Drug Testing Products> Technical Report

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INTENDED USE

The DrugCheck 5 ^TM is a immunochromatographic assay for rapid, qualitative detection of five drugs and their principal metabolites in urine at specified cut-off concentrations. A five drug combination is composed from the following drugs:

SUMMARY AND EXPLANATION OF THE TEST

The DrugCheck 5 ^TM is an easy, fast, qualitative, visually read competitive binding immunoassay method for screening without the need of instrumentation. The method employs unique mixture of antibodies to selectively identify the drugs of abuse and their metabolites in test samples with a high degree of sensitivity.

Drug abuse remains a growing social and economical concern in many developed and developing countries throughout the world. The above stated drugs are among the most frequently abused illicit drugs, according to the U.S. Substance Abuse and Mental Health Services Administration. Opiates are among a class of heavily abused prescription drugs.

The sensitivity of DrugCheck 5 ^TM is set as required for the screening immunoassays of these drugs in the reference guidelines set by the U.S. Substance Abuse and Mental Health Services Administration (SAMHSA) and the U.S. Department of Health and Human Services.

PRINCIPLE OF THE TEST

The DrugCheck 5 is a competitive binding immunoassay in which drug and drug metabolites in a urine sample compete with immobilized drug conjugate for limited labeled antibody binding sites. By utilizing antibodies that are specific to different drug classes, the test permits independent, simultaneous detection of five drugs from a single sample. The approximate run time is 5 minutes.

In the assay procedure, urine mixes with labeled antibody-dye conjugate and migrates along a porous membrane. When the concentration of a given drug is below the detection limit of the test, unbound antibody-dye conjugate binds to antigen conjugate immobilized on the membrane, producing a rose-pink color band in the appropriate Test Zone for that drug. Conversely, when the drug level is at or above the detection limit, free drug competes with the immobilized antigen conjugate on the membrane by binding to antibody-dye conjugate, forming an antigen- antibody complex, preventing the development of a rose-pink color band.

Regardless of the drug levels in the sample, a rose-pink color band is produced in each Control Zone by a parallel immunochemical reaction. These bands serve as built-in quality control measures by demonstrating antibody recognition, verifying that the reagents are chemically active.

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REAGENTS AND MATERIALS PROVIDED

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MATERIALS REQUIRED BUT NOT PROVIDED

1.  Clock or timer.

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