For professional use only.
The COVID-19 IgG/IgM (Whole Blood/Serum/Plasma) Rapid Test Device EcoTest utilizes lateral flow technology that is used for the qualitative, differential detection of both anti-SARS-CoV-2 IgM and IgG antibodies. In general, antibodies can be detected 1-3 weeks after infection. This test is intended to screen patients for COVID-19. Combining RNA and Antibody tests can significantly raise the sensitivity for detecting COVID-19 in infected individuals.
Coronaviruses are enveloped RNA viruses that are distributed broadly among humans, other mammals, and birds that cause respiratory, enteric, hepatic and neurological diseases. Four viruses – 229E, OC43, NL63, and HKU1 are prevalent and typically cause common cold symptoms in immunocompromised individuals. Three other strains SARS-CoV, MERS-CoV, and SARS-CoV-2 (COVID-19) are can be transmitted from between non-human vertebrates to humans.
Features & Benefits:
- Results in 15 minutes
- Easy to use and read
- Tests for both IgM and IgG antibodies
- Individually packaged kits for one time use
- Validated against RT-PCR results
- This test has been authorized by FDA under an EUA for professional use.
- This test has not been FDA cleared or approved.
- 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.
- 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 Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.
- Positive results may be due to past or present infection with non-SARS-CoV-2 coronavirus strains, such as coronavirus HKU1, NL63, OC43, or 229E.
- This product is not for the screening of donated blood.
- This product is intended for professional use and not for home use.