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  • Troponin I Rapid Test

Troponin I Rapid Test

Usage
The Troponin I Rapid Test is a rapid, serological, lateral flow chromatographic immunoassay for the qualitative detection of cardiac Tropnin I (cTnI) and its complex in human whole blood, serum or plasma specimens at a level of 1.0 ng/mL or greater. It is intended to be used by healthcare professionals as an aid in the diagnosis of acute myocardial infarction (AMI). The test only provides preliminary analysis results but not critical diagnosis criteria. Any use or interpretation of the test must be analyzed and confirmed with alternative testing method(s) and clinical findings based on professional judgment of health care providers.

 

Background of Clinical Indications

Cardiac Troponin I (cTnI) 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. The high specificity often measurements for the identification of myocardial damage has been demonstrated in conditions such as the perioperative period, after marathon runs, and blunt chest trauma.3 cTnI release has also been documented in cardiac conditions other than acute myocardial infarction (AMI) such as unstable angina, congestive heart failure, and ischemic damage due to coronary artery bypass surgery.4 Because of its high specificity and sensitivity in the myocardial tissue, Troponin I has recently become the most preferred biomarker for myocardial infarction.5 The Troponin I Rapid Test is a simple rapid test which utilizes a combination of anti-cTnI antibody coated particles and capture reagent to detect cTnI in human whole blood, serum or plasma specimens at the cut-off level of 1.0 ng/mL.

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Packing specification

Principle of Inspection

The Troponin I Rapid Test is a qualitative membrane-based immunoassay for the detection of cardiac Troponin I(cTnI) in human whole blood, serum or plasma specimens. During the test procedure, capture reagent is immobilized in the test line region (T) of the test. After specimen is added to the specimen well (S) of the device, it reacts with anti-cTnI antibody coated colloid gold particles in the test. This mixture migrates chromatographically through the length of the test and reacts with the immobilized capture reagent. The test format can detect cardiac Troponin I(cTnI) in specimens. If the specimen contains cardiac Troponin I(cTnI), a colored line will appear in the test line region (T), indicating a positive result. If the specimen does not contain cardiac Troponin I(cTnI), a colored line will not appear in this region, indicating 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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