Abstract
Objective To evaluate the performance of the latex particle-enhanced turbidimetric immunoassay for the determination of plasma and urinary neutrophil gelatinase-associated lipocalin. Methods Latex particle-enhanced turbidimetric immunoassay was used to measure the concentration of NGAL in plasma and urinary samples for confirmatory study.The assay imprecision,limit of blank (LOB),limit of detection (LOD),linearity,accuracy and interference factors were assessed according to CLSI protocols.Twenty samples of patients with acute kidney injury (AKI),166 samples of patients with chronic kidney disease (CKD) and 100 healthy adult samples were tested. Results Repeatability estimate of the NGAL was 1.90% (Level 1) & 1.22% (Level 2),and the within-Laboratory imprecision was 4.06% (Level 1) & 2.57% (Level 2) respectively.The LOB was 3.1μg/L and the LOD of plasma NGAL (sNGAL) and urinary NGAL (u NGAL) were 12.5μg/L, 21μg/L respectively.The linear coverage was from 25 to 4250μg/L.The accuracy of sNGAL and uNGAL was 98.89%,98.28% (Level 1) & 102.61%,95.44% (Level 2).The results were basically identical with similar foreign kit measurement results.No interference in plasma was observed with hemoglobin≤7 g/L,bilirubin≤0.6 g/L,vitamin C≤0.6 g/L,sodium heparin≤5 g/L and introlipid≤1%.The concentration of u NGAL was in the acceptable range with the hemoglobin≤10 g/L,bilirubin≤0.6 g/L and vitamin C≤0.6 g/L.In general,the measured NGAL levels in AKI group and CKD group were higher than control group; AKI group was significantly higher than CKD group.The evaluated glomerular filter rate (eGFR) was significantly inverse correlated with sNGAL and u NGAL (r=-0.758 & -0.692,P<0.01). Conclusions The data show that excellent imprecision and linearity are achieved using the particle-enhanced turbidimetric immunoassay for testing plasma and urinary NGAL concentrations.The assay of NGAL has advantages including high automation and fast speed detection which are suited for clinical application and laboratory automation.(Chin J Lab Med,2013,36:1027-1032) Key words: Acute-phase proteins; Lipocalins; Latex particle enhanced immunoassay
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