| Customization: | Available |
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| Type: | IVD Reagent |
| Kit Size: | 40 Tests |
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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).
PRINCIPLE
The Troponin I (cTnI) Rapid Test detects cardiac Troponin I through visual interpretation of color development on the internal strip. Anti-cTnI antibodies are immobilized on the test region of the membrane. During testing, the specimen reacts with anti-cTnI antibodies conjugated to colored particles and precoated on the sample pad of the test. The mixture then migrates through the membrane by capillary action, and interacts with reagents on the membrane. If there are sufficient cTnI in the specimen, a colored band will form at the test region of the membrane. The presence of this colored band indicates a positive result, while its absence indicates a negative result. The appearance of a colored band at the control region serves as a procedural control, indicating that the proper volume of specimen has been added and membrane wicking has occurred.
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.
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.
PERFORMANCE CHARACTERISTIC
Relative Sensitivity: 99.45%
Relative Specificity: 99.52%
Overall Agreement: 99.49%
For further operation or performance details, please refer to final instruction manual.
1.Are you a Manufacturer?
Yes,we are manufacturer based in Foshan,China with 100 workers,more than 5000 square meter non-dust workshop,advanced automate machines and professional R&D team ensure the high quality,speedy delivery and large production capacity.
2.Can we put our logo/text om the product or package?
Yes,we can do OEM or even ODM.All of our products can be customized.
3.Can you provide free samples?
Yes, free sample are available.
4.How long is your production time?
Our production time is usually two weeks after receiving the deposit and four weeks for one contaoner order quantity.
5.How to make the payment?
By T/T,L/C,Paypal,Western union and made in China is also acceptable.
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