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FDA Drug Abuse Test Kit Detection On Surfaces And In Solids

Categories Drug Abuse Test Kit
Brand Name: AllTest
Model Number: Multidrug panel
Certification: CE, FDA 510K
Place of Origin: CHINA
MOQ: 500
Price: USD0.25
Supply Ability: 100 Million a year
Packaging Details: 25T/Kit
Format: Panel
Specimen: Urine
Kit Size: 25T/Kit
Cut-Off: /
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    FDA Drug Abuse Test Kit Detection On Surfaces And In Solids

    A rapid test for the detection of drugs on surfaces and in solids CE certified


    Applications:


    The Multi-Drug Rapid Test Panel is a rapid chromatographic immunoassay for the qualitative detection of multiple drugs and drug metabolites on surfaces and in solids at the following cut-off concentrations:

    Configurations of the Multi-Drug Rapid Test Panel come with any combination of the above listed drug analytes.This assay provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are indicated.


    Description:


    The Multi-Drug Rapid Test Panel is a rapid surfaces or solids screening test that can be performed without the use of an instrument. The test utilizes monoclonal antibodies to selectively detect elevated levels of specific drugs on surfaces and in solids.


    How to use?


    Test device (in closed pouches), samples, and controls should be brought to room temperature (15-30°C) prior to testing. Do not open pouches until ready to perform the assay.

    Remove the test device from its protective pouch and label the device with patient’s identification or control label.

    FOR SURFACES

    1. Wipe with the strips over the surface in which the drugs are expected
    2. Take off the cap of supplied tube;
    3. Fill all buffers from the supplied tube of buffer into the protection cover.
    4. Insert the Multi Test slowly and carefully into the protection cover with buffer

    4. Wait for lines to appear on the membrane and read the results after 5 minutes and do not interpret the result after 10 minutes.

    FOR SOLIDS

    1. Open the tube and put the solid in to the buffer.

    2. Close the tube with dropper and cap. Shake it a short time. Wait for 30 sec.

    3. Take off the cap of supplied tube;

    4. Fill all buffers with dissolved substances into the protection cover.

    5. Insert the Multi Test slowly and carefully into the protection cover with buffer.

    6. Wait for lines to appear on the membrane and read the results after 5 minutes and do not interpret the result after 10 minutes.



    Specifications


    Model

    Multi-Drug Rapid Test Panle for drugs on surface

    Format

    Strip,panel, Uncut sheet

    Accuracy

    99.2%

    Shelf life

    24months

    Component

    Test panel, Droppers, Package insert

    Specimen

    surface powder/solid

    Storage

    2-30°C

    Read time

    5 mins

    Others

    The kits can be made according to the customers' artwork or design


    PRINCIPLE


    During testing, specimen migrates upward by capillary action. A drug, if present in the specimen 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 region of the specific drug dipstick. 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 region.

    A drug-positive specimen will not generate a colored line in the specific test region of the dipstick because of drug competition, while a drug-negative specimen will generate a line in the test region because of the absence of drug competition.

    To serve as a procedural control, a colored line will always appear at the control region, indicating that proper volume of specimen has been added and membrane wicking has occurred.


    INTERPRETATION OF RESULTS

    (Please refer to the illustration above)

    NEGATIVE:* A colored line appears in the Control region (C) and colored lines appear in the Test region (T). This negative result means that the concentrations in the sample are below the designated cut-off levels for a particular drug tested.

    *NOTE: The shade of the colored lines(s) in the Test region (T) may vary. The result should be considered negative whenever there is even a faint line.

    POSITIVE: A colored line appears in the Control region (C) and NO line appears in the Test region (T). The positive result means that the drug concentration in the sample is greater than the designated cut-off for a specific drug.

    INVALID: No line appears in the Control region (C). Insufficient specimen volume or incorrect procedural techniques are the most likely reasons for Control line failure. Read the directions again and repeat the test with a new test card. If the result is still invalid, contact your manufacturer.


    QUALITY CONTROL

    A procedural control is included in the test. A line appearing in the control region (C) is considered an internal procedural control. It confirms sufficient specimen volume, adequate membrane wicking and correct procedural technique.

    Control standards are not supplied with this kit. However, it is recommended that positive and negative controls be tested as good laboratory practice to confirm the test procedure and to verify proper test performance.


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