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
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 |
|
| 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 |
|
| Tests / Kit | 25 Tests / Kit |
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