AmeriDx® SARS-CoV-2 Antibody Rapid Test Kit (10 Tests, Product Code: R30143012)
FDA Notification (Registration number 3016774578)
The typical symptoms of coronavirus infection include respiratory infectious, fever, cough, shortness of breath, and dyspnea. In more severe cases, the infection can cause pneumonia, severe acute respiratory syndrome (SARS), kidney failure, and even death. Coronavirus can be excreted through respiratory secretions or transmitted through oral fluids, sneezing, physical contact, and through air droplets.
AmeriDx® SARS-CoV-2 Antibody Rapid Test is a visual one step in vitro assay. It is intended for professional use to help diagnosing SARS-CoV-2 virus infection in human.
The conjugate pad harboring the recombinant virus N protein (detection antigen) grasps the novel coronavirus antibodies in the sample fluid, and moves along with the flow toward the capture antibody line (T ) via capillary action, form a color line (the test line will capture not only IgG but also IgM). The test is positive. If no specific coronavirus antibodies in the sample flow, only a control line (C, mouse IgG) will show up, the test results is negative.
Fig 1. AmeriDx® SARS-CoV-2 Virus Antibody Rapid Test Kit
The AmeriDx® SARS-CoV-2 IgG/IgM Antibody Rapid Test Kit is an in vitro diagnostic test for the qualitative detection of total IgG and IgM antibodies to the SARS‐CoV‐2 in human finger stick blood collected in CLIA certified laboratories and/or by healthcare workers at the point‐of‐care.
(more details please refer the product insert. This product is waiting for FDA to approve the EUA)