INTENDED USE

The PCT Rapid Test is a rapid chromatographic immunoassay for the qualitative detection of Procalcitonin in whole blood, serum or plasma.

SUMMARY

Procalcitonin(PCT) is a small protein that comprises 116 amino acid residues with a molecular weight of approximately 13 kDa which was first described by Moullec et al. in 1984. PCT is produced normally in C-cells of the thyroid glands. In 1993, the elevated level of PCT in patients with a system infection of bacterial origin was reported and PCT is now considered to be the main marker of disorders accompanied by systemic inflammation and sepsis. The diagnostic value of PCT is important due to the close correlation between PCT concentration and the severity of inflammation. It was shown that “inflammatory” PCT is not produced in C-cells. Cells of neuroendocrine origin are presumably the source of PCT during inflammation.

PRINCIPLE

The PCT Rapid Test is a qualitative, lateral flow immunoassay for the detection of PCT in serum or plasma. The membrane is pre-coated with anti-PCT antibody on the test line region of the strip. During testing, the serum or plasma specimen reacts with the particle coated with anti-PCT antibody. The mixture migrates upward on the membrane chromatographically by capillary action to react with anti-PCT antibody on the membrane and generate a colored line. The presence of this colored line in the test 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.