The virus crown test is a medical device intended for the professional user, as defined in art. 2 point 1.26) of the Medical Devices Act of 20.05.2010. Please note that the tests are not intended for home use by private persons.
The kit consists of a package containing 25 quick test cassettes. The price is for a box with 25 tests.
COVID-19 IgM / IgG Antibody (IgM / IgG) Combined Test Kit is a rapid immunochromatographic test for the qualitative detection of IgM and IgG antibodies against SARS-CoV-2 in human serum, plasma or whole blood for use in the diagnosis of COVID-19 infections . Negative results do not exclude COVID-19 infection and should not be used as the sole basis for making treatment decisions or other decisions regarding patient management.
There are so far 7 types of human coronavirus (HCoV) causing respiratory diseases 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 coronavirus strain that causes COVID-19 that has never been seen in humans before. Clinical manifestations of COVID-19 are systemic symptoms such as fever and fatigue, accompanied by a dry cough and shortness of breath, etc., which can quickly develop into severe pneumonia, respiratory failure and severe breathing disorders. Emergency, septic shock, multiple organ failure, severe acid-base metabolism disorders, etc. are even life-threatening.
Generally, the body can produce IgM and IgG antibodies after infection with the virus. IgM levels generally begin to rise within 1 week of the first infection and reach a peak within 2-3 weeks. IgG appears later than IgM, usually around 14 days after infection, reaches a peak in 5 weeks, and can last for 6 months or even years. The patient's convalescence period is 4 times or more, longer than the occurrence of acute phase IgG titers or, if shortened, has clinical diagnostic significance for a viral infection.
COVID-19 IgM / IgG Antibody (IgM / IgG) Combined Test Kit is a qualitative lateral flow immunoassay for detecting IgM and IgG antibodies against SARS-CoV-2 in human serum, plasma or whole blood. In this test, the monoclonal anti-human IgM antibody and the monoclonal anti-human IgG antibody are separately coated areas of the test cassette test line. During the test, the sample reacts with recombinant SARS-CoV-2 antigens that are labeled on latex particles. The mixture migrates up the membrane, and reacts with antibodies against human IgM and / or human IgG on the membrane and forming 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 was performed correctly.
The kit includes the SARS-CoV-2 virus spike-protein S surface protein and labeled nucleocapsid protein particles, and an anti-human IgG antibody coated on a membrane.
Before performing the test, please read all the information in this package leaflet.
The product is intended for professional in vitro diagnostic use only. Do not use after the expiry date.
The test must remain in a sealed bag until use.
Proper storage and transport of samples is critical to making this test.
All samples should be considered potentially hazardous and procedures for dealing with infectious agents should be used.
Protective clothing such as laboratory clothing, disposable gloves and safety goggles should be worn when testing samples.
Used tests should be disposed of in accordance with national regulations.
25 individual sealed bags, each containing_
■ 1 x test cassette
■ 1 x bag with dryer
25 disposable droppers
Buffer (2 * 3ml)
Leaflet included in the package
Necessary materials not included in the scope of delivery
Sample storage containers
Centrifuge (only for plasma)
Lancets (only for whole blood from finger on the strip)
STORAGE AND DURABILITY
Store packed at room temperature or in the refrigerator (2-30 ° C). The test is stable until the expiration date printed on the sealed bag. The test must remain in a sealed bag until use. DO NOT FREEZE. Do not use after the expiry date. The buffer solution should be resealed after use. Keep away from heat.
Who can buy tests?
Health care facilities, hospitals, at