Nebraska DHHS HAI Team, Nebraska Medicine, and The University of - PowerPoint PPT Presentation

Presented in collaboration with Nebraska ICAP, Nebraska DHHS HAI Team, Nebraska Medicine, and The University of Nebraska Medical Center Moderated by Mounica Soma Guidance and responses were provided based on information known on 8/25/2020 and may become out of date. Guidance is being updated rapidly, so users should look to CDC and jurisdictional guidance for updates.

Questions and Answer Session Use the QA box in the webinar platform to type a question. Questions will be read aloud by the moderator If your question is not answered during the webinar, please either e-mail it to NE ICAP or call during our office hours to speak with one of our IPs A transcript of the discussion will be made available on the ICAP website https://icap.nebraskamed.com/coronavirus/ https://icap.nebraskamed.com/covid-19-webinars/ Panelists today are: Dr. Nada Fadul, MD nada.Fadul@unmc.edu Kate Tyner, RN, BSN, CIC ltyner@nebraskamed.com Margaret Drake, MT(ASCP),CIC Margaret.Drake@Nebraska.gov Teri Fitzgerald, RN, BSN, CIC TFitzgerald@nebraskamed.com Sarah Stream, MPH, CDA sstream@nebraskamed.com

Facility Transfer Assessment

Facility Transfer Assessment • Developed by Leading Age Nebraska, Ne Health Care Association and Ne Hospital Association as a tool to help with post acute-care facility transfer of patients during Covid-19 • Recently updated with the latest CDC guidance on signs and symptoms and discontinuation of isolation guidance • Can be found at https://leadingagene.org/ on the homepage under the Covid-19 Resources

What would you do…. Scenario: A primary care patient is a resident in a LTCF. The facility reports that the resident was exposed to COVID-19 by a positive staff member. Today is Tues. and the reported exposure occurred the previous Wed. and Thurs. The patient is asymptomatic. The facility would like to know next steps. A. Testing and isolation is indicated B. No testing is warranted, but isolation is recommended C. Neither isolation nor testing is indicated

What would you do…. Scenario: A primary care patient is a resident in a LTCF. The facility reports that the resident was exposed to COVID-19 by a positive staff member. Today is Tues. and the reported exposure occurred the previous Wed. and Thurs. The patient is asymptomatic. Testing is indicated. Choose the method-- A. PCR testing via nasopharyngeal swab B. Rapid antigen detection testing via nasal swab alone. C. Both

CDC Testing Guidance Dr. Nada Fadul

How to diagnose COVID-19 How do you diagnose viral infections? • Clinically – symptom-based • Imaging • Serology – IgM, IgA, IgG • Rapid tests – antigen or antibodies • Culture • Molecular Testing

Clinical Diagnosis • Hospitalized Chinese - mostly older (63% >50 yo), 63% male • HCW - mostly younger (55% <45 yo), 73% female Symptoms Hospitalized Chinese (N=140) US HCW (N=9282) Fever, cough, or SOB NA 92% Cough 80% 78% Fever 87% 68% SOB 38% 41% Myalgia 21% 66% Headache 8% 65% Sore Throat 5% 38% Diarrhea, Nausea/vomiting 2%/1% 32%/20% Loss of Smell or Taste NA 16% Runny Nose 4% 12% Huang, C, et al. Lancet . 2020;395:497. Chen, N, et al. Lancet . 2020;395:507-13. CDC. MMWR . 2020;69:477-81.

Imaging in COVID-19 CXR insensitive for diagnosis Typical CT findings should prompt testing CT changes occur within 0-4 days after symptoms and peak around day 6-13 with improvement around day 14 CT progression: – Initial phase  bilateral multilobar ground-glass opacification (GGO) with peripheral or posterior distribution, mainly in the lower lobes – Progression  GGO into multifocal consolidative opacities, septal thickening, and development of a crazy paving pattern Salehi S, et al. AJR. 2020;215:1-7 Simpson S, et al. Radiology: CT Imaging, 2020;2 https://doi.org/10.1148/ryct.2020200152

Testing Primer • The sensitivity of a test means how well it can correctly identify those who have COVID-19 infection • The specificity of a test means how well it can correctly identify those who do not have COVID-19 infection • The positive predictive value of a test is the likelihood that a positive test result indicates that a person is truly positive for COVID-19 infection. • The negative predictive value of a test is the likelihood that a negative test result indicates that a person is truly negative for COVID-19 infection.

Different Tests Available • Serology • Molecular Tests (PCR, NAAT) – Detect antibodies made by – Amplify RNA of the virus the immune system – Use Case = Diagnosis of – Detected after acute acute infection • Antigen Tests infection develops – Use Case = defining – Detect viral antigens previous infection, – Don’t amplify population prevalence – Use Case = Rapid diagnosis • Culture of acute infection – Grow the virus – Slow and not widely available – Use Case = Defining infectivity period

Serology What we know Serologic Response in Severe and Mild COVID-19 Infection (N=23) – Robust and rapid serologic response of IgM, IgA and IgG – IgM rises within 5-7 days symptom onset – Seropositivity at 14 days: IgM (88- 94%), IgG (94-100%) NM Serology Performance (IgG assay) – 0-5 days illness onset – 25% agreement – 6-14 days – 90% agreement – >15 days – 94.5% agreement – Specificity 99.3% – 16/214 positive (7.8%) To, K, et al. Lancet. 2020 https://doi.org/10.1016/S1473-3099(20)30196-1

Serology Questions What we don’t know Utility in diagnosing acute infection? – IgG poor early – IgM assay cross-reactivity Performance in mild disease? Performance in asymptomatic? The false positive question Is a positive serology protective against subsequent infection and for how long?

How to Test

Rapid Testing CLIA waived tests Results in 5-15 minutes Molecular Antigen and serologic coming Performance parameters undefined Reports of decreased sensitivity – Useful early in infection – Good for ruling in, less so for ruling out – Urgent care, ED, clinic??

CDC Testing Guidance • The CDC “Interim Guidance for Rapid Antigen Testing for SARS- CoV2” document was updated on August 16, 2020 • Document is intended to give guidance on test types, usage and differences of each of these tests • Guidance can be found at: https://www.cdc.gov/coronavirus/2019- ncov/lab/resources/antigen-tests-guidelines.html

CDC Testing Guidance PCR/ Antigen Test Differences Rapid PCR Test Rapid Antigen Test Intended Use Detect Current Infection Detect Current Infection Analyte Detected Viral RNA Viral Protein, Antigen Specimen Types NP swab, Sputum, Saliva Nasal Swab Sensitivity High Moderate Specificity High High Test Complexity Varies Relatively easy use Authorized for Point-of-care Most are not Yes testing Turnaround Time 15 min. > 2 days Approx. 15 min. Cost per Test Moderate Low https://www.cdc.gov/coronavirus/2019-ncov/lab/resources/antigen-tests- guidelines.html

Test Results Interpretation • Slight variations in how results are reported based on targets – Understand what is being reported at your facility • Roche (E- and ORF1a-) – E- and ORF1a- not detected = COVID Not Detected – E- and ORF1a- detected = COVID Detected – Only E- detected = Presumptive positive • E- is same in SARS-CoV-1 but this virus is not circulating – Invalid – test didn’t work  Repeat swab • NE COV Test (E- and N-) – E- not detected = Not Detected – E- detected  Will be retested on next run for both E- and N- • If either detected = COVID Detected • If neither detected = Inconclusive  Repeat swab

How to Interpret Antigen Test Results - 1 • When Antigen tests are used for screening testing in congregate settings, test results for SARS-CoV-2 should be considered presumptive. • Confirmatory nucleic acid testing following a positive antigen test may not be necessary when the pretest probability is high, especially if the person is symptomatic or has a known exposure. • When the pretest probability is low, those persons who receive a positive antigen test should isolate until they can be confirmed by RT-PCR. https://www.cdc.gov/coronavirus/2019-ncov/lab/resources/antigen-tests- guidelines.html

How to Interpret Antigen Test Results - 2 • Confirmatory nucleic acid testing following a negative antigen test used for screening testing may not be necessary if the pretest probability is low: • the person is asymptomatic or • has no known exposures, or • is part of a cohort that will receive rapid antigen tests on a recurring basis. • Nucleic acid testing is also considered presumptive when screening asymptomatic persons • The potential benefits of confirmatory testing should be carefully considered in the context of person’s clinical presentation. https://www.cdc.gov/coronavirus/2019-ncov/lab/resources/antigen-tests- guidelines.html

CDC Testing Guidance Definitions: Surveillance Screening Testing Diagnostic Testing Testing • Identifies • Identifies • Monitors asymptomatic current infection population level infections infection • Performed on • Performed to person with • Testing done on prevent symptoms or de-identified transmission after recent individuals for within an exposure data gathering asymptomatic and analysis on group a large scale https://www.cdc.gov/coronavirus/2019-ncov/lab/resources/antigen-tests- guidelines.html