COVID-19 Testing Disclaimers

The following disclosures are designed to be included with all marketing materials associated with emergency use authorized tests. In this emergency situation – where no test is FDA approved – it is important to let potential patients know that they are receiving a test that is only authorized, not approved, and that this authorization may expire at the end of the emergency, or beforehand, if deemed necessary.

Below, please find the language that applies to each test type. For more information on specific devices/reagents – including appropriate uses/limitations of each test and additional disclosures – follow the links to the devices/manufacturers currently used by ARCpoint locations and their affiliate high complexity laboratories, listed by test developer.

Antigen and PCR tests without Flu:

  • 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 SARSCoV-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.

Siemens: https://www.fda.gov/media/137687/download

TaqPath: https://www.fda.gov/media/138295/download

Accula: https://www.fda.gov/media/136345/download

Roche: https://www.fda.gov/media/136046/download

SalivaDirect/Yale: https://www.fda.gov/media/141194/download

Quidel/Sofia: https://www.fda.gov/media/137886/download

BD Veritor: https://www.fda.gov/media/139752/download

CareStart: https://www.fda.gov/media/142916/download

Antigen tests with Flu A/B:

  • 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 proteins from SARSCoV-2, and influenza, 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 Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.

Quidel Sofia 2: https://www.fda.gov/media/142701/download

Antibody tests:

  • 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 presence of antibodies against SARSCoV-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.

Siemens: https://www.fda.gov/media/138439/download

DIazyme: https://www.fda.gov/media/141252/download; https://www.fda.gov/media/139866/download

Genscript: https://www.fda.gov/media/143584/download

Vibrant America: https://www.fda.gov/media/138626/download

Roche: https://www.fda.gov/media/144034/download

Healgen: https://www.fda.gov/media/138435/download

Ethos: https://www.fda.gov/media/140777/download

Microgen/COVID-19 Key: https://www.fda.gov/media/137369/download

 

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