A colloidal gold-based lateral flow immunoassay was developed for the rapid quantitative detection of Cystatin-C in serum and whole blood. This device has an assay time of 15 min, making it a convenient point-of-care diagnostic tool. The device has a quantification range spanning from 0.5 to 7.5 µg/mL, with a lower limit of detection at 0.18 µg/mL. To validate its accuracy, the test was compared to a standard nephelometric immunoassay, and the results exhibited a robust linear correlation with an adjusted r2 value of 0.95. Furthermore, the device demonstrates satisfactory levels of analytical performance in terms of precision, sensitivity, and interference, indicating its potential for precise Cystatin-C quantification, particularly in renal-failure patients. Notably, the Cystatin-C-LFA device also demonstrates satisfactory stability, as a 30-day accelerated stability study at 50 °C showed no change in the device performance, indicating a long shelf life for the product when stored at room temperature.
Keywords: Cystatin-C; gold nanoparticles; lateral flow immunoassay; patient-whole blood; serum-samples.