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FDA authorizes 15-minute coronavirus test
By Arman Azad
(CNN) Federal health officials on Friday approved a coronavirus test that can provide results in less than 15 minutes, using the same technology that powers some rapid flu tests.
Teased by Vice President Mike Pence in a Thursday press briefing, the new diagnostic test could accelerate testing in the United States, allowing for rapid results in doctors’ offices. But shortages of critical equipment used to collect patient specimens, like masks and swabs, could blunt its impact.
The Muslim Times has the best collection of articles about epidemiology, diagnosis and treatment of coronavirus, Covid 19
The US Food and Drug Administration authorized the test for emergency use, signaling that federal regulators were satisfied with the test’s validation data and believe its benefits outweigh any risks, such as false positives or negatives.
The test’s maker, Abbott Laboratories, said it expects to deliver 50,000 tests per day beginning next week. The technology behind the test looks for genes that are present in the virus, similar to PCR (polymerase chain reaction) tests already on the market.
The platform used to run the test weighs less than 7 pounds, according to Abbott, and could be deployed “where testing is needed most.”
Last week, the FDA authorized another rapid test from molecular diagnostics company Cepheid, which provides results in about 45 minutes. Most laboratory tests for the coronavirus take anywhere from a few hours to days to receive results.
Testing being performed on Abbott’s ID NOW platform
A new COVID-19 test can return results in 5 minutes
It can run at urgent care clinics and doctors’ offices
A new COVID-19 test from the medical device company Abbott can return positive results in five minutes — and it can be run in a doctor’s office. The test was approved for emergency use in the United States by the Food and Drug Administration last night.
The test uses Abbott’s small, portable ID NOW platform, and doesn’t have to be sent to a central lab for analysis. Instead, it can be done directly in an emergency room or urgent care clinic, which could cut down on the days-long wait time some patients now face for test results. Doctors could take a swab from a patient’s nose or throat and insert it directly into the machine, and have results within 15 minutes (it can take up to 13 minutes if the sample is negative for the virus).
Dr. Zia H Shah, Chief Editor of the Muslim Times and in charge of health section
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“We project that roughly 56 percent of our population – 25.5 million people – will be infected with the virus over an eight week period,” Governor Newsom of California wrote on 3/19/2020.
Categories: Health, The Muslim Times
– The Abbott ID NOW™ COVID-19 test brings rapid testing to the front lines
– Test to run on Abbott’s point-of-care ID NOW platform – a portable instrument that can be deployed where testing is needed most
– ID NOW has the largest molecular point-of-care installed base in the U.S. and is available in a wide range of healthcare settings
– Abbott will be making ID NOW COVID-19 tests available next week and expects to ramp up manufacturing to deliver 50,000 tests per day
– This is the company’s second test to receive Emergency Use Authorization by the FDA for COVID-19 detection; combined, Abbott expects to produce about 5 million tests per month
https://abbott.mediaroom.com/2020-03-27-Abbott-Launches-Molecular-Point-of-Care-Test-to-Detect-Novel-Coronavirus-in-as-Little-as-Five-Minutes
As the world leader in point-of-care diagnostics, Abbott is adding its expertise and scale to help fight the COVID-19 global pandemic. First introduced in 2014, ID NOW is the leading molecular point-of-care platform for Influenza A & B, Strep A and RSV testing in the U.S.
ID NOW is a rapid, instrument-based, isothermal system for the qualitative detection of infectious diseases. Its unique isothermal nucleic acid amplification technology provides molecular results in just minutes, allowing clinicians to make evidence-based clinical decisions during a patient visit.
https://abbott.mediaroom.com/2020-03-27-Abbott-Launches-Molecular-Point-of-Care-Test-to-Detect-Novel-Coronavirus-in-as-Little-as-Five-Minutes
To purchase:
https://www.alere.com/en/home/product-details/id-now.html
ID now training videos:
https://www.alere.com/en/home/support/product-demos/id-now-training-videos.html