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 (570 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.
SPECIFICATIONS
ACCURACY - The bias of control is ±10%.
PRECISION - The CV of the test should be 55%.
LINEARITY - The assay is linear up to 32.0 mg/dL.
INTERFERENCE - The following analytes were tested up to the levels indicated and found not to interfère: Intralipid: 1000 mg/dL; Hemoglobin: 500 mg/dL Bilirubin: 30 mg/dL