High Precision Troponin I /Ctnl Rapid Test

• Classification: Physiological Functions of Diagnosis and Monitoring Equipment
• Type: Urine Analyzer
• Certification: CE, FDA, ISO13485
• Group: All People
• Medical Device Regulatory Type: Type 1
• Transport Package: Pouch, Carton
• Model NO.: cTni-w23
• Specification: 4.0mm
• Trademark: OEM
• Origin: China
• HS Code: 3002190090
• Production Capacity: 200000PCS/Week

Product Description

High Sensitivity Cardiac Marker Ck-MB Rapid Diagnostic Test

INTENTED USE 
The Troponin I (cTnl) Test 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).
SUMMARY 
Cardiac Troponin (cTnl) 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 cardiac Tnl is similar to CK-MB, but while CK-MB levels return to normal after 72 hours, Troponin I remains elevates for 6-10 days, thus providing for a longer window of detection for cardiac injury. The high specificity of cTnl measurements for the identification of myocardial damage has been demonstrated in conditions such as the perioperative  period, after marathon runs, and blunt chest trauma. cTnl 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.
 Troponin I (cTnl) Test is a simple test that utilizes a combination of colloidal gold conjugate, biotinylated anti-cTnl antibodies and streptavidin to selectively detect cTnl in whole blood, serum or plasma. The minimum 
detection level is 0.5 ng/mL. 
 
MATERIALS
Materials Provided
• Troponin I (cTnl) Test device
• Disposable specimen droppers
• Package insert
Materials required but not provided
• Specimen collection containers
• Timer
• Lancet (for fingerstick whole blood only)
• Centrifuge (for plasma and serum only)
• Heparinized capillary tubes and dispensing bulb (for fingerstick whole blood only)
 
LIMITATIONS
• The Troponin I (cTnl) Test is for in vitro diagnostic use only. The test should be used for the detection of Troponin I in whole blood, serum of plasma specimens only.
• The Troponin I (cTnl) Test will only indicate the qualitative level of cardiac Troponin I in the specimen and should not be used as the sole criteria for the diagnosis of myocardial inferarction.
• The Troponin I (cTnl) Test cannot detect less than 0.5 ng/mL of cTnl in specimens. A negative result at any time does not preclude the possibility of myocardial infarction.
• As with all diagnostic tests, all results must be interpreted together with other clinical information available to the physician.
• Some specimens containing unusually high titers of heterophile antibodies or rheumatic factor (RF) may affect expected results. Even if the test results are positive, further clinical evaluation should be
considered with other clinical information available to the physician.





INTENDED USE:
The Rapid Cardiac Markers Panel test is an immunochromatography based one step in vitro test. It is designed for qualitative determination of cardiac troponin I (cTnI), CK-MB and Myoglobin in human serum, plasma or whole blood specimens as an aid in the diagnosis of myocardial infarction.

SPECIFICATION:
1) Specimen: Whole blood/serum/plasma
2) Format: Panel

FEATURE:
1) Simple: Simply add specimen and dilution(if necessary) into sample well
2) Rapid: Results come out at 15 minutes
3) Visually interpreted: Don't need any equipment
4) Stable: More than 12 month period of validity

PACKING:
Panel: 25 tests/box, 50 tests/box

ASSAY PROCEDURE:
1) Bring all materials and specimens to room temperature.
2) Remove the test card from the sealed foil pouch.
3) Place the transfer pipette in the specimen and depress the bulb to withdraw a sample.
4) Hold the pipette in a vertical position over the sample well of the test card and deliver
7-10 drops (300-500 mL) of sample into the sample well.
Note: Please deliver sample drop by drop to ensure the best performance
5) Read the result at 15 minutes.

INTERPRETATION OF RESULTS
Positive:
If two colored bands are visible on any strip of the device within 15 minutes, the test result is positive and valid. The test result can be read as soon as a distinct colored band appears in the test area.
Note: Specimens containing very low levels of cardiac markers may develop two color bands over 15 minutes.
Negative:
If test area has no color band and the control area displays a colored band, the result is negative and valid.
Invalid result:
If a colored band does not form in the control region of any strip, the test result is invalid. The sample must be re-tested, using a new test device.