Cystatin-C

This is an in vitro diagnostic medical device that helps diagnose kidney disease by quantifying the concentration of Cystatin-C contained in human serum and plasma (EDTA, Heparin) using latex turbidimetric immunoassay.

Feature

■ Sensitively reflects the decrease in glomerular filtration rate (GFR)

■ Less affected by various factors such as weight, muscle mass, age, gender, and race

■ Expanding clinical utility of Cystatin-C as a measure of renal dysfunction

Measurement Conditions

■ Test Procedure for Analyzers (Hitachi 7180)

- Assay Mode: 2 Point End 18-28

- Wave length(main/sub): 570/800nm

■ Open reagent

Performance

■ Linearity: 0.1~8.5 mg/L

■ Sensitivity: Initial absorbance 0.8-1.5 / Reagent Blank(AAbs): 0.01 or less

■ Accuracy: Within 100±10% of the expected value when measuring standard substances of base activity

■ Reproducibility: CV less than 10% when measuring 0.85 mg/L Cystatin-C sample 10 times.

■ Interference reaction:
    Bilirubin : 20 mg/dL
    Hemoglobin : 500 mg/dL
    Intralipid : 5 %
    EDTA 2Na : 200 mg/dL
    Heparin sodium : 40 U/mL
    Sodium fluoride : 2000 mg/dL
    Sodium citrate : 1000 mg/dL