Troponin I(cTnI) Test cassette

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 membranethrough 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

• 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.

• Dispense 2 drops of serum specimen (100ul) into the specimen well.

• Wait for 20 minutes and read the result. Do not read the results after 20 minutes.

INTERPRETATION OF RESULTS

• Negative: Only 1 colored band appears on the control (C) region and no apparent band on the test (T) region.

• Positive: In addition to a pink control (C) band, a distinct pink band also appears in the test (T) region.

• 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.