COVID-19 ANTIBODY TEST

COVID-19 IgM/IgG Antibody Test

  • TEST RESULTS IN MINUTES
  • THIS TEST HAS BEEN AUTHORIZED BY FDA UNDER AN EMERGENCY USE AUTHORIZATION (EUA) FOR USE BY AUTHORIZED LABORATORIES. AUTHORIZATION CAN BE FOUND HERE
  • NOT FDA APPROVED 
  • NOT A REPLACEMENT FOR PCR LAB-BASED TESTING 
  • FOR PROFESSIONAL USE AND NOT HOME USE
  • RESULTS SHOULD NOT BE USED AS THE SOLE BASIS TO DIAGNOSE OR EXCLUDE SARS-CoV-2 INFECTION OR TO INFORM INSPECTION STATUS.
SARS-CoV-2 (COVID-19 virus) is a beta coronavirus. It is the family of Coronaviruses, named for the crown-like spikes on their surface. There are four main sub-groupings of coronaviruses, alpha, beta, gamma, and delta. Common human coronaviruses are 229E (alpha coronavirus), NL63 (alpha coronavirus), OC43 (beta coronavirus) and HKU1 (beta coronavirus). The infection usually causes mild to moderate upper-respiratory tract illnesses, like the common cold. Other human coronaviruses such as MERS-CoV and SARS-CoV (the beta coronavirus that causes severe acute respiratory syndrome or SARS) have caused more severe respiratory illness with higher rates of morbidity and mortality. The SARS-CoV-2 or COVID-19 is a novel coronavirus that causes coronavirus disease 2019. SARS-CoV-2 caused an outbreak in December 2019 in Wuhan City, Hubei Province, China. It has spread globally. Patients with COVID-19 have had mild to severe respiratory illness with symptoms of fever, cough and shortness of breath, even pneumonia in both lungs. 
After COVID-19 infection, the body develops IgM antibodies that mainly exist in the blood from a few hours to several days. IgM antibodies appear (symptomatic 3-5 days, asymptomatic 7 days) and gradually disappear earlier than IgG antibodies, while IgG antibodies are relatively longstanding.

COVID-19 IgM/IgG Antibody Screen Test utilizes indirect immunoassay to detect COVID-19 IgM/IgG antibodies qualitatively and selectively in serum or plasma or whole blood.

Updated United States Food and Drug Administration guidance issued on March 16, 2020, allows the distribution of this product for diagnostic use in laboratories or by healthcare workers at the point-of-care. The updated policy can be viewed by clicking here. In April 2020, the FDA released a statement related to serological tests for antibodies responding to COVID-19 which can be found here.

The rapid antibody test is limited in that it only provides a preliminary result. Any reactive specimen with the COVID-19 IgM/IgG Rapid test Cassette (whole blood/serum/plasma) must be confirmed with alternate testing method(s) and clinical findings. When IgG antibodies are present, it generally indicates past infection, but may also appear with recently-infected patients that are contagious. It is unknown how long IgM or IgG antibodies to SARS-CoV-2 will remain present in the body after infection or if they confer immunity to infection.

The COVID-19 IgM/IgG Antibody Screen Test is a qualitative membrane strip-based immunoassay for the detection of COVID-19 IgM/IgG antibody in serum or plasma or whole blood. According test procedure, anti-human IgM/IgG is immobilized in the test line region of the test. After a serum, plasma, or whole blood specimen is added in the specimen well, it reacts with COVID-19 antigen coated particles that have been applied to the specimen pad. This mixture migrates chromatographically along the test strip and interacts with the immobilized anti-human IgM/IgG. If the specimen contains COVID-19 IgM/IgG antibodies, a colored band will appear in the test line region indicating a positive result. If the specimen does not contain COVID-19 IgM/IgG antibodies, no colored band would appear in this region indicating a negative result. To serve as a procedural control, a colored band does always present at the control line region. It indicates that the test results are valid.
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