FDA அமெரிக்காவின் உணவு மட்டும் மருந்து கட்டுப்பாட்டு துறை : கோவிட் 19 தாக்கத்திற்குள்ளாவர்களை 45 நிமிடத்தில் அறியலாம்

[ampanai]

இதுவரை பல நாட்கள் எடுத்த பரிசோதனை தற்பொழுது 45 நிமிடங்களில் அறியலாம் என கூறப்படுகின்றது. 

FDA அமெரிக்காவின் உணவு மட்டும் மருந்து கட்டுப்பாட்டு துறை இது பற்றி அறிவித்துள்ளது. 

https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-issues-first-emergency-use-authorization-point-care-diagnostic

Today, the U.S. Food and Drug Administration issued the first emergency use authorization for a point-of-care COVID-19 diagnostic for the Cepheid Xpert Xpress SARS-CoV-2 test.

“The test we’re authorizing today will be able to provide Americans with results within hours, rather than days like the existing tests, and the company plans to roll it out by March 30, which is an incredibly rapid timeline for such an effort. With new tools like point-of-care diagnostics, we are moving into a new phase of testing, where tests will be much more easily accessible to Americans who need them,” said HHS Secretary Alex Azar. “With the development of point of care diagnostics, Americans who need tests will be able to get results faster than ever before. More and more options for reliable, convenient testing are becoming available at an incredibly rapid pace, thanks to the hard work of our FDA team and the ingenuity of American industry.”

“Our dedicated team at the FDA has been working nonstop to expedite the review and authorization of novel diagnostics during the COVID-19 public health emergency,” said FDA Commissioner Stephen Hahn, M.D. “Today marks an important step in expanding the availability of testing and, importantly, rapid results. Point-of-care testing means that results are delivered to patients in the patient care settings, like hospitals, urgent care centers and emergency rooms, instead of samples being sent to a laboratory. With today’s authorization, there is now an option for testing at the point of care, which enables patient access to more immediate results.”

The FDA issued an emergency use authorization to Cepheid for the Xpert Xpress SARS-CoV-2 test for use in high- and moderate-complexity CLIA-certified laboratories as well as in certain patient care settings. The company intends to roll-out availability of its point-of-care testing by March 30.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

 

 

[ampanai]

சந்தோஷமான செய்தி: கொரோனா Test-Kit - உண்மையானால் ...
DECN Finalizes FDA Pre-EUA Version of Its Genviro! Screening Covid-19 Swift Kit, Providing Results in 15 Seconds Using Only 1.0-2.0 Microliters Whole Blood

DECN Finalizes FDA Pre-EUA Version of Its Genviro! Screening Covid-19 Swift Kit, Providing Results in 15 Seconds Using Only 1.0-2.0 Microliters Whole Blood

https://apnews.com/ACCESSWIRE/66324eff9e38b7e669031f4dee5d3d8d

[ampanai]

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.

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.

https://www.cnn.com/2020/03/27/us/15-minute-coronavirus-test/index.html

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.

 

All FDA-authorized tests, however, require samples from patients and health care facilities say they're facing shortages of critical supplies needed to collect specimens.

 

[nunavilan]