CK-MB/cTnI/Myo Fast Test Kit 

(Immunofluorescence Assay)

Intended Use

CK-MB/cTnI/Myo Fast Test Kit (Immunofluorescence Assay) is intended for in vitro quantitative determination of CK-MB/cTnI/Myo in serum, plasma or whole blood. This test is used as an aid in the clinical diagnosis, prognosis and evaluation of myocardial injury such as Acute Myocardial Infarction (AMI), Unstable Angina, Acute Myocarditis and Acute Coronary Syndrome (ACS).

About CK-MB/cTnI/Myo

CK-MB: Creatine kinases are dimer isozymes composed of two monomer subunits, CK-M (for skeletal muscle derived) and CK-B (for brain derived), which can form all three combinations of monomers: CK-BB, CK-MM, and CK-MB. BB is found primarily in the brain. Skeletal muscles primarily contain the MM isoform, with trace amount of MB (around 1-4% of total CK activity). Cardiac muscles also contain the MM isoform, but higher amount of MB, typically around 20% of total CK activity. CK-MB is a more sensitive marker of myocardial injury than total CK activity, because it has a lower basal level and a much narrower normal range.

cTnI: Troponin complex consists of three regulatory proteins: T, which connects the troponin complex and tropomyosin (another cardiac muscle regulatory protein); I, which prevents muscle contraction in the absence of calcium; and C, which binds calcium. Cardiac troponin I (MW 22.5 kDa) and the two skeletal muscle isoforms of troponin I have considerable amino acid sequence homology, but cTnI contains an additional N-terminal sequence and is highly specific for myocardia.

Myo: Myoglobin is a small monomeric protein which serves as an intracellular oxygen storage site. It is found in abundance in the muscle and can get through into the blood circulation directly when myocardial cell is damaged mildly. Therefore, myoglobin has been advocated as a sensitive marker for early acute myocardial injury by American College of Cardiology Committee.

Contents

1. For Getein1100

Package specifications: 25 tests/box, 10 tests/box

1) CK-MB/cTnI/Myo test card in a sealed pouch with desiccant

2) Disposable pipet

3) User manual: 1 piece/box

4) SD card: 1 piece/box

5) Whole blood buffer: 1 bottle/box

2. For Getein1600

Package specifications: 2×24 tests/kit, 2×48 tests/kit

1) Sealed cartridge with 24/48 Getein CK-MB/cTnI/Myo test cards

2) User manual: 1 piece/box

Materials required for Getein1600:

1) Sample diluent: 1 bottle/box

2) Box with pipette tips: 96 tips/box

3) Mixing plate: 1 piece/box

Note: Do not mix or interchange different batches of kits.

Specifications

Applicable Device

Getein1100 Immunofluorescence Quantitative Analyzer

Getein1600 Immunofluorescence Quantitative Analyzer

Clinical Application

1. As an aid in the early diagnosis of myocardial infarction (MI);

2. As an aid in the diagnosis on various myocardial injury;

3. As an aid in the evaluation of thrombolysis treatment;

4. Estimate size of myocardial infarction;

5. As an aid in the detection of the degree of myocardial injury during surgery;

6. As an aid in the diagnosis and risk classification of ACS.