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:
DHHS Application for BinaxNOW Ag Test Cards
Important Note: Please choose “Independent physician
practice” under the ‘Respondent Organization Type’ drop-down.
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:
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
- 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
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
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,
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.
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.
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
Journal of Infectious Disease: Virucidal
Efficacy of Different Oral Rinses Against Severe Acute Respiratory Syndrome
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
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
There are three major antigen tests
- 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
- 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
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
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
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.
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
Clinical Observations/Miscellaneous Information/Call
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
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
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
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
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
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
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
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
Please note that attendees are asked to register in
advance for this and the remaining webinars in this series:
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
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
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".