CE Marked Multi-Panel DOA rapid test 4 parameter Ecotest
Intended Use of Multi Drug Rapid Test Panel
The DOA Cassettes / Panels are rapid chromatographic immunoassays for the qualitative and simultaneous detection of one to fourteen of the following drugs in a variety of combinations in human urine. The designed cutoff concentrations and direct calibrator for these drugs are as follows:
Principle of Multi Drug Rapid Test Panel
The DOA Cassettes / Panels are one-step immunoassay in which chemically labeled drugs (drug-protein conjugates) compete for limited antibody binding sites with drugs which may be present in urine. The test device contains membrane strips which are pre-coated with drug-protein conjugates on the test band(s). Each strip, the drug antibody-colloidal gold conjugate pad is placed at one end of the membrane. In the absence of drug in the urine, the solution of the colored antibody-colloidal gold conjugate move along with the sample solution upward chromatographically by capillary action across the membrane to the immobilized drug-protein conjugate zone on the test band region. The colored antibody-gold conjugate then attach to the drug-protein conjugates to form visible lines as the antibody complex with the drug conjugate. Therefore, the formation of the visible precipitant in the test zone occurs when the test urine is negative for the drug. When the drug is present in the urine, the drug/metabolite antigen competes with drug-protein conjugate on the test band region for the limited antibody. When a sufficient concentration of the drug is present, it will fill the limited antibody binding sites. This will prevent attachment of the colored antibody (drug-protein conjugate)-colloidal gold conjugate to the drug-protein conjugate zone on the test band region. Therefore, absence of the color band on the test region indicates a positive result. A control band with a different antigen/antibody reaction is added to the immunochromatographic membrane strip at the control region (C) to indicate that the test has performed properly. This control line should always appear regardless of the presence of drug or metabolite. If the control line does not appear the test device should be discarded.
Procedure and Result Reading of Single Drug Rapid Test Panel