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Novel Coronavirus Covid-19 Igg/Igm Rapid Test Kit, Corona Virus Ivd
2020-03-21
COVID-19 IgG/IgM Rapid Test Kit
(Whole Blood/Serum/Plasma)
For Professional Use
INTENDED USE
IgG/IgM Rapid Test Kit (Whole Blood/Serum/Plasma) is a solid phase immunochromatographic assay for the rapid, qualitative and differential detection of IgG and IgM antibodies to 2019 Novel Coronavirusi in human whole blood, serum or plasma. This test provides only a preliminary test result. Therefore, any reactive specimen with the COVID-19 IgG/IgM Rapid Test kit (Whole Blood/Serum/Plasma) must be confirmed with alternative testing method(s) and clinical findings.
INTRODUCTION
Coronaviruses are enveloped RNA viruses that are distributed broadly among humans, other mammals, and birds and that cause respiratory, enteric, hepatic, and neurologic diseases. Seven coronavirus species are known to cause human disease. Four viruses - 229E, OC43, NL63, and HKU1 - are prevalent and typically cause common cold symptoms in immunocompetent individuals.4 The three other strains - severe acute respiratory syndrome coronavirus (SARS-CoV), Middle East respiratory syndrome coronavirus (MERS-CoV) and 2019 Novel Coronavirus (COVID-19) - are zoonotic in origin and have been linked to sometimes fatal illness. IgG and IgM antibodies to 2019 Novel Coronavirus can be detected with 2-3 weeks after exposure. IgG remains positive, but the antibody level drops overtime.
PRINCIPLE
The COVID-19 IgG/IgM Rapid Test kit (Whole Blood/Serum/Plasma) is a lateral flow immunochromatographic assay. The test uses anti-human IgM antibody (test line IgM) , anti-human IgG (test line IgG) and goat anti-rabbit IgG (control line C) immobilised on a nitrocellulose strip. The burgundy colored conjugate pad contains colloidal gold conjugated to recombinant COVID-19 antigens conjugated with colloid gold (COVID-19 conjugates) and rabbit IgG-gold conjugates. When a specimen followed by assay buffer is added to the sample well, IgM &/or IgG antibodies if present, will bind to COVID-19 conjugates making antigen antibodies complex. This complex migrates through nitrocellulose membrane by capillary action. When the complex meets the line of the corresponding immobilized antibody (anti-human IgM &/or anit-human IgG) the complex is trapped forming a burgundy colored band which confirm a reactive test result. Absence of a colored band in the test region indicates a non-reactive test result. The test contains an internal control (C band) which should exhibit a burgundy colored band of the immunocomplex goat anti rabbit IgG/rabbit IgG-gold conjugate regardless of the color development on any of the test bands. Otherwise, the test result is invalid and the specimen must be retested with another device.
Packing
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25pcs/box, 80box/ctn
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ctn size 64.5*38*47cm
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N.W/G.W. 17kgs/18kgs
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