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  • Troponin I/Myoglobin/CK-MB Rapid Test

Troponin I/Myoglobin/CK-MB Rapid Test

Usage
The Troponin I/Myoglobin/CK-MB Rapid Test is a rapid, serological, lateral flow chromatographic immunoassay for the qualitative detection of cardiac Troponin I (cTnI), Myoglobin (Myo) and Creatine Kinase MB(CK-MB) in human whole blood, serum or plasma as an aid in the diagnosis of myocardial infarction (MI).

 

Background of Clinical Indications

Cardiac Troponin I, Myoglobin and Creatine Kinase MB are proteins released into the blood stream after cardiac injury. Cardiac Troponin I is a cardiac muscle protein with a molecular weight of 22.5 kilodalton.1 Troponin I is part of a three subunit complex comprising 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.2 After cardiac injury occurs, Troponin I is released into the blood 4-6 hours after the onset of pain. The release pattern of cTnI 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. Myoglobin is a hemeprotein normally found in skeletal and cardiac muscle with a molecular weight of 17.8 kDa. It constitutes about 2 percent of total muscle protein and is responsible for transporting oxygen within muscle cells.3 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.4,5 CK-MB is an enzyme also present in the cardiac muscle, with a molecular weight of 87.0 kDa.6 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.7 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.8 The Troponin I/Myoglobin/CK-MB Rapid Test utilizes a combination of antibody coated particles and capture reagents to qualitatively detect Troponin I, Myoglobin and CK-MB in human whole blood, serum or plasma specimens. The minimum detection level is 1.0 ng/mL Troponin I,50 ng/mL Myoglobin and 5.0 ng/mL CK-MB.

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Packing specification

Principle of Inspection

The Troponin I/Myoglobin/CK-MB Rapid Test is a qualitative membrane-based immunoassay for the detection of cardiac Troponin I, Myoglobin and CK-MB in human whole blood, serum or plasma specimens. The membrane is pre-coated with specific capture antibodies in each of the test line regions (CTNI, CKMB or MYO) of the test device. During the test procedure, the whole blood, serum or plasma specimen reacts with the particle coated with specific antibodies. The mixture migrates upward on the membrane chromatographically by capillary action to react with specific capture reagents on the membrane and generate a colored line. The presence of this colored line in the specific test line region (CTNI, CKMB or MYO) indicates a positive result, while absence of the test line indicates a negative result. An internal quality control is included in the test, in the form of a colored line appearing in the control line region (C), indicating that the test is functional, and proper and sufficient volume of specimen has been applied to enable migration through the test and control line, regardless of whether there is a test line or not. If the control line (C) does not appear within the testing time, test result is invalid and the test should be repeated with a new test device.

Specification packaging

25 Tests/Kit, 40 Tests/Kit.

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About Kangte

Zhejiang Kangte Biotechnology Co., Ltd

Zhejiang Kangte Biotechnology Co., Ltd. was established in 2001 and is located in Zhejiang Xinchang Provincial High-tech Industrial Park. It is a national high-tech enterprise integrating R&D, production and sales of in vitro diagnostic reagents. Relying on the pioneering team spirit and scientific management, the company has repeatedly won the national advanced production unit in the in vitro diagnostic industry. 

The company has GMP standard workshops, clean workshops, R&D laboratories, equipped with high-precision testing equipment and fully automatic production equipment. In order to enhance the company's overall R&D strength, it has established a good "production-study-research" cooperative relationship with many colleges and universities. The company has obtained a number of invention patents and utility model patents and has passed ISO9001, ISO14001, ISO13485, and other system certifications. The company currently has more than 100 registered products, covering biochemical, immunological, and other fields, and many of the products have reached the leading domestic level in technology. 

The company adheres to the concept of "integrity, professionalism, efficiency and innovation" to serve customers, and constantly introduces products with higher technological content to provide customers. The company will, as always, position itself in "service technology, professionalism and efficiency, and achieve customers", and work hard to jointly shape the IVD industry and continuously improve the level of human health.

 

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