REI
customer survey 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.
PERFORMANCE CHARACTERISTICS
Accuracy - The accuracy of the Rapid Exams Dip card was evaluated in comparison to commercially available drug screen tests. Sixty (60) negative urine samples collected from presumed non-user volunteers were tested by both Rapid Exams Dip card and commercially available drug screen tests. Of these negative urine samples tested, all were found negatives by both methods. In a separate study, positive urine samples,obtained from clinical laboratories where the drug concentrations were determined by GC/MS (TCA concentrations were determined by HPLC), were tested by Rapid Exams Dip card and commercial drug screen tests.
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