Expected use
This one-step drug abuse test is a lateral flow chromatographic immunoassay for the qualitative detection of drugs and drug metabolites in urine. This assay provides only a preliminary analytical test result. A more specific alternative chemical method must be used to obtain a confirmed analytical result.
Gas chromatography / mass spectrometry (GC / MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test results, particularly when preliminary positive results are indicated.
Summary and explanation
The Rapid One-Step Drug Test is an immunoassay based on the principle of competitive binding. Drugs that may be present in the urine sample compete against their respective drug conjugate for binding sites on their specific antibody. During the test, a urine sample migrates upward by capillary effect. The drug, if present in the urine sample below its cut-off concentration, will not saturate the binding sites of its specific antibody.
The antibody will then react with the drug-protein conjugate and a visible colored line will appear in the test line region of the drug-specific strip. The presence of drug above the cutoff concentration will saturate all antibody binding sites. Therefore, the color line will not form in the test line region. To serve as a procedural control, a colored line will always appear in the control line region, indicating that the appropriate volume of sample has been added and membrane absorption has occurred.