This panel is a rapid screening test designed for the simultaneous qualitative detection of multiple drugs of abuse and their metabolites in human urine. It is intended for medical use and in vitro diagnostic applications in clinical and laboratory diagnostic activities only

Summary

Urine screening tests are used to detect the presence of multiple drugs of abuse in urine at concentrations above the normal range. The rapidity and sensitivity of immunoassay tests have made them one of the most widely accepted methods for the detection of various drugs of abuse in urine. The multi-panel urine drug screening test detects any combination of drug analytes listed in the table above. This test provides only a preliminary analytical result. A more specific alternative method must be used to confirm preliminary positive results. Gas chromatography/mass spectrometry (GC/MS) is considered the preferred confirmatory method. Clinical and professional judgment should be applied when interpreting drug test results, especially in cases where the preliminary result is positive.

The multi-panel urine drug screening test is based on a competitive binding immunoassay principle. Drugs present in the urine sample compete with drug-coated analytes for binding sites on specific antibodies. During testing, the urine sample migrates upward through the membrane by capillary action. If the concentration of the drug in the urine sample is below the Cut-off level, it will not saturate the antibody binding sites. The gold nanoparticle-conjugated antibodies then bind to the coated analyte immobilized on the test line, producing a colored line in the test region (T). If the concentration of the drug in the urine sample is above the Cut-off level, no colored line will appear in the test region because all antibody binding sites become saturated by the drug present in the sample. Therefore, the gold nanoparticle-conjugated antibodies cannot bind to the coated analyte on the test line, and no test line (T) is formed. Therefore, in a positive urine sample, the competitive reaction prevents the formation of a line in the test region (T). In contrast, in a negative urine sample, the absence of drug competition allows the formation of a visible line in the test region (T). For quality control purposes, a colored line must always appear in the control region (C), indicating that an adequate volume of sample has been applied and that the test has been performed correctly.

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