A rapid test for the qualitative detection of IgG and IgM antibodies against 2019-nCoV in human whole blood, serum or plasma samples. For professional in vitro diagnostic use only.
The 2019-nCoV IgG/IgM Rapid Test Cassette is a lateral flow chromatographic immunoassay for the qualitative detection of IgG and IgM antibodies against 2019-nCoV in human blood, serum or plasma samples.
In early January 2020, a new coronavirus (2019-nCoV) was identified as the infectious agent causing an outbreak of viral pneumonia in Wuhan, China, where the first cases had their symptom onset in December 2019. Coronaviruses are enveloped RNA viruses that are widely distributed among humans, other mammals, and birds and cause respiratory, enteric, liver, and neurological diseases. Six species of coronavirus are known to cause disease in humans. Four viruses: 229E, OC43, NL63, and HKU1, are prevalent and generally cause common cold symptoms in immunocompetent people.
The other two strains, severe acute respiratory syndrome coronavirus (SARS-COV) and Middle East respiratory syndrome coronavirus (MERS-COV ), are zoonotic in origin and have been linked to sometimes fatal diseases. Coronaviruses are zoonotic, which means they are transmitted between animals and people. Common signs of infection include respiratory symptoms, fever, cough, shortness of breath, and shortness of breath.
In more severe cases, the infection can cause pneumonia, severe acute respiratory syndrome, kidney failure, and even death. Standard recommendations to prevent the spread of infection include regular hand washing, covering your mouth and nose when coughing and sneezing, cooking meat and eggs thoroughly. Avoid close contact with anyone showing symptoms of respiratory illness, such as coughing and sneezing.
The 2019-nCoV IgG/IgM All Test Cassette (Whole Blood/Serum/Plasma) is a qualitative test Membrane-based immunoassay for the detection of IgG and IgM antibodies against 2019-nCoV in whole blood, serum, or plasma samples. This test consists of two components, an IgG component and an IgM component. In the IgG component, anti-human IgG is coated on the IgG test line region. During testing, the sample reacts with 2019-nCoV antigen-coated particles in the test cassette.
The mixture then migrates chromatographically up the membrane by capillary action and reacts with anti-human IgG in the IgG test line region, if the sample contains IgG antibodies to 2019-nCoV. As a result, a coloured line will appear in the IgG test line region. Similarly, anti-human IgM is coated on the IgM test line region and, if the sample contains IgM antibodies to 2019-nCoV, the conjugate-sample complex reacts with anti-human IgM. As a result, a coloured line appears in the IgM test line region.
Therefore, if the sample contains 2019-nCoV IgG antibodies, a coloured line will appear in the IgG test line region. If the sample contains 2019-nCoV IgM antibodies, a coloured line will appear in the IgM test line region. If the sample does not contain 2019-nCoV antibodies, no coloured line will appear in any of the test line regions, indicating a negative result. To serve as a procedural control, a coloured line will always appear in the control line region, indicating that the proper volume of sample has been added and membrane absorption has occurred.
The test contains anti-human IgM and anti-human IgG as a capture reagent, 2019-nCoV antigen as a detection reagent. A goat anti-mouse IgG is used in the control line system.