TnI Troponin I Cassette Test

Product Description

TnI Troponin I Cassette Test 

PRINCIPLE:

The One Step Troponin I Test Device (Whole Blood/Serum/Plasma) is a qualitative, membrane based immunoassay for the detection of cTnI in whole blood, serum or plasma. The membrane is pre-coated with capture reagent on the test line region of the test. During testing, the whole blood, serum or plasma specimen reacts with the particle coated with anti-cTnI antibodies. The mixture migrates upward on the membrane chromatographically by capillary action to react with capture reagent on the membrane and generate a colored line. The presence of this colored line in the test line region indicates a positive result, while its absence indicates 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.  

PRECAUTIONS:

• For professional in vitro diagnostic use only. Do not use after expiration date.
• The test device should remain in the sealed pouch until use.
• Do not eat, drink or smoke in the area where the specimens or kits are handled.
• Do not use if pouch is damaged.
• Handle all specimens as if they contain infectious agents. Observe established precautions against microbiological hazards throughout the procedure and follow the standard procedures for proper disposal of specimens.
• Wear protective clothing such as laboratory coats, disposable gloves or eye protection when specimens are being tested.
• Humidity and temperature can adversely affect results.

STORAGE AND STABILITY:

Store as packaged in the sealed pouch either at room temperature or refrigerated (***0°C). The test device is stable through the expiration date printed on the sealed pouch. The test device must remain in the sealed pouch until use. DO NOT FREEZE. Do not use beyond the expiration date.

INTERPRETATION OF RESULTS:

POSITIVE:

Two distinct colored lines appear. One line should be in the control line region (C) and another 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 cTnI 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 apparent colored line appears in the test line region (T).

INVALID:

Control line (C) 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 device. If the problem persists, discontinue using the test kit immediately and contact your local distributor.

QUALITY CONTROL:

An internal procedural control is included in the test. A colored line appearing in the control line region (C) is 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.