DIAKEY DOA6 RAPID

INTENDED USE : DIAKEY DOA6 Rapid Test is consisted of six individual one-step lateral flow chromatographic immunoassays. The test is a lateral flow, one-step immunoassay for the qualitative detection of specific drugs and their metabolites in human urine at the following cut off concentrations: .

TEST METHOD : Immunochromatographic assay, ICA

This assay provides only a preliminary test result. A more specific alternative chemical method must be used in order 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 result, particularly when preliminary results are positive.

PRINCIPLE OF THE ASSAY

DIAKEY DOA6 Rapid Test is a competitive lateral flow chromatographic immunoassays that is used to screen for the presence of drugs or metabolites in human urine. The test device consists of six individual test strips into separate plastic holder.

Drugs or metabolites which be detected in the urine specimen compete against their respective drug conjugate for binding sites on their specific antibody. On each test strip, a drug–BSA conjugate is pre-coated onto specific region known as the test line region (T). A colored antibody-colloidal gold conjugate is coated onto a pad and placed at one end of the strip.

During testing, the DIAKEY DOA6 Rapid Test device is dipped into a urine sample. This allows the urine to come into contact with the sample pads, which allows the urine to move across the strip. If any drug is present in the urine, it competes with the drug conjugate for the limited binding sites on the colored antibody colloidal gold conjugate. When a sufficient amount of drug is present, the drug will saturate the antibody binding sites and the colored colloidal gold conjugate cannot bind to the drug conjugate on the strip. Therefore, the colored line will not form in the test line region.

A drug-positive urine specimen will not generate a colored line in the specific test line region of the strip because of drug competition, while a drug-negative urine specimen will generate a line in the test line region because of the absence of drug competition.

A control line with a different antigen/antibody reaction is added to the membrane strip at the control region (C) to indicate that the test performed properly. This control line should always appear regardless of the presence of drug or metabolite. The appearance of the control line during testing indicates that the test has completed and the test is valid.