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The one step Cassette Style Drug test is a rapid test based on the principle of immunoassay combined with conjugated colloid gold technology. The tests are designed to obtain a visual , qualitative result and are intended for professional use only . They are not intented for quantitative results ,nor for over-the-counter sale.
The Drug Test provides only preliminary analytical data , A more specific ,alternative method is required to obtain a confirmed analytical result .SAMHSA has established gas chromatography / mass spectrometry (GC/MS) as the preferred confirmatory method. Clinical considerations and professional judgment should be applied to any drug of abuse test result ,particularly when preliminary positive Results are indicated.
PRINCIPLE OF THE PROCEDURE
The Drug Test is a competitive ,IVD, immunochromatographic ,urinary assay in which a chemically modified and bound drug conjugate competes with urinary MED for limited ,specific drug antibody binding sites. The one step Cassette Style Drug Test have five strips ,Each test stip contain a sample reaction unit , a pink-colored , antibody-colloidal gold conjugate unit pre-labeled with specific antibody ,and a chromatographic membrane pre-coated with drug conjugate in the device test region .
When free drug is absent from urine or at concentration lower than the urinary detection cut-off level, the pink-colored ,antibody-colloidal gold conjugate is free to bind to the immobilized drug conjugate pre-coated on the chromatographic membrane test region .Consequently ,a pink-colored band will form in the test region indicating a negative result .When drug is present in urine at concentrations at or exceeding the detection cut-off level, it will bind to limited epitopes on the pink-colored, antibody-colloidal gold conjugate , completely competing with drug conjugate in the test region .In such cases , no band forms in the test region ,indicating a positive result.
The one step Cassette Style Drug test also provide a built-in process control . A pink-colored band should always appear in the control region , regardless of the presence of any urinary MED . This pink-colored control band verifies that :1) sufficient urine volume was added, and
2) proper flow was obtained. If the control band is missing , the test was not performed correctly or failed to function correctly. In summary , negative urine will produce two pink-colored bands, one in the control region and one in the test region .Positive urine will produce one pink-colored band in the control region only .
INTERPRETATION OF RESULTS
Negative: Two pink-colored bands appear, one in the control region and one in the test region. A negative result indicates free drug is absent from urine or at concentrations lower than the detection cut-off level of the test.
Positive: One pink-colored band appears in the control region with no apparent band appering in the test region. A positive result indicates free
drug is present in urine at concentrations at or exceeding the detection cut-off level of the test.
Invalid: No band appears in the control region, or a pink-colored band appears in the test region only. An invalid test result may be due to improper assay procedures or damage to the device. If results are invalid, the assay is inconclusive and the specimen should be re-tested using a new test device.
Note: The band intensity may be weaker or stronger than that of the control band.
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