CK-MB Fast Test Kit 

(Immunofluorescence Assay)

Intended Use

CK-MB Fast Test Kit (Immunofluorescence Assay) is intended for in vitro quantitative determination of CK-MB 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

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. Medical literatures commonly state that CK-MB levels are elevated in 4 to 6 hours, peak at 10 to 24 hours, and return to normal within 3 to 4 days after an acute myocardial infarction. Classically, an increase of the myocardial-specific enzymeCK-MB is considered as the hallmark of acute myocardial infarction, and increased levels are frequently interpreted by the clinician as objective evidence of myocardial cell damage.

Contents

1. For Getein1100/ Getein1180:

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

1) CK-MB 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 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

Getein1180 Immunofluorescence Quantitative Analyzer

Getein1600 Immunofluorescence Quantitative Analyzer

Clinical Application

As an aid in the early diagnosis and risk classification of acute myocardial infarction (AMI).