Cardiac Troponin T (cTnT) Rapid Test, rapid chromatographic immunoassa,WB/S/P
A rapid test for the diagnosis of myocardial infarction (MI) to detect cardiac Troponin T(cTnT) qualitatively in whole blood, serum or plasma.
For professional in vitro diagnostic use only.
The Cardiac Troponin T Rapid Test Cassette (Whole Blood/Serum/Plasma) is a rapid chromatographic immunoassay for the qualitative detection of human cardiac Troponin T in whole blood, serum or plasma as an aid in the diagnosis of myocardial infarction (MI).
Cardiac Troponin T(cTnT) is a structurally bound protein found in striated muscle cells with a molecular weight of 37kD.1 Troponin T is part of a three subunit complex comprising of Troponin I 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 acute myocardial infarction (AMI), serum cTnT levels are elevated 2 to 8 hours after onset, peak in 12-24 hours and can persist for up to 14 days.3 Cardiac Troponin T(cTnT) as currently recognized as the most valuable diagnostic index for myocardial injury, has shown broad application prospects and replaced creatine phosphate kinase MB isoenzyme (CK-MB) as the "gold standard" for judging myocardial injury, especially for diagnosing acute myocardial infarction. It plays an important role in the diagnosis of heart failure, unstable angina pectoris, myocarditis, drug-induced myocardial injury, cardiac injury monitoring in thoracic surgery, various critical diseases and multiple organ failure.
The Cardiac Troponin T Rapid Test Cassette (Whole Blood/Serum/Plasma) is a simple test that utilizes a combination of anti-cTnT antibody coated particles and capture reagent to detect cTnT in whole blood, serum or plasma. The minimum detection level is 0.5ng/mL.
The Cardiac Troponin T Rapid Test Cassette (Whole Blood/Serum/Plasma) is a qualitative, membrane based immunoassay for the detection of cardiac Troponin T (cTnT) 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-cTnT 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 T (cTnT) in specimens. If the specimen contains cardiac Troponin T (cTnT), a colored line will appear in the test line region, indicating a positive result. If the specimen does not contain cardiac Troponin T (cTnT), 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.
The test contains anti-cTnT antibody coated colloid gold particles and capture reagent coated on the membrane.
- 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 cassette 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 proceduresfor 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.
STORAGE AND STABILITY
Store as packaged in the sealed pouch either at room temperature or refrigerated (2-30°C). The test is stable through the expiration date printed on the sealed pouch. The test must remain in the sealed pouch until use. DO NOT FREEZE. Do not use after the expiration date.
SPECIMEN COLLECTION AND PREPARATION
The Cardiac Troponin T Rapid Test Cassette (Whole Blood/Serum/Plasma) can be performed using whole blood (from venipuncture or fingerstick), serum or plasma.
- To collect Fingerstick Whole Blood specimens
- Wash the patient’s hand with soap and warm water or clean with an alcohol swab. Allow to dry.
- Massage the hand without touching the puncture site by rubbing down the hand towards the fingertip of the middle or ring finger.
- Puncture the skin with a sterile lancet. Wipe away the first sign of blood.
- Gently rub the hand from wrist to palm to finger to form a rounded drop of blood over the puncture site.
- Add the Fingerstick Whole Blood specimen to the test by using a capillary tube:
- Touch the end of the capillary tube to the blood until filled to approximately 75uL. Avoid air bubbles.
- Place the bulb onto the top end of the capillary tube, then squeeze the bulb to dispense the whole blood to the specimen well of the test cassette.
- Separate serum or plasma from blood as soon as possible to avoid hemolysis. Use only clear non-hemolyzed specimens.
- Testing should be performed immediately after the specimens have been collected. Do not leave the 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 1 day of collection.
- Do not freeze whole blood specimens. Whole blood collected by fingerstick should be tested immediately.
- Bring specimens to room temperature prior to testing. Frozen specimens must be completely thawed and mixed well prior to testing. Specimens should not be frozen and thawed repeatedly.
- If specimens are to be shipped, they should be packed in compliance with local regulations
DIRECTIONS FOR USE
Allow the test cassette, specimen, buffer and/or controls to reach room temperature (15-30°C) prior to testing.
1. Bring the pouch to room temperature before opening it. Remove the test cassette from the sealed pouch and use it as soon as possible.
2. Place the cassette on a clean and level surface.
For Serum or Plasma specimen:
Hold the dropper vertically and transfer 3 drops of serum or plasma (approximately 75 uL) to the specimen well, and start the timer. See illustration below.
For Venipuncture Whole Blood specimen:
Hold the dropper vertically and transfer 3 drops of whole blood (approximately 75uL) to the specimen well, then add 1 drop of buffer (approximately 40 uL), 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 uL of fingerstick whole blood specimen to the specimen well of test cassette, then add 1 drop of buffer (approximately 40 uL) and start the timer. See illustration below.
3. Wait for the colored line(s) to appear. Read result at 10 minutes. Do not interpret the result after 20 minutes.
Note: It is suggested not to use the buffer, beyond 6 months after opening the vial.
INTERPRETATION OF RESULTS
(Please refer to the illustration above)
POSITIVE:* Two colored lines appear. One colored line should be in the control line region (C) and another colored line should be in the test line region (T).
*NOTE: The intensity of the color in the test line region (T) will vary depending on the concentration of cardiac Troponin T (cTnT) present in the specimen. Therefore, any shade of color in the test line region (T) should be considered positive.
NEGATIVE: One colored line appears in the control line region (C). No line appears in the test line region (T).
INVALID: Control line fails to appear. Insufficient specimen volume or incorrect procedural techniques are the most likely reasons for control line failure. Review the procedure and repeat the test with a new test. If the problem persists, discontinue using the test kit immediately and contact your local distributor.
A procedural control is included in the test. A colored line appearing in the control line region(C) is considered an internal procedural control. It confirms sufficient specimen volume, adequate membrane wicking and correct procedural technique.
Control standards are not supplied with this kit; however, it is recommended that positive and negative controls be tested as a good laboratory practice to confirm the test procedure and to verify proper test performance.
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