NGAL Rapid Test Kit (Colloidal Gold) is intended for qualitative determination of NGAL levels in urine in vitro diagnostic. It is used as a supplementary method in the early diagnosis of acute kidney injury (AKI), as NGAL is an early and sensitive biomarker of AKI.
【Background】
NGAL (neutrophil gelatinase-associated lipocalin, lipocalin-2,siderocalin) is a small protein expressed in neutrophils and certain epithelia, including the renal tubules. Under normal conditions NGAL levels are low in urine and plasma, but rise sharply
from basal levels in response to AKl to reach diagnostic levels within 2-4h, making NGAL an early and sensitive biomarker of acute kidney injury.
【Principle】
NGAL Rapid Test Kit utilizes colloidal gold labeling and immune chromatography based on the principle of double-antibody sandwich method to selectively detect elevated levels of NGAL in urine. During testing, a urine specimen migrates upward by capillary action. For a positive, NGAL is captured by anti-NGAL antibody 2-colloidal gold particles, forming antigen-anti-NGAL antibody 2-colloidal gold particles complex, then this complex reacted with anti-NGAL antibody 1 immobilized on the test line region(T), forming anti-NGAL antibody 1-antigen-anti-NGAL antibody 2-colloidal gold particles complex, and produces a pink color band when NGAL concentration is equal to or greater than 20 ng/mL. For a negative, no colored line appears in the test line region(T).
To serve as an internal procedural control, the control line region (C) is coated with monoclonal antibody which will always conjugate binds to antibody 2-colloidal gold, so a colored line will always appear in the control line region(C).