【INTENDED USE】
The Troponin I (cTnI) 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. It 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
【MAIN CONTENTS】
• Rapid test cassette with desiccant
• Disposable pipettes
• Buffer
• Package insert
【PRECAUTIONS】
• For professional in vitro diagnostic use only.
• Do not use after the expiration date indicated on the package. Do not use the test if the foil pouch is damaged. Do not reuse tests.
• This kit contains products of animal origin. Certified knowledge of the origin and/or sanitary state of the animals does not completely guarantee the absence of transmissible pathogenic agents. It is therefore, recommended that these products be treated as potentially infectious, and handled by observing usual safety precautions (e.g., do not ingest or inhale).
• Avoid cross-contamination of specimens by using a new specimen collection container for each specimen obtained.
• Read the entire procedure carefully prior to testing.
• Do not eat, drink or smoke in the area where the specimens and kits are handled. Handle all specimens as if they contain infectious agents. Observe established precautions against microbiological hazards throughout the procedure and follow standard procedures for the proper disposal of specimens. Wear protective clothing such as laboratory coats, disposable gloves and eye protection when specimens are assayed.
• Humidity and temperature can adversely affect results.
• Used testing materials should be discarded according to local regulations.
【STORAGE AND STABILITY】
• Store at 2 ~ 30 º C in the sealed pouch for 24 months.
• Keep away from direct sunlight, moisture and heat
• DO NOT FREEZE.
【SAMPLE COLLECTION】
•The Troponin I (cTnI) Rapid Test 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 assoon 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.
【DIRECTION OF USE】
Bring tests, specimens, buffer, and/or controls to room temperature (15-30°C) before use.
1. Remove the test from its sealed pouch, and place it on a clean, level surface. Label the device with patient or control identification. For best results, the assay should be performed within one hour.
2. Transfer 1 drop of whole blood, serum or plasma specimen to the specimen well (S) of the device with the provided disposable pipette, then add 1 drop of buffer and start the timer. Avoid trapping air bubbles in the specimen well (S), and do not add any solution to the result window. As the test begins to work, color will migrate across the membrane.
3. Wait for the colored band(s) to appear. The result should be read within 15 minutes. Do not interpret the result after 20 minutes.
【INTERPRETATION OF RESULTS】
POSITIVE: The presence of two lines as control line (C) and test line (T) within the result window indicates a positive result.
NEGATIVE: The presence of only control line (C) within the result window indicates a negative result. INVALID: If the control line (C) is not visible within the result window after performing the test, the result is considered invalid. Some causes of invalid results are because of not following the directions correctly or the test may have deteriorated beyond the expiration date. It is recommended that the specimen be re-tested using a new test.
【QUALITY CONTROL】
• Internal procedural controls are included in the test. A colored band appearing in the control region (C) is considered an internal positive procedural control, confirming sufficient specimen volume and correct procedural technique.
• External controls are not supplied with this kit. It is recommendedthat positiveand negative controls be tested as a good laboratory practice to confirmthetestprocedure and to verify proper test performance.
【LIMITATIONS】
1. The cTnI Rapid Test is for professional in vitro diagnostic use, andshouldonlybe used for the qualitative detection of cardiac Troponin I. No meaningshouldbeinferred from the color intensity or width of any apparent bands.
2. The cTnI Rapid Test will only indicate the presence of TroponinI inthespecimen and should not be used as the sole criteria for the diagnosis of myocardialinfarction.
3. If the test result is negative and clinical symptoms persist, additional testingusingother clinical methods is recommended. The test cannot detect less than0.5ng/mLofcTnI in specimens. Thus, a negative result does not at anytime rule out the existenceofTroponin I in blood, because the antibodies may be absent or belowtheminimumdetection level of the test.
4. Like with all diagnostic tests, a confirmed diagnosis should only be madebyaphysician after all clinical and laboratory findings have been evaluated.
5. Some specimens containing unusually high titers of heterophile antibodiesorrheumatoid factor (RF) may affect expected results. Even if the test resultsarepositive, further clinical evaluation should be considered with other clinicalinformation available to the physician.
【PERFORMANCE CHARACTERISTIC】
Relative Sensitivity: 99.45%
Relative Specificity: 99.52%
Overall Agreement: 99.49%
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