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Product name

2019-nCoV IgG/IgM Antibody Rapid Test Kit

Release time 2020-03-18
Clicks 4647

    In 2020, Coronavirus (COVID-19) is raging around the world. In February, Diagreat successfully developed the Coronavirus detection kit, 2019-nCoV IgG/IgM Antibody Rapid Test Kit, which is based on the Colloidal Gold Assay. 


Intended use

    The rapid test kit is used for qualitative determination of IgG and IgM antibodies of novel coronavirus in human serum, plasma or whole blood in vitro. This kit is offered to clinical laboratories and healthcare workers for point-of-care testing, and not for at home testing, in compliance with Section IV.D. of the FDA’s Policy for COVID-19 Diagnostic Test.



Product principle

    The product is based on the principle of colloidal gold technology. If the Coronavirus IgG/IgM antibodies are high enough, they will combine with the colloidal gold-labeled antigen to form a colloidal gold-antigen-antibody complex. If (IgG) G and (IgM) M lines are colored, the patient will be detected positive. If not colored, the patient will be detected negative. The quality control (C) line is always colored to indicate the test is effective.


Clinical Application

    In human infected with a novel coronavirus (COVID-19), the body's immune system produces an immune response to the virus, producing specific antibodies. The determination of relevant antibodies can be used to screen for infection with novel coronavirus. 

·        This test has not been reviewed by the FDA.

·        Negative results do not rule out SARS-CoV-2 infection, particularly in those who have been in contact with the virus. Follow-up testing with a molecular diagnostic should be considered to rule out infection in these individuals.

·        Results from antibody testing should not be used as the sole basis to diagnose or exclude SARS-CoV-2 infection or to inform infection status.

·        Positive results may be due to past or present infection with non-SARS-CoV-2 coronavirus strains, such as coronavirus HKU1, NL63, OC43, or 229E.

Not for the screening of donated blood.


Applicable Department 

    Emergency Department

    ICU

    Pneumology Department

    Cardio-Pulmonary Function Department


Test Kit Procedure

2019-nCoV IgG/IgM Antibody Rapid Test Kit


Result Reference

2019-nCoV IgG/IgM Antibody Rapid Test Kit







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