EUA ACON® COVID-19 IgG/IgM Rapid Test

Detects IgG/IgM antibodies to SARS-CoV-2

ACON Laboratories, Inc
COVID-19 Rapid Test

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

EUA ACON® COVID-19 IgG/IgM Rapid Test

Product Features

High Sensitivity and Specificity

  • Combined Sensitivity: 

100 % (88.7 %; 100 %)*

  • Combined Specificity:

96.2 % (95% CI: 89.5%; 98.7%)

*95% Confidence Intervals

Device Highlights

  • Test Cassette
  • Detects IgG and IgM
  • Small sample volume
  • Multiple sample formats
  • Fast results

Specimen Format

  • Serum
  • Plasma
  • Venous Whole Blood

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.

EUA ACON® COVID-19 IgG/IgM Rapid Test

Product Specifications

Feature Specification
Test Format(s) Cassette
Specimen Format(s) Serum / Plasma / Venous Whole Blood 
Detects IgG/IgM antibodies to SARS-CoV-2 
Sample Volume
  • Serum / Plasma: 10 μL
  • Whole Blood: 15 μL
Combined Sensitivity 100 % (95% CI: 88.7 %; 100 %)
Combined Specificity 96.2 % (95% CI: 89.5 %; 98.7 %)
Test Time 15 minutes
Shelf Life 9 Months
Storage Temperature 2 – 8 °C
Package Includes
  • Cassette(s)
  • Disposable specimen applicator(s)
  • Buffer
  • Package Insert
Tests / Kit 25 Tests / Kit

Resource Library

Browse our Resources Library for documents available for download.