An antibody test looks for antibodies that are made by the immune system in response to a threat, such as a specific virus. Antibodies can help fight infections. A rapid test is an antibody test that uses a blood sample from the fingertip to assess if you have IgM and IgG antibodies to the virus that causes COVID-19, with results available in 15 minutes.
Premier Biotech™ COVID-19 Rapid Antibody Test
The Premier Biotech COVID-19 IgG/IgM Rapid Test Cassette is a finger prick test for the detection of SARS-CoV-2 antibodies in venous whole blood, serum or plasma. The COVID-19 IgG/IgM Rapid Test Cassette is intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection, as well as being able to determine if they have been vaccinated.
- FDA EUA: Yes
- Results: 10 minutes
- Type: finger prick
- Detection of IgM/IgG antibodies specific to SARS-CoV-2
- For in vitro diagnostic use only
- Availability: Immediate
Statements And Conditions:
This test has been authorized by FDA under an EUA for use by authorized laboratories;
This test has not been FDA cleared or approved;
This test has been authorized only for the presence of lgM 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)(l) of the Act, 21 U.S.C. § 360bbb-3(b)(l), unless the authorization is terminated or revoked sooner.
This product is not for home use (Emergency Use Authorization – In Vitro Diagnostic Use Only)
Not for screening of donated blood
AccessBio CareStart™ COVID-19 Rapid Antibody Test
The CareStart™ COVID-19 IgM/IgG is intended for use as an aid in identifying and monitoring individuals previous infection history and immune response to COVID-19. This rapid test detects and differentiates IgM/IgG antibodies specific to SARS-CoV-2.
The CareStart™ COVID-19 IgM/IgG is an immunochromatographic lateral flow assay intended for the qualitative detection and differentiation of Immunoglobulin M (IgM) and Immunoglobulin G (IgG) antibodies to SARS-CoV-2 in human serum, plasma (sodium citrate, sodium heparin, or dipotassium EDTA), and venous whole blood (sodium citrate, sodium heparin, or dipotassium EDTA).
- FDA EUA: Yes
- Results: 10 minutes
- Type: finger prick
- Detect and differentiate IgM/IgG antibodies specific to SARS-CoV-2
- For in vitro diagnostic use only
- Availability: Immediate
- IgM Sensitivity and Specificity: 90% and 98.8%
- IgG Sensitivity and Specificity: 100% and 98.8%
This test has not been FDA cleared or approved;
This test has been authorized by FDA under an EUA for use by authorized laboratories;
This test has been authorized only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens; and;
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.
The emergency use of your product as described in this letter of authorization must comply with the conditions and all other terms of this authorization.
The emergency use of your product as described in this letter of authorization must comply with the conditions and all other terms of this authorization.
