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The AMDL-ELISA DR-70® (FDP) immunoassay is designed for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of DR-70® (FDP) in human serum. Serial testing using the AMDL- ELISA DR-70® (FDP) is to be used as an aid in monitoring the disease progression in patients who have been diagnosed previously with colorectal cancer. Results of DR-70® (FDP) testing should be used in conjunction with other clinical modalities that are standard of care for monitoring disease progression in these patients.

The AMDL, Inc. DR-70® (FDP) assay is an ELISA based assay utilizing removable strips in a 96 micro titer plate well format. The wells are coated with affinity purified rabbit anti-DR-70® (FDP) antibodies. The DR-70® (FDP) in diluted sera (1:200) is captured from the sera by these antibodies immobilized on the well of a micro titer plate. After a wash step, anti-DR-70® (FDP) antibodies conjugated to horseradish peroxidase are added to the wells. If the DR-70® (FDP) antigen is present, the anti-human fibrinogen peroxidase complex will bind to the captured tumor marker to form an immunological sandwich with the immobilized antibodies. After a second wash step, the enzyme substrate 3,3',5'-tetramethylbenzidine (TMB) is added to the well. The end point is read in a micro plate reader at 450 nm once the reaction is stopped with 0.1N HCl. The intensity of the color formed is proportional to the amount of DR-70® (FDP) in the serum. The amount is quantified by interpolation from a standard curve using the calibrators provided with the kit.