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INTENDED USE

Multi DOA Screen Panel are rapid chromatographic immunoassays for the qualitative and simultaneous detection of one to fourteen of the following drugs in a variety of combinations in human urine. The designed cutoff concentrations and direct calibrator for these drugs are as follows:

The test is used to obtain visual qualitative result and is intended for health care professionals use including professionals at point of care sites to assist in the determination of drug compliance. It is not intended for over the counter sale to non-professionals.

This assay provided only a preliminary analytical 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) or Liquid Chromatography/ Mass Spectrometry (LC/MS) are the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are indicated.

INTRODUCTION

Urine based screening tests for drugs of abuse range from simple immunoassay tests to complex analytical procedures. The speed and sensitivity of immunoassays have made them the most widely accepted method for screening urine for drugs of abuse.

The DOA Panels are based on the principle of the highly specific immunochemical reactions of antigens and antibodies, which are used for the analysis of specific compounds in human urine. The DOA Screen Panels are rapid, visual, competitive panel immunoassay that can be used for the simultaneous, qualitative detection of 11-nor-D⁹-tetrahydrocannabinol-9-carboxylic acid, Benzoylecgonine, Phencyclidine, Morphine, Methadone, Methamphetamine, Amphetamine, Barbiturates, Oxazepam, Nortriptyline, MDMA, ，Ketamine，Buprenorphine-3-D-Glucuronide, Tramadol and EDDP in urine. The length of time following drug use for which a positive result may occur is dependent upon several factors including the frequency and amount of drug, metabolic rate, excretion rate, drug half-life, and the drug user’s age, weight, activity and diet.

PRINCIPLE

The DOA Panels are one-step immunoassay in which chemically labeled drugs (drug-protein conjugates) compete for limited antibody binding sites with drugs which may be present in urine. The test device contains membrane strips which are pre-coated with drug-protein conjugates on the test band(s). Each strip, the drug antibody-colloidal gold conjugate pad is placed at one end of the membrane. In the absence of drug in the urine, the solution of the colored antibody-colloidal gold conjugate move along with the sample solution upward chromatographically by capillary action across the membrane to the immobilized drug-protein conjugate zone on the test band region. The colored antibody-gold conjugate then attach to the drug-protein conjugates to form visible lines as the antibody complex with the drug conjugate. Therefore, the formation of the visible precipitant in the test zone occurs when the test urine is negative for the drug. When the drug is present in the urine, the drug/metabolite antigen competes with drug-protein conjugate on the test band region for the limited antibody.  When a sufficient concentration of the drug is present, it will fill the limited antibody binding sites. This will prevent attachment of the colored antibody (drug-protein conjugate)-colloidal gold conjugate to the drug-protein conjugate zone on the test band region. Therefore, absence of the color band on the test region indicates a positive result.

A control band with a different antigen/antibody reaction is added to the immunochromatographic membrane strip at the control region (C) to indicate that the test has performed properly. This control line should always appear regardless of the presence of drug or metabolite. If the control line does not appear the test device should be discarded. 

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【公司名稱】 廣州健侖生物科技有限公司

【市場部】       楊永漢
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【騰訊 】
【公司地址】 廣州市清華科技園健新基地番禺石樓鎮健啟路63號二期2幢101-103室