COVID-19 Rapid Test
COVID-19 Rapid Test

San Diego, CA, December 17, 2020 — ACON Laboratories, Inc., a leading global medical device manufacturer announced today that its SARS-COV-2 IgG/IgM Rapid Test has been authorized for emergency use by FDA under an EUA for use by authorized laboratories.*

ACON’s SARS-CoV-2 IgG/IgM Rapid Test is a lateral flow chromatographic immunoassay intended for the qualitative detection and differentiation of IgM and IgG antibodies to SARS-CoV-2 in human serum, plasma, and venous whole blood.

ACON’s test is intended as an aid in identifying individuals with an adaptive response to SARS-CoV-2, indicating a recent or prior infection. The test is for the detection and differentiation of IgM and IgG antibodies.

“ACON Labs is continuing its pursuit of excellence in develop high quality tests in the fight against COVID-19 and we are very pleased to have been issued an EUA for our SARS-CoV-2 IgG/IgM Rapid Test” said Jinn-nan Lin, President of ACON Labs.

ACON’s COVID-19 lateral flow immunoassay has a high sensitivity and specificity and is therefore highly reliable.  The Rapid Test can be performed using a small amount of serum, plasma or whole blood specimen. The result should be read at 15 minutes.

The ACON Test is available for distribution in the United Sates now that it has received the Food and Drug Administration (FDA) Emergency Use Authorization (EUA).

About ACON Laboratories, Inc.  

* This test has not been FDA cleared or approved, but has been authorized for emergency use by FDA under an EUA for use by authorized laboratories;

  • This test has been authorized only for the presence of IgM and IgG antibodies against SARS-CoV-2, not for any other viruses or pathogens; and
  • The emergency use of this test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. § 360bbb- 3(b)(1), unless the declaration is terminated or authorization is revoked sooner.