Description
A rapid test for the qualitative detection of IgG and IgM antibodies to 2019-nCoV in human whole blood, serum or plasma specimens.
For professional in vitro diagnostic use only.
INTENDED USE
The 2019-nCoV IgG/IgM Rapid Test Cassette is a lateral flow chromatographic immunoassay
for the qualitative detection of IgG and IgM antibodies to 2019-nCoV in human whole blood, serum or plasma specimen.
SUMMARY
Early January 2020, a novel 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 2019.1
Coronaviruses are enveloped RNA viruses that are distributed broadly among humans, other mammals, and birds and that cause respiratory, enteric, hepatic, and neurologic diseases.2 Six coronavirus species are known to cause human disease.3 Four viruses — 229E, OC43, NL63, and HKU1 — are prevalent and typically cause common cold symptoms in immunocompetent individuals.3 The two other 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 illness.4
Coronaviruses are zoonotic, meaning they are transmitted between animals and people. Common signs of infection include respiratory symptoms, fever, cough, shortness of breath and breathing difficulties. In more severe cases, infection can cause pneumonia, severe acute respiratory syndrome, kidney failure and even death.5
Standard recommendations to prevent infection spread include regular hand washing, covering mouth and nose when coughing and sneezing, thoroughly cooking meat and eggs. Avoid close contact with anyone showing symptoms of respiratory illness such as coughing and sneezing.
PRINCIPLE
The 2019-nCoV IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) is a qualitative
membrane-based immunoassay for the detection of IgG and IgM antibodies to 2019-nCoV in whole blood, serum or plasma specimen. This test consists of two components, an IgG component and an IgM component. In the IgG component, anti-human IgG is coated in IgG test line region. During testing, the specimen reacts with 2019-nCoV antigen-coated particles in the test cassette. The mixture then migrates upward on the membrane chromatographically by capillary action and reacts with the anti-human IgG in IgG test line region, if the specimen contains IgG antibodies to 2019-nCoV. A colored line will appear in IgG test line region as a result of this. Similarly, anti-human IgM is coated in IgM test line region and if specimen contains IgM antibodies to 2019-nCoV, the conjugate-specimen complex reacts with anti-human IgM. A colored line appears in IgM test line region as a result.
Therefore, if the specimen contains 2019-nCoV IgG antibodies, a colored line will appear in IgG test line region. If the specimen contains 2019-nCoV IgM antibodies, a colored line will appear in IgM test line region. If the specimen does not contain 2019-nCoV antibodies, no colored line will appear in either of the test line regions, indicating a negative result. To serve as a procedural control, a colored line will always appear in the control line region, indicating that the proper volume of specimen has been added and membrane wicking has occurred.
REAGENTS
The test contains anti-human IgM and anti-human IgG as the capture reagent, 2019-nCoV
antigen as the detection reagent. A goat anti-mouse IgG is employed in the control line system.
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