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QUALITY CONTROL
An internal procedural control is included in the test device.
A line must form in the Control band region regardless of the presence or absence of drugs or metabolites. The presence of the line in the Control region
indicates that the proper sample volume has been used and that the reagents are migrating properly. If the line in the Control region does not form,
the test is considered invalid.
To ensure proper kit performance, it is recommended that the test devices be tested once a week with external controls. External controls are available from
commercial sources. It is important to make sure that the control values are within established limits. If the values of external control do not fall within established
limits, the test results are invalid. Additional controls may be tested according to guidelines or requirements of local, state, and/or federal regulations or
accrediting organizations.
LIMITATIONS OF PROCEDURE
• The assay is designed for use with human urine only.
• A positive result with any of the tests indicates only the presence of a drug/metabolite and does not indicate or measure intoxication.
• There is a possibility that technical or procedural error as well other substances as factors not listed may interfere with the test
and cause false results. See SPECIFICITY for lists of substances that will produce positive results, or that do not interfere with test performance.
• If adulteration is suspected, the test should be repeated with new sample.
PRINCIPLE USE
The One Step Multi-Drug, Multi-CLIN Screen Test Device is an immunoassay based on the principle of competitive binding. Drugs, which may be present in the urine sample, compete against their respective drug conjugate for binding sites on their specific antibody.
During testing, a urine sample migrates upward by capillary action. A drug, if present in the urine sample below its cut-off concentration, will not saturate the binding sites of its specific antibody. The antibody will then react with the drug-protein conjugate and a visible colored line will show up in the test line region of the specific drug strip. The presence of drug above the cut-off concentration will saturate all the binding sites of the antibody. Therefore, the colored line will not form in the test line region.
A drug-positive urine sample will not generate a colored line in the specific test line region of the strip because of drug competition, while a drug-negative urine sample will generate a line in the test line region because of the absence of drug competition.
To serve as a procedural control, a colored line will always appear at the control line region, indicating that proper volume of sample has been added and membrane wicking has occurred.
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