Particle-enhanced turbidimetric immunoassay for determination of serum neutrophil gelatinase-associated lipocalin on the Roche Cobas c501 analyzer.
OBJECTIVE
Neutrophil gelatinase-associated lipocalin (NGAL) has been reported to be a good marker for tubular damage and acute kidney injury. The aim of this study was to develop a high throughput assay for the quantification of serum NGAL (sNGAL).


METHODS
Imprecision, interference, linearity, recovery, and reference values were evaluated on Cobas c501.


RESULTS
The assay was linear over the dynamic range of the study (R(2)=0.9988). The total assay imprecision was below 5%. The assay recovery was estimated at 98.89%-102.61%. The assay displayed a good linearity over the range from 35 μg/L to 4250 μg/L. A typical high-dose hook effect was observed for the assay at NGAL concentration>28,800 μg/L. No interference was observed with hemoglobin ≤ 5 g/L, bilirubin ≤ 0.3g/L, vitamin C ≤ 0.5 g/L, sodium heparin≤ 5 g/L and intralipid ≤ 1%. The 95th centile for serum NGAL was <122.57 μg/L from 454 healthy donors. There were no gender-related differences for serum NGAL. There were significant age-related differences between the 21-44 and 45-75 year categories for serum NGAL. The reference value for sNGAL was <116.52 μg/L in the 21-44 year group and <126.9 μg/L in the 45-75 year group.


CONCLUSIONS
The NGAL assay verified to be a reliable assay with convenient performance characteristics. The assay improves and simplifies the laboratory workload.
Department of Clinical Laboratory, Chinese People's Liberation Army General Hospital, Beijing 100853, China.
Daijun
D
Xiang
Hongrui
H
Zhang
Jie
J
Bai
Junlong
J
Ma
Mianyang
M
Li
Wen
W
Gao
Xiaorui
X
Zhang
Jimin
J
Gao
Chengbin
C
Wang
D000209:Acute-Phase Proteins; D000328:Adult; D000368:Aged; D005260:Female; D006801:Humans; D007118:Immunoassay / Q000295:instrumentation* / Q000379:methods*; D007840:Latex / Q000737:chemistry*; D000071068:Lipocalin-2; D054834:Lipocalins / Q000097:blood*; D008297:Male; D008875:Middle Aged; D009391:Nephelometry and Turbidimetry / Q000295:instrumentation* / Q000379:methods*; D011518:Proto-Oncogene Proteins / Q000097:blood*; D012016:Reference Values; D055815:Young Adult
D000209:Acute-Phase Proteins; C489506:LCN2 protein, human; D007840:Latex; D000071068:Lipocalin-2; D054834:Lipocalins; D011518:Proto-Oncogene Proteins
Biomarker; Kidney function test; NGAL; PETIA; Reference values