度为22.3 ng/L;线性范围为45-28 150 ng/L,r=0.998 6;批内不精密度为3.3%-5.2%,总不精密度为5.4%-7.1%;胆红素、血红蛋白、乳糜在试剂说明书提供的浓度对测定均无明显干扰（平均差异均〈10%）;与电化学发光法比对,相关方程为Y=0.81X-72.9,r=0.999,平均百分偏差为-11.6%。NT-proBNP随年龄增加呈上升趋势,65岁以上各年龄组差异有统计学意义（P均〈0.05）;各年龄组女性显著高于男性（P=0.015）。结论HIA测定NT-proBNP的各项性能指标良好,符合临床需要。目前各年龄性别组参考范围接近国外人群,适用于本实验室。
Objective To validate the various performances of N-terminal pro-B type natriuretic peptide （ NT-pro BNP） hy heterogeneus immunoassay （HIA） method and try its preliminary clinical application. Methods The zero calibrator of NT-proBNP was tested 10 times and low level plasma was tested 3 times in the same analytical run for functional sensitivity. Linearity, imprecision,accuracy,interferences and reference interval were studied according to National Committee for Clinical Laboratory Standards （NCCLS） EP6-A, EP15-A and EP7-P protocol. Compared with electrochemiluminescent immunoassay （ECLIA） appraised the bias. The levels of NT-proBNP in 345 apparently healthy individuals and no chronic heart failure （CHF） patients were detected for verifying reference range. The levels of NT-proBNP in 63 patients with CHF and acute coronary syndrome （ACS） were detected mad its distribution was evaluated also. Results The functional sensitivity of this method was 22.3 ng/L. The linearity range was 45 - 281 50 ng/L, r = 0. 998 6. Within and total coefficient of variation （CV） % were 3.3 % - 5.2% and 5.4% - 7.1%. Bilirubin, turbidity and hemoglobin had no effect on evaluated methods（ mean differences 〈 10% ）. Compared with ECLIA, Y =0. 81X - 72. 9, r =0. 999, average percent error was - 11.6%. The level of NT-proBNP increased with the age going. Significant difference was seen among the groups over the age of 65 （P 〈 0.05 ）. NT-proBNP ievel in females was higher than that in males in each age group （P=0.015）. Conclusions The HIA method used to detect the NT-proBNP level has good performance and corresponds to clinical needs. Reference ranges of different age and sex groups are closed to that of foreigners, and are used in our laboratory.
出处
《检验医学》
CAS
北大核心
2007年第6期627-632,共6页
Laboratory Medicine
关键词
氨基端前B型钠尿肽
非均相免疫法
分析性能
N-terminal pro-B type natriuretic peptide
Heterogeneus immunoassay
Analysis performance
