When an antigen-antibody reaction occurs between Mb in a sample and anti-Mb 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 Mb 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 - In the range of 10 " 850 ng/ml, the linear corrélation coefficient r2 ≥ 0.990.
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: 50 mg/dL; Ascorbic acid: 50 mg/dL