Dakshidin Corporation (DKSC)

[Q7]

On May 21, 2020, the U.S. Food and Drug Administration (FDA) posted a list of antibody tests that
are being removed from the “notification list” of tests being offered

Hangzhou Clongene Biotech Co., Ltd. COMBRA COVID-19 IgM/IgG Rapid Test Cassette



https://www.tchd.org/DocumentCenter/View/7223/HAN-Advisory---List-of-COVID-19-Antibody-Tests-that-should-no-longer-be-used-in-the-US-5272020


? Health care providers and local laboratories should no longer use the antibody tests removed from the FDA notification list. Health care providers and local laboratories should review this list regularly.
? Published scientific data are insufficient to determine whether serologic assays can or should be used to diagnosis COVID-19. Additionally, it is unknown whether having IgG antibodies against COVID-19 means that the person has developed protective immunity and cannot be reinfected. Until more studies are completed, results from serologic tests should not be used to make decisions about disease control (e.g., stop wearing PPE). CDC is evaluating the performance of several commercially manufactured antibody tests for SARS-CoV-2 in collaboration with other federal organizations; results from these studies are pending.
On May 21, 2020, the U.S. Food and Drug Administration (FDA) posted a list of antibody tests that
are being removed from the “notification list” of tests being offered under the Policy for
Coronavirus Disease-2019 Tests During the Public Health Emergency.
Antibody tests on this removal list are those which have been voluntarily withdrawn by the test’s
commercial manufacturer and those for which there is not a pending Emergency Use Authorization
(EUA) request or issued EUA. It is expected that this removal list will continue to be updated.