IGG/IGM Antibody Rapid Diagnostics Test (RDT) for COVID 19 (SARS-COV 2 or SARS 2) Venial Blood

The COVID-19 Antibody (IgG/IgM) Rapid Test Device utilizes lateral flow technology for the qualitative, differential detection of both anti-SARS-CoV-2 IgM and IgG antibodies in whole blood, serum, and plasma. In general, antibodies can be detected 1-3 weeks after infection. This test is intended to screen patients for SARS-CoV-2 antibodies.

FEATURES

• Clinical Evaluation
  • Positive Percent Agreement (PPA): IgG 96.7%; IgM 86.7%; Overall 96.7%
  • Negative Percent Agreement (NPA): IgG 98.0%; IgM 99.0%; Overall 97.0%
• Clinical Agreement with Characterized Samples
  • Sensitivity: IgG 96.7%; IgM 100%; Combined 100%​
  • Specificity: IgG 97.5%; IgM 100%; Combined 97.5%​
• Results in 10 minutes

MATERIALS SUPPLIED

• 25 sealed pouches, each containing a test cassette, a dropper, and a desiccant
• 1 Buffer

WARNING:

• This test has been authorized by FDA Approved 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 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 the 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 intended for professional use and not for home use.