Myoglobin (Myo) Point Of Care Testing Kits CFDA Certification Immunocompetency Technology

High sensitivity cFDA approved MYO Quantitative Detection Kit (TRFIA)

1. Product Description

Principle:

Based on time-resolved fluorescence immunochromatography, the Myoglobin (MYO) Test Kit (Time Resolved Fluorescence Immunochromatographic Assay)was used to quantitatively determine the concentration of MYO in blood samples. The sample was added to the reagent card, and the MYO in the sample was coupled with the fluorescent microspheres on the marker pad to form a complex against human MYO monoclonal antibody, and was captured to form a double antibody sandwich complex. As a result, the more MYO in the sample, the more complex accumulation on the detection band. The excess unreacted fluorescent microspheres continued to be chromatographic to the control line. fluorescence intensity on the detection line reflects the content of captured MYO in the sample. The concentration of MYO in the sample was quantitatively reflected by the LTRIC-300/ LTRIC-600/LTRIC-1000 of time-resolved fluorescence immunoassay.

Intended Use: 

This Myoglobin (MYO) Test Kit (Time Resolved Fluorescence Immunochromatographic Assay) is suitable for quantitative detection of Myoglobin(abbreviated as MYO below)in human Serum/plasma/whole blood in vitro.

Myoglobin is an early marker of myocardial necrosis. Clinical studies have shown that myoglobin can be detected within 1 hour of onset and peak in 4~5 hours. But in many cases myoglobin levels rise, such as skeletal muscle injury, skeletal muscle or neuromuscular dysfunction, cardiac shunt surgery, renal failure, and high-intensity physical exercise. Therefore, the elevation of myoglobin must be used in the auxiliary diagnosis of acute myocardial infarction (AMI) together with the detection of other cardiac markers, electrocardiogram (ECG), clinical symptoms and signs, etc. The detection platform of this project mainly includes chemiluminescence technology, immunocompetency technology, colloidal gold technology, immunofluorescence technology, time-resolved fluorescence technology and so on..

2. Specification

3. High sensitivity cFDA approved MYO Quantitative Detection Kit (TRFIA) Main component

• Myoglobin (MYO) Test Kit (Time Resolved Fluorescence Immunochromatographic Assay) :Contains 20/50 reagent cards ,1 IC card ,1 instruction for use , 20/50 sample buffers.
• The reagent card consists of plastic casings and test strips, A sample pad, a marker pad (with a mouse anti-human myoglobin (MYO) monoclonal antibody nano-microsphere fluorescent probe (0.5% micro-sphere solid content), detection of membrane(monoclonal antibody (1.5 mg/mL) against human myoglobin (MYO) and polyclonal antibody (1.0 mg/mL) against mouse immunoglobulin (Ig G) ).Sample buffer, 290 µL/one person, The main components were phosphate (PBS) buffer of 0.5% calf serum albumin (BSA) and 0.05% preservative Proclin-300( are 2-methyl-4-isothiazoline-3-one and 5-chloro-2-methyl-4-isothiazoline-3-one).
• ※Do not exchange different batch numbers.

4. Storage conditions and expiry date?

• The unopened kit was stored in 2℃~8℃ for 18 months. The reagent card sealed in the aluminum foil bag package can be stored at temperature (2℃~30℃) for 30 days if it does not exceed expiry printed on the aluminum foil bag package. The temperature change during transportation (<37℃) has no effect on product quality. The reagent strip after the aluminum foil bag is unsealed can be stabilized for 1 hour at room temperature.

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