Key Features:

• 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
• High accuracy by NIH independent test (110 samples)
• IgG/IgM combined sensitivity 100%
• IgG sensitivity of 100%
• Overall specificity of 95%
• Quick result: 15 mins
• No additional equipment needed
• Possible results:
  • Recent infection with the virus
  • Previous infection with the virus
  • No infection or non-detectable antibodies
• Authorized by the FDA under a EUA for use by authorized laboratories.
• This test has not been FDA cleared or approved
• This test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostic tests 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.

Packaging:

• 25 test kits per box; room temperature storage