Troponin I/Myoglobin/CK-MB (3 in 1) Test Cassette (Whole Blood/Serum/Plasma)

A test for the diagnosis of myocardial infarction (MI) to detect cardiac Troponin I (cTnI), Myoglobin and CK-MB in whole blood, serum or plasma with the use of Ciest Fluorescence Immunoassay Analyzer.

For professional in vitro diagnostic use only.

INTENDED USE

The Ciest Troponin I/Myoglobin/CK-MB (3 in 1) Test Cassette (Whole Blood/Serum/Plasma) is intended for in vitro quantitative determination of human cardiac Troponin I, Myoglobin and CK-MB in whole blood, serum or plasma as an aid in the diagnosis of Myocardial Infarction (MI).

【SUMMARY】

Myoglobin (MYO), Creatine Kinase MB (CK-MB) and cardiac Troponin I (cTnI) are proteins released into the bloodstream after cardiac injury. Myoglobin is a heme-protein normally found in skeletal and cardiac muscle with a molecular weight of 17.8 kDa.1 When muscle cells are damaged, Myoglobin is released into the blood rapidly due to its relatively small size.

The level of Myoglobin increases measurably above baseline within 2-4 hours post-infarct, peaking at 9-12 hours, and returning to baseline within 24-36 hours.2,3 CK-MB is an enzyme also present in the cardiac muscle, with a molecular weight of 87.0 kDa.

Creatine Kinase is a dimeric molecule formed from two subunits designated as “M” and “B”, which combine to form three different isoenzymes, CK-MM, CK-BB and CK-MB. CK-MB is the isoenzyme of Creatine Kinase most involved in the metabolism of cardiac muscle tissue.5 The release of CK-MB into the blood following an MI can be detected within 3-8 hours after the onset of symptoms. It peaks within 9 to 30 hours, and returns to baseline levels within 48 to 72 hours.

Cardiac Troponin I is a protein found in cardiac muscle, with a molecular weight of 22.5 kDa.7 Troponin I is part of a three subunit complex comprised of Troponin T and Troponin C. Along with tropomyosin, this structural complex forms the main component that regulates the calcium sensitive ATPase activity of actomyosin in striated skeletal and cardiac muscle.8 After cardiac injury occurs, Troponin I is released into the blood 4-6 hours after the onset of pain.

The release pattern of Troponin I is similar to CK-MB, but while CK-MB levels return to normal after 72 hours, Troponin I remains elevated for 6-10 days, thus providing for a longer window of detection for cardiac injury.

The combined detection of three myocardial injury markers including CK-MB, cTnI and myoglobin has better sensitivity and specificity, which makes the diagnosis more accurate.

To achieve early diagnosis, early treatment, reduce missed diagnosis and timely risk stratification of patients.The Ciest Troponin I/Myoglobin/CK-MB (3 in 1) Test Cassette (Whole Blood/Serum/Plasma) is a simple test that utilizes a combination of antibody coated particles and capture reagent to detect cardiac Troponin I, Myoglobin and CK-MB in whole blood, serum or plasma.

CITEST DIAGNOSTICS INC., an emerging In Vitro Diagnostics company based in Canada, is experiencing growth on a global scale, engaging in multinational operations. CITEST was founded by highly experienced IVD industry professionals with proven track records building and growing successful companies.

CITEST manufactures its IVD products in ISO13485:2016 accredited manufacturing facilities under strict quality assurance systems. Our innovative products are developed using industry-leading design control systems, which ensures consistent product quality and performance.

Our products are used in the clinical market to help people live more healthy lives. When you select CITEST products, you can be assured of high performance and accuracy along with a dedicated customer support team.