【摘要】 目的评价化学发光法检测半乳糖凝集素3(Gal-3)的分析性能并初步探讨其对心力衰竭(HF)的诊断价值。方法依据相关文件评价化学发光法检测Gal-3的分析性能[空白检测限(LoB)、检出限(LoD)、定量限(LoQ)、精密度、线性范围及抗干扰能力]并验证厂家声明的参考区间,比较年龄、性别和样本类型对化学发光法测定Gal-3的影响。检测55例HF患者(HF组)及80名体检健康者(正常对照组)的血浆Gal-3水平,采用受试者工作特征(ROC)曲线评估Gal-3诊断HF的价值。结果 Gal-3试剂(化学发光法)生产厂家声明的LoB、LoD、LoQ分别为0.80、1.0、1.0 ng/mL,验证均通过。重复精密度[以变异系数(CV)表示]为1.9%～4.8%、期间精密度(以CV表示)为2.6%～6.1%,精密度验证通过。在4.07～113.11 ng/mL范围内,化学发光法测定Gal-3呈线性。血红蛋白<20 g/L、总胆红素(TB)<403.2μmol/L、直接胆红素(DBil)<214.08μmol/L、乳糜浊度<7 450 FTU对化学发光法检测血清Gal-3无干扰。血浆的Gal-3测定值高于血清(P<0.05)。男、女性之间Gal-3水平差异无统计学意义(P>0.05)。将研究对象按样本类型(血清、血浆)分组后再按年龄分组,血清组中3个年龄亚组(20～<45岁组、45～<60岁组、≥60岁组)之间Gal-3水平差异有统计学意义(P<0.05),血浆组2个年龄亚组(20～<60岁组、≥60岁组)之间Gal-3水平差异有统计学意义(P<0.05)。Gal-3水平随年龄增高而升高。HF患者血浆Gal-3水平明显高于正常对照者(P<0.001)。ROC曲线分析显示,血浆Gal-3诊断HF的曲线下面积(AUC)为0.969,最佳临界值为20.04 ng/mL,敏感性为85.5%,特异性为100.0%。结论化学发光法检测Gal-3的分析性能良好,需注意的是年龄对Gal-3水平有一定的影响。Gal-3对HF有较高的辅助诊断价值。更多还原

【Abstract】 Objective To evaluate the performance of galectin-3(Gal-3) detection by chemiluminescence and its preliminary application in heart failure(HF). Methods According to related documents,the performance of Gal-3 detection by chemiluminescence [limit of blank(LoB),limit of detection(LoD),limit of quantitation(LoQ),precision,linear range and interference] was evaluated,and the manufacturer’s reference interval was veri?ed. The effects of age,sex and specimen type on Gal-3 detection were compared. A total of 55 patients with HF(HF group) and 80 healthy subjects(healthy control group) were enrolled,and their plasma samples were collected for Gal-3 detection. Receiver operating characteristic(ROC) curve was used to analyze the role of Gal-3 in HF diagnosis. Results The Gal-3 kit(chemiluminescence) got a satisfying result in veri?cation on LoB,LoD and LoQ,with the values of 0.80,1.0 and 1.0 ng/mL by the manufacturer,respectively. The repeat precision expressed by coef?cient of variation(CV) was 1.9%-4.8%,and the within-laboratory precision expressed by CV was 2.6%-6.1%,and the manufacturer’s precision got veri?cation. In the range of 4.07-113.11 ng/mL,there was a good linearity of Gal-3 detection by chemiluminescence. Serum Gal-3 level determined by chemiluminescence would not be affected in samples with hemoglobin level <20 g/L,total bilirubin(TB)<403.2 μmol/L,direct bilirubin(DBil) < 214.08μmol/L or the turbidity of chyle <7 450 FTU. The plasma Gal-3 level was higher than that in serum(P<0.05). There was no statistical significance in Gal-3 levels between males and females(P>0.05). The research subjects were classi?ed by sample types(serum and plasma) and ages. In serum group,Gal-3 level had statistical signi?cance in 3 age subgroups(20～<45-year-old group,45～<60-year-old group and ≥60-year-old group)(P<0.05),and there was statistical significance for plasma Gal-3 levels in 20～<60-year-old group and ≥60-year-old group(P<0.05). Gal-3 levels increased with ages. The level of Gal-3 was higher in patients with HF than that in healthy control group(P<0.001). The area under ROC curve(AUC) of Gal-3 for HF diagnosis was 0.969,and the optimal cut-off value was 20.04 ng/mL,with a sensitivity of 85.5% and a speci?city of 100.0%. Conclusions The analytical performance of Gal-3 detection by chemiluminescence is good. Age has a certain effect on Gal-3 levels.Gal-3 plays a role in the auxiliary diagnosis of heart failure.更多还原