摘要
目的对胶乳增强免疫比浊法（LEIA）定量测定血浆中性粒细胞明胶酶相关脂质运载蛋白（NGAL）进行方法学评价并探讨其初步的临床应用。方法应用美国临床实验室标准化协会（CLSI）的标准化评价方案评价LEIA测定血浆NGAL的不精密度、回收率、线性范围、抗干扰性、稳定性等指标。同时测定86例2型糖尿病（T2DM）患者（其中包括41例糖尿病肾病（DN）患者）、40名体检健康者（正常对照组）的血浆NGAL水平。结果LEIA测定血浆NGAL低、高水平的批内变异系数（CV）分别为3.76%、1.79%;日间CV分别为6.62%、3.45%。平均回收率为97.3%~104.6%;在0~5 000μg/L内线性良好,线性范围内偏差〈8%。与进口同类试剂盒（粒子增强免疫比浊法）具有高度相关性（R2=0.996 6）,两种检测方法在200和700μg/L处的偏倚分别为3.66和11.79μg/L,均满足厂家规定的要求。总胆红素≤600μg/L、血红蛋白≤10 g/L、维生素C≤0.6 g/L、甘油三酯≤15 mmol/L时对LEIA测定血浆NGAL均无明显干扰;试剂在仪器2~8℃的条件下放置,至少可保存稳定35 d;20名健康体检者血浆NGAL水平均处于厂家声明的参考区间内。正常对照组、T2DM组和DN组血浆NGAL水平呈逐步增高趋势,各组间差异均有统计学意义（P均〈0.01）。血浆NGAL与血清半胱氨酸蛋白酶抑制剂C（Cys C）、肌酐（Cr）呈正相关（相关系数分别为0.58、0.43,P均〈0.01）。结论 LEIA测定血浆NGAL具有较高的灵敏度和精密度,所测结果准确可靠,能直接在自动生化分析仪上使用,操作简便、快速,适用于大批量测定。
Objective To evaluate latex-enhanced immunoturbidimetric assay（ LEIA） for the detection of plasma neutrophil gelatinase-associated lipocalin（ NGAL） and its clinical application. Methods LEIA was used to determine the concentration of plasma NGAL according to the Clinical and Laboratory Standards Institute（ CLSI） standardization evaluation protocal. The imprecision,recovery rate,linear range,anti-interference and stability were assessed. The plasma NGAL levels of 86 patients with type 2 diabetes mellitus（ T2DM）,including 41 patients with diabetic nephropathy（ DN）,and 40 healthy subjects（ healthy control group） were determined. Results The within-run coefficients of variation（ CV） for low and high levels of NGAL were 3. 76% and 1. 79%,respectively. The inter-day CV were 6. 62% and 3. 45%,respectively. The average recovery rate was 97. 3%-104. 6%. The linear range was from 0 to5 000μg / L,and the deviation was 8%. Comparing with similar foreign kit（ particle-enhanced immunoturbidimetric assay）,the correlation was high（ R2= 0. 996 6）. The system biases of 200 μg / L and 700 μg / L were 3. 66 μg / L and11. 79 μg / L,respectively. The results met the requirements of manufacturers. There was no significant interference on the determination of plasma NGAL with total bilirubin≤600 μmol / L,hemoglobin≤10 g / L,vitamin C≤0. 6 g / L and triglyceride≤15 mmol / L. The reagent could be stable for 35 d in the instrument under the condition of 2-8 ℃. The plasma levels of NGAL in healthy control group were all in manufacturers＇ reference range. The level of plasma NGAL had been gradually increasing in healthy control group,T2 DM group and DN group with statistical significance（ P〈0. 01）. The plasma NGAL were positively correlated with serum cystatin C（ Cys C） and creatinine（ Cr）（ correlation coefficients were 0. 58 and 0. 43,P〈0. 01）. Conclusions The LEIA for plasma NGAL determination has high sensitivity and precision,which is fast and easy to operate,and c
出处
《检验医学》
CAS
2015年第7期734-739,共6页
Laboratory Medicine
基金
徐州市科技局资助项目(XZZD1348)
