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We have compiled a list of documents to help keep you informed

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Antibody tests, a type of serological test, detect antibodies present in the blood when the body is responding to or has responded to a specific infection, such as COVID-19. Antibody tests detect the body’s immune response to the infection caused by the virus rather than detecting the virus itself. This is why they should not be used to diagnose current SARS-CoV-2 infection.

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This Fact Sheet contains information to help you understand the risks and benefits of using this test to evaluate your adaptive immune response to SARS-CoV-2, the virus that causes COVID-19. After reading this Fact Sheet, if you have questions or would like to discuss the information provided, please talk to your healthcare provider.

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This General Fact Sheet informs you of the significant known and potential risks and benefits of the emergency use of certain SARS-CoV-2 Antibody Tests.

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Pharmacists, in partnership with other healthcare providers, are well positioned to aid COVID-19 testing expansion. Pharmacists are trusted healthcare professionals with established relationships with their patients. The vast majority of Americans live close to a retail or independent community-based pharmacy.

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ADVISORY OPINION 20-02 ON THE PUBLIC READINESS AND EMERGENCY PREPAREDNESS ACT AND THE SECRETARY’S DECLARATION UNDER THE ACT MAY 19, 2020

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The Public Readiness and Emergency Preparedness Act (PREP Act) authorizes the Secretary of Health and Human Services (the Secretary) to issue a Declaration to provide liability immunity to certain individuals and entities (Covered Persons) against any claim of loss caused by, arising out of, relating to, or resulting from the manufacture, distribution,
administration, or use of medical countermeasures (Covered Countermeasures), except for claims involving “willful misconduct” as defined in the PREP Act. This Declaration is subject to amendment as circumstances warrant.

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