Diagnostic Kit for Procalcitonin

(fluorescence immunochromatographic assay)

For in vitro diagnostic use only 

Please read this package insert carefully prior to use and strictly follow the instructions. Reliability of assay results cannot be guaranteed if there are any deviations from the instructions in this package insert.

INTENDED USE

Diagnostic Kit for Procalcitonin (fluorescence immunochromatographic assay) is a fluorescence immunochromatographic assay for the quantitative detection of Procalcitonin (PCT) in human serum or plasma, it is used for auxiliary diagnosis of bacterial infection and sepsis. All positive sample must be confirmed by other methodologies. This test is intended for healthcare professional use only.

SUMMARY

Procalcitonin is composed of 116 amino acids and its molecular weight is 12.7KD. PCT is expressed by neuroendocrine cells and broken down by enzymes into (immature) calcitonin, carboxy-terminating peptide, and amino terminating peptide. Healthy people only have a small amount of PCT in their blood, which can be significantly increased after bacterial infection. When sepsis occurs in the body, most tissues can express PCT, so PCT can be used as a prognostic indicator of sepsis. For some patients with inflammatory infection, PCT can be used as an indicator of antibiotic selection and efficacy judgment.

PRINCIPLE OF THE PROCEDURE

The membrane of the test device is coated with anti PCT antibody on the test region and goat anti rabbit IgG antibody on the control region. Lable pad are coated by fluorescence labeled anti PCT antibody and rabbit IgG in advance. When testing positive sample, the PCT antigen in sample combine with fluorescence labeled anti PCT antibody, and form immune mixture. Under the action of the immunochromatography, the complex flow in the direction of absorbent paper, when complex passed the test region, it combined with anti PCT coating antibody, forms new complex. PCT level is positively correlated with fluorescence signal, and the concentration of PCT in sample can be detected by fluorescence immunoassay assay.