COVID19 Testing COVID19 Module 2 642021 2020 National

The following content is for informational purposes only. It should not be construed or

SARS-Co. V-2 Tests • Owing to the speed at which SARS-Co. V-2 has spread,

SARS-Co. V-2 Tests • SARS-Co. V-2 RNA can be detected from respiratory specimens using

Guidance for Licensed Pharmacists, COVID-19 Testing, and Immunity under the PREP Act • Recognizing

SARS-Co. V-2 Tests • Currently the COVID-19 tests that are appropriate for pharmacy testing

SARS-Co. V-2 Antibody Tests • Since up to 50% of the patients who are

SARS-Co. V-2 Antibody Tests • Several serologic antibody tests are currently available under the

COVID-19 Test Result Reporting • Results of COVID-19 testing should be reported. • Sites

Summary • Under current HHS guidance, pharmacies are authorized to perform COVID-19 and serology

• FDA Emergency Use Authorizations (https: //www. fda. gov/medical-devices/emergency-situations-medicaldevices/emergency-use-authorizations) • Health and Human

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The following content is for informational purposes only. It should not be construed or relied upon as legal advice, guidance, or counsel. You should consult your attorney regarding the content or interpretation of the information herein prior to use. NACDS assumes no responsibility or liability for any errors or omissions in the content. 6/4/2021 © 2020 National Association of Chain Drug Stores, Inc. All rights reserved. 2

SARS-Co. V-2 Tests • Owing to the speed at which SARS-Co. V-2 has spread, the development of tests has been rapidly evolving. • On February 4, 2020, the Department of Health and Human Services (HHS) issued a declaration of emergency under the Public Readiness and Emergency Preparedness Act (PREP) for medical counter measures. • Allows for use of non-FDA-approved tests under Emergency Use Authorization (EUA) authority. • As of April 18, 2020, 39 tests have been authorized for use; 3 for CLIA-waived settings. • Two broad categories of tests have emerged: • Testing for acute infection • Detection of prior exposure 6/4/2021 © 2020 National Association of Chain Drug Stores, Inc. All rights reserved. 3

SARS-Co. V-2 Tests • SARS-Co. V-2 RNA can be detected from respiratory specimens using reverse polymerase chain reaction (PCR). • Typically exhibit high sensitivity and specificity. • Specimens include bronchoalveolar lavage (BAL), nasopharyngeal (NP) swab, nasal mid-turbinate (NMT) swab, nasal (N) swab, oropharyngeal (OP) swab, and nasal wash • Does not differentiate between live and non-viable viruses or viral fragments • Most of the tests are classified as high or moderate complexity. 6/4/2021 © 2020 National Association of Chain Drug Stores, Inc. All rights reserved. 4

Guidance for Licensed Pharmacists, COVID-19 Testing, and Immunity under the PREP Act • Recognizing the value of pharmacists in expanding access to COVID-19 testing, HHS issued the following guidance on April 8: • "[Pharmacists] may receive immunity under the PREP Act with respect to all claims for loss caused by, arising out of, relating to, or resulting from, the administration or use of FDAauthorized COVID-19 tests. " (https: //www. hhs. gov/sites/default/files/authorizing-licensedpharmacists-to-order-and-administer-covid-19 -tests. pdf) • This statement removed barriers that limited a pharmacist’s ability to perform a test for COVID-19. • Some CLIA-waiver restrictions may still need to be addressed in certain states. 6/4/2021 © 2020 National Association of Chain Drug Stores, Inc. All rights reserved. 5

SARS-Co. V-2 Tests • Currently the COVID-19 tests that are appropriate for pharmacy testing all employ rapid real-time PCR. • The devices are capable of detecting viruses from various specimen types, including NP, OP, or nasal swabs. • The tests are reported to have lower limits of detection (Lo. D) ranging from 100 -250 copies/m. L and exhibit good agreement with other PCR-based tests. • Slightly higher than high/moderate complexity tests • Test results are available within 30 minutes. • Existing platforms can only run one test at a time. • Might be used in pharmacy test-and-treat models. 6/4/2021 © 2020 National Association of Chain Drug Stores, Inc. All rights reserved. 6

SARS-Co. V-2 Antibody Tests • Since up to 50% of the patients who are infected with SARS-Co. V-2 are asymptomatic, it is difficult to determine how many individuals have actually been infected with the virus. • In order for social distancing measures to be lifted safely, knowledge of virus immunity versus susceptibility within the population is needed. • Detection of antibodies to the SARS-Co. V-2 virus may allow us to determine the level of immunity that exists. • Ig. M antibodies develop first in an infection and indicate presence of an acute or recent infection. • Ig. G antibodies develop later during an infection and may circulate long after a pathogen has been eradicated from the body. 6/4/2021 © 2020 National Association of Chain Drug Stores, Inc. All rights reserved. 7

SARS-Co. V-2 Antibody Tests • Several serologic antibody tests are currently available under the EUA. • Tests vary with respect to the specimen types required. • Most require collection venipuncture; however, at least one test allows whole blood collection via fingerstick. • Data regarding the use of these tests are limited and require additional study. • Cross-reactivity may occur from pre-existing antibodies or from other causes, including other coronavirus types. (False positives or positive agreement) • Uncertainty about durability of natural immunity. (False negatives or negative agreement) • Timing of onset of infection with testing. (False negatives or negative agreement) 6/4/2021 © 2020 National Association of Chain Drug Stores, Inc. All rights reserved. 8

COVID-19 Test Result Reporting • Results of COVID-19 testing should be reported. • Sites performing tests should seek guidance from the CDC and their state/local health departments regarding appropriate documentation. 6/4/2021 © 2020 National Association of Chain Drug Stores, Inc. All rights reserved. 9

Summary • Under current HHS guidance, pharmacies are authorized to perform COVID-19 and serology testing. • Several PCR-based tests appear to be appropriate for use in pharmacies. • Presently, serology tests are slightly more complex to perform and have performance concerns that may need to be studied further before they are widely employed. • Pharmacies will play a significant role in provision of tests for COVID-19. 6/4/2021 © 2020 National Association of Chain Drug Stores, Inc. All rights reserved. 10

• FDA Emergency Use Authorizations (https: //www. fda. gov/medical-devices/emergency-situations-medicaldevices/emergency-use-authorizations) • Health and Human Services Guidance for Licensed Pharmacists, COVID-19 Testing, and Immunity under the PREP Act (https: //www. hhs. gov/sites/default/files/authorizing-licensed-pharmacists-to-order-and-administercovid-19 -tests. pdf) • CDC Evaluating and Testing Persons for Coronavirus Disease 2019 (COVID-19) (https: //www. cdc. gov/coronavirus/2019 -n. Co. V/hcp/clinical-criteria. html) • CDC Information for Health Departments on Reporting Cases of COVID-19 (https: //www. cdc. gov/coronavirus/2019 -ncov/php/reporting-pui. html) 6/4/2021 © 2020 National Association of Chain Drug Stores, Inc. All rights reserved. 11