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FACT SHEET FOR HEALTHCARE PROVIDERS Coronavirus
Azure Biotech Inc. September 23, 2020 Disease 2019
Assure COVID-19 IgG/IgM Rapid Test Device (COVID-19)
Risks to a patient of a false negative result include:
restriction of activities potentially deemed acceptable for Where can I go for updates and more information?
patients with evidence of an antibody response to
SARS-CoV-2, lack of monitoring of infected individuals CDC webpages:
and their household or other close contacts for General: https://www.cdc.gov/COVID19
symptoms resulting in increased risk of spread of Symptoms:
COVID-19 within the community, or other unintended https://www.cdc.gov/coronavirus/2019-ncov/symptoms-
adverse events testing/symptoms.html
Healthcare Professionals:
What is an EUA? https://www.cdc.gov/coronavirus/2019-nCoV/guidance-hcp.html
The United States FDA has made this test available Information for Laboratories: https://www.cdc.gov/coronavirus/2019-
under an emergency access mechanism called an nCoV/guidance-laboratories.html
Emergency Use Authorization (EUA). The EUA is Laboratory Biosafety: https://www.cdc.gov/coronavirus/2019-
supported by the Secretary of Health and Human nCoV/lab-biosafety-guidelines.html
Service’s (HHS’s) declaration that circumstances exist to Isolation Precautions in Healthcare Settings:
justify the emergency use of in vitro diagnostics (IVDs) https://www.cdc.gov/coronavirus/2019-ncov/infection-control/control-
recommendations.html
for the detection and/or diagnosis of the virus that Specimen Collection: https://www.cdc.gov/coronavirus/2019-
causes COVID-19. nCoV/guidelines-clinical-specimens.html
Infection Control: https://www.cdc.gov/coronavirus/2019-
An IVD made available under an EUA has not ncov/infection-control/index.html
undergone the same type of review as an FDA-approved
or cleared IVD. FDA may issue an EUA when certain
criteria are met, which includes that there are no FDA webpages:
adequate, approved, available alternatives, and based General: www.fda.gov/novelcoronavirus
on the totality of scientific evidence available, it is EUAs:(includes links to patient fact sheet and manufacturer’s
instructions) https://www.fda.gov/medical-devices/coronavirus-
reasonable to believe that this IVD may be effective at disease-2019-covid-19-emergency-use-authorizations-medical-
diagnosing recent or prior infection with SARSCoV-2 by devices/vitro-diagnostics-euas
identifying individuals with an adaptive immune response
to the virus that causes COVID-19.
Contact Information:
The EUA for this test is in effect for the duration of the Assure Tech. (Hangzhou) Co., Ltd.
COVID-19 declaration justifying emergency use of IVDs, 2nd-5th Floor, Building 4, No. 1418-50, Moganshan Road,
unless terminated or revoked (after which the test may Gongshu District, Hangzhou, Zhejiang 310011, China
no longer be used).
contact@diareagent.com
What are the approved available alternatives? www.assurelabs.com
There are no approved available alternative tests. FDA
has issued EUAs for other tests that can be found at:
https://www.fda.gov/emergency-preparedness-and-
response/mcm-legal-regulatory-and-policy-
framework/emergency-use-authorization
Report Adverse events, including problems with test performance or results, to MedWatch by submitting the online FDA Form 3500
(https://www.accessdata.fda.gov/scripts/medwatch/index.cfm?action=reporting.home) or by calling 1-800-FDA-1088
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