Diagnostic Kit for IgM/IgG Antibody of SARS-CoV-2 (Colloidal Gold Immunochromatography)
20 tests / Kit.
The outbreak of the n SARS-CoV-2 is now a pandemic and a serious public health crisis worldwide. Detection of viral nucleic acid by Real-time PCR is still the gold standard for diagnosis of COVID-19，however, the RT-PCR based tests have showed many limitations in clinical utilization, e.g. Time consuming, relatively high facility requirement and remarkable false negative rate in throat swab sample. There is an urgent need for the introduction of an accurate, easy, and rapid alternative test to identify potential infected individuals. The Diagnostic Kit for Antibody IgM/IgG of Novel Coronavirus Kit was therefore designed to rapidly detect both IgM and IgG antibodies against the SARS-CoV-2 in human serum, plasma or whole blood in vitro. This kit used recombined spike (S) protein and nucleocapsid (N) protein of the SARS-CoV-2 as antigen to detect specific IgM and IgG antibodies in human blood samples. IgM antibodies was generally considered to provide the first line of defense during pathogen infections, followed by the production of high affinity IgG antibodies for long term and more effective immunity. Therefore, simultaneous detection of SARS-CoV-2 IgM and IgG antibodies is an effective strategy for the rapid and precise diagnosis of COVID-19. Furthermore, detection of IgM antibodies usually indicates an acute infection of SARS-CoV-2, whereas detection of IgG antibodies usually indicates a later stage of infection. Thus, this
combined test could also provide information on the stage of infection.
This kit was based on the colloidal gold immunochromatography technology. In brief, anti-human IgM antibodies, anti-human IgG antibodies and colloidal gold labeled SARS-CoV-2 S/N antigen were coated on nitrocellulose membranes which were then inserted into the test card. Upon binding with their specific IgM and\or IgG antibodies, the gold-labeled antigen and these specific antibodies forms a complex. The complex moves forward along the test strip due to chromatography effect and will be captured by the solid-phase anti-human IgM or anti-human IgG antibody that were embedded in the detected line and finally show color line.