摘要
目的建立中性粒细胞明胶酶相关脂质运载蛋白（NGAL）免疫比浊检测方法并探讨该方法学的肾损伤早期临床检测意义。方法应用杂交瘤技术制备抗人NGAL单克隆抗体,建立免疫比浊检测方法,用于肾病患者尿液NGAL定量检测。结果该法测定NGAL线性范围：25~5 000 ng/ml,CV≤7.37%,特异性98.00%。对肾炎、肾病综合征、肾衰和狼疮性肾炎的检出率分别为：89.58%、100%,100%和88.89%,NGAL水平均显著高于健康人群（P〈0.01）。该方法对肾损伤患者检出率高于β2微球蛋白和胱抑素C,同时β2微球蛋白检测为阳性的,NGAL同样为阳性,符合率较高。结论该法能够定量检测人尿液NGAL蛋白,与β2微球蛋白符合率较高,比胱抑素C具有优势,为后续NGAL免疫比浊检测方法的临床应用和推广奠定基础。
Objective To establish the immunoturbidimetric assay for detection of neutrophil gelatinase - associated lipocalin（ NGAL） and to explore the clinical significance for early detection of renal impairment. Methods The anti - human NGAL monoclonal antibody had been obtained by hybridoma technique,and immunoturbidimetric assay had been applied for quantitative detection of urinary NGAL in patients with re-nal impairment. Results The linear range of this assay for detection of NGAL was 25 ~ 5 000 ng/ ml,with CV less than 7. 37% and analytical specificity of 98. 00% . The detection rates for nephritis,nephrotic syndrome,renal failure and lupus nephritis were 89. 58% ,100% ,100% and 88. 89% respectively,in which the level of NGAL was much higher than that of controls（ P 〈 0. 01）. The assay of NGAL showed higher level of detection rate than that of detection of β2 - microglobulin and CysC,meanwhile,it had high coincidence with β2 - microglobulin in diagnosis of patients with renal impairment. Conclusion This method can quantitatively detect urinary NGAL with high coincidence with β2 - microglobulin and it has an obvious advantage compared with CysC,and it may lay the foundation for its clinical promotion and application.
出处
《临床和实验医学杂志》
2016年第11期1135-1136,F0003,共3页
Journal of Clinical and Experimental Medicine
