Maine Medicine Weekly Update - November 13, 2020
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MMA Partnering With State to Distribute BinaxNOW Ag Tests

The Maine Medical Association is partnering with the Maine Department of Health and Human Services on plans to distribute the federally supplied Abbott BinaxNOW COVID-19 Antigen Cards to Maine’s independent physician practices to support rapid testing of symptomatic individuals.

 

The Maine Medical Association is partnering with the Maine Department of Health and Human Services on plans to distribute the federally supplied Abbott BinaxNOW COVID-19 Antigen Cards to Maine’s independent physician practices to support rapid testing of symptomatic individuals. Maine has now received a supply of the Abbott Rapid Ag (antigen) test cards from the Federal government, which have been authorized by the FDA for testing symptomatic individuals for COVID-19 within the first 7 days of symptoms.  Additionally, the Ag Card can also be used in limited circumstances to serially test critical infrastructure staff who are identified to be a close contact of an individual confirmed to have COVID-19.  The test is authorized for use at the Point of Care in settings operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation. Additional requirements to meet in order to receive and use Ag Cards from Maine DHHS are listed at the end of this message. 

Maine DHHS recognized early on the logistical challenges of distributing the test kits to potentially hundreds or even thousands of interested clinical and community sites. Therefore, they reached out to a number of organizations to ask whether they might be willing to serve as a partner with DHHS. The MMA quickly agreed to receive, distribute, or arrange distribution of the BinaxNOW test cards to our independent practice members throughout around the state. 

The DHHS plan allows all interested and qualified organizations to apply for the Ag Cards, with an allocation process that aims to ensure both access for all people in Maine and a priority for those at greater risk of COVID-19. 

Additional requirements to receive Ag cards from Maine DHHS:

  • Organization that are not currently receiving BinaxNOW Ag test cards directly from the Federal government
  • Must have valid/current CLIA certificate or Certificate of Waiver (contact Dan Morin at MMA for CLIA waiver application)
  • Must use the BinaxNOW Ag card test in accordance with Maine DHHS Guidance
  • Must complete a brief online instructional training on appropriate use of the BinaxNOW Ag Cards as posted on Abbott BinaxNOW Online Training.
  • Must report any positive test results to Maine CDC as required by Maine CDC Notifiable Conditions reporting and agree to report all test results to Maine CDC once such a reporting system is finalized
  • Must be prepared to direct individuals to a testing site and/or identify a health care provider to order a confirmatory PCR test when needed

 

To apply, please use the following link:

Maine DHHS Application for BinaxNOW Ag Test Cards

Important Note: Please choose “Independent physician practice” under the ‘Respondent Organization Type’ drop-down.

Maine DHHS Guidance on Use of BinaxNow COVID-19 Ag Card Testing

For more information, along w/ additional resources and a recording of Maine DHHS’s informational session to provide more information on appropriate use and requirements for using BinaxNOW Ag tests is posted to the “Health Care Provider” page of the ME CDC COVID website:

https://www.maine.gov/dhhs/mecdc/infectious-disease/epi/airborne/coronavirus/providers.shtml

Do not hesitate to email or call/text Director of Communications and Government Affairs, Dan Morin at (207) 838-8613 for more information or background.

Abbott BinaxNOW Ag Test Cards

Please note, some Maine providers, but NOT independent physician practices will be getting Ag Cards from the Federal government will not get them from the state.

Maine will distribute:

  • The Federal government is distributing two-thirds of its 150 million to states and one-third directly to health care providers, such as assisted living facilities and nursing facilities.
  • Three-fourths of its amount to one distributor who has sites across Maine, which will be drive-through and accessible to the public;
  • One-fourth to organizations that meet basic requirements and can help target high-risk populations, high-risk settings, and places with difficultly accessing testing.

The Three Cs: Close Contact, Close Faces and Crowded Places

The following information is a summary and highlights of the Thursday, November 12, call for clinicians led by COVID-19 Response Team Clinical Advisor, Stephen Sears, M.D.

 

“Guidance for today is guidance for today.”—Dr. Stephen Sears

The information below is a summary and highlights of the Thursday, November 12, call for clinicians led by COVID-19 Response Team Clinical Advisor, Stephen Sears, M.D. For information on scheduled days and times for upcoming calls please reach out to MMA Director of Communications and Government Affairs Dan Morin by email or call/text at (207) 838-8613. Note: There will be no call on Thanksgiving, November 26. Calls will resume Thursday, December 10.

Maine’s positivity rate over the last few weeks has risen from 1.49 to 2.47.

Why is there a surge? The three Cs: Close Contact, Close Faces and Crowded Places.

  • Our rates have become higher as we move indoors
  • Respiratory viruses seem to do better in cooler temperatures and lower humidity

Good news is it may have less virulence overall and a lower fatality rate per hospitalization than what was seen early in the summer. It is believed that is due to better treatments and more effective management of oxygen early on and improved ICU treatment(s). Death rates are down and some consider it partly a result of improving therapeutics and a better understanding of symptoms and diagnosis.

Pfizer Vaccine

The preliminary data looks promising but Dr. Sears emphasized that the data is preliminary. Vaccine planning in Maine is ongoing and logistics are being developed. There is expected to be different levels of prioritization for dissemination toward priority groups such as first responders and hospital personnel first, and then high risk groups. There have been questions and concerns expressed about the necessity for ultra-cold storage of the Pfizer vaccine which requires -80 centigrade. However, it can remain outside cold storage for for delivery and use over several days. A vaccine from Moderna also seems to be close to release behind Pfizer

Studies & Observations

It’s important to note a common cautionary statement by Dr. Sears to be cognizant of studies and reports resulting from case reports versus those from controlled data. Some determination and observations may seem reasonable but they oftentimes do not yet tell us the answers.

 

Monoclonal antibody treatment was highlighted: First trials show it is not effective on hospitalized patients but did show efficacy for people prior to hospitalization according to a New England Journal of Medicine study. The federal government is making it available to all states in small quantities and for specific populations. The supply may grow but right now Maine plans to receive only 90 doses so will be used for those most likely to benefit according to the data.

He also referenced an MBio reference looking at the mutation rate in SARS-CoV-2 virus. We’ve now moved  to period showing a homogenous transmission rate countrywide.

None of the drugs are magic bullets but just another tool in the box.

Journal of Infectious Disease: Virucidal Efficacy of Different Oral Rinses Against Severe Acute Respiratory Syndrome Coronavirus 2

Dr. Sears—It does appear that mouthwash will not back viral load for a period of time after use. Listerine, for example, has shown to help. It may not protect from infection but it could theoretically decrease the viral load for infected persons.

US CDC Morbidity and Mortality Weekly Report: SARS-CoV-2 Exposure and Infection Among Health Care Personnel SARS-CoV-2 Exposure and Infection Among Health Care Personnel

Dr. Sears—Health care workers continue to be at risk due to exposures at work and publicly along with everyone else. The study shows hospitalized health care workers tend to be similar to general population in that those had underlying conditions such as obesity. Forty-three percent were in nursing.

Reminder to be aware of increasing mental health challenges associated with the pandemic, whether through COVID-19 or the environmental and personal effects of the pandemic. Continuing concerns about very strong data showing an increase in depressive disorders, anxiety disorders and suicide.

Dr. Sears referenced a current study for a new diagnostic test involving the placement of small nasal strips in the nostrils that absorb nasal fluid. They are not yet available . If effective they could be very helpful for pediatric patients. The study conclusion is in preprint phase and currently shows they are a reliable non-invasive sampling method.

Travel Medicine and Infectious Disease: Self-reported symptoms from exposure to Covid-19 provide support to clinical diagnosis, triage and prognosis:

Dr. Sears—An exploratory analysis survey 20,000 people had COVID and categorized symptoms and concluded the triad of anosmia, ageusia and fever best distinguished those who tested positive from those who tested negative and differentiates COVID-19 from other viral diseases. Loss of smell/taste with fever is highly associated with COVID and not much else. It’s not astounding but shows the effectiveness of those symptom screens when looking at a large population

Antigen testing

There are three major antigen tests

  • Quidel
  • BD
  • BinaxNOW
    • The test Maine has received from the federal government (different than Abbot ID NOW test) and the test outlined in this edition of Maine Medicine Weekly Update. The test will be more widespread due to the number available
    • Best used within symptomatic people within 7 days of symptoms. Not approved for anything other than symptomatic people but is increasingly being used for asymptomatic.
    • Currently being distributed to Walgreens, prisons, EMTs, and FQHCs. Other health care facilities and practice groups can apply for them. It may also potentially be used for serial testing of critical infrastructure workers.

They are not  as sensitive as PCR testing. First, the background prevalence will determine the predictive positive value and the predictive negative value.  Practically, if someone has symptoms consistent with COVID and have tested negative they should have the test repeated with PCR (be concerned with false negatives). If a-symptomatic and it’s positive you should be very concerned with false positives. Because of our relative low prevalence in Maine the positive predictive value of the BinaxNOW test is not as high as we would like (40% to 50% range). The thought is if someone has clinically compatible symptoms and gets a positive result it can be a very useful test.

Maine CDC urges to keep using POCR tests for outbreak settings

Oxford University has developed a rapid test not yet available in the that allegedly can identify the virus in 5 minutes or less. The company said it may apply for authorization from the U.S. Food and Drug Administration.

American Journal of preventative Medicine: Predictive Factors for a New Positive Nasopharyngeal Swab Among Patients Recovered From COVID-19

Dr. Sears—Close to 17 percent of patients recovered from COVID-19 could still carry virus. If retested within two weeks they still show positive which is why retesting is not recommended. It is not viable virus. It is viral particles (RNA) which are amplified within the genetic test.

JAMA: Cytokine Levels in Critically Ill Patients With COVID-19 and Other Conditions

Dr. Sears—JAMA study shows that much of what we thought about cytokine storm may not be all that different from sepsis and a number of the SERS syndromes.

There are some diagnostic studies that combine rapid PCR with antibody testing. According to Dr. Sears, it may be useful for people farther out in illness. It’s not widespread but coming along.

A key point emphasized was that there are a lot of different diagnostic studies appearing. Unfortunately, we’re getting them a lot earlier in their development. It doesn’t mean they aren’t useful but there are caveats which we wall need to be aware. Dr. Sears pointed one study example of a study conclusion being different this week than a few weeks ago. Three weeks ago a study suggested that ocular disease is a problem with COVID-19. Another was just released saying it isn’t a problem. We spent the first 4 or 5 months running to catch up clinically and now we have the opportunity to do appropriaste clinical trials to see what eventually turns out to be the most effective overall

Clinical Observations/Miscellaneous Information/Call Q&A:

Post COVID fatigue: By the second week most people remain ill but by six weeks most are better but some have chronic long term fatigue, mental fogginess and for people with serious pulmonary problems. Some have chronic symptoms for months although those are mostly people who were in the ICU. Long haulers-don’t have positive virus but positive symptoms

There’s a lot of reassessment on anticoagulation for the acute individual. The risk of clots is about 16 percent with severe COVID but the risk of complications of anticoagulation is really unknown but appears to be in the 10 percent range,

Antiphospholipid antibodies studies that seem to be associated with increased risk of anticoagulation disorders.

Autoimmunity is looking like one of the hallmarks of the disease and we are getting to better defining the conditions. Some of the neurologic effects seems to be related to immune responses. Questions remain as to why steroids and some other interventions seem to work? Unsure. There’s a lot of clinical data but it’s not controlled data so we need to be careful on how the information is interpreted. Things that we thought were useful sometimes turn out not to be.

Oral health issues remain something to be aware of. There’s a significant decline in treatment and routine care.

Remdesivir indications have been increased to include anyone hospitalized with COVID. Initially it was for those with sever COVID with a certain oxygen saturation  level or headed toward repository decline. Now indications have increased. There is a caveat. Those are US guidelines but WHO is looking at multi-national data that doesn’t show much benefit from Remdesivir.

Study about convalescent plasma showed it doesn’t have significant benefit although monoclonal antibodies do appear to have benefit. Prior to hospitalization, those with chronic conditions, over 65, obese, and other risk factors showed a clearly decreased viral load and decreased hospitalization.

Updates on antibody testing: There are a couple of companies (Seamans and Roche) seems to have higher sensitivity and specificity but the immune correlative for protection and/or immunity. Clearly it has something to do with anti-spike antibodies. It’s useful for some but difficulty to interpret.

PCR remains the best test overall but we are moving back into the area of reagents shortage and PCR availability. Some areas of Maine of moving back to prioritization for PCR. One pitfall is when large population screening is done with PCR it potentially prevents the flexibility of investigating outbreaks.

CMS is covering monoclonal antibody treatments for Medicare recipients without cost, however, there is concern because there are very few available and they will be needed for very specific populations. How well does it work? Just another tool but not a major breakthrough and is useful in certain situations

England study on infection fatality rate: 1.15 percent looking at compilation of approximately 175 various studies but we nee more studies of subpopulations

Neuropilin-1 (NRP1) is another molecular target now identified along with Ace2

No confirmed case yet for influenza in Maine. It’s still early. It’s typically seen later in November.

Vitamin D studies have been for and against. In most studies it doesn’t make much difference in most studies, however it’s not from controlled data.

Maine DHHS Health Equity Webinar - Wed, Nov 18 (7:30A) - Vaccine Hesitancy & Building Trust

The webinar will be focused on the very important issue of preparing for the upcoming COVID-19 vaccines, and how clinicians can work to build trust with their patients to accept vaccines that can help provide important protection during this pandemic.

 

Maine DHHS Health Equity Webinar - Wed, Nov 18 (7:30A) - Vaccine hesitancy & building trust

The webinar will be focused on the very important issue of preparing for the upcoming COVID-19 vaccines, and how clinicians can work to build trust with their patients to accept vaccines that can help provide important protection during this pandemic.

Wednesday, November 18, 2020

7:30 a.m. – 8:30 a.m.

Exploring Vaccine Hesitancy & Building Trust for COVID-19 Vaccines

Please join Maine DHHS for a conversation with…

  • Sana Osman, Community Health Worker, Maine Access Immigrant Network (MAIN)
  • Inza Ouattara, State Refugee Health Coordinator, Catholic Charities Maine
  • Sandra C. Qunn PhD, Professor and Chair, Department of Family Science and Senior Associate Director, Maryland Center for Health Equity

Please note that attendees are asked to register in advance for this and the remaining webinars in this series:

https://zoom.us/meeting/register/tJcsfuGvpj0jGdaRiW5Y15qnYa2AMVriHgaI

Also, please note that video recordings of the previous ME DHHS Health Equity webinars (Aug – Oct) are posted on the ME CDC website: www.maine.gov/dhhs/mecdc/infectious-disease/epi/airborne/coronavirus 

(scroll down to “Health Equity webinars”)

A Belated Veterans Day Thank You

Happy Belated Veterans Day to all who have or are still serving, and a special thanks to those MMA member veterans!

 

Happy Belated Veterans Day to all who have or are still serving, and a special thanks to those MMA member veterans!

One interesting Maine related veteran tidbit was highlighted by the Portland Press Herald. Did you know Maine had the 1st veterans hospital in the country? According to the article, on November 10, 1866, nineteen months after the Civil War’s end, the first patient is admitted to the National Asylum for Disabled Volunteer Soldiers, Eastern Branch, at the former Togus Springs summer resort near Augusta, the first such facility in the nation. The hospital complex accommodates fewer than 400 patients at first, but an aggressive building program in the late 1860s eventually provides services for nearly 3,000 veterans.

The U.S. Department of Veterans Affairs describes the history of the VA starting in 1865 near end of the Civil War, when President Lincoln signed an act creating the National Asylum (later changed to Home) for Disabled Volunteer Soldiers. The Eastern Branch at Togus, Maine was the first of the new homes to open in November 1866. The name "Togus" comes from the Native American name Worromontogus, which means "mineral water".