Cys-C FIA Test

The cysteine protease inhibitor Cys-C, also called gamma trace or postgamma-globulin, is a valuable biomarker in diagnosing early kidney injury. Cys-C is removed from the bloodstream by glomerular filtration in the kidney. The concentration of Cys-C in blood is only determined by glomerular filtration rates, not by age, gender, or diet. When both kidney function and glomerular filtration rates decrease, the levels of Cys-C in the blood elevate. Cys-C is also used to detect kidney injury due to acute rejection reaction and medical treatment, making Cys-C a useful and sensitive biomarker for diagnosing diabetic nephropathy.

  • Quantitative, non-subjective results
  • Increased sensitivity and broader detection range compared to rapid tests

Range

  • Working range: 0.2-8.0 mg/L

Precision

Intra-lot Precision

  •  Intra-lot precision was determined by testing of Cys-C reference materials using 10 test devices from the same lot. CV ≤ 15%.

Inter-lot Precision

  • Inter-lot precision was determined by testing of Cys-C reference materials using 30 test devices from three consecutive lots randomly (10 test devices from each lot). CV ≤ 20%.

Accuracy

  • Cys-C control materials with three different concentrations were tested by every lot of test device, and the deviations were within ±15%.

Linearity

  • A serial concentration of Cys-C reference materials at 0.4-8.0 mg/L was tested, and the correlation coefficient (R) is ≥ 0.9900.

Reagents and Materials provided:

  1. Individually sealed foil pouches containing:
    1. One test device
    2. One desiccant
  2. Detection buffer tubes
  3. SD card
  4. Instructions for Use

Materials required but not provided:

  1. Clock or timer
  2. RaFIA Immunofluorescence Analyzer
  3. RaFIA Immunofluorescence Incubator

FOR EXPORT ONLY