化学发光免疫分析法测定血浆B型钠尿肽的评价及其参考区间调查

Evaluation of an immunochemiluminescence assay for human plasma B-type natriuretic peptide(BNP) and the reference interval of BNP

目的评价血浆B型钠尿肽（BNP）的化学发光免疫分析法（CLIA）以了解其检测性能，同时调查国人参考区间。方法用Biosite公司的TriageBNP试剂盒，在Beckman Coulter AccessⅡ上测定，参照EP文件，对该方法的线性、测定下限、灵敏度、精密度、抗干扰能力进行评价，观察BNP的体外稳定性；选择表观健康人共421名（男202名，女219名），按性别，以10岁为一个间隔分为6个年龄组，测定EDTA抗凝血浆中的BNP浓度，并确立各年龄和性别组的参考区间。结果CLIA法测定人血浆BNP的线性范围15-5040ng／L，测定下限9．2ng／L；灵敏度1．4ng／L；CV10％处为30ng／L；胆红素〈253μmol／L、Hb浓度〈4g／L、TG〈12．88mmol／L对BNP测定无影响。BNP在全血中室温可稳定8h，4oC可稳定24h；在血浆中室温可稳定6h，4℃可稳定8h，-70℃稳定6个月。BNP随年龄逐渐升高，女性高于男性。〈55岁者年龄差异无统计学意义（P〉0．05），但性剐差异有统计学意义（P〈0．05），男性P975为34．5ng／L，女性为57．8ng／L；〉55岁者性剐间无差异（P〉0．05），55-74岁P95 63．6ng／L，％596ng／L；I〉75岁者％99．7ng／L，％5为100．7ng／L。结论测定BNP的CLIA法线性范围宽，灵敏度高，测定下限、检测精密度以及抗干扰能力均能满足临床要求；BNP在常规条件下保存时稳定性良好。建议采用单侧P97.5作为参考区间，〈55岁男性为〈34．5ng／L，女性为〈57．8ng／L；55岁以上不分性别均为〈100．4ng／L。

Objective To evaluate an immunochemilumineseence assay for human plasma B-type natriuretic peptide （BNP）, and to investigate the reference interval of BNP in healthy Chinese. Methods EDTA anti-coagulant plasmas from 421 healthy volunteers （202 men and 219 women） were included. BNP was measured with Triage BNP kit developed by Biosite on the Beckman Coulter Access II. Referring to the EP documents, a series of tests were designed to investigate the assay＇s linearity, detection limit, sensitivity, precision,interference factors,and BNP＇s stability under different storage conditions. Results The assay had a linearity of 15 -5 040 ng/L,and the detection limit was 9.2 ng/L. The concentration at 10% of CV was 30 ng/L. There was no obvious interference in the assay when bilirubin was 〈 253 μmol/L, hemoglobin was 〈 4 g/L, or triglyceride was 〈 12.88 mmol/L. In whole blood, BNP could be stable for 8h at room temperature and for 24 h at 4℃;in plasma, it could be stable for 6h at room temperature, 8h at 4℃, and at least for 6 months at -70℃. BNP was higher in female than in male （P 〈0.05） ;the 97.5% percentile was 34.5 ng/L for male and 57.8 ng/L for female. The 97.5% percentile for 55 -74 years old persons was 96 ng/L, and that for 〉75 years old persons was 100.7 ng/L. Conclu, sion The immunochemiluminescence assay for human BNP is highly sensitive. The characteristic of its wide detection linearity, precision,and anti-interference ability meets the clinical requirement. We recommend that the 97.5% percentile be a reference interval; when the age is 〈 55 years old, the value is 〈 34.5 ng/L for male and 〈 57.8 ng/L for female ; when the age is 〉 55 years old, the value is 〈 100.4 ng/L for both genders.