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

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1 year ago

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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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Soldier Charged With Assault After Shoving Black Man in Viral Video

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6 hours ago

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April 15, 2021

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  • Authorities charged Army soldier Jonathan Pentland with third-degree assault and battery on Wednesday after a viral video showed him shoving a Black man while yelling at him to leave a South Carolina neighborhood.
  • Many people, including dozens who protested outside Pentland’s home this week, condemned the confrontation as another instance of someone being attacked for “walking while Black.”
  • Pentland and others claimed the unidentified man was picking a fight with neighbors, which the man denied, but police said nothing that may have happened earlier justified Pentland’s actions.
  • If convicted, Pentland faces a $500 fine and 30 days in jail.

Viral Video

A U.S. soldier was charged with assault on Wednesday after a video that circulated online showed him yelling at and shoving a Black man in a South Carolina neighborhood.

Footage of the April 8 incident was posted to social media Monday. It shows the Army soldier, Jonathan Pentland, confronting the unidentified man and telling him to leave the neighborhood. 

The other man explains that he’s just walking through the area and doing nothing wrong, but Pentland becomes increasingly aggressive. “You better walk away,” he shouts at the man after shoving him.

“You either walk away, or I’m gonna carry your ass out of here,” he continues before adding, “You’re in the wrong neighborhood motherf*ker. Get out!”

The man then tries to tell Pentland that he lives in the neighborhood, and Pentland then asks for his address, which he does not give.

The confrontation continues with Pentland cursing and getting in the man’s face. As he does so, the man says that Pentland smells drunk. 

It’s unclear what exactly led up to the confrontation, but in the video, a woman off-camera says the man “picked a fight with some random young lady that’s one of our neighbors.”

“I don’t even know who she is. Nobody picked a fight when someone ran up on me,” the man replies. Another woman off-screen then encourages the man to leave with her, saying, “What’s your name? Come on. You don’t want no trouble.”

Video Triggers Protests Outside Pentland’s Home

After this video spread online, many social media users condemned it as another instance of someone being attacked for “walking while Black.”

In fact, protesters even began demonstrating outside of Penland’s home. Those protests started off peaceful, but deputies were then called after 8 p.m. because unknown individuals vandalized the house. That forced police to shut down access to the area and remove Pentland’s family to another location.

As far as the viral video, deputies were told that the man approached “several neighbors in a threatening manner” and that someone had asked Pentland to “intervene.”

Police did confirm that there are two reports of alleged assault against the unnamed man Pentland shoved that are being investigated. However, they also added that the man has “an underlying medical condition that may explain the behavior exhibited in the alleged incidents.”

Pentland Charged

Either way, police said whatever happened earlier did not justify Pentland’s actions. He was ultimately arrested Wednesday morning and was charged with third-degree assault and battery. He faces a $500 fine and 30 days in jail if convicted.

“We’re not going to let people be bullies in our community,” Richland County Sheriff Leon Lott said at a news conference Wednesday. “And if you are, you’re going to answer for it, and that’s what we’ve done in this case.”

On top of that, the Justice Department reportedly was investigating. Pentland’s Commanding General even issued a statement condemning his behavior, adding that Pentland “brought disrespect to @fortjackson our Army and the trust with the public we serve.”

See what others are saying: (The Washington Post) (ABC News) (Huffpost)

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Texas Students Created Snapchat Group To ‘Slave Trade’ Black Classmates

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1 day ago

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April 14, 2021

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  • Freshmen at a Texas high school set up a Snapchat group to pretend to sell their Black classmates. 
  • A screenshot showed the group name being changed from “Slave Trade” with emojis of a Black man, a gun, and a white police officer to “[racial slur] Farm” and then “[racial slur] Auction.”
  • That image also shows a person saying they would spend $100 on a peer while a second student said they would spend $1 on another, adding “would be better if his hair wasn’t so bad.”
  • The school faced backlash for initially describing it as “an incident of cyberbullying and harassment,” without acknowledging the racism. The district later issued a stronger condemnation and said the students were disciplined but did not list specific consequences.

Racist Snapchat Group

Aledo high school students at Daniel Ninth Grade Campus in Northern Texas are making headlines for setting up a Snapchat group to pretend to sell their Black classmates. 

A screenshot reviewed by several local news outlets showed the group name being changed from “Slave Trade” with emojis of a Black man, a gun, and a white police officer to “[racial slur] Farm” and then “[racial slur] Auction.”

That image also shows a person saying they would spend $100 on a peer. A second student said they would spend $1 on another, adding “would be better if his hair wasn’t so bad.”

Screenshot of group chat message via KXAS

At least one student who was mentioned as being “sold” in the chats was later sent screenshots of the conversations.

According to a report from the Star-Telegram reported last week, when the issue was brought to Principal Carolyn Ansley, she sent parents an email that didn’t mention the Snapchat group but only cited “an incident of cyberbullying and harassment.”

That caused frustrations because parents felt the issue of racism wasn’t being addressed or acknowledged.

Mark Grubbs, a father of three former students, told KXAS he was sickened by the students’ actions. Grubbs, who is Black, also said he had taken his children out of the district over other racist incidents in the past.

“My son being called out of his name and what not and it got to the point he didn’t mind fighting and that didn’t sit right with me and my wife. My son was never a fighter,” he said.

District Responds

After the incident garnered media attention, the Aledo Independent School District issued a statement.

The district said it learned of the incident more than two weeks ago and started an investigation that involved law enforcement.

“There is no room for racism or hatred in the Aledo ISD, period,” it added. “Using inappropriate, offensive and racially charged language and conduct is completely unacceptable and is prohibited by district policy.”

District officials spoke with the students responsible as well as their parents, saying they “made it clear that statements and conduct that targets a student because of his or her race is not only prohibited but also has a profound impact on the victims.”

The district also said it assigned disciplinary consequences, though it did not explicitly state what those consequences were or state how many students were involved.

See what others are saying: (The Washington Post) (ABC) (Fort Worth Star-Telegram)

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What You Need To Know About the Johnson & Johnson Vaccine Pause

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2 days ago

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April 13, 2021

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  • The CDC and the FDA have issued a joint recommendation to pause distribution of Johnson & Johnson’s COVID-19 vaccine amid reports that six women experienced “extremely rare” blood clots after receiving the single-dose shot.
  • The vast majority of the 6.8 million Americans who were given the Johnson & Johnson vaccine have reported minor to no side effects, and no direct link has been established between the vaccine and blood clots at this time. 
  • The two agencies are expected to release updated guidance in the coming days.
  • Several states and cities are now automatically giving the two-dose Pfizer vaccine to people who were scheduled to receive the Johnson & Johnson vaccine this week. 

CDC and FDA Recommend J&J Vaccine Halt

The Centers for Disease Control and Prevention, as well as the Food and Drug Administration, released a statement Tuesday recommending a pause on the use of Johnson & Johnson’s COVID-19 vaccine.

So far, 6.8 million people in the U.S. have been vaccinated with Johnson & Johnson’s single-dose vaccine, most with zero or only mild side effects.

The updated guidance comes after six women, all between the ages of 18 to 48, experienced what both agencies described as “extremely rare” blood clots six to 13 days after being vaccinated. One of those women has died and another is in critical condition.

Neither the CDC nor the FDA has confirmed that the Johnson & Johnson vaccine is the cause of these blood clots; rather, they said this guidance comes “out of an abundance of caution.”

That’s also in line with Johnson & Johnson itself, which said it’s aware of the reports but added that “no clear causal relationship has been established between these rare events.” As a precaution, Johnson & Johnson has also now delayed the rollout of its vaccine in Europe. 

What Happens From Here?

Principal Deputy Director of the CDC Anne Schuchat said further recommendations will come quickly.

FDA Acting Commissioner Janet Woodcock echoed that statement, saying, “We expect it to be a matter of days for this pause.”

Wednesday, a CDC committee will convene to discuss the cases and assess their potential significance.

When asked if the government was overreacting to just six cases out of nearly 7 million vaccinations (a criticism made by some online), Schuchat said the CDC pulled its recommendation specifically because the type of blood clots seen in these 6 women requires special treatment, so “it was of the utmost importance to us to get the word out.”

In the meantime, both agencies are urging Johnson & Johnson vaccine recipients to contact their doctors if they experience any combination of severe headaches, abdominal pain, leg pain, or shortness of breath. 

What If I Had A J&J Appointment?

Both agencies, as well as other health officials, are still urging unvaccinated people to take the Moderna and Pfizer vaccines when available in their area.

The White House’s COVID-19 response coordinator has said that 28 million doses of those vaccines will be made available this week. Notably, that’s more than enough for the country to continue giving 3 million shots a day. 

If you had an appointment scheduled to get the Johnson & Johnson vaccine, you’re likely not completely out of luck.

For example, while D.C. vaccination sites are canceling all Johnson & Johnson appointments between Tuesday and this Saturday, the health department there has said it’ll send out invitations on Wednesday to reschedule.

Similar situations were reported in Virginia and Maryland, though some vaccination sites in Maryland are still honoring existing appointments by automatically giving people Pfizer instead. That’s also a process that is now being conducted in places like New York State and Memphis.

See what others are saying: (Associated Press) (NBC News) (The Washington Post)

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