CK-MB FIA Test

The Creatine Kinase-MB (CK-MB) Fluorescence ImmunoAssay (FIA) Test is a lateral flow chromatographic fluorescence immunoassay for the quantitative detection of CK-MB in human serum or plasma, with a cut-off level of 5.0 ng/mL, using the RaFIA system. This test is intended for in vitro diagnostic use only.

As a heart-specific isoenzyme, CK-MB can be used to assist in the diagnosis of an acute myocardial infarction. The levels of CK-MB in blood elevate in 3-6 hours after acute myocardial infarction, peak between 12-24 hours and then return to normal within about 48-72 hours.

Diseases other than acute myocardial infarction may also cause elevated blood CK-MB. Other tests or diagnosis should be performed for comprehensive evaluations.

The CK-MB FIA Test was developed to detect the concentration of CK-MB in serum and plasma within 15 minutes, without the use of cumbersome laboratory equipment, and requiring minimally trained laboratory personnel.

  • 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.

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

FOR EXPORT ONLY