Diagnostic Kit for hypersensitive C-reactive protein

(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 hypersensitive C-reactive protein (fluorescence immunochromatographic assay) is a fluorescence immunochromatographic assay for the quantitative detection of C-reactive protein (CRP) in human serum /plasma/ Whole blood. It is a non-specific indicator of inflammation. All positive sample must be confirmed by other methodologies. This test is intended for healthcare professional use only.

SUMMARY

C-reactive protein is an acute phase protein produced by lymphokine stimulation of liver and epithelial cells. It exists in human serum, cerebrospinal fluid, pleural and abdominal fluid, etc., and is a part of non-specific immune mechanism. 6-8h after the occurrence of bacterial infection,CRP began to increase, 24-48h reached the peak, and the peak value could reach hundreds of times of normal. After the elimination of the infection, CRP dropped sharply and returned to normal within one week. However, CRP does not increase significantly in the case of viral infection, which provides a basis for the identification of early infection types of diseases, and is a tool for identifying viral or bacterial infections.

PRINCIPLE OF THE PROCEDURE

The membrane of the test device is coated with anti CRP antibody on the test region and goat anti rabbit IgG antibody on the control region. Lable pad are coated by fluorescence labeled anti CRP antibody and rabbit IgG in advance. When testing positive sample, the CRP antigen in sample combine with fluorescence labeled anti CRP 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 CRP coating antibody, forms new complex. CRP level is positively correlated with fluorescence signal, and the concentration of CRP in sample can be detected by fluorescence immunoassay assay.

REAGENTS AND MATERIALS SUPPLIED

25T package components：

Test card individually foil pouched with a desiccant 25T

Sample diluents 25T

Package insert 1

MATERIALS REQUIRED BUT NOT PROVIDED

Sample collection container,timer

SAMPLE COLLECTION AND STORAGE

1. The samples tested can be serum, heparin anticoagulant plasma or EDTA anticoagulant plasma.
2. According to standard techniques collect sample. Serum or plasma sample can be kept refrigerated at 2-8℃ for 7days and cryopreservation below -15°C for 6 months. Whole blood sample can be kept refrigerated at 2-8℃ for 3 days
3. All sample avoid freeze-thaw cycles.