The kit has been designed for the quantitative determination of Neutrophil Gelatinase-associated Lipocalin (NGAL) in human urine. The method can be used for samples over the range of 1.0-1500.0 ng/mL.
SUMMARY AND EXPLANATION OF THE TEST
Neutrophil Gelatinas-associated Lipocalin (NGAL) detection kit (CLIA) (hereinafter referred to as the kit) is used for the in vitro quantitative determination of NGAL concentration in human urine. NGAL is an early sensitive marker for AKI and a new potential marker for chronic kidney damage.
NGAL is a kind of apolipoprotein, ubiquitous with a molecular mass of 25,000. It exists in the bone marrow rather than leukocytes in peripheral blood. It is synthesized only in the differentiation stage of myelocyte and metamylocyte. It is a new member of the lipocalin family, which is biomarker of the early renal damage.
PRINCIPLE OF THE TEST
Sandwich methods:
NGAL Antibody labeled by FITC and NGAL Antibody pair labeled by AP bind with the NGAL antigen in the sample, control or calibrator and form sandwich complex. Then add the magnetic beads binding with Anti-FITC, through the specific binding between the FITC and Anti-FITC, the complex will be bound by the magnetic beads. Then the entire complex will be captured by the external applied magnetic field and separate from the unbound substance. After washing, add the substrate. The substrate will be catalytically cracked under the action of the enzyme, and form an unstable intermediate in excited state. When the intermediate in excited state returns to the ground state, it will issue photons and make a light-emitting reaction. Then the CLIA analyzer will measure the luminous intensity