COVID-19 Update: FDA authorizes first COVID-19 test for self-testing at home

Today, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the first COVID-19 diagnostic test for self-testing at home and that provides rapid results. The Lucira COVID-19 All-In-One Test Kit is a molecular (real-time loop mediated amplification reaction) single use test that is intended to detect the novel coronavirus SARS-CoV-2 that causes COVID-19.

“The FDA continues to demonstrate its unprecedented speed in response to the pandemic. While COVID-19 diagnostic tests have been authorized for at-home collection, this is the first that can be fully self-administered and provide results at home. This new testing option is an important diagnostic advancement to address the pandemic and reduce the public burden of disease transmission,” said FDA Commissioner Stephen M. Hahn, M.D. “Today’s action underscores the FDA’s ongoing commitment to expand access to COVID-19 testing.”

The Lucira COVID-19 All-In-One Test Kit test has been authorized for home use with self-collected nasal swab samples in individuals age 14 and older who are suspected of COVID-19 by their health care provider. It is also authorized for use in point-of-care (POC) settings (e.g., doctor’s offices, hospitals, urgent care centers and emergency rooms) for all ages but samples must be collected by a healthcare provider when the test is used at the POC to test individuals younger than 14 years old. The test is currently authorized for prescription use only.

The test works by swirling the self-collected sample swab in a vial that is then placed in the test unit. In 30 minutes or less, the results can be read directly from the test unit’s light-up display that shows whether a person is positive or negative for the SARS-CoV-2 virus. Positive results indicate the presence of SARS-CoV-2. Individuals with positive results should self-isolate and seek additional care from their health care provider. Individuals who test negative and experience COVID-like symptoms should follow up with their health care provider as negative results do not preclude an individual from SARS-CoV-2 infection.

“Today’s authorization for a complete at-home test is a significant step toward FDA’s nationwide response to COVID-19. A test that can be fully administered entirely outside of a lab or healthcare setting has always been a major priority for the FDA to address the pandemic. Now, more Americans who may have COVID-19 will be able to take immediate action, based on their results, to protect themselves and those around them,” said Jeff Shuren, M.D., J.D., director of FDA’s Center for Devices and Radiological Health. “We look forward to proactively working with test developers to support the availability of more at-home test options.”

An important component to successful at-home testing is the ability to efficiently track and monitor results. As noted in this EUA, prescribing health care providers are required to report all test results they receive from individuals who use the test to their relevant public health authorities in accordance with local, state and federal requirements. Lucira Health, the test manufacturer, has also developed box labeling, quick reference instructions and health care provider instructions to assist with reporting.

Diagnostic testing remains one of the pillars of our nation’s response to COVID-19. The FDA continues its public health commitment to pursue new approaches that help make critical tests available to more Americans through EUA authority.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.




Need a Covid Test? Free Testing is Available in New Bedford & Fall River

We often get asked “where can I get a Covid test?” Fortunately in both New Bedford and Fall River there are several options. Get tested, stay safe, wear your masks, avoid crowds and wash your hands.

Directly from the state of MA website:

Stop the Spread
The Commonwealth is launching a strategic testing program in communities across Massachusetts that have continued to see a higher number of residents testing positive for COVID-19. You can find all the New Bedford testing sites here: https://www.mass.gov/info-details/stop-the-spread#new-bedford- For Fall River click here: https://www.mass.gov/info-details/stop-the-spread#fall-river-

This program will support the testing of asymptomatic individuals in these communities to help stop the spread of COVID-19. If you are a resident of one of these communities, even if you have no COVID symptoms, please get tested to help stop the spread.

The Commonwealth urges residents of these communities to get tested for COVID-19:
Brockton, Chelsea, Everett, Fall River, Framingham, Holyoke, Lawrence, Lynn, Marlborough, Methuen, New Bedford, Randolph, Revere, Salem, Saugus, Springfield, Winthrop, and Worcester.
This testing is free for all Massachusetts residents.
———-
The Stop the Spread program is intended to provide low barrier, free, and easy to access testing to all Massachusetts residents.

Open to all Massachusetts residents
Testing is not restricted to residents of the cities where sites are located
You don’t need to have any symptom(s)
No cost to you
Out-of-state residents are not eligible for free testing under the Stop the Spread program





Governor Baker to re-establish field hospital at the DCU Center in Worcester

The Baker-Polito Administration today announced that the first field hospital will be stood up at the DCU Center in Worcester as the Commonwealth prepares additional capacity for COVID-19 patients. This site will be built by the National Guard and is the first field hospital to re-open in the state since June.

“The Commonwealth continues to see an alarming rise in cases and hospitalizations for COVID-19 and we are acting now to expand hospital capacity,” said Governor Charlie Baker. “All residents are urged to follow guidance to wear masks, stay home at night and stop gathering. We are preparing our hospital system to add more beds and stand up our first field hospital to care for COVID-19 patients if these trends continue. We will keep working with our health care system to monitor capacity and will be prepared to open more locations if needed.”

The plan to re-establish the field hospital in Worcester was activated this week. The site is expected to be available for patients in the first week of December if needed and additional locations will be added in other regions if necessary. No further changes or restrictions to regular hospital services in Massachusetts are being implemented at this time.

“Since Day One of our response to this crisis, we have worked to ensure that our hospitals and health care providers have the resources they need to meet the acute care health needs of our residents,” said EOHHS Secretary Marylou Sudders, the COVID-19 Command Center Director. “We are in a much better position to respond to what will be a difficult next few months, and the early re-opening of this field hospital is based on the data we see is the right action to take at this time.”

State officials have closely monitored several metrics and note that hospitalizations since Labor Day have increased from 178 to 661. While the hospital system manages the current demand for COVID and non-COVID care, the DCU site will provide approximately 240 additional beds to care for lower-acuity COVID-19 patients, helping preserve hospital system capacity for higher-risk patients diagnosed with COVID-19 or other serious health conditions.

The Massachusetts Emergency Management Agency (MEMA) will coordinate the logistics of the DCU Center field hospital, in close collaboration with the Command Center, City of Worcester, and UMass Memorial Health Care, which will again lead all clinical, day-to-day, operations.

“The Commonwealth’s forward planning and ability to stand up this Alternate Care Site with our partners is a direct result of lessons learned and our experience during the first wave of the pandemic,” said MEMA Director Samantha Phillips. “We hope that we won’t need all of these overflow beds, but if we do, they’ll be ready.”

The DCU Center was the first of five field hospitals constructed by the Commonwealth during the response to the springtime surge of COVID-19 cases. From early April until late May, when it was de-mobilized, the DCU site served 161 patients. In total, the DCU and the Boston Hope field hospitals cared for more than 570 hospital patients during the first pandemic surge.

“This is the right thing to do and at the right time. The field hospital was an enormous asset for Central Massachusetts hospitals during the spring surge. I believe it can serve an even greater purpose today because we have learned so much more about the virus and caring for COVID-19 patients since then. Our team is ready to deploy and to assist the state’s hospitals,” said Eric W. Dickson, MD, President and CEO of UMass Memorial Health Care.

Alternate Care Sites are designed as clinical spaces for lower acuity patients. These sites provide a relief valve for hospitals, allowing them to manage or reconfigure their facilities to care for more seriously ill patients. Each site is built to safely accommodate the beds, equipment, and medical supplies needed to appropriately care for COVID-19 patients.

The establishment of field hospitals has been a critical strategy in Massachusetts’ response to COVID-19. Additionally, the Command Center has added 30 specialty beds at two long term care facilities to increase capacity for individuals being discharged from acute care hospitals to nursing home level of care and are on ventilators or had tracheotomies. The Commonwealth’s continued preparedness has also included the stockpiling of millions of pieces of PPE, including gloves, masks, gowns, and other essential equipment as hundreds of additional ventilators. The state’s emergency stockpile will buttress strong preparedness that hospitals and other health care facilities have undertaken in the last several months, including building their own inventories to respond to the next stage of the pandemic.




Massachusetts Sheriffs re-arrest repeat offenders who were released due to COVID-19

Hampden County Sheriff Cocchi announced today that over the past several months, more than a dozen individuals released by the courts due to the COVID-19 Pandemic were re-arrested by the department’s apprehension team after committing new crimes in the community.

One of these individuals, who was previously released, cut off his GPS monitoring device and was later arrested for carjacking and armed robbery.

“What we have here are repeat offenders leaving more victims in the community after having been released early over COVID-19 concerns. This is a very dangerous situation for the public,” Sheriff Nick Cocchi said. “I have ordered my apprehension team along with our law enforcement task force partners to locate and arrest these individuals to bring them to justice. The safety of the public is my top concern.”


Hampden County Sheriff’s Department photo.

Read the full story via WWLP-22News here: https://www.wwlp.com/news/local-news/hampden-county/hampden-county-sheriffs-department-re-arrests-repeat-offenders-released-by-courts/




Field hospitals going up in Massachusetts in preparation for fall and winter COVID-19 surge

By Matt Murphy
State House News Service

In April when the state began setting up field hospitals in Boston, Worcester and elsewhere to deal with the crushing volume of COVID-19 patients needing care, more than 2,000 people a day were being diagnosed with the virus and hospitals were seeing coronavirus patient volumes creep close to 4,000 statewide.

But as Gov. Charlie Baker prepares to bring back the medical tents and convention center cots to prepare for the fall and winter surge of COVID-19, the governor said Thursday the situation facing Massachusetts is “nowhere near” the dire circumstances of the spring.

Baker plans to announce detailed plans to reopen field hospitals on Friday, at which point Massachusetts will have likely crossed the grim threshold of 10,000 confirmed deaths from the disease. There had been 9,994 deaths reported by the state through Wednesday.

He said the facilities will be reopening “in places that will be familiar to people,” which could include the Boston Convention and Exhibition Center, the DCU Center in Worcester, the University of Massachusetts Lowell or Joint Base Cape Cod in Bourne, all of which hosted field hospitals in the spring.

“This is a drill and a process that I think at this point we have a fair amount of experience with and I think in many ways, this is not just an issue for Massachusetts. It’s a challenge for the rest of the country and frankly most of the western world,” Baker said.

Baker was in Carlisle with Education Secretary Jim Peyser and Elementary and Secondary Education Commissioner Jeff Riley to tour classrooms and observe how the district has adapted to the pandemic to provide in-person learning.

The administration has been adamant that schools are largely safe spaces if proper precautions are taken, and that students should be learning in the classroom, as opposed to remote from home.

Along with 2,495 new cases on Wednesday, the Department of Public Health reported that the state’s hospitals were operating at 72 percent occupancy of non-intensive care unit beds and 50 percent capacity in ICUs.

The number of patients hospitalized Wednesday stood at 659, which was up from 513 last Friday.

Asked about entering “uncharted water” with the rise in confirmed COVID-19 cases, Baker said the situation this fall cannot be compared to the spring when the state was testing 10 times fewer residents each day and the health care system had never seen the virus and was unprepared.

“We’re nowhere near the uncharted territory we were at in the spring. Nowhere near it. Nowhere,” Baker said. “We are definitely dealing with a surge that we talked about throughout the summer and the beginning of the fall and we’re currently the largest per capita tester in the United States.”

While the virus has been spreading more rapidly over the past several weeks, Baker has increased his pressure on school systems to bring students back into classrooms to prevent more lost learning time, and Health and Human Services Secretary Marylou Sudders has said the administration does not plan to shut down the health care system for preventative care and elective procedures as it did in the spring.

“We currently have about 550 people in the hospital. We had 5,500 people in hospital at the peak of this back in the spring. Ten times. It’s very different,” Baker said, though his numbers were not correct. Hospitalization never climbed higher than 4,000, according to DPH data.

Baker pointed to a story in the Washington Post published Thursday that blamed social gatherings like dinner parties, game nights and sleepovers for the rise of COVID-19 across the country.

“It’s the stuff I’ve been talking about for months now. Small informal casual gatherings with a bigger circle of friends than people were spending time with back at the beginning of the summer,” Baker said.

Baker visited two classrooms where he said it was clear the Carlisle public schools were using “every single square inch of space that’s available” to keep students distanced, and using unique lunch scheduling and other strategies to ensure students and teachers remain safe.

“The other thing is, every child we saw as we wandered through there was wearing a mask and didn’t seem all that stressed about it, which makes them a lot more mature than many of the adults I know,” Baker said.

Earlier in the day, Baker teamed up with the governors of six other regional states to suspend interstate youth hockey competitions for public and private school teams through the end of the year in response to coronavirus outbreaks linked to the on-ice tournaments.

Baker announced the decision with a coalition of Republican and Democratic governors from New Jersey, Maine, Rhode Island, New Hampshire, Vermont and Connecticut, but not New York.

The governor said that the regional approach was necessary as COVID-19 cases continue to spike across the states, and contact tracing has led investigators to outbreaks stemming from interstate youth hockey activities.

He said the problem had less to do with the actual competitions on the ice and more to do with the day-long congregation and socialization of parents and players at the rink while tournaments are being played.

“We want everyone playing across the region with the same set of rules, the same set of protocols, the same set of guidelines that are all being enforced and administered the same way in every state and it’s going to take us a few weeks to figure that out,” Baker said.

Baker’s day concluded with a virtual ribbon cutting to celebrate the completion of the second phase of the Overlook Terrace housing development in Boston’s Orient Heights East Boston neighborhood.

On that Zoom call with Boston Mayor Marty Walsh and others, Baker renewed his call for the Legislature to address the exclusionary zoning rules that he said have made it very difficult in places outside of Boston to build affordable, transit-oriented and other types of housing.

The House and Senate are both considering Baker’s housing proposals as part of a larger economic development package currently being negotiated by a conference committee.

“I really do hope that we can get that done before the end of the session,” Baker said.




2,000+ new COVID-19 cases, hospitalizations above 600 in Massachusetts

Colin A. Young
State House News Service

Another 2,047 cases of the coronavirus and 21 COVID-19 deaths were added to the state’s grand totals Tuesday as the percent of tests that come back positive for the virus continues to climb.

The Department of Public Health’s report for Tuesday increased the total case count to 169,976 infections and elevated the virus’s death toll here to 10,184 people with confirmed or probable COVID-19. The seven-day weighted average of the positive test rate stands at 2.63 percent, up from 2.35 percent Monday. If repeat testing from higher education institutions is left out of the equation, the positive test rate would be 4.42 percent, DPH said.

The number of people with COVID-19 who are hospitalized increased by 30 and stood at 618 as of midday Tuesday. Gov. Charlie Baker said Tuesday that the state’s COVID-19 trends are headed in the “wrong direction and show no signs of changing.” DPH estimated Tuesday that there are 23,702 active cases of the highly-infectious coronavirus in Massachusetts.




Surge continues in Massachusetts with over 4,000 COVID-19 cases over weekend

Matt Murphy
State House News Service

The week began Monday with the state tracking 22,023 active cases of COVID-19 after public health officials reported 4,009 new cases of the coronavirus over the weekend and 43 new confirmed deaths from the disease.

The Department of Public Health reported on Sunday that 568 people were in the hospital for confirmed cases of COVID-19, including 144 patients who were in intensive care units. That was an increase of 55 patients hospitalized with the virus since Friday and 26 patients newly being treated in ICUs around the state.

The state reported a combined 172,858 new molecular tests on Saturday and Sunday, which put the state’s seven-day average positivity rate at 2.27 percent. When removing repeat higher education testing from the equation, the positivity rate over the past week was 3.92 percent.

This past weekend was the first since Gov. Charlie Baker put in place a new mandatory mask policy in public, and began imposing curfews on some businesses, forcing them to close by 9:30 p.m. so that people have time to return home and comply with the new statewide advisory that people remain in their homes from 10 p.m. until 5 a.m. The new guidelines were put in place to slow what Baker has newly described as a second surge of COVID-19, with the seven-day average of new confirmed cases up 717 percent from a low of 157 a day and the average number of patients hospitalized with COVID-19 over the past week up 222 percent from a low of 155. The death toll from the virus now stands at 9,923 people with confirmed cases of COVID-19.




New State guidance urges in-person schooling in Massachusetts

By Chris Lisinski
State House News Service

In the midst of a COVID-19 surge and after weeks of prodding schools through press conferences and memos to bring more students back into classrooms, the Baker administration upped the ante Friday by formally urging all communities to avoid remote-only education wherever possible.

New guidance from the state Department of Early and Secondary Education (DESE) instructs cities and towns in any risk designation below the most severe level to resume fully in-person schooling. Even those in the highest-risk red category should opt for hybrid models rather than fully virtual options, the administration now says.

Schools should only reverse course from prioritizing partial or fully in-person learning if there is suspected in-school transmission or a major outbreak in the community, officials said.

About 23 percent of districts are still fully remote, a DESE spokesperson said Friday.

The push for in-person schooling comes as the administration also overhauled its stoplight system measuring COVID-19 transmission risks, making changes that will sharply curtail the number of high-risk communities.

The updated guidance represents an escalation in the administration’s expectations as officials and medical experts continue to warn about the lasting educational, social and emotional harm that staying home can inflict on children.

“Educators, students and parents all agree that even under favorable circumstances, remote learning is a second-best option that should only be used as a last resort,” Education Secretary James Peyser said at a Friday press conference.

In August, DESE’s guidance anticipated that communities color-coded red would operate schools remotely and those marked yellow would choose hybrid models or fully remote with extenuating circumstances.

Gov. Charlie Baker and other administration officials have been increasingly arguing that there is little evidence linking COVID-19 transmission to in-person schooling. They have also been ramping up the push to bring students back in most communities, even as local officials in some cities and towns opt for remote models as a precaution.

“At the same time Governor Charlie Baker is advising families not to gather inside with others for the holidays because it is not safe, he is pressuring schools to open for full in-person learning. The state’s demands make no sense,” said Massachusetts Teachers Association President Merrie Najimy. “Indeed, educators have wanted nothing more than to be back in person with their students. It has been joyful for educators and students to be back together, no matter which model they are following. The state should not threaten or pressure districts to adopt practices that they have good reason to believe are not safe – and that is what is being done today.”

DESE reported 252 new cases in Massachusetts schools over the past week as statewide infection numbers continue to rise, but Baker said the total number of positive cases is minute compared to the more than 450,000 students now in public school classrooms each week.

State data based on contact tracing, while covering only a portion of confirmed COVID-19 cases, also found little evidence of cluster outbreaks in schools.

“At this point, there is clear and convincing scientific data that shows children are at significantly less risk of developing serious health issues from exposure to COVID-19, and there is clear and convincing scientific data that shows learning in a classroom, as long as people are playing by the rules, does not lead to higher transmission rates,” Baker said.

While the new guidance significantly ramps up the administration’s push for more in-person learning, it is not clear how hard Baker and his deputies would crack down on local or union leaders who still hold out.

The administration has in recent months threatened to audit districts that remain remote in communities with low infection levels, even as Baker and other officials stress the importance of local decision-making.

Asked Friday if a district would face penalties for remaining remote for several more months as an added precaution, DESE Commissioner Jeff Riley declined to answer directly.

“We’ll address that with each individual,” Riley said. “I don’t want to speak about hypotheticals, but we’ll certainly, based on your track record in the past, address when we feel that people aren’t following state guidance.”

The state will also provide rapid mobile testing for schools with clusters of positive cases at no costs to the districts, starting this month. Riley said those tests should not be used for “broad-scale asymptomatic testing in schools,” instead limited only to those who display symptoms for the highly infectious coronavirus.

“The time to get kids back to school is now,” Riley said. “It has become increasingly clear that this virus is going to be with us for a while.”

Dr. Mary Beth Miotto, vice president of the Massachusetts chapter of the American Academy of Pediatrics, joined administration officials at the press conference, where she praised the updated school guidance as a step that will “help school districts and local boards of health create COVID plans that are more relevant to transmission in their specific populations.”

She warned that the health risks of remote learning are becoming more and more clear to medical professionals, citing personal experience in her Worcester practice of pediatric patients adopting sedentary lifestyles during the pandemic and an observed rise in youth suicide attempts.

“Many of these kids with suicidal thoughts and attempts don’t have a history of behavioral health problems,” she said. “They’re typical children bending or breaking under the stress of the pandemic, and specifically from being alone for long hours at the computer.”

Administration officials increased their push to expand in-person learning with case numbers on the rise in Massachusetts — Baker told municipal officials on Thursday that a “second surge” is “certainly underway” — and alongside a significant overhaul to how the state measures COVID-19 risks at the community level.

The state will now measure color-coded local public health outlooks on different scales for small-, medium- and large-population cities and towns, taking into account both a higher threshold of cases per 100,000 residents as well as positive test rates.

Under the system that has been in place since August, only incidence rates count toward a community’s risk level, with those home to an average daily rate of eight or more cases per 100,000 over the past two weeks marked red.

To earn the highest-risk designation moving forward, communities with fewer than 10,000 residents must record more than 25 cases in the sample period. Those with populations between 10,000 and 50,000 must have either 10 or more cases per 100,000 residents or a positive test rate of 5 percent or higher. Those home to more than 50,000 people will only be deemed in the red if they report both at least 10 cases per 100,000 and also a positivity rate of at least 4 percent.

With those changes, the number of communities marked red will be slashed by nearly 85 percent, from 121 in last week’s report under the old metrics to 16 this week under the new metrics.

Asked Friday if the administration was changing the rules to reduce the number of highest-risk communities, Baker said including more measurements improves the utility of the system and helps incentivize testing.

“I happen to think this is a more nuanced and more accurate way to test how communities are doing: not just in terms of their cases per 100,000, but how they’re doing with respect to testing practices and policies,” Baker said. “We want communities to test. I don’t want some communities to say, ‘I’m not going to test because I’m worried about increasing my numbers.’ ”

Najimy, of the MTA, said the new metrics “will dramatically reduce the number of communities identified as high-risk just as the numbers of coronavirus cases, hospitalizations and deaths are increasing in Massachusetts. There is a real disconnect between the changes and the current situation. In fact, the new metrics may encourage people to relax their guard when they should be more vigilant than ever.”

The changes bring Massachusetts more in line with how neighboring states measure municipal risk levels and better account for nuance at a granular level, Baker administration officials said Friday.

They pointed as an example to Nahant — a tiny town with a population of slightly more than 3,400 — where only 12 confirmed cases could have pushed it into the red under the older measurement.

Because the count of communities in the red is smaller, the updates will also likely allow more cities and towns to advance into the next stage of economic reopening, in which they can bring back indoor performance venues and several recreational activities.




More than 140 inmates test positive for COVID-19 at Massachusetts jail

Norfolk is one of the 16 cities in Massachusetts that have been designated by state officials to be of high-risk for COVID-19.

A week ago the Massachusetts Department of Corrections ordered facility-wide testing at MCI-Norfolk after two inmates tested positive for COVID-19. More than 1,200 inmates were tested and presently 140 of those tests came back positive, with 300 tests still pending.

While all inmates who tested positive were primarily asymptomatic they were still immediately transferred to quarantine and are currently receiving treatment within MCI-Norfolk.

All in-person visitations to the facility have been suspended until further notice.




Acushnet Fire & EMS utilize CARES Act funds for COVID testing trailer

“If you have driven by the station the past few days you have probably noticed our newest addition.

With CARES Act funds made available by the Board of Selectmen, we have purchased an 18-foot trailer from which we will continue our COVID testing initiative during the colder months.

The trailer is set up as two evaluation rooms with heat, air conditioning and forced air ventilation. We will be adding a few items, changing the logos and rolling this testing unit out as soon as possible.

The trailer has never been used, the previous owner ordered but never used!” -Acushnet Fire & EMS Department.


Acushnet Fire & EMS photo.


Acushnet Fire & EMS photo.