CTnI Rapid Test

PocTell^® Troponin I - cTnI Rapid Test (Whole Blood/Serum/Plasma) is a rapid chromatographic immunoassay for the qualitative detection of human cardiac Troponin I in whole blood, serum or plasma as an aid in the diagnosis of myocardial infarction (MI). For professional in vitro diagnostic use or care/near patient testing use..

PocTell^® Troponin I - cTnI Rapid Test (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 Strepavidin-IgG on the test line region of the test and cTnI-biotin on the sample pad. During testing, the whole blood, serum or plasma specimen reacts with the cTnI-biotin on the sample pad first, then migrates and react 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..

Allow the test, 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 device from the sealed pouch and use it as soon as possible.

2.Place the test device on a clean and level surface.

For Whole Blood, Serum or Plasma specimens:

Hold the dropper vertically and transfer 2 drops of specimen (or approximately 50 µL) to the specimen well (S) of the test device, then add 1 drop of buffer (or approximately 40 µL) and start the timer.

For Fingerstick Whole Blood specimens:

• To use a capillary tube: Fill the capillary tube and transfer approximately 50 µL of fingerstick whole blood specimen to the specimen well (S) of the test device, then add 1 drop of buffer (or approximately 40 µL) and start the timer.
• To use hanging drops: Allow 2 hanging drops of fingerstick whole blood specimen (approximately 50 µL) to the specimen well (S) of the test device, then add 1 drop of buffer (or approximately 40 µL) and start the timer.

3.Wait for the colored line(s) to appear. Read results at 10 minutes. Do not interpret results after 20 minutes. .

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