Accurex Cardiac Troponin 1 Fast

Accurex Cardiac Troponin 1 Fast is designed for in vitro quantitative determination of Cardiac Troponin I (cTnI) in serum, plasma or whole blood. This test is primarily used to aid in diagnosing Acute Myocardial Infarction (AMI), Unstable Angina, Acute Myocarditis and Acute Coronary Syndrome (ACS). Clinical studies have demonstrated the release of cTnI into the bloodstream within hours following acute myocardial infarction. Elevated levels of cTnl are probably detected in blood within 4 to 6 hours after the onset of chest pain or angina, reaching their peak concentrations within approximately 8 to 28 hours, and remain elevated for 3 to 10 days following myocardial infarction. cTnl has become an important marker in diagnosing and evaluating patients suspected of having an AMI.

Uses: For analyzing cardiac troponin levels in the blood for diagnosing myocardial injury.

Product Specifications and Features:

• The test uses an anti-human cTnl monoclonal antibody conjugated with fluorescence latex and another anti-human cTnl monoclonal antibody coated on the test line

• After the sample has been applied to the test strip, the fluorescence latex-labelled anti-human cTnl monoclonal antibody binds with the cTnl in the sample and forms a marked antigen-antibody complex

• This complex moves to the test detection zone by capillary action. Then marked antigen-antibody complex is captured on the test line by the anti-human cTnl monoclonal antibody

• The fluorescence intensity of the test line increases in proportion to the amount of cTnl in the sample

• Then, the test card is directly inserted into ACCUDx CQ Immunofluorescence Quantitative Analyzer

• The concentration of cTnl in the sample is measured and displayed on the screen

• The value is stored in ACCUDx CQ Analyzer, and the result is transmitted to the laboratory or hospital information system

Directions For Use:

• Collect specimens according to safe phlebotomy procedures

• Test card, reagent and sample should be brought down to room temperature before testing

• Confirm that the SD card lot number matches the test kit lot No.

• Perform SD Card calibration whenever the lot number is changed and when necessary

• On the main menu of ACCUDx CQ Analyzer, press the ENT button to enter the testing interface

• Remove the test card from the pouch prior to use

• Label the test card with patient identification

Safety Information:

• For in vitro diagnostic use only

• For professional use only

• Do not use the kit beyond the expiry date

• Discard the test card if the foil pouch or the cartridge is damaged

• Open pouches or the cartridge when you are ready to perform the test

• Do not reuse the test card

• Do not reuse the pipet tips

• Handle all specimens as potentially infectious

• Store the test card at 4-30°C

• Use the test card within 1 hour of opening

• Store the blood buffer at 0-30°C

• For best results, store the whole blood buffer at 2-8°C