[CTK Biotech] CK-MB FIA Test

[CTK Biotech] CK-MB FIA Test

 

REAGENTS AND MATERIALS PROVIDED:

1. Individually sealed foil pouches containing:
   a. One test device
   b. 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

 

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

RANGES

• Working range: 1.0-80.0 ng/mL

PRECISION

• Intra-lot Precision
  Intra-lot precision was determined by testing of CK-MB reference materials using 10 test devices from the same lot. CV ≤ 15%.
• Inter-lot Precision
  Inter-lot precision was determined by testing of CK-MB reference materials using 30 test devices from 3 consecutive lots randomly (10 test devices from each lot). CV ≤ 15%.

ACCURACY

• CK-MB 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 CK-MB reference materials at 2.5-80.0 ng/mL was tested, and the correlation coefficient (R) is ≥0.9900.