Getein Biomedical – POCT Diagnostic Reagent

Intended Use

CK-MB/cTnI/H-FABP Fast Test Kit (Immunofluorescence Assay) is intended for in vitro quantitative determination of CK-MB/cTnI/H-FABP in human serum, plasma or whole blood samples. 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/H-FABP

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. Clinical studies have demonstrated the release of cTnI into the blood stream within hours following acute myocardial infarctions (AMI) or ischemic damage.

H-FABP: H-FABP (Heart-type Fatty Acid Binding Protein) that finds in abundance in cardiomyocytes is one of the Fatty acid-binding proteins (FABPs). The molecular weight of H-FABP is about 15 kDa, the combination of their low molecular weight and cytoplasmic location means that H-FABP proteins are released very rapidly following Acute Myocardial Infarction (AMI). H-FABP has been repeatedly shown to a highly sensitive early rise biomarker across the full spectrum of ACS, detectable as early as 30 minutes following the onset of an ischemic episode.

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Contents

1. For Getein1100

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

1) CK-MB/cTnI/H-FABP 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/H-FABP

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

Note: Do not mix or interchange different batches of kits

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