FDA approves COVID-19 test to be done at home, while in Miami they test people without symptoms – Telemundo Miami (51)

The COVID-19 diagnostic center at Charles Hadley Park in Miami-Dade County now extends its capacity to asymptomatic adults over 65. Located at 1350 NW and 50th Street, those interested should call 305 – 960 – 5050 to request an appointment.

But if you can’t get out of the house, the
US Food and Drug Administration, FDA,
authorizes home coronavirus testing.

The test, created by the Corporation of
Laboratorios de America, (LabCorp), can be done by the patient himself and
consists of collecting a nasal sample, using the self-collection kit of
LabCorp. It contains the appropriate cotton swabs for this type of
exam. Once finished, the patient must send their sample in a package
isolated, to the LabCorp laboratory for later analysis.

FDA Commissioner Stephen M. Hahn said
that this new coronavirus test variant is as reliable and safe as
those currently practiced in diagnostic sites.

These kits will be available to the population in the coming weeks at a cost of $ 119. The first LabCorp Kits will be for healthcare personnel and for emergency personnel.

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The FDA approves a kit to take the COVID-19 test at home – Telemundo San Antonio (60)

WASHINGTON – The Food and Drug Administration (FDA) approved this Tuesday a test that allows the diagnosis of COVID-19 through the study of samples obtained by patients themselves from home, They must then send them to a laboratory for analysis.

This was announced by this federal organization in a statement published on its website, in which it explains that this PCR test – that is, that looks for fragments of genetic material of the pathogen – developed by Laboratory Corporation of America (LabCorp) allows the study of samples Nasally collected by the patients themselves using a kit that has swabs and a saline solution.

Once patients collect the sample, they will have to send it in an isolated package to LabCorp, where it will be studied.

FDA Commissioner Stephen Hahn stressed the safety and effectiveness of the new test: “We work with LabCorp to ensure that the data obtained from the collection of samples from patients at home is as safe and accurate as the collection of samples in a doctor’s office, hospital, or other testing site. “

On its website, Pixel, a company owned by LabCorp, announces that the general consumer will be able to access this test in the coming weeks, although at the moment it will only be available to healthcare personnel, although its price is $ 119 for everyone.

In its statement, the FDA stresses that patients should only use the cotton swabs provided by LabCorp in the package that makes up the test, as there is concern about the possible cross contamination that could cause the use of cotton swabs other than those supplied .

Also, remember that this authorization does not mean that all the SARS-CoV-2 tests that can be performed at home have been authorized or will be.

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“In confinement, the benefit of massive screening has not been demonstrated” – Release

“In confinement, the benefit of massive screening has not been demonstrated” Release.

For the Sick, an agonizing wait for tests in Massachusetts – NBC Boston

Danni Aubain has cancer, so when she started feeling lousy late last month, she was particularly worried.

Aubain said the disease hit her like a ton of bricks. He had a 103-degree fever and a horrible, dry cough.

“I really couldn’t breathe,” he said, “and that’s scary for anyone undergoing chemotherapy.”

When seeking medical attention, Aubain said that both her oncologist and a Massachusetts General Hospital emergency room doctor pushed for her to be tested for COVID19, the new coronavirus disease that spreads worldwide.

But despite their recommendations, the response they got from state epidemiologists was that Aubain did not meet the test criteria.

“They called the Public Health Department and I was told that if I couldn’t name a person I knew had a positive test and that I hadn’t traveled outside the country, I couldn’t have been tested,” he said.

In response to NBC10 Boston’s questions, Mass. General said he cannot discuss the treatment of any patient.

But Aubain’s story is like so many others streamed to NBC10 Boston investigators in the past week by spectators across the state who have not been able to take a test. Many said they experienced symptoms of the disease, such as fever and shortness of breath. Like Aubain, some have also been seen by doctors who were convinced they need to be screened.

But with a shortage of test kits available in the state until the end of last week and with restrictive guidelines in place by the federal government, many said they were frustrated, scared and confused as to what to do next.

Federal officials are rapidly increasing the nation’s infrastructure to test COVID-19 this week after a series of missteps hampered the country’s ability to control the virus as it migrated from its epicenter in China to destinations around the world. As of Monday, there have been over 4,000 disease cases reported in the United States, which have so far seen over 70 deaths.

On Monday, health officials in Massachusetts announced that around 1,300 people were tested for the disease and 197 tested positive.

The state’s ability to test patients has increased significantly in the past few days when federal officials have granted Massachusetts clearance to begin testing the samples at the state’s public health laboratory, rather than sending them to a centralized, managed location. by the US Centers for Disease Control and Prevention.

Federal officials also expanded their testing guidelines, offering doctors more discretion to order a test for the virus, and last week they shipped around 5,000 additional test kits to Massachusetts, easing local supply.

The CDC has also published new guidelines that allow doctors and nurses to subject a single nasal swab to tests, rather than a nasal swab and another sample from the patient’s throat. The change is expected to allow Massachusetts to double its testing capacity, bringing the number of tests conducted every day from 200 to 400, public health commissioner Monica Bharel said at a press conference on Sunday.

The Food and Drug Administration, which must approve the test sites, also granted permission at the end of last week to a couple of private companies – Quest Diagnostics and LabCorp – to begin testing samples collected from patients in Massachusetts. Massachusetts hospital labs are expected to launch their testing programs shortly.

“With more and more clinical labs in Massachusetts working to gain FDA approval, more online capabilities will also be available soon,” said Bharel on Sunday.

Federal officials say the United States is now on track to test thousands of patients a day for the virus after falling far behind other countries in its efforts to detect the virus.

Independent research cited by the CDC indicates that the United States had completed approximately 20,000 tests as of March 13. That number pales in comparison to the aggressive testing effort in South Korea, which has a much smaller population, but has tested around 15,000 people per day.

While the United States is ready to learn more about the extent of the pandemic soon, many in the Bay State who fear having contracted the disease say they believe the government has missed an important opportunity to help curb its spread.

“I have a couple of friends in my social circle who are experiencing flu-like symptoms and are just writing it as flu,” said Rita Czernewski, a Cantonese resident who had an unexplained illness a few weeks ago and was frustrated by her inability to get tested for the new coronavirus.

“We are just a little stuck,” he said. “The only thing we can do is just be careful.”

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The FDA expands coronavirus tests after CDC defects undermine the fight against disease

The effort of the U.S. Centers for Disease Control and Prevention to protect Americans from the new coronavirus has been hampered by a poor disease test and limited access to reliable analysis, resulting in significant delays in determining which people have the virus, according to officials and experts.

But the Food and Drug Administration announced Saturday that labs and hospitals across the nation will now be able to conduct the tests and will not have to wait for the results of the CDC.

“We believe this policy strikes the right balance during this public health emergency,” said FDA commissioner Dr. Stephen Hahn in a note. “We will continue to help ensure solid science before clinical trials and follow-up with independent critical review by the FDA, rapidly expanding testing capabilities in the United States.”

The anomalies in the CDC test system contrasted the wide-ranging surveillance tests to track the disease and eliminate concerns for healthy people by simply fighting a common cold.

China currently has the ability to test 1.6 million people per week for COVID-19 and South Korea has already tested around 65,000 people, according to Science Magazine. As of Friday, fewer than 500 people in the United States had been tested, according to the CDC.

The CDC has ignored the World Health Organization’s testing guidelines to design its own test. But several test kits sent to states have had inconclusive results, so most states have had to rely on CDC analysis, creating a backlog, according to ProPublica.

“We are weeks behind because we had this problem,” Scott Becker, chief executive officer of the Association of Public Health Laboratories, told ProPublica. “Usually we are in the foreground, in the center and ready.”

Until recently, the CDC has also limited the use of kits to suspected cases of COVID-19 among people who had traveled to China within two weeks of developing symptoms or who had been in close contact with someone with the disease.

A Washington County health director, where the nation’s first coronavirus fatality occurred, complained on Saturday of the delay in critically identifying people with the disease caused by blocking tests and strict CDC criteria before they could even conduct a test.

“If we had had the chance to run the tests earlier, I’m sure we would have identified the patients earlier,” said Jeff Duchin. Early detection is critical for people to be able to start treatment and be isolated before passing on the virus to someone else.

Washington state officials announced two new cases of illness on Friday, the death of a coronavirus man on Saturday and an apparent outbreak of COVID-19 in a nursing home in the Seattle area where two people have already given positive results and dozens of others have symptoms.

This week New York and the state got permission from CDC and FDA to develop their tests in an attempt to simplify the process. CDC said that the tests it provides should offer reliable reading on COVID-19 in many laboratories, although other elements of the test may not work. But New York officials aren’t convinced they can rely on the results of the CDC tests.

“Tests for coronavirus are not yet available in New York City,” said Department of Health spokeswoman Stephanie Buhle in an email to ProPublica. “The kits that have been sent to us have shown performance issues and cannot be relied on to provide an accurate result.”

Dozens of state, university and private company labs have already applied for emergency approval for their tests. Once they have presented evidence of how these tests work, they will be able to use them immediately, according to the New York Times.

President Donald Trump at a press conference on Saturday announced measures to block visitors to the United States from countries hit hard by the virus and encouraged Americans not to travel to those countries. He did not address the test problem.

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The FDA approves the heart and lung support system for critically ill patients

The FDA approves the heart and lung support system for critically ill patients higher

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