INTRODUCTION
Troponin I (cTnl) Test is a qualitative, membrane-based immunoassay for the detection of the cTnl present in the whole blood, serum or plasma. The membrane is pre-coated with streptavidin on the test line region of the kit.
PRINCIPLE
During testing, the whole blood, serum or plasma specimen reacts with the particle coated with anti-cTnl antibodies and biotinylated anti-cTnl antibodies. The mixture migrates upward on the membrane through chromatography by capillary action to react with the streptavidin present on the membrane and develop a red line. The presence of this red line in the test region indicates a positive result, while its absence indicates a negative result. A red line will always appear in the control line region (C) it serves as a procedural control and indicates that proper volume of specimen has been added and the membrane wicking has occurred.
TEST PROCEDURE
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Remove the test card from the pouch and allow it to equilibrate to room temperature prior to testing. Place the card flat on a clean, dry and non-absorbent surface.
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Dispense 2 drops of serum specimen (100ul) into the specimen well.
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Wait for 20 minutes and read the result. Do not read the results after 20 minutes.
INTERPRETATION OF RESULTS
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Negative: Only 1 colored band appears on the control (C) region and no apparent band on the test (T) region.
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Positive: In addition to a pink control (C) band, a distinct pink band also appears in the test (T) region.
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Invalid: Absence of color in both regions indicates a procedural error and/or the test reagent has deteriorated.
STORAGE AND STABILITY
The test kit should be stored at room temperature between 4 to 30° C in the sealed pouch until the date of expiry. The test kit should be kept away from direct sunlight, moisture, and heat.
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