MYO FIA Test

The Myoglobin (MYO) Fluorescence ImmunoAssay (FIA) Test is a lateral flow chromatographic fluorescence immunoassay for the quantitative detection of MYO in human serum or plasma, with a cut-off level of 55.0 ng/mL, using the RaFIA system. This test is intended for in vitro diagnostic use only.

Myoglobin is an iron and oxygen-binding protein found in the heart and skeletal muscles. In the human body, myoglobin is only found in the bloodstream after heart or muscle tissues are injured. When injury occurs, myoglobin can be rapidly released into the blood and exceeds its normal levels in about 1 hour. Thus, myoglobin is a sensitive marker for heart or muscle injury, making it a potential indicator of heart attack in patients with chest pain. However, elevated myoglobin has low specificity for acute myocardial infarction (AMI). Therefore, CK-MB, cardiac Troponin, ECG, and clinical signs should be taken into account to make diagnosis.

The MYO FIA Test was developed to detect the concentration of myoglobin 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: 2.5-400.0 ng/mL

PRECISION

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

ACCURACY

  • MYO 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 MYO reference materials at 20.0-400.0 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

Catalog #

Product

Quantity

Specimen

F3030MYO FIA Test25/kitSerum, Plasma

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Materials required but not provided:

Catalog #

Product

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Catalog #

Product

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To learn about distribution opportunities or for additional product information, please contact info@ctkbiotech.com

FOR EXPORT ONLY