Too many rules? FDA restricts coronavirus at-home test kits
The Food and Drug Administration (FDA) is under fire for being too slow to approve at-home tests in the coronavirus crisis.
Earlier this month, the agency announced it would allow labs to sell tests, and apply for emergency approval 15 days later. Several companies jumped to offer their tests in a use-at-home format, and some even began selling them.
Most of the tests were to be taken by an individual at home, and then would be mailed to an approved lab for analysis – a process already used for many medical tests.
But on March 20, the FDA updated their guidance, saying their regulatory waivers "do not apply to at-home testing, including self-collection of samples to be sent to a clinical laboratory."
That forced the companies offering at-home tests to immediately shut down sales.
Ten days later, no at-home kits have been approved by the FDA. The FDA defended its action and said it wants to ensure tests are accurate
“It is critical to ensure that home collection and transport of specimens to labs still provide for accurate test results,” an FDA spokesperson told Fox News by email.
But critics say the approach is too cautious.
“It’s baffling,” Danielle Bradnan, a researcher and biologist at consulting firm Lux Research, told Fox News. “Everlywell was wrapping up the infrastructure to be able to handle [up] to a quarter-million of these tests a week and they were ready to launch last Monday."
Everlywell had 30,000 use-at-home kits ready to go before regulations put their sale on hold. The company instead directed those kits to hospitals. Their test kit, if approved, would sell for $135. Two other health testing companies – Carbon Health and Nurx– had already begun sales of at-home kits before having to halt them.
“We have stopped all new test requests,” Nurx’s website said.
The FDA said that it has concerns about at-home kits, because after the user takes a sample, it then gets shipped to labs, and the shipping could reduce reliability.
“Self-collection at home or at sites other than designated collection sites staffed by [health care providers] raise concerns regarding specimen stability, transport, and appropriate collection materials,” the FDA said in a statement to Fox News.
The FDA last week approved people to self-test under the guidance of health care workers at an approved location, after a study found that an easy-to-collect sample from the nostril is usable (previously, a sample had to be taken from behind the nasal cavity, which would have been extremely difficult to self-collect.)
Bradnan noted that the labs selling the kits already offer approved testing for sexually transmitted diseases in the same at-home way.
“The companies’ whole infrastructure is based on this method. Apparently the FDA doesn't have a problem with them doing at-home testing for STDs,” Bradnan said.
“Unless there's something huge that they're not disclosing, I don't understand why it's not okay for the tests to be done at home, and mailed in,” she added.
The FDA said that the hold up is worth ensuring the accuracy of the test.
“False results can lead to significant adverse public health consequences, especially during an unprecedented public health emergency,” it added.
The FDA said it is “actively working with test developers in this space,” and a spokeswoman for Everlywell said the company is working with the FDA to get approval.
“We have been meeting regularly with the FDA since they made their statement last Friday to discuss a path forward for an at-home sample collection test,” Christina Song, director of communications at Everlywell, told Fox News.
“The test will likely use a short nasal swab for easy collection and will include free telehealth consultations with an independent physician for those with positive results to receive diagnosis at home. We hope to make it available to the public soon,”
The FDA said it is evaluating applications for at-home test kits but did not provide a timeframe for the first approval. An FDA spokeswoman said that once a full, detailed application with data is received, it can sometimes be approved as quickly as within 24 hours.
“The FDA is interested in early interactions with test developers and we encourage them to reach out to us to begin pre-EUA discussions, even if they do not have validation and/or documentation completed,” the agency said in a statement.
Asked what kind of data test creators needed to submit, an FDA spokesman pointed to section V of FDA guidelines requiring a minimum of 60 experimental tests, among other things.
Economists who study regulation argue the FDA is being too strict.
“Right now, we need as many tests as possible and it doesn't make sense to overburden nurses, hospitals and clinics with potentially sick people. The FDA has repeatedly delayed new tests, putting the United States weeks behind at the expense of lives,” Alex Tabarrok, an economics professor at George Mason University, told Fox News.
Many experts believe that the path out of the pandemic involves widespread testing of nearly everyone; then infected individuals can be identified and quarantined, while the rest of the country can go about their lives and revive the economy.
Data from Iceland, and the Diamond Princess cruise ship, show that nearly half of people with the coronavirus do not show symptoms, but can still spread the disease. Very widespread testing would be needed to identify such carriers.
“We need testing because once we have a sense of who's infected, we can start moving from a uniform stay-at-home advisory and more rapidly return to normal life, with testing and checking in,” Bradnan said.
Even an imperfect test would be better than no home testing, Tabarrok said. On his site, Marginal Revolution, he has compiled information from several respected economists who ran the numbers and came to the same conclusion.
“At this point in time we need to unleash American ingenuity and enterprise and evolve our way to the frontier as conditions improve,” Tabarrok wrote.
美國紐約時間 2020年3月31日 黃昏
美國已確認感染人數:186265
作者: JINGKE7158 時間: 2020-4-1 06:57 AM
xeno-2007 發表於 2020-4-1 04:09 AM
有美國企業早就想到,如果Trump突然說 ,測試劑已用完,等明年再測吧,怎辦?
那樣,我們就提供測試劑給地 ...
186,265心里沒有其他感想,只有兩個字:臥槽作者: xeno-2007 時間: 2020-4-2 05:56 AM
本帖最後由 xeno-2007 於 2020-4-2 07:01 AM 編輯
JINGKE7158 發表於 2020-4-1 06:57 AM
186,265心里沒有其他感想,只有兩個字:臥槽
Coronavirus: US Navy captain pleads for help over outbreak
The captain of a US aircraft carrier carrying more than 4,000 crew has called for urgent help to halt a coronavirus outbreak on his ship.
Scores of people on board the Theodore Roosevelt have tested positive for the infection. The carrier is currently docked in Guam.
"We are not at war. Sailors do not need to die," Captain Brett Crozier wrote in a letter to the Pentagon.
Captain Crozier recommended quarantining almost the entire crew.
In the letter Captain Crozier said that with large numbers of sailors living in confined spaces on the carrier isolating sick individuals was impossible.
The coronavirus' spread was now "ongoing and accelerating", he warned, in the letter dated 30 March.
"Decisive action is needed," he said.
"Removing the majority of personnel from a deployed US nuclear aircraft carrier and isolating them for two weeks may seem like an extraordinary measure. This is a necessary risk."
It is not clear how many crew members on the Theodore Roosevelt have the coronavirus. The San Francisco Chronicle, which first reported on the letter, said at least 100 sailors were infected.
Speaking to Reuters news agency, a US Navy spokesman said the service was "moving quickly to take all necessary measures to ensure the health and safety of the crew of USS Theodore Roosevelt".
On Tuesday the coronavirus death toll in the US passed the figure reported in China, where the outbreak began. At least 3,400 have died.
The number of recorded cases stands at over 175,000, more than any other country, according to a tally from Johns Hopkins University.
New York state has seen the largest number of infections and its governor, Andrew Cuomo, warned the peak was still to come.
"We're still going up the mountain. the main battle is on the top of the mountain," he said.
Field hospitals are being built in Central Park and other New York landmarks to help ease the pressure on the city's health system.
155 sailors on USS Teddy Roosevelt test positive for coronavirus, 42 percent of all Navy infections
At least 155 sailors on the USS Theodore Roosevelt have tested positive for COVID-19, according to the Navy’s latest update.
They account for 42 percent of all cases among all U.S. sailors worldwide.
The Navy said only about 1,500 sailors have so far been removed from the carrier, which has a crew of 5,000. Earlier this week, Navy brass promised 2,700 would be ashore by now.
About 44 percent of the crew have received coronavirus tests so far. None of the crew members who tested positive have required hospitalization.
The vessel’s commanding officer was relieved of duty earlier this week after he was accused of leaking a letter to the media that went "outside the chain of command," pleading for help after more than 100 sailors on board tested positive for the coronavirus.
Acting Navy Secretary Thomas Modly said he removed the carrier’s commander, Capt. Brett Crozier, because his letter "created panic on the ship" and "misrepresented the facts."
USS THEODORE ROOSEVELT COMMANDING OFFICER RELIEVED OF DUTY, ACTING NAVY SECRETARY ANNOUNCES
"It unnecessarily raised alarms with the families of our sailors and Marines with no plan to address those concerns," Modley said at a press conference Thursday. "It raised concerns about the operational security and operational capability of that ship that could have emboldened our adversaries to seek advantage and it undermined the chain of command."
The outbreak aboard the carrier prompted it to dock in Guam last month.
Crozier wrote a letter to senior military officials, which was leaked to the San Francisco Chronicle and published Tuesday.
USS THEODORE ROOSVELT COMMANDER SAYS ENTIRE CREW NEEDS TO BE ISOLATED
In the letter, Crozier warned that “if we do not act now, we are failing to properly take care of our most trusted asset -- our sailors.”
Modly said he didn't mind Crozier raising the issue, but "it was the way in which he did it."
The USS Theodore Roosevelt's crew made a strong show of support for Crozier as he disembarked.
Coronavirus patients delivered to hospital ship Comfort in New York by mistake: US officials
EXCLUSIVE - Multiple patients infected with coronavirus were transferred to the hospital ship Comfort from the Javits Center in New York by mistake, three U.S. officials tell Fox News.
The number of Covid-19 patients brought on board the hospital ship was estimated to be “less than five,” one official said. The information had not been previously reported.
The patients were transferred sometime Friday, according to the officials. At the time that the patients were transferred to the hospital ship, the initial screening did not indicate they were positive, officials said.
The top general leading the coronavirus response for the U.S. military told Fox News there was another COVID-19 patient who showed up to the hospital ship Comfort in New York earlier Saturday after being delivered by ambulance. The patient later tested positive on board while in isolation.
“We are treating the emergency situation that needs to be treated,” Air Force Gen. Terrence O'Shaughnessy said in a phone interview with Fox News Saturday afternoon and disclosed the new case aboard Comfort.
While Navy officials say the handful of previously unknown COVID-19 patients testing positive for the virus on board is proof the protocols put in place are working, it’s also a sign of the complexity this pandemic presents for medical personnel battling the pandemic in New York.
Until Friday, the 3,000-bed makeshift hospital at the Javit Center only treated non-COVID-19 patients. One day earlier, President Trump approved New York Gov. Andrew Cuomo’s request to have Javits treat COVID patients.
That meant all the patients at Javits -- a few dozen in all -- had to be sent to the hospital ship Comfort about 10 blocks away. Some of those patients later tested positive on board, as Fox News first reported Saturday afternoon.
The hospital ship is located on Pier 90 on Manhattan’s west side and arrived in New York Monday. The vessel has a “couple dozen” patients on board right now, according to chief Pentagon spokesman Jonathan Hoffman.
Part of the protocol before receiving patients onboard Comfort is for a coronavirus test to be performed. The swab test came back hours later, the patients remained in isolation and spent a night onboard the vessel, which is only supposed to treat trauma patients, not Covid-19 positive patients.
About a dozen patients from the Javits Center in midtown Manhattan were transferred to the hospital ship Comfort one day after President Trump approved New York Gov. Cuomo’s request to have Covid-19 patients treated at the Javits Center.
All the patients at Javits Center were then transferred to the hospital ship a short distance away where they were isolated and tested for the novel coronavirus.
Up to the point of embarking aboard the hospital ship, the patients had only filled out a questionnaire and had their temperature taken as part of an initial screening process. It’s been reported that half of people infected with coronavirus show no symptoms, according to the latest data.
The Covid-19 positive patients have already been delivered back to the Javits center Saturday morning to continue their treatment, one official said.
The Javits Center has been transformed into a 3,000 bed makeshift hospital by the Army Corps of Engineers.
The officials called the risk to the hospital ship’s crew “low,” because of the protocols were already in place.
“We were prepared with a contingency plan in case we received patients that later tested positive. Immediately upon arrival the patients were isolated while awaiting the test results,” the official added.
Another official pointed out this was why the hospital ship did not want to fill all 1,000 beds on board too quickly because the risk of the virus coming on board is so great.
The Comfort crew is scrubbing the area where the patients were housed on board. All U.S. Navy medical personnel were wearing complete PPE (personal protective equipment), the officials added.
“We have infectious disease specialists on board as well,” another official said.
Cmdr. Ashley Hockycko, spokeswoman for U.S. Second Fleet, told Fox News: "While admitting patients who were transferred to USNS Comfort for treatment, a few patients tested positive for COVID-19.
"The Comfort has infection control procedures that are followed just like hospitals ashore. Our medical experts on board are well prepared for cases like this, and have taken the appropriate precautionary measures. The patients were isolated and received care aboard the ship while working to transfer the patients as soon as practical to the Javits Federal Medical Station, which is treating COVID-19 patients. The Comfort is capable of continuing its mission.”
Right now both hospital ships Comfort in New York and Mercy in Los Angeles do not take Covid-19 patients, but top Pentagon leaders are “reassessing” that policy, the chairman of the Joint Chiefs of Staff, Army Gen. Mark Milley, told Fox News’ Harris Faulkner Friday afternoon.
That decision is “not imminent,” a Pentagon spokesman later said in a press conference Friday.
The coronavirus has claimed the lives of 3,500 people in New York, a number that has doubled since Wednesday.