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

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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


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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

  • n 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become out of date.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.

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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 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

https://icap.nebraskamed.com/coronavirus/ https://icap.nebraskamed.com/covid-19-webinars/

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Facility Transfer Assessment

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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

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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
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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
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CDC Testing Guidance

  • Dr. Nada Fadul
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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
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Clinical Diagnosis

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%

  • Hospitalized Chinese - mostly older (63% >50 yo), 63% male
  • HCW - mostly younger (55% <45 yo), 73% female

Huang, C, et al. Lancet. 2020;395:497. Chen, N, et al. Lancet. 2020;395:507-13.

  • CDC. MMWR. 2020;69:477-81.
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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

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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.

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Different Tests Available

  • Molecular Tests (PCR, NAAT)

– Amplify RNA of the virus – Use Case = Diagnosis of acute infection

  • Antigen Tests

– Detect viral antigens – Don’t amplify – Use Case = Rapid diagnosis

  • f acute infection
  • Serology

– Detect antibodies made by the immune system – Detected after acute infection develops – Use Case = defining previous infection, population prevalence

  • Culture

– Grow the virus – Slow and not widely available – Use Case = Defining infectivity period

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Serology

What we know – Robust and rapid serologic response

  • f IgM, IgA and IgG

– IgM rises within 5-7 days symptom

  • nset

– 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

Serologic Response in Severe and Mild COVID-19 Infection (N=23)

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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?

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How to Test

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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??

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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

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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 testing Most are not Yes 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

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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
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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

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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
  • n 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

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CDC Testing Guidance Definitions:

Diagnostic Testing

  • Identifies

current infection

  • Performed on

person with symptoms or after recent exposure Screening Testing

  • Identifies

asymptomatic infections

  • Performed to

prevent transmission within an asymptomatic group Surveillance Testing

  • Monitors

population level infection

  • Testing done on

de-identified individuals for data gathering and analysis on a large scale

https://www.cdc.gov/coronavirus/2019-ncov/lab/resources/antigen-tests- guidelines.html

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CDC Testing Guidance Testing Strategies by Type:

Diagnostic Screening Surveillance Symptomatic or Known Exposure Yes No N/A Asymptomatic w/out Suspected Exposure No Yes N/A Determine Incidence and Prevalence in Community N/A N/A Yes Results Returned to Individual Yes Yes No Results Returned to Requesting Institution No No Yes Results Reported to Public Health Yes Yes If Requested Testing performed in CILA-Certified Lab Yes Yes Yes Testing performed in Non-CILA-Certified Lab No No Yes Test System Must be FDA Authorized Yes Yes NO

https://www.cdc.gov/coronavirus/2019-ncov/lab/resources/antigen-tests- guidelines.html

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CDC Discontinuation of Isolation

  • CDC updated Discontinuation of Isolation Guidelines on Aug. 16,

2020

https://www.cdc.gov/coronavirus/2019-ncov/hcp/duration- isolation.html#:~:text=Recommendations,- Duration%20of%20isolation&text=For%20most%20persons%20with%20COVID,with%20improvem ent%20of%20other%20symptoms.

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CDC Discontinuation of Isolation

https://www.cdc.gov/coronavirus/2019-ncov/hcp/duration- isolation.html#:~:text=Recommendations,- Duration%20of%20isolation&text=For%20most%20persons%20with%20COVID,with%20improvement %20of%20other%20symptoms.

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CDC Discontinuation of Isolation

https://www.cdc.gov/coronavirus/2019-ncov/hcp/duration- isolation.html#:~:text=Recommendations,- Duration%20of%20isolation&text=For%20most%20persons%20with%20COVID,with%20improvem ent%20of%20other%20symptoms.

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UNMC Discontinuation of Isolation: Outpatient

Immunologically Normal:

  • Positive test – self-isolate for at least 10 days after symptom
  • nset AND at least 3 days after symptoms subside
  • Negative test – self-isolate for at least 3 days after symptoms

subside unless another etiology defined (influenza, etc.). If another etiology defined follow protocol for that pathogen

  • Unable to test – Treat as if had positive test unless another

etiology defined.

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UNMC Discontinuation of Isolation: Outpatient

Immunosuppressed: Bone marrow transplant, organ transplant, poorly controlled HIV, steroids >20mg per day for >2 weeks,

  • ther severe forms of immunosuppression.
  • Positive test – self-isolate for at least 21 days after symptom
  • nset
  • Negative test – self-isolate for at least 3 days after symptoms

subside unless another etiology defined (influenza, etc.). If another etiology defined follow protocol for that pathogen

  • Unable to test – Treat as if had positive test unless another

etiology defined.

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UNMC Discontinuation of Isolation: Outpatient

Asymptomatic Patients: Patients who test positive for COVID- 19 who do not have symptoms should be monitored for the development of symptoms. If no symptoms develop, they can leave home isolation per the above guidelines for duration of home isolation (10 days immunocompetent, 21 days immunocompromised). If symptoms develop, management should be based on meeting the time after symptom onset as described above.

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UNMC Discontinuation of Isolation: Inpatient

  • Inpatients diagnosed with COVID-19 will remain in isolation

for 21 days after their first positive test unless they meet test-based criteria for exiting isolation.

  • After 21 days we do not consider them infectious.
  • The exception to this are patients who test positive for SARS-

CoV-2 but are asymptomatic. – Immunologically normal persons who remain asymptomatic can exit isolation 10 days after their positive test. – Those who are immunocompromised should remain in isolation for 21 days unless they meet test-based criteria for exiting isolation.

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UNMC Discontinuation of Isolation: Inpatient

Test-based Criteria for exiting isolation:

  • Symptomatic inpatients may exit isolation earlier

than 21 days if they have 2 negative tests for SARS- CoV-2 spaced approximately 24 hours apart.

  • Testing should not be performed until the following

criteria are met: – • Resolution of fever without fever suppressing medication • Significant improvement in respiratory symptoms (cough, SOB, etc.)

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Testing Summary …..

Antigen tests are appropriate to be used for screening asymptomatic individuals although a positive result in this population may need to be confirmed by a PCR test while keeping the individual in isolation in the meantime. If antigen test is used on a symptomatic individual then a negative test will have to be confirmed by a PCR test while keeping the individual in isolation in the meantime In an outbreak investigation, PCR tests are preferred. If antigen tests are used then their results may have to be confirmed by PCR tests. (Note: Usually ICAP team and/or local health departments are involved in guiding those decisions)

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Infection Prevention and Control Office Hours

Monday – Friday 7:30 AM – 9:30 AM Central Time 2:00 PM -4:00 PM Central Time Call 402-552-2881

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Questions and Answer Session

Use the QA box in the webinar platform to type a question. Questions will be read aloud by the moderator, in the order they are received A transcript of the discussion will be made available on the ICAP website Panelists:

  • Dr. Nada Fadul, MD

Kate Tyner, RN, BSN, CIC Margaret Drake, MT(ASCP),CIC Teri Fitzgerald, RN, BSN, CIC Sarah Stream, MPH, CDA Moderated by Mounica Soma, MHA Supported by Sue Beach, Marissa Chaney, and Margaret Deacy https://icap.nebraskamed.com/covid-19-webinars/

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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 NE DHHS guidance for updates. NETEC – NICS/Nebraska DHHS HAI-AR/Nebraska ICAP Small and Critical Access Hospitals-Outpatient Region VII Webinar on COVID-19 8/25/2020

  • 1. If the patient was negative… in that situation, you would still need to isolate for 14 days, so

what is the use of testing? This question highlights what Dr. Fadul was presenting about the nuances of congregate

  • settings. In a congregate setting like long-term care, the way the scenario was presented was

that a person who lives in long-term care with other residents, very likely has a roommate, etc., that test is one point in time. So we have to repeat the testing again, most likely, at the end of the quarantine period. But in a congregate setting, the value of knowing if this resident is positive is very high, because we can move the resident into a private room and do different PPE approaches with this resident to make it less likely to spread in the congregate setting. That’s really the idea of calling an antigen test presumptive and being very cautious in doing PCR testing for validation in settings where you are unsure of what the result means because in congregate settings, there is just such high risk. That’s why we wanted to call out that specific example. Teri Fitzgerald added that you would be giving a dedicated staff to anybody who'd be positive. Therefore, it's very important that we find out who is positive up front so that we're dedicating staff to the positives and they're not taking care of both groups. Kate said our approach in long- term care has been incredibly strict, more strict than what we see in the acute care

  • environment. And that's why, Kate agreed with Teri’s point that ICAP is really glad to be a

resource in those situations to help with that.

  • 2. Kate asked Dr. Fadul about PCR rapid testing results. Since Kate is not as familiar with them

(and doesn’t want to advertise for certain businesses) but for the sake of the audience, asked what are some of those PCR rapid testing machines, or capabilities? What do you call those? She asked for Dr. Fadul’s input so that people might be able to kind of differentiate what's in their facility.

  • Dr. Fadul said they are different ones available in the market, but the most commonly used one

in hospital settings is a Gene Expert. It's a safe machine, and it's actually used for a lot of other infections, most commonly for C Diff and also for tuberculosis and other infections when we use molecular diagnosis. But that same machine can be used for COVID 19 and the turnaround time is pretty quick. Depending on the setting and how often they are running the test, it could be

  • ne hour to a few hours. So here in our institution, we use it, sometimes for patients we need to

go to the OR if they need to have an urgent surgery, for example, instead of waiting for the test to come back in less than 24 hours or less we do the rapid testing so we can move to the OR

  • quickly. Occasionally we use it for patients who are being admitted from the emergency room,

and we feel like we need to, or we have a problem with the COVID fluoroscope, so then we

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might need to do the rapid PCR in that case to move the patient to the regular floor. But most commonly, we're using it in the pre-op setting.

  • 3. In terms of symptomatic individuals, do rapid PCR tests (like rapid antigen tests) need to be

confirmed by send-out PCR testing? The answer is no. In that case, rapid PC tests, just like the lap the other types of PCR tests are pretty sensitive and pretty specific. If you have a rapid PCR test result, you could rely on it as if you had the PCR test, the other types of PCR tests. There's really no decreasing sensitivity or specificity by doing it a rapid PCR rather than just regular PCR.

  • 4. Dr. Fadul, you work in outpatient clinic environment sometimes. Can you tell us some

examples of scenarios where you would use a rapid antigen test? I would probably use it if I had a symptomatic patient come into the clinic. If you think about the rapid COVID test, think about it as the rapid flu test. If you are in an outpatient setting or an urgent care setting, and you have a patient coming in with symptoms adjustable influenza doing it rapid flu test can be very helpful because if it's positive and the patient has symptoms suggestive of the illness, then you can pretty much say, “You do have the flu, go home and do this and take Tamiflu, etc.”. It's very similar with COVID. If you have patients coming in with symptoms suggestive of COVID, and you do a rapid COVID antigen test in the clinic and the an antigen testis positive, then you could pretty much stop there and say, “Yeah, you do have

  • COVID. Go home and isolate, etc.” However, if the patient has symptoms of COVID and the

rapid antigen test is negative, then you would have to send a PCR test in that case. Now, if you think about it, the sensitivity is about 80%. So, meaning one out of five patients who do have COVID are going to come back negative, but that also means four out of five are going to come back positive. So it might actually save you a lot of time and a lot of extra work and waiting for that patient. If you're able to do the rapid antigen test to test symptomatic patients. Dr. Fadul thinks that's really the most useful scenario for the use of these tests.

  • 5. In a non-nursing home setting, we try to hold off on testing asymptomatic patients who have

had a significant exposure for at least 7 days. What are your thoughts? We are concerned with testing too early, on asymptomatic people. They are under isolation during this time.

  • Dr. Fadul thinks It's also helpful to discuss how this question relates to the nursing home setting,

She agrees that's a very valid point. If you have an outpatient who had an exposure, the incubation period of the virus is anywhere between 2- 14 days. If you test immediately after the exposure, you might actually be before the window off the virus replication. Therefore, a negative test in that case cannot rule out that this patient had COVID 19. So we recommend

  • waiting. There is really no good guidance on how long to wait, so five days seems to be the most

cited number, You could wait for five days after exposure and then test them at that time. You don't want to wait too long, because if you wait too long, then especially if you're using an antigen test, the test might come back negative. And that again does not allow the infection If you are using a PCR test then it's okay to wait maybe seven days or so, because that's kind of in the midst of that incubation period. If you can trust your patient to stay under isolation, then you might just monitor in the first few days of COVID or the first few months, we did not just any asymptomatic patients, period, because we just did not have the testing capacity that we have

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right now on. Back then, we would just tell these patients, “Yeah, you were exposed. You may have it. Just stay at home and quarantine for 14 days.” So that's also an option, depending with testing capacity. Kate Tyner added that when we're doing contact tracing on COVID exposures, we always use the 48 hours before the first day of symptoms or testing. Kate would say to this person who asked the question, “You just have to be careful to include those two days that proceed the symptoms

  • r the tes,t” because that's a period of time that we think that the person, if they had exposure

during that, that should be considered already in that incubation period, especially in a congregate setting. That's where we have the most experience with. A a husband and wife couple, for example, if the husband tested on Wednesday, did he start exposing the wife to COVID on Wednesday? No, he started exposing the wife to COVID, most likely Monday, 48 hours before testing. By that rationale, by the time you get results on Thursday or Friday, you're already 3 to 4 days in. In congregate settings, we will test that early. It's actually pretty rare, still, that we will have that rapid turnaround of testing since we are using the PCR test. In most places across the state so far, it's more likely that we're kind of late in the game on doing look

  • backs. And so then we're testing as soon as we can.
  • 6. The testing units that are being sent out to the long-term care facilities, what type of tests do

these perform? Is it PCR/Antigen? In the long-term care facilities in Nebraska ICAP knows of about 10 facilities that have been provided the anti gin detection units there, either the BD Veritas or the Sofia units, and those are an antigen detection unit. Nationally, this is why CDC has become more instructive about how to use these antigen detection tests because they're going to become much more widely used here within the next couple weeks.

  • Dr. Fadul closed by advising people to go to the CDC website and look up the new testing

guidance that was just released, as well as the new isolation guidelines, and visit the Nebraska Medicine website; find the “Resources for Providers for COVID 19”. That is inpatient and ambulatory, and there are all kinds of resources available there.