Procalcitonin Rapid Test

Intended Use

Procalcitonin Rapid Test (Whole Blood/Serum/Plasma) is a rapid visual immunoassay for the qualitative presumptive detection of Procalcitonin in human whole blood, serum or specimens. Procalcitonin Rapid Test is intended for use as an aid in the diagnosis of inflammation.

What is Procalcitonin (PCT)?

Procalcitonin (PCT) is the precursor of calcitonin, and is normally produced in the C-cells of the thyroid gland. During systemic and severe infections, PCT is also produced rapidly in other tissues, and serum PCT concentrations increase to very high levels.. Assicot et al first described PCT as an inflammation-induced protein in 1993. Since then, numerous clinical studies have demonstrated the utility of this marker. PCT is more specific for detecting bacterial infection than other inflammatory markers, such as C-reactive protein (CRP) and white blood cell counts (WBC), because viral infections, autoimmune and allergic disorders do not induce PCT.

Materials

Materials Provided

● Individually packed test devices

● Package insert

● Disposable pipettes

● Buffer

Materials Required but Not provided

● Specimen collection container

● Timer

● Centrifuge

Test Procedure

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 2 drops of serum/plasma (approximately 50 µL) or 3 drops of whole blood (approximately 75µL) to the specimen well of the device with the provided disposable pipette, and then start the timer.

Avoid trapping air bubbles in the specimen well (S), and do not add any solution to the result area.

As the test begins to work, color will migrate across the membrane.

3. If the test fails to migrate across the membrane after 1 minute, add 1 drop of buffer to the specimen well (S).

4. Wait for the colored band(s) to appear. The result should be read at 10 minutes. Do not interpret the result after 20 minutes.

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