Berkeleyhealth Easy Check Ctni Rapid Test Self-Test 1 Pc

Product Description:

• A Cardiac Troponin I Rapid Test, Myocardial Infarction Test Kit, Heart Attack Detection Test, and Cardiac Biomarker Test for the diagnosis of myocardial infarction (MI) to detect cardiac Troponin I (cTnI) qualitatively in whole blood, serum or plasma. For professional in vitro diagnostic use only.


• The Cardiac Troponin I Rapid Test Cassette (Whole Blood/Serum/Plasma) is a rapid chromatographic immunoassay for the qualitative detection of human cardiac Troponin I in whole blood, serum or plasma as an aid in the diagnosis of myocardial infarction (MI).


• 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 cardiac marker, heart attack biomarker, and myocardial infarction diagnostic marker for myocardial infarction.


• The Cardiac Troponin I Rapid Test Cassette (Whole Blood/Serum/Plasma) is a simple rapid diagnostic test kit that utilizes a combination of anti-cTnI antibody coated particles and capture reagent to detect cTnI in whole blood, serum or plasma. The minimum detection level is 0.5ng/mL.

Product Features:

• The Cardiac Troponin I Rapid Test Cassette (Whole Blood/Serum/Plasma) is a qualitative, membrane based immunoassay test kit for the detection of cardiac Troponin I (cTnI) in whole blood, serum or plasma. In this test procedure, capture reagent is immobilized in the test line region of the test. After specimen is added to the specimen well of the cassette, it reacts with anti-cTnI antibody coated colloid gold particles in the test. This mixture migrates chromatographically along the length of the test and interacts 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, 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.


• To serve as a procedural control, a colored line will always appear in the control line region, indicating that proper volume of specimen has been added and membrane wicking has occurred.

How to use:

• Allow the test, specimen, buffer and/or controls to reach room temperature (15-30°C) prior to testing.


• Bring the pouch to room temperature before opening it. Remove the Cardiac Troponin I Rapid Test Cassette from the sealed pouch and use it as soon as possible.


• Place the cassette on a clean and level surface.


• For Serum or Plasma specimen: Hold the dropper vertically and transfer 2 drops of serum or plasma (approximately 50 μL) to the specimen well, then add 1 drop of buffer (approximately 40 μL), and start the timer. See illustration below.


• For Venipuncture Whole Blood specimen: Hold the dropper vertically and transfer 3 drops of whole blood (approximately 75 μL) to the specimen well, then add 1 drop of buffer (approximately 40 μL), and start the timer. See illustration below.


• For Fingerstick Whole Blood specimen:


• To use a capillary tube: Fill the capillary tube and transfer approximately 75 μL of fingerstick whole blood specimen to the specimen well of test cassette, then add 1 drop of buffer (approximately 40 μL) and start the timer. See illustration below.


• To use hanging drops: Allow 3 hanging drops of fingerstick whole blood specimen (approximately 75 μL) to fall into the specimen well of test cassette, then add 1 drop of buffer (approximately 40 μL) and start the timer. See illustration below.


• Wait for the colored line(s) to appear. Read results at 10 minutes. Do not interpret the result after 20 minutes.

Caution & Warnings:

• For professional in vitro diagnostic use only. Do not use after expiration date.


• Do not eat, drink or smoke in the area where the specimens or kits are handled.


• Do not use test if pouch is damaged.


• Handle all specimens as if they contain infectious agents. Observe established precautions against microbiological hazards throughout all procedures and follow the standard procedures for proper disposal of specimens.


• Wear protective clothing such as laboratory coats, disposable gloves and eye protection when specimens are assayed.


• The used test should be discarded according to local regulations.


• Humidity and temperature can adversely affect results

Ingredients:

• Materials provided:


• Test Cassettes


• Droppers


• Buffer


• Package insert Materials required but not provided:


• Specimen Collection Containers


• Centrifuge


• Timer For fingerstick whole blood


• Lancets


• Heparinized capillary tubes and dispensing bulb