Multi-Drug LazyCup Test Cup (Urine)

Multi-Drug LazyCup Test Cup (Urine) is a competitive binding immunoassay in which drugs and drug metabolites in a urine sample compete with immobilized drug conjugate for limited labeled antibody binding sites. When a sufficient amount of urine specimen is applied to the sample pad of the test device, the urine specimen migrates through the test device by capillary action. If the drug or drug metabolite concentration in the specimen is below the cut-off level, the anti-drug antibodies in colloidal gold particles will bind to the drug antigens coated in the test line of the nitrocellulose membrane to form a T line, which indicates a negative result. If the concentration of drug in the urine specimen is above the cut-off level, it will bind with antibodies conjugated with colloidal gold particles, so that no T line will be developed in the test region, which indicates a positive result.

TEST PROCEDURE

Allow the cup, urine specimen, and/or controls to reach room temperature (15-30°C) before testing.

1. 1. Remove the cup from the sealed pouch and use it as soon as possible.
2. 2. Collect specimen in the cup and secure the cap tightly.
3. 3. Read urine temperature between 2-4 minutes after voiding to verify the temperature ranges between 90-100℉.
4. 4. Place the cup on a flat surface.
5. 5. Date and initial the security seal, and place the security seal on the cap.
6. 6. Peel off the label on the cup to view the results.
7. 7. If adulteration test is included on the test cup, read the adulteration test results between 2 to 5 minutes. See the color chart for interpretation. If the specimen indicates adulteration, we recommend not to interpret the drug test results and either retest the urine or collect another specimen.
8. 8. Read the test results at 5 minutes. See the illustration below. For detailed operation instructions, please refer to the Procedure Card.
9. 

10. INTERPRETATION OF RESULTS

    Positive: One colored line appears in the Control zone (C). No line appears in the Test Zone (T). The absence of a line in the test region (T line) indicates a positive result. The positive result indicates that the drug level is above the detectable level.

    Note: The samples with positive results should be confirmed with more specific method.

    Negative: One colored line appears in the Control zone, and another colored line appears in the Test zone. The negative result indicates the drug or its metabolite level is below the detectable level.

    Invalid: No line appears in the Control zone. If no C line or no C line and T line develop within 5 to 10 minutes, the test is invalid. The test should be repeated with a new test device. Insufficient specimen volume or the incorrect procedural techniques are the most likely reasons for invalid result. Review the procedure and repeat the test using a new test strip or cup. If the problem persists, discontinue using the current lot and contact your suppliers.

    ADULTERATION INTERPRETATION

    (Please refer to the color chart, if applicable)

    Semi-quantitative results are obtained by visually comparing the reacted color blocks on the strip to the printed color blocks on the color chart. No instrumentation is required.

    LIMITATIONS
    

    1. For professional in vitro diagnostic use only.
    2. 1. Multi-Drug LazyCup Test Cup (Urine)provides only a qualitative, preliminary testing result. A more specific testing method must be used in order to obtain a confirmed testing result. Gas Chromatography/Mass
    3. 2. Spectrometry (GC/MS) is the preferred confirmatory method.
    4. 3. There is a possibility that technical or procedural errors, as well as other interfering substances in the urine specimen may cause erroneous results.
       4. 4. Adulterants such as bleach or other oxidizing agents may produce erroneous results. If suspected, the test should be repeated with a fresh specimen and a new device.
       5. 5. The urine specimens with bacterial contamination should not be used for testing, as these contaminations may interfere with the test and cause false results.
       6. 6. A positive result does not indicate the level of intoxication, the route of the drug administration or the concentration of the drug in the urine.
       7. 7. A negative result may not necessarily indicate drug-free urine. Negative results can be obtained when drug is present but below the cut-off level of test.
       8. 8. Test does not distinguish between drugs of abuse and certain medications.
       9. 9. Certain foods or food supplements may cause a false positive result.

       9.The test results can be used to provide evidence and basis for therapy and treatment plans of drug dependence and toxic psychosis. For laboratory professional in vitro diagnostic use only.

       10.The test should only be performed by health professionals in a clinical/hospital setting to aid in screening of drug of abuse to determine the follow-up treatment measures in combination of clinical symptoms.