About
INTENDED USE
AccuTest Troponin I Rapid Test is a lateral flow chromatographic immunoassay for the qualitative detection of cardiac Troponin I (cTnl) and its complex in human serum, plasma or whole blood at a level equal to or higher than 0.5 ng/ml. It is intended to be used as a screening test and as an aid in the diagnosis of acute myocardial infarction (AMI)
Principle
EXPLANATION OF THE TEST
Cardiac Troponin I (cTnl) is a cardiac muscle protein with a molecular weight of 22.5 kilodaltons. Together with troponin T (TnT) and troponin C (TnC), TnI forms a troponin complex in the heart to play a fundamental role in the transmission of intracellular calcium signals actin-myosin interaction. The human cTl has additional amino acid residues in its N-terminal that does not exist in the skeletal forms thus making cTnl a specific cardiac marker.
The test employs a monoclonal anti-cTni antibody gold conjugate in the mobile phase, monoclonal anti-cTni antibodies fixed in the test line, and polyclonal anti-rabbit IgG antibodies in the control line.
As the sample flows through the sample pad, human troponin I is bound by the anti-cTl-gold conjugate reacts to form an immunocomplex, which binds to the anti-c™n antibodies in the test line and produce a red / violet test line (T). Excess conjugate reacts in the control line with the anti-rabbit igG antibodies, forming a second red / violet line (C) to demonstrate the correct function of the reagents.
Warnings & Precautions
PRECAUTIONS
1.For in Vitro Diagnostic Use. This package insert must be read completely before performing the test. Failure to follow the insert gives in accurate test results.
2.Do not open the sealed pouch unless ready to conduct the assay.
3.Wear protective clothing and disposable gloves while handlingthe kit reagents and clinical specimens. Wash hands thoroughly after performing the test.
4.Dispose of all specimens and materials used to perform the test as biohazardous waste.
Procedure
TEST PROCEDURE
Step 1: Bring the specimen and test components to room temperature if refrigerated or frozen. Mix the specimen well prior to assay once thawed.
Step 2: When ready to test, open the pouch at the notch and remove device. Place the test device on a clean, flat surface.
Step 3: Apply 2-3 drops (70ul) of Serum/Plasma or 4 drops (100 ul) of whole blood into the sample well. Read results at 15 minutes.
3. A negative result can occur if the level of cIni present in the specimen is below the detection limits of the assay or cl that is detected is not present during the stage of AMI in which a sample is collected.
4. A positive result from a patient suspected of AMI may be used as a rule-in diagnosis and requires further confirmation. Serial sampling of patients suspected of AMI is also recommended due to the delay between the onset of symptoms and the release of the cTl in to the bloodstream.
5. Some specimens containing unusually high titers of heterophile antibodies or rheumatoid factor may affect expected results.
Other Details
Sensitivity:
The Troponin I Rapid Test can detect cTni in serum, plasma or whole bloodwith concentration of 0.5 ng/mL. or greater.
Whole Blood:
Drops of whole blood can be obtained by either finger tip puncture or veinpuncture. Do not use any hemolyzed blood for testing.
Whole blood specimens should be stored in refrigeration (2°C – 8°C) if not tested immediately. The specimens must be tested within 24 hours of collection.
Mahesh –
Best Kit for self use.
Shubham –
This kit is user-friendly and easy to use