CRP (ultra sensitive)

 

Method: Immunoturbidimetric

 

INTENDED USE

For the in vitro quantitative determination of CRP in serum and plasma samples.

 

CLINICAL SIGNIFICANCE
CRP (C-reactive protein) is an acute phase protein whose concentration is seen to increase as a result of the inflammatory process, most notably in response to pneumococcal (bacterial) infectious, histolytic disease and a variety of disease states. Originally discovered by Tillet et al. in 1930 in patient sera with acute infection, CRP has now come to be used as a marker or general diagnostic indicator of infections and inflammation, in addition to serving as a monitor of patient response to therapy and surgery. Furthermore, regular measurements of CRP in infants can be a useful aid in the early diagnosis of infectious disease.

 

PRINCIPLE
When an antigen-antibody reaction occurs between CRP in a sample and anti-CRP antibody which has been sensitized to latex particles, agglutination results. This agglutination is detected as an absorbance change (572 nm), with the magnitude of the change being proportional to the quantity of CRP in the sample. The actual concentration is then determined by interpolation from a calibration curve prepared from calibrators of known concentration.

 

LINEARITY
The assay is linear up to an CRP concentration of 0.08-35 mg/dl. If the concentration exceeds the top standard value, further dilute the sample 1+1 with 0.9% NaCl. Multiply the result by 2.

 

INTERFERENCE 

The following analytes were tested up to the levels indicated and found not to interfere:

Hemoglobin: 500 mg/dl
Conjugated Bilirubin: 30 mg/dl
Intralipid: 4%
Ascorbic Acid: 50 mg/dl
RF: 500 IU/ml

 

SENSITIVITY
The minimum detectable concentration of CRP with an acceptable level of precision was determined as 0.01 mg/dl.

 

PROZONE
No prozone Phenomenon occurs when CRP ≤ 60mg/dl.

 

PRECISION
The CV of the test should be ≤ 5%.