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FAMILY MEDICINE testDescription A lateral flow immunoassay for the qualitative detection of specific drugs and their metabolites in human urine at the following cut-off concentrations: Test Calibrator Threshold limit (ng/ml) Cocaine Benzoylecgonine 300 Marijuana Marijuana 50 Methamphetamine Methamphetamine 1000 opioids Morphine 2000 ketamine ketamine 1000 The test provides a preliminary result; to obtain a confirmatory analytical result, an alternative, more specific chemical method should be used. The preferred confirmatory method is gas chromatography/mass spectrometry (GC/MS). Clinical analysis and professional judgment will be required for each drug of abuse test result, especially if the preliminary results are positive. How to use Sample collection and preparation • Wash your hands with warm water and mild soap. Open the sealed package and remove the test. • Open the container lid and urinate directly into it. The sample volume must exceed the minimum urine level. Close the container. Running the test The test should be performed at room temperature (10°C-30°C). 1. After collecting urine, close the container with a lid and place it on a flat surface. 2. Lift the label from right to left and read the result within 5 minutes. Do not read the results after 5 minutes. Interpretation of results POSITIVE (+) A pink band is visible in each control region. No colored band appears in the corresponding test region. This indicates a positive result for the drug corresponding to that specific region. NEGATIVE (-) A pink band is visible in each control region of the corresponding test region. This indicates that the drug concentration corresponding to that test region is zero or below the detection limit of the test. NULL If no colored band is visible in any of the control regions or if it is visible only in the test regions, the test is invalid. Another test should be performed to reevaluate the sample. No importance is given to the intensity of the color or the width of the line. limitation 1. This test was developed exclusively for urine specimens. The performance of this test using other specimens has not been demonstrated. 2. Adulterated urine samples may produce erroneous results. Strong oxidizing agents, such as bleach (hypochlorite), can oxidize drug assays. If you suspect a sample has been adulterated, collect a new sample. 3. This test is a qualitative control. It is not designed to determine the quantitative concentration of drugs or the level of intoxication. 4. Technical or procedural errors, as well as other substances that interfere with the urine sample, can lead to erroneous results. 5. A negative result does not necessarily indicate drug-free urine. Negative results can also occur when drugs are present but below the test cut-off level. 6. The test result does not distinguish between drugs of abuse and some medications. 7. Some foods or supplements may cause positive results. warnings This kit is for external use only. Do not swallow. • Discard after use. The test cannot be used more than once. • Do not use after the expiration date. • Do not use the kit if the packaging is punctured or not properly sealed. • Keep out of reach of children. • Product not intended for medical diagnostic purposes. Conservation Store at 4°C-30°C until expiration date. Store away from light, moisture and heat. Do not freeze. Format Package containing: a test, a desiccant, an information leaflet
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