Immunoassay 25 pcs.

    Producer: Iso Trade
    Product code: 5902802916143
    External code: 00010701

    The Corona virus test is a medical device intended for a professional user, as defined in Art. 2 point 1.26) of the Act on Medical Devices of May 20, 2010. Please note that the tests are not intended for home use by private individuals.

    The kit consists of a box containing 25 Rapid Cassette Tests. The price is for a box with 25 tests.


    DESTINY

    COVID-19 IgM / IgG Antibody (IgM / IgG) Combined Test Kit is a rapid immunochromatographic test for the qualitative detection of IgM and IgG antibodies to SARS-CoV-2 in human serum, plasma or whole blood for use as an aid in the diagnosis of COVID-19 infections . Negative results do not rule out COVID-19 infection and should not be used as the sole basis for making a treatment or other patient management decision.

    So far, there are 7 types of human coronavirus (HCoV) causing respiratory disease in humans: HCoV-229E, HCoV-OC43, HCoV-NL63, HCoV-HKU1, SARS-CoV, MERS-CoV and SARS-CoV-2, is an important pathogen causing respiratory infections in humans. Among them, SARS-CoV-2 is a new strain of the coronavirus that causes COVID-19 that has never occurred in humans before. The clinical symptoms of COVID-19 are systemic symptoms such as fever and fatigue accompanied by dry cough and shortness of breath etc., which can rapidly develop into severe pneumonia, respiratory failure and severe respiratory distress. The state of emergency, septic shock, multi-organ failure, severe disturbances in acid-base metabolism, etc. are even life-threatening.

    In general, when infected with the virus, the body can make IgM and IgG antibodies. IgM antibody levels generally begin to rise within 1 week of the first infection and peak within 2-3 weeks. IgG appears later than IgM, typically around 14 days after infection, peaks within 5 weeks and can last 6 months or even years. The recovery period of the patient is 4 times or more longer than the acute phase IgG antibody titre or, if shortened, it is of clinical diagnostic importance for viral infection.

    PRINCIPLE

    COVID-19 IgM / IgG Antibody (IgM / IgG) Combined Test Kit is a qualitative lateral flow immunoassay for the detection of IgM and IgG antibodies to SARS-CoV-2 in human serum, plasma or whole blood. In this assay, the anti-human IgM monoclonal antibody and the anti-human IgG monoclonal antibody are separately coated regions of the test cassette test line. During the test, the sample reacts with recombinant SARS-CoV-2 antigens, which are labeled on the latex particles. The mixture migrates up the membrane and reacts with anti-human IgM and / or human IgG antibodies on the membrane to form one or two colored lines in the test areas. A colored line in one or both test areas indicates a positive result. A colored control line always appears in the control area if the test has been performed correctly.

    REAGENTS

    The kit contains the SARS-CoV-2 virus surface S (spike-protein) and labeled nucleocapsid protein particles and an anti-human IgG antibody, an anti-human IgM antibody coated on the membrane.

    PRECAUTIONS

    Please read all the information in this package insert before performing the test.

    • The product is intended only for professional in vitro diagnostics. Do not use after the expiry date.

    • The test must remain in the sealed pouch until use.

    • Correct storage and transport of samples is critical to this test.

    • All specimens should be considered potentially hazardous and infectious agent management procedures should be followed.

    • Wear protective clothing such as lab clothing, disposable gloves, and safety goggles when testing samples.

    • Used tests must be disposed of in accordance with national regulations.

    BASIC INGREDIENTS

    Materials provided

    • 25 individual sealed pouches, each containing:

    ¦ 1 x test cassette

    ¦ 1 x desiccant bag

    • 25 disposable droppers

    • Buffer (2 * 3ml)

    • Package leaflet

    Required materials not included in the scope of delivery

    • Containers for storing samples

    • Centrifuge (for plasma only)

    • Timepiece

    • Lancets (only for whole blood samples from finger on strip)

    • STORAGE AND DURABILITY

    • Store packaged at room temperature or in a refrigerator (2-30 ° C). The test is stable until the expiration date printed on the sealed pouch. The test must remain in the sealed pouch until use. DO NOT FREEZE. Do not use after the expiry date. The buffer solution should be resealed in time after use. Keep away from heat sources.




    Who can purchase the tests?


    Healthcare facilities, hospitals, clinics, as well as a doctor, laboratory technician, pharmacist, nurse, veterinarian, when providing the number of the profession, some professions require a written consent for a finger puncture. In addition, each company provides the tax identification number.
    In the event of a purchase by unauthorized persons, the order will be canceled and any money payments will be refunded REDUCED by the costs of payment processing, specified during the purchase.



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