Troponin I Diagnostic Rapid Test

Intended Use

Troponin I Diagnostic Rapid Test (Whole Blood/Serum/Plasma) is a rapid visual immunoassay for the qualitative presumptive detection of cardiac Troponin I in human whole blood, serum or plasma specimens. Troponin I Diagnostic Rapid Test is intended for use as an aid in the diagnosis of myocardial infarction (MI).

Introduction

Cardiac Troponin I (cTnI) is a protein found in cardiac muscle with a molecular weight of 22.5 kDa. 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. 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 of cTnI measurements for the identification of myocardial damage has been demonstrated in conditions such as the perioperative period, after marathon runs, and blunt chest trauma. 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. Because of its high specificity and sensitivity in the myocardial tissue, Troponin I has recently become the most preferred biomarker for myocardial infarction

Specimen Collection and Storage

● The cTnI Rapid Test Device (Whole Blood/Serum/Plasma) is intended for use with human whole blood, serum, or plasma specimens only.

● Only clear, non-hemolyzed specimens are recommended for use with this test. Serum or plasma should be separated as soon as possible to avoid hemolysis.

● Perform testing immediately after specimen collection. Do not leave specimens at room temperature for prolonged periods. Serum and plasma specimens may be stored at 2-8°C for up to 3 days. For long term storage, specimens should be kept below -20°C. Whole blood collected by venipuncture should be stored at 2-8°C if the test is to be run within 2 days of collection. Do not freeze whole blood specimens. Whole blood collected by fingerstick should be tested immediately.

● Containers containing anticoagulants such as EDTA, citrate, or heparin should be used for whole blood storage.

● Bring specimens to room temperature prior to testing. Frozen specimens must be completely thawed and mixed well prior to testing. Avoid repeated freezing and thawing of specimens.

● If specimens are to be shipped, pack them in compliance with all applicable regulations for transportation of etiological agents.

● Icteric, lipemic, hemolysed, heat treated and contaminated specimens may cause erroneous results.

● There is a slight possibility that some whole blood specimens with very high viscosity or which have been stored for more than 2 days may not run properly on the test device. Repeat the test with a serum or plasma specimen from the same patient using a new test device.

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