CK-MB/cTnI Fast Test Kit

 (Immunofluorescence Assay)

Intended Use

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

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.

Contents

1.For Getein1100:

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

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

2) Disposable pipet

3) User manual: 1 piece/box

4) SD/RFID 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 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. Aid in the diagnosis and risk classification of ACS

2. Aid in the diagnosis on various myocardial injury

3. Aid in the evaluation of thrombolysis treatment

4. Estimate size of myocardial infarction

5. Detect degree of myocardial injury during surgery