Orawell Oral Fluid Drug Screen Device

INTENDED USE

The Urine Drug Screen Dip Test is a rapid, one-step immunoassay for the qualitative detection of 6-AM/AMP/BAR/BUP/BZO/COC/FEN/K2/KRA/MET/MTD/OPI/OXY/KET/PCP/PPX/TCA/THC/TRA/ EDDP and their metabolites.

Test principle

Urine Drug Screen Dip Test is a rapid lateral fluid immunoassay utilizing monoclonal antibodies to selectively detect specific drugs and their metabolites at above cutoff levels in human urine. The assay is based on competitive immunoassay procedure in which the drug conjugates immobilized on nitrocellulose membrane compete with the drugs if present in specimen for the limited amount of antibody on colloidal gold conjugates. If there is no drug present or the drug concentration in the specimen is below cutoff level, the red colloidal gold conjugate will bind to the drug conjugate at the specific test region, to form a visible band which indicated a negative result. If there is drug present in the specimen at above cutoff level, the drug will bind to the limited antibodies on colloidal gold, leaving no antibody available for binding to the drug conjugates on membrane. Thus, the absences of a test line band present at specific test region indicate a presumptive positive result for that particular drug.

Reagents

The Urine Drug Screen Dip Test contains up to 12 membrane strips. Each strip consists of a membrane immobilized with drug-protein conjugates and corresponding specific drug monoclonal antibody colloidal gold conjugate pad and a sample pad.

Quality Control

The device has built-in control band in each window at the control regions (C) to indicate that the test has performed properly. If the control bands do not appear, the test device should be discarded. The use of external controls is strongly recommended as good laboratory testing practice to verify test performance. The same assay procedure should be followed with external control materials as with a urine specimen. When external controls do not produce the expected results, do not run test specimens. Laboratories should comply with all federal, state, and local laws, guidelines and regulations.