INTENDED USE

The CRP Rapid Test Device (Whole Blood/Serum/Plasma) is used for semi-quantitative determination and monitoring of CRP concentrations in whole blood/serum/plasma specimens.

SUMMARY

C-­reactive Protein (CRP) in patient’s sera has been found in association with acute infections, necrotic  conditions  and  a  variety  of  inflammatory  disorders.  There  is  a  strong  correlation  between serum levels of CRP and the onset of the inflammatory process. Monitoring the levels of CRP in patient’s sera indicates the effectiveness of treatment and the assessment of patient recovery. It is used in particular to differentiate bacterial infections from virus infections.

PRINCIPLE

The  CRP  Rapid  Test  Device  (Whole  Blood/Serum/Plasma)  detects  C-­reactive  Protein  through  visual interpretation of color development on the internal strip. Anti-­CRP antibodies are immobilized  on  the  test  region  of  the  membrane.  During  testing,  the  specimen  reacts  with  anti-­CRP antibodies conjugated to colored particles and precoated on the sample pad of the test. The mixture then migrates through the membrane by capillary action, and interacts with reagents on the membrane. If the intensity of the test band is weaker than reference band (R), it indicates that the CRP level in the specimen is between 10-­60 mg/L. If the intensity of the test band  (T)  is  stronger  than  the  reference  band  (R),  it  indicates  that  the  CRP  level  is  above  60  mg/L. The appearance of control line serves as a procedural control, indicating that the proper volume of specimen has been added and membrane wicking has occurred.