EUA ACON^® COVID-19 IgG/IgM Rapid Test

Detects IgG/IgM antibodies to SARS-CoV-2

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

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100 % (88.7 %; 100 %)*

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

*95% Confidence Intervals

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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

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

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