INTENDED USE
GLOB Multi-Drug 5in 1 Test is a diagnostic, qualitative, lateral flow, immunochromatographic, urinary assay in a convenient one step multiple test strip format for rapid detection of drugs of abuse in human urine at cut- off levels specified by SAMHSA. Test strips include in the Glob Mulit-Drug 5 Test This test is designed to obtain a visual, qualitative result and intended for professional use only. It is not intended for quantitative results, not for over-the-counter sale.
SUMMARY&EXPLANATION
The Glob Mulit-Drug 5Test device is a conventient holder allowing five individual determinations in one dip using Glob Drugs of Abuse test strips. The test employ easy, fast and visually read, competitive binding immunoassay methods to arrive at determination without the need for instrumentation. Individual test strips function independently and employ unique, specific antibodies to selectively identify individual drugs of abuse or their metabolites in human urine. There is no intercommunication between test strips.
ASSAY PROCEDURE
1.Do not open foil pouch until ready to begin testing. Refrigerated test device should be allowed to equilibrate to room
temperature before pouch is opened.
2. Remove the test device from the sealed foil pouch by tearing along the notch.
3. Draw the urine sample into the pipette and dispense four drops (approximately 0.2ml) into the sample well of test device.
5. Read the result within five minutes.
RESULTES
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 appearing in the test region with no apparent band appearing 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. With an invalid result, the specimen should be re-tested using a new test.