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FDA News Release - Coronavirus (COVID-19) Update: FDA Authorizes First Diagnostic Test Using At-Home Collection of Saliva Specimens
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If 80% of Americans Wore Masks, COVID-19 Infections Would Plummet, New Study Says
There's compelling evidence that Japan, Hong Kong, and other East Asian locales are doing it right and we should really, truly mask up—fast......May 8, 2020.....https://www.vanityfair.com/news/2020/05/masks-covid-19-infections-would-plummet-new-study-says
If you're wondering whether to wear or not to wear, consider this. The day before yesterday, 21 people died of COVID-19 in Japan. In the United States, 2,129 died. Comparing overall death rates for the two countries offers an even starker point of comparison with total U.S. deaths now at a staggering 76,032 and Japan's fatalities at 577. Japan's population is about 38% of the U.S., but even adjusting for population, the Japanese death rate is a mere 2% of America's.
Wearing Mask Study:
https://arxiv.org/pdf/2004.13553.pdf
Results show a nearperfect correlation between early universal masking andsuccessful suppression of daily case growth rates and/orreduction from peak daily case growth rates, as predictedby our theoretical simulations.
ABM simulation shows that universal masking can signif-icantly reduce virus spread if adopted sufficiently early,even if the masks are nonmedical or homemade.
Two US studies using different methods confirmed statistical links between social distancing, similar measures, and falling SARS-CoV-2 transmission or new COVID-19 cases across the country [1,2]. One study tied wearing masks to fewer COVID-19 cases [2]. Both studies appear as medRxiv preprints that have not been peer-reviewed.
1. Dreher N, Spiera Z, McAuley FM, et al. Impact of policy interventions and social distancing on SARS-CoV-2 transmission in the United States. medRxiv preprint. 2020. doi: https://doi.org/10.1101/2020.05.01.20088179 . (This preprint report has not been peer-reviewed.)
2. Associations of stay-at-home order and face-masking recommendation with trends in daily new cases and deaths of laboratory-confirmed COVID-19 in the United States. medRxiv preprint. 2020. https://doi.org/10.1101/2020.05.01.20088237 . (This preprint report has not been peer-reviewed.)
3. Bennhold K, Eddy M. Germany's reopening offers hope for a semblance of normal life. New York Times. May 6, 2020.
https://www.nytimes.com/2020/05/06/world/europe/germany-merkel-coronavirus-reopening.html
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FDA News Release
Coronavirus (COVID-19) Update: FDA Authorizes First Diagnostic Test Using At-Home Collection of Saliva Specimens
Immediate Release:
May 08, 2020
https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-first-diagnostic-test-using-home-collection-saliva
Today, the U.S. Food and Drug Administration authorized the first diagnostic test with the option of using home-collected saliva samples for COVID-19 testing. Specifically, the FDA issued an emergency use authorization (EUA) to Rutgers Clinical Genomics Laboratory for their COVID-19 laboratory developed test (LDT), which had been previously added to the high complexity molecular-based LDT "umbrella" EUA, to permit testing of samples self-collected by patients at home using the Spectrum Solutions LLC SDNA-1000 Saliva Collection Device. This announcement builds on last month's EUA for the first diagnostic test with a home-collection option, which uses a sample collected from the patient's nose with a nasal swab and saline.
"Authorizing additional diagnostic tests with the option of at-home sample collection will continue to increase patient access to testing for COVID-19. This provides an additional option for the easy, safe and convenient collection of samples required for testing without traveling to a doctor's office, hospital or testing site," said FDA Commissioner Stephen M. Hahn, M.D. "We will continue to work around the clock to support the development of accurate and reliable tests, as we have done throughout this pandemic. The FDA has authorized more than 80 COVID-19 tests and adding more options for at-home sample collection is an important advancement in diagnostic testing during this public health emergency."
Today's EUA for Rutgers Clinical Genomics Laboratory's molecular test permits testing of a saliva sample collected from the patient using a designated self-collection kit. Once patients collect their saliva sample, they return it to the Rutgers Clinical Genomics Laboratory in a sealed package for testing.
The Rutgers Clinical Genomics Laboratory test is currently the only authorized COVID-19 diagnostic test that uses saliva samples to test for SARS-CoV-2, the strain of coronavirus that causes COVID-19. The test remains prescription only.
Today's authorization is limited to testing performed at the Rutgers Clinical Genomics Laboratory using their molecular LDT COVID-19 authorized test for saliva specimens collected using the Spectrum Solutions LLC SDNA-1000 Saliva Collection Device. It is important to note that this is not a general authorization for at-home collection of patient samples using other collection methods, saliva collection devices, or tests, or for tests fully conducted at home.
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.
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FDA authorizes the first at-home Covid-19 saliva test
CNN
Updated 3:46 AM ET, Sat May 9, 2020
(CNN)The US Food and Drug Administration on Friday issued an emergency use authorization for the first at-home Covid-19 test that uses saliva samples, the agency said in a news release.
Rutgers University's RUCDR Infinite Biologics lab received an amended emergency authorization late Thursday. With the test, people can collect their own saliva at home and send their saliva samples to a lab for results.
Testing for Covid-19 so far has usually involved nose or throat swab samples.
In April, Rutgers University announced that the FDA authorized the saliva test that it developed with other groups for "emergency use" for diagnosing Covid-19.
"What's new and next is expanding access to testing for people," Andrew Brooks, chief operating officer and director of technology development at the RUCDR Infinite Biologics lab, told CNN.
"If people are committed to do self-collection and can facilitate that collection at home, certainly with a prescription under medical care, we can get to those that are quarantined, don't have the means for transportation or are too scared to go outside," Brooks said. "So they get the test in the mail or from a distribution center."
Brooks said the test includes instructions on how to spit into a funnel to collect a saliva sample and seal with a cap to preserve the sample. A preservation agent will appear, blue in color, and once the whole sample is blue, it's put back in a biohazard bag provided with the kit and sent to a lab for testing.
"Authorizing additional diagnostic tests with the option of at-home sample collection will continue to increase patient access to testing for COVID-19. This provides an additional option for the easy, safe and convenient collection of samples required for testing without traveling to a doctor's office, hospital or testing site," FDA Commissioner Dr. Stephen M. Hahn said in the FDA's press release on Friday.
"We will continue to work around the clock to support the development of accurate and reliable tests, as we have done throughout this pandemic," Hahn said. "The FDA has authorized more than 80 COVID-19 tests and adding more options for at-home sample collection is an important advancement in diagnostic testing during this public health emergency."
The FDA noted in its release that the Rutgers test is currently the only authorized Covid-19 diagnostic test that uses saliva samples to test for the novel coronavirus. The test remains prescription only.
Another prescription-only test kit, made by LabCorp, received FDA authorization in April and allows patients to collect their own samples by nasal swab and send to a lab for testing.
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