COVID-19 IgG/IgM Rapid Test [FDA Registered – Emergency Use Authorized (EUA)]
Rapid Point-of-care qualitative test for the detection of early marker IgG and IgM antibodies to COVID-19 in human serum, plasma or whole blood. These tests provide a differential detection of anti-SARS-CoV-2 IgM antibodies and can be used for the presumptive distinction between a primary and secondary Coronavirus infection. This test is for in-vitro diagnostic use only.
The Serological tests measure the amount of antibodies or proteins present in the blood when the body is responding to a specific infection and are able to detect COVID-19 antibodies for a prolonged period of time after disease resolution, which enables identification of prior infection. Knowledge of prior infection is epidemiologically important and represents a significant unmet need in the management of the COVID-19 pandemic.
Background: Coronavirus (CoV) belongs to the Coronaviridae family and is divided into three types: α, β and γ. Alpha and beta are only pathogenic to mammals and gamma mainly causes bird infections. CoV is mainly transmitted through direct contact with secretions or through aerosols and droplets. There is also evidence that it can be transmitted through the fecal-oral route as well. So far there are seven types of human coronavirus (HCoV) that cause human respiratory diseases: HCoV-229E, HCoV-NL63, HCoV-OC43, HCoV-HKU1, SARS-CoV, MERS-CoV and the novel coronavirus (2019). The novel coronavirus (2019) was discovered in 2019 in Wuhan, China with viral pneumonia cases and clinical manifestations were fever, fatigue, cough, and other symptoms which can rapidly develop into severe pneumonia, respiratory failure, septic shock, multiple organ failure, severe acid-base metabolism disorders, etc. and is life threatening. Human coronaviruses primarily replicate in the respiratory tract and cause infections ranging from common colds to severe acute respiratory syndrome (SARS). Coronaviruses are single-stranded RNA viruses with outer envelopes that have distinct crown-like morphologies. Patients with SARS-CoV-2 infection often exhibit symptoms of viral pneumonia, including fever, cough, runny nose, shortness of breath, bilateral lung infiltration and respiratory failure in the most severe cases. Currently, there is no specific treatment or available vaccine that protects against SARS-CoV-2 infection. Spike (S) protein, nucleocapsid (N) protein, membrane (M) protein, and the envelope (E) protein are the four major structural proteins of SARS-CoV-2. Amongst them, the S-protein supports strong interaction with human cell receptors, indicating the greatest potential as an effective target for the development of neutralizing antibodies and antiviral drugs. The general immune response to this virus includes the production of IgM antibodies by the 5th day of symptoms which remain in the circulatory system for 30-60 days. IgG antibodies appear by the 14th day of infection and may persist for life. A secondary infection also induces an IgM antibody response after 20 days of infection and IgG antibodies rise within 1-2 days after the onset of symptoms. Therefore, patients with secondary infections will have a positive IgG result, usually along with a positive IgM result. Thus, the use of a reliable and sensitive rapid serological test that can simultaneously detect the presence of anti-coronavirus IgG and IgM antibodies is of great clinical utility.