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COVID-19: A Review of the Evolving Science and September 14, 2020 Current CDC Guidance COVID-19: A Review of the Evolving Science and Current CDC Guidance September 14, 2020 1 1 Welcome Martha DeCastro, MS, RN Vice President for Nursing


  1. COVID-19: A Review of the Evolving Science and September 14, 2020 Current CDC Guidance COVID-19: A Review of the Evolving Science and Current CDC Guidance September 14, 2020 1 1 Welcome Martha DeCastro, MS, RN Vice President for Nursing and Clinical Care Policy Florida Hospital Association 2 2 Florida Hospital Association 1

  2. COVID-19: A Review of the Evolving Science and September 14, 2020 Current CDC Guidance Presenters David Cook, MD Dr. David Cook’s research focuses on human malaria clinical trials at the National Institutes of Health, Laboratory of Malaria Immunology and Vaccinology (LMIV) at NIAID. His research focus is on malaria vaccines in humans. Before taking a position with NIH, Dr. Cook completed his Infectious Disease training at the NIH Clinical Center in 2019. He received his medical degree from the Uniformed Services University and is originally from Idaho. Neha Shah, MD, MPH Dr. Neha Shah’s work focuses on tuberculosis and HIV clinical trials at National Institutes of Health, Division of AIDS at NIAID. Her research focuses on tuberculosis therapeutics and vaccines. Before taking a position with NIH, Dr. Shah worked for the CDC and was part of CDC’s EIS (Epidemic Intelligence Service) from 2007-2009. She then served as the Medical Director of Tuberculosis in Chicago from 2009-2011 and then went on to be the director of California’s TB Free initiative until she moved to the NIH in 2019. 3 3 COVID-19: Update on Evidence and Guidelines for Testing and Reinfection David Cook, MD Neha Shah, MD MPH September 14, 2020 4 Florida Hospital Association 2

  3. COVID-19: A Review of the Evolving Science and September 14, 2020 Current CDC Guidance Disclaimer • The findings and conclusions in this presentation are those of the authors • The information in this presentation is current as of September 8, 2020 5 5 Overview of presentation  COVID testing  Recent CDC guideline updates  Re-infection 6 Florida Hospital Association 3

  4. COVID-19: A Review of the Evolving Science and September 14, 2020 Current CDC Guidance Testing for COVID 7 What types of tests are there?  Antibody  Antigen  PCR 8 Florida Hospital Association 4

  5. COVID-19: A Review of the Evolving Science and September 14, 2020 Current CDC Guidance Antibody (indirect) testing 9 What is the difference between an antibody and an antigen test? Republic reporting; illustration by Nicole Schaub 10 Florida Hospital Association 5

  6. COVID-19: A Review of the Evolving Science and September 14, 2020 Current CDC Guidance What do COVID-19 antibody and antigen tests detect? Daniel Wrapp et al. Science 2020;367:1260-1263 11 SARS-CoV-2 Antibody Tests 12 Florida Hospital Association 6

  7. COVID-19: A Review of the Evolving Science and September 14, 2020 Current CDC Guidance Antibodies can be detected week 2  Peak week 3  IgG persists Sethuraman et al, JAMA 2020 13 Two months after symptom onset, IgG still elevated among inpatients Katharina Roeltgen Oliver Wirz Stanford https://www.youtube.com/watch?v=rd9kpT-TaJM&t=2317s 14 Florida Hospital Association 7

  8. COVID-19: A Review of the Evolving Science and September 14, 2020 Current CDC Guidance More rapid decrease in asymptomatic outpatients Katharina Roeltgen Oliver Wirz Stanford https://www.youtube.com/watch?v=rd9kpT-TaJM&t=2317s 15 Lower antibodies levels among those with higher cycle thresholds Saurabh Gombar Stanford https://www.youtube.com/watch?v=rd9kpT-TaJM&t=2317s 16 Florida Hospital Association 8

  9. COVID-19: A Review of the Evolving Science and September 14, 2020 Current CDC Guidance Unsure how long antibodies last Gudbjartsson; September 1, 2020 DOI: 10.1056/NEJMoa2026116 17 Sensitivity and specificity varies during course of infection Deeks, Cochrane Systematic Review - Diagnostic Version published: 25 June 2020 18 Florida Hospital Association 9

  10. COVID-19: A Review of the Evolving Science and September 14, 2020 Current CDC Guidance Sensitivity and specificity varies during course of infection Deeks, Cochrane Systematic Review - Diagnostic Version published: 25 June 2020 19 Sensitivity and specificity varies during course of infection Deeks, Cochrane Systematic Review - Diagnostic Version published: 25 June 2020 20 Florida Hospital Association 10

  11. COVID-19: A Review of the Evolving Science and September 14, 2020 Current CDC Guidance Sensitivity and specificity varies during course of infection Deeks, Cochrane Systematic Review - Diagnostic Version published: 25 June 2020 21 Sensitivity and specificity varies during course of infection Deeks, Cochrane Systematic Review - Diagnostic Version published: 25 June 2020 22 Florida Hospital Association 11

  12. COVID-19: A Review of the Evolving Science and September 14, 2020 Current CDC Guidance Antibody testing is helpful for surveillance  Not ideal for diagnosis as are not detectable until later in infection  Great to help understand current population prevalence  Demographic and geographic patterns can identify communities who experienced a higher infection rate  Identify individuals who can donate convalescent plasma treatment 23 Antigen testing 24 Florida Hospital Association 12

  13. COVID-19: A Review of the Evolving Science and September 14, 2020 Current CDC Guidance 25 What about using antigen tests instead of PCR?  Antigen tests detect proteins on the virus  Antigen tests can tell you if someone is currently infected 26 Florida Hospital Association 13

  14. COVID-19: A Review of the Evolving Science and September 14, 2020 Current CDC Guidance Advantages to antigen tests  Cheaper  Rapid  More amenable to point-of-care use  Nasopharyngeal or nasal swab 27 Limitations include limit of detection Lateral Flow https://www.youtube.com/watch?v=kNADw5io9Ms&t=448s 28 Florida Hospital Association 14

  15. COVID-19: A Review of the Evolving Science and September 14, 2020 Current CDC Guidance Could be used as screening tool if done frequently  Screening in high-risk congregate settings where infection prevention and control measures can be implemented immediately  Requires frequent testing with no delays in reporting Larremore: doi.org/10.1101/2020.06.22.20136309 More available at: https://www.cdc.gov/coronavirus/2019-ncov/lab/resources/antigen-tests-guidelines.html 29 PCR/NAAT 30 Florida Hospital Association 15

  16. COVID-19: A Review of the Evolving Science and September 14, 2020 Current CDC Guidance Hadaya J, Schumm M, Livingston EH. Testing Individuals for Coronavirus Disease 2019 (COVID-19). JAMA. 2020;323(19):1981. doi:10.1001/jama.2020.5388 31 Viral culture Harcourt J, Tamin A, Lu X, et al. Severe Acute Respiratory Syndrome Coronavirus 2 from Patient with Coronavirus Disease, United States. Emerging Infect Dis. 2020;26(6):1266-1273. doi:10.3201/eid2606.200516. 32 Florida Hospital Association 16

  17. COVID-19: A Review of the Evolving Science and September 14, 2020 Current CDC Guidance Updated CDC guidelines: Shift to symptom-based strategy 33 34 Florida Hospital Association 17

  18. COVID-19: A Review of the Evolving Science and September 14, 2020 Current CDC Guidance  n = 9  Cluster detected in January 2020  Single hospital in Munich, Germany  RT– PCR and viral culture results were cross-confirmed in two laboratories  Participants not stratified by disease severity Wölfel R, Corman VM, GuggemosW, et al. Virologicalassessment of hospitalized patients with COVID-2019. Nature. May 2020:1-12. doi:10.1038/s41586-020-2196-x. 35 The likelihood of recovering replication-competent virus declines after onset of symptoms Wölfel R, Corman VM, Guggemos W, et al. Virological assessment of hospitalized patients with COVID-2019. Nature. May 2020:1-12. doi:10.1038/s41586-020-2196-x. 36 Florida Hospital Association 18

  19. COVID-19: A Review of the Evolving Science and September 14, 2020 Current CDC Guidance  n = 12  January - February 2020 in six US states  SARS-CoV-2 RT-PCR and viral culture  Mild to moderately severe illness  No positive viral cultures after day 9 post-symptom onset Kujawski SA, Wong KK, Collins JP, et al. Clinical and virologic characteristics of the first 12 patients with coronavirus disease 2019 (COVID-19) in the United States. Nature Medicine. June 2020:1-23. doi:10.1038/s41591-020-0877-5. 37  n = 90  Public health lab in Manitoba, Canada  No viral culture were isolated 7 days after symptom onset Bullard J, Dust K, Funk D, et al. Predicting infectious SARS-CoV-2 from diagnostic samples. Clin Infect Dis. May 2020. doi:10.1093/cid/ciaa638. 38 Florida Hospital Association 19

  20. COVID-19: A Review of the Evolving Science and September 14, 2020 Current CDC Guidance Bullard J, Dust K, Funk D, et al. Predicting infectious SARS-CoV-2 from diagnostic samples. Clin Infect Dis. May 2020. doi:10.1093/cid/ciaa638. 39  n = 89  Survey of nursing home in Washington State in March 2020  RT-PCR+ in 48 individuals , followed by viral cultures  No viral cultures positive after day 9 post symptom onset Arons MM, Hatfield KM, Reddy SC, et al. Presymptomatic SARS-CoV-2 Infections and Transmission in a Skilled Nursing Facility. N Engl J Med. 2020;382(22):2081-2090. doi:10.1056/NEJMoa2008457. 40 Florida Hospital Association 20

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