AmeriDx® SARS-CoV-2 IgG/IgM Rapid Test Kit (10 Tests, Product Code: R30143011)

FDA Notification (Registration number 3016774578) EC REP

Introduction
The typical symptoms of coronavirus infection include respiratory symptoms, 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.

Principle
AmeriDx® SARS-CoV-2 IgG/IgM 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 section (T1-IgG and T2-IgM) via capillary action, form one or two positive lines, the test is positive. If no specific coronavirus antibodies in the sample flow, only a control line (C, mouse IgG) displays the purple color line, the test results is negative.

 


 three lines reference

Fig 1. AmeriDx® SARS-CoV-2 virus IgG/IgM Rapid Test Kit

Intended Use
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-prick blood collected in CLIA certified laboratories and/or by healthcare workers at the point‐of‐care. 

For more information, please read the product insert. (this kit is waiting for EUA approval from FDA)


SARS-CoV-2 Rapid Test Card Inquiry, production code: R30143011/R30143012