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.

Biovantion Inc is independent from international department of Bioneovan Co., Ltd., which established in 2 0 0 5, is an in vitro diagnostic reagents manufacturer engaged in the research, development, production, and focus on clinical testing for infectious diseases, such as Hepatitis virus, Noro virus, Parvo virus test kits, our products include rapid test cassette and Elisa kits.

All our products have been registered in National Medical Products Administration of China, in year 2020 we get Certificate of ISO 13485:2016 – QUALITY MANAGEMENT SYSTEMS FOR MEDICAL DEVICES from SGS. More importantly, we have awarded the registration certificate from National Medical Products Administration for Diagnostic Kit for IgM Antibody to COVID-19 and IgG antibody to COVID-19 during the outbreak in China, and also we developed COVID-19 Antigen test ; Neutralizing Antibody Test, these products selling well all overthe world