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FDA Authorizes Portable Test Kit That Can Detect COVID-19 in 5 Minutes

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  • The FDA has approved the use of a new coronavirus test kit that can give positive results in as little as 5 minutes and negative results in 13, leaps faster than the hours and sometimes days laboratory tests normally take. 
  • The tests are run on a lightweight and small portable device that can be used in emergency rooms, urgent care clinics, and even outside hospital walls.
  • Abbott, the medical device company that makes the kits, plans to send out 50,000 tests a day starting next week.

New Test Approved

The U.S. Food and Drug Administration gave Emergency Use Authorization to the medical device company Abbott for a new coronavirus test kit that gives results within minutes.

Abbott announced the news in a Friday press release, saying it plans to start delivering 50,000 tests a day beginning next week. The tests run on the company’s ID NOW platform, a portable device about the size of a small toaster than weights only 6.6 pounds.

Its portability means it can be used directly in an emergency room or urgent care clinic and even, “outside the traditional four walls of a hospital in outbreak hotspots.”

The company called it “the fastest available molecular point-of-care test for the detection of novel coronavirus(COVID-19), delivering positive results in as little as five minutes and negative results in 13 minutes.”

Second Rapid Test to Be Approved by FDA 

The approval from federal health officials means that regulators were satisfied with the test’s validation data and are confident that its benefits outweigh any risk, like false positives or negatives. 

The FDA’s approval marks the seconds time it has green-lit a fast working test that could accelerate testing across the country.  Last week, it approved a 45-minute rapid point of care test by the molecular diagnostics company Cepheid. However, that test is primarily intended for emergency rooms and hospitals, not doctors’ officers or urgent care clinics.  

Still, those turnaround times are leaps faster than the hours to days it takes most laboratory tests to bring results. 

Medical Shortages Still Cause Concern 

The approval of the Abbott test comes as cities across the nation battle with numbers of potential patients that surpass available tests and resources. Even with insufficient testing, the United States became the country with the largest number of reported cases of coronavirus on Thursday, exceeding China and Italy. By Friday, the U.S. hit more than 100,000 cases. 

Many fear that shortages of other critical medical equipment, like masks and swabs, could stifle the new rapid test’s impact. That’s because the kit requires a swab sample collected from patients, and many health care facilities are running desperately low on the tools needed to safely collect those samples.

The Center for Disease Control issued guidance Tuesday that allows some patients to collect their own nasal swabs in health care facilities, in an effort to reduce the amount of protective equipment needed for health care workers. 

On the opposite end, however, others note that fast and efficient testing can help medical professionals determine how much protective equipment they actually need to wear when interacting with a patient, as well as what kind of care to provide. Since this test can be done in a doctor’s office, it could even potentially help diagnose patients with mild or asymptomatic cases of the virus and help stop them from unknowingly spreading it. 

Experts also say drastically increasing testing capacity can help get the economy back on track sooner. With increased testing, measures like keeping everyone at home could be replaced with more targeted identification and isolation of those infected. 

See what others are saying: (The Hill) (CNBC) (CNN

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Biden to Mandate COVID Vaccines for Federal Workers as CDC Changes Masking Guidance

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News of the efforts came on the same day that the U.S. reported more than 100,000 new daily COVID cases for the first time since February.


Federal Vaccine Mandate

President Joe Biden will announce Thursday that all federal employees must get vaccinated against COVID-19 or consent to strict testing and other safety precautions, White House officials told reporters Tuesday.

Earlier in the day, Biden said he was considering the requirement but did not provide any more information.

While the officials also said the details are still being hashed out, they did note that the policy would be similar to ones recently put in place by California and New York City, which respectively required state and city workers to get the jab or submit to regular testing.

Also on Tuesday, the Centers for Disease Control and Prevention updated their guidelines to recommend that Americans who live in areas “of substantial or high transmission,” as well as all students and teachers, wear masks indoors regardless of their vaccination status.

Delta Causes Spikes, But Vaccines Still Prove Effective

The renewed COVID mitigation efforts come as the delta variant is driving massive surges all over the country.

Coronavirus cases have quadrupled throughout July, jumping from a weekly average of 11,799 on the first day of the month to 63,248 on Tuesday, according to The New York Times tracker. Tuesday also saw new daily infections topping 100,000 for the first time since February, with more than 108,000 reported, per The Times.

While the vast majority of new infections are among people who have not been vaccinated, there have also been increasing reports of breakthrough cases in people who have received the jab. 

Those cases, however, do not mean that the vaccines are not effective. 

No vaccine prevents 100% of infections. Health officials have said time and time again that the jabs are intended to prevent severe disease and death, and they are doing just that.

According to the most recent data for July 19, the CDC reported that only 5,914 of the more than 161 million Americans who have gotten the vaccine were hospitalized or died from COVID-19 — a figure that represents 0.0036% of vaccinated people.

While safety precautions may be recommended for some people who have received the vaccine, many media narratives have overstated the role breakthrough cases play in the recent spikes. As New York Magazine explains, it is imperative to understand these new mask recommendations are not happening because the vaccine is not effective, but because not enough people are getting the vaccine.

“Because breakthrough infections have so often made the news due to their novelty, that can create a perception of more cases than are actually happening — particularly without more robust tracking of the actual cases to provide context,” the outlet wrote.

See what others are saying: (The Washington Post) (The New York Times) (CNBC)

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Wisconsin Police Deny Planting Evidence in Viral Video, Release Their Own Body Cam Footage

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The footage police released shows that during a search, officers found a corner tear from a plastic bag inside a backseat passenger’s pocket. An officer then discarded it into the car after determining that it was empty.


Viral Video Appears To Show Officer Planting Evidence

The Caledonia Police Department in Wisconsin has responded to a viral cell phone video that appears to show an officer planting a small plastic baggie inside of a car during a traffic stop.

The now-viral footage was posted to Facebook by a man who goes by GlockBoy Savoo.

The user, who also filmed the clip, wrote in his post’s caption that the officer did this “just to get a reason to search the car” and said the cop didn’t know he was being recorded by the passenger.

Source: Facebook/ GlockBoy Savoo

Police Shut Down Accusations With Their Own Footage

After that video spread across social media, many were outraged, calling the Caledonia police dirty for seemingly planting evidence. All the outrage eventually prompted the department to announce an investigation Saturday.

Within hours, the department provided an update, claiming that officers didn’t actually plant any evidence or do anything illegal.

Police shared a lengthy summary of events, along with two body camera clips from the incident. That statement explained that the driver of the vehicle was pulled over for going 63 in a 45mph zone.

Two passengers in the backseat who were then spotted without seatbelts were asked to identify themselves and step out of the car. During a search of one passenger’s pockets, an officer pulled out “an empty corner tear” from a plastic baggie.

Police claim the corner tear did not contain any illegal substances, though they said this type of packaging is a common method for holding illegal drugs.

In one body cam clip, an officer can be heard briefly questioning the backseat passenger about the baggie. Then, that piece of plastic gets handed off to different officers who also determined it as empty before the officer in the original viral video discarded it into the back of the car.

The officer can also be seen explaining where the plastic came from to the passenger recording him.

“Aye, bro you just threw that in here!” the front seat passenger says, as heard in his version of the events.

“Yeah, cause it was in his pocket and I don’t want to hold onto it. It’s on their body cam that they took it off of him…I’m telling you where it came from, so. It’s an empty baggie at the moment too, so,” the officer replies.

The department went on to explain that while it would discourage officers from discarding items into a citizen’s car, this footage proves that evidence was not planted.

Authorities also noted that no arrests were made in this incident and the driver was the only one issued a citation for speeding. The statement added that since four officers were present at the scene, police have more than six hours of footage to review but they promised to release the footage in full in the near future.

See what others are saying: (Heavy)(CBS 58) (Milwaukee Journal Sentinel)

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Medical Groups, Local Leaders Push for Healthcare Workers and Public Employees To Get Vaccinated

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The move comes as COVID cases have nearly quadrupled in the last month due to the rapid spread of the highly infectious delta variant.


Increased Calls for Mandatory Vaccinations in Certain Sectors

More than 50 of America’s largest medical groups representing millions of healthcare workers issued a statement Monday calling for employers of all health and long-term care providers to require mandatory COVID-19 vaccinations.

The groups, which included the American Medical Association, the American Nurses Association, and 55 others, cited contagious new variants — including delta — and low vaccination rates.

“Vaccination is the primary way to put the pandemic behind us and avoid the return of stringent public health measures,” they wrote.

The call to action comes as new COVID cases have almost quadrupled during the month of July, jumping from just around 13,000 infections a day at the beginning of this month to more than 50,000.

While the vast majority of new infections and hospitalizations are among those who have not received the vaccines, many healthcare workers remain unvaccinated. According to data collected by the Centers for Medicare and Medicaid Services, over 38% of nursing home staff were not fully vaccinated as of July 11. 

An analysis by WebMD and Medscape Medical News found that around 25% of hospital workers who were in contact with patients had not been vaccinated by the end of May when vaccinations became widely available.

In addition to calls for medical professionals to get vaccinated, some local leaders have also begun to impose mandates for public employees as cases continue spiking.

Last month, San Francisco announced that it was requiring all city workers to get vaccinated. Also on Monday, New York City Mayor Bill de Blasio said that all municipal employees — including police officers and teachers — must either get the jab or agree to weekly testing by the time school starts in September.

Dr. Fauci Says U.S. Officials Are Considering Revising Mask Guidance for Vaccinated People

Numerous top U.S. health officials have applauded efforts by local leaders to mitigate further spread of the coronavirus, including the nation’s top infectious disease expert, Dr. Anthony Fauci, who confirmed Sunday that federal officials are actively considering whether to revise federal masking guidelines to recommend that vaccinated Americans wear face coverings in public settings.

In May, the Centers for Disease Control and Prevention said people who are vaccinated do not need to mask in public. Although that was a non-binding recommendation, many states and cities that had not already lifted restrictions on masking began to do so shortly after.

But now, local leaders in areas seeing big spikes have begun reimposing mask mandates — even for those who are vaccinated — including major counties like Los Angeles and St. Louis.

In his remarks Sunday, Fauci also emphasized that, despite claims from many conservatives, those efforts are in line with the federal recommendations, which leave space for local leaders to issue their own rules.

While Fauci and other top U.S. public health officials have encouraged local governments to take action, Republican lawmakers in several states are taking steps to limit the ability of local leaders and public health officials to take certain mitigation measures.

According to the Network for Public Health Law, at least 15 state legislatures have passed or are considering bills to limit the legal authority of public health agencies — and that does not even include unilateral action taken by governors.

Some of the leaders of states suffering the biggest spikes have banned local officials from imposing their own mask mandates, like Arkansas, which has the highest per capita cases in the country right now, as well as Florida, which currently ranks third.

Notably, some of the laws proposed or passed by Republicans could go beyond just preventing local officials from trying to mitigate surges in COVID cases and may have major implications for other public health crises.

For example, according to The Washington Post, a North Dakota law that bans mask mandates applies to other breakouts — even tuberculosis — while a new Montana law also bars the use of quarantine for people who have been exposed to an infectious disease but have not yet tested positive.

See what others are saying: (The Washington Post) (The New York Times) (The Guardian)

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