Australia’s drugs regulator has approved four rapid antigen Covid-19 tests for distribution throughout the country with health workers and departments among the first to use the tests than can deliver results in 15 minutes.

The Australian pathology and pharmaceutical companies approved to import and distribute the tests are required to provide the Therapeutic Goods Administration with data about the efficacy of the tests over time. Supply of the tests will be limited to accredited laboratories, medical practitioners, healthcare professionals in residential or aged care facilities, and to government health departments.

Rapid antigen tests detect the presence of viral protein from Covid-19 and may be used to diagnose the virus in a patient with symptoms. They work best in the first week of infection – after that antigens tend to drop.

“This test will be useful in settings where speed is paramount,” Thacker said. “If you can test someone quickly before they go on-site to their workplace, and can do that regularly, you may avoid the massive shutdowns of workplaces that we have seen in some industries.”

In late August, the White House announced the US had struck a deal with US pharmaceutical company Abbott Laboratories to acquire 150m tests, deploying them to nursing homes and schools. But Williamson said it was important to monitor use of the tests in Australia and not to extrapolate data from US and other studies of the tests.

https://www.theguardian.com/australia-news/2020/sep/24/australias-drug-regulator-tga-approves-covid-tests-that-deliver-results-in-15-minutes

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United Airlines will offer some Hawaii-bound customers rapid-response coronavirus tests at the airport, an effort to get around quarantine requirements and eventually, open up more destinations to travelers during the pandemic.

United is the first U.S. airline to offer a Covid-19 testing program. Passengers booked from United’s San Francisco hub to Hawaii, one of its most popular destinations, will have that option starting Oct. 15, the airline said Thursday. The date is when Hawaii is scheduled to lift a two-week quarantine requirement on arriving travelers as long as they test negative for Covid-19 within 72 hours of their departure. Passengers will be responsible for payment. Firm pricing is still in the works but the tests will at first cost $250.

The nasal swab tests could later provide an opening for passengers to enter regions that are currently off-limits because of coronavirus concerns. Global airlines this week urged government officials around the world to consider Covid-19 testing for passengers before international flights as an alternative to blanket travel bans that have driven down passenger traffic.

“We are very interested in opening this up to other destinations,” Janet Lamkin, United’s California president, told CNBC.

The results of the molecular tests, which will be administered by GoHealth Urgent Care and Dignity Health, take about 15 minutes. The tests will be conducted in the international terminal, a site the airport announced last month that at first was for airport employees.

United and Delta Air Lines have rolled out rapid coronavirus tests for their crew members.

The tests at the airport will be conducted prior to security checkpoints. Travelers who test positive for Covid-19 won’t be allowed to fly.

https://www.cnbc.com/2020/09/24/united-airlines-to-offer-coronavirus-tests-for-hawaii-bound-passengers-for-coronavirus.html

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Dr. Anthony Fauci told Gov. Phil Murphy on Thursday that New Jersey has made enough progress to safely and "competently" reopen its economy and schools, and he addressed why. Murphy also spoke about what steps the Garden State may take next (you can watch it here, below).

Fauci spoke to Murphy as New Jersey announced 588 new coronavirus cases and 10 more deaths on Thursday.

Fauci said New Jersey's baseline of cases and community spread — despite getting "hit really very badly" in March and April — is so low that the state's situation is "positioning you well to do a number of things."

https://patch.com/new-jersey/pointpleasant/watch-live-murphy-speaks-dr-fauci-addresses-njs-next-moves

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One of the big challenges healthcare workers are facing in this global pandemic is identifying those COVID-19 patients most at risk of severe illness and death. COVID-19 certainly is more dangerous, on average, in the elderly or those with pre-existing health problems, but that doesn’t preclude a 96-year-old from presenting with no symptoms, or a healthy 21-year-old losing her life. A team of researchers from Massachusetts General Hospital have been trawling through hospital admission data to find some way to help doctors better assess those patients most at risk of suffering the worst effects of the disease.

The researchers analyzed blood samples from 1,641 patients admitted to Boston hospitals with COVID-19 earlier this year. The plan was to closely study the samples to identify any particular molecular patterns that could predict disease severity. Before looking at more complicated blood-based biomarkers the researchers first looked at biomarkers gathered in the most routine blood tests.

"We were surprised to find that one standard test that quantifies the variation in size of red blood cells – called red cell distribution width, or RDW – was highly correlated with patient mortality, and the correlation persisted when controlling for other identified risk factors like patient age, some other lab tests, and some pre-existing illnesses," says co-author on the new study, Jonathan Carlson.

RDW is a very common metric gathered in most standard blood count tests. The new study found patients displaying an elevated RDW at time of admission were 2.7 times more likely to die from COVID-19. Elevated RDW was also more significantly associated with mortality in younger COVID-19 patients.

The study also notes that patients whose RDW was seen to increase during hospitalization were more likely to suffer worse outcomes from the disease. The researchers suggest this indicates RDW may be a useful biomarker to track the progress of a patient while admitted in hospital.

The finding needs further validation in broader cohorts of patients, but if confirmed, this simple laboratory test may be a useful way to detect those COVID-19 patients most in need of clinical care.

https://newatlas.com/health-wellbeing/coronavirus-blood-test-predicts-mortality-disease-severity-rdw/

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Centers for Disease Control and Prevention Director Robert Redfield told senators that he didn’t mean to imply last week that it could take into the second half of next year for enough Covid-19 vaccine to be available to inoculate all Americans.

Redfield said at a Senate health committee hearing Wednesday that about 700 million vaccine doses should be available by April, echoing a timeline laid out by Paul Mango, deputy chief of staff at the Department of Health and Human Services, last week.

The vaccine candidates that are furthest along in development will require a two-dose regimen. Redfield’s comments last week, in an appearance before a different Senate panel, were “alluding to how long I thought it would take to get those doses into the American public,” he said. It could take through July to disburse the vaccine to all Americans that want one, Redfield said.

Anthony Fauci, the director of the National Institute of Allergy and Infectious Diseases, agreed Wednesday with the timeline of 700 million doses by April.

https://www.bloomberg.com/news/articles/2020-09-23/child-covid-hospitalizations-rose-in-summer-cdc-to-tell-senate

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Buoyed by positive results in its earlier studies, Johnson & Johnson has begun the final stage of clinical trials for its coronavirus vaccine.

Although they are a couple of months behind the other so-called Phase 3 trials in the United States, Johnson & Johnson’s trials will be the largest, with plans to enroll 60,000 participants. And the experimental vaccine may have considerable advantages over some of its competitors, experts said. It does not need to be stored in subzero temperatures, and it may require just one dose instead of two.

“It would be fabulous if we had something at a single dose,” said Dr. Judith Feinberg, the vice chairwoman for research in medicine at West Virginia University, who was not involved in the study.

Only a Phase 3 trial, which compares the effects of a vaccine with those of a placebo, could determine if a single dose was indeed effective, Dr. Feinberg said. But if it worked, that could greatly speed efforts to curb the pandemic.

The trial started on Monday. At a news conference on Tuesday, Dr. Paul Stoffels, chief scientific officer of Johnson & Johnson, said the company might be able to determine by the end of the year if the vaccine is safe and effective. The company will soon be posting a manuscript online with data from the earlier phases of its trials, he said.

https://www.nytimes.com/2020/09/23/health/covid-19-vaccine-johnson-and-johnson.html

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Thousands of students and teachers have become sick with the coronavirus since schools began opening last month, but public health experts have found little evidence that the virus is spreading inside buildings, and the rates of infection are far below what is found in the surrounding communities.

This early evidence, experts say, suggests that opening schools may not be as risky as many have feared and could guide administrators as they charter the rest of what is already an unprecedented school year.

“Everyone had a fear there would be explosive outbreaks of transmission in the schools. In colleges, there have been. We have to say that, to date, we have not seen those in the younger kids, and that is a really important observation,” said Michael Osterholm, director of the Center for Infectious Disease Research and Policy at the University of Minnesota.

On Wednesday, researchers at Brown University, working with school administrators, released their first set of data from a new National COVID-19 School Response Data Dashboard, created to track coronavirus cases. It found low levels of infection among students and teachers.

https://www.washingtonpost.com/education/feared-covid-outbreaks-in-schools-yet-to-arrive-early-data-shows/2020/09/23/0509bb84-fd22-11ea-b555-4d71a9254f4b_story.html

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The share of Californians who tested positive for COVID-19 in the last week dipped below 3% for the first time, a sign that the Golden State is finally starting to beat back the spread of the coronavirus, officials said Monday.

Just 3.1% of Californians who were tested over the last two weeks received a positive result, and that ratio dropped to 2.8% in the last seven days, state officials said. Hospitals in California are treating the fewest patients with the virus since April, and admissions to the state’s intensive care units have been dropping steadily, too.

It’s a rare piece of good news for 40 million Californians, who are contending with raging wildfires and toxic air quality on top of the economic, physical and emotional effects of the coronavirus pandemic.

https://www.latimes.com/california/story/2020-09-21/california-covid19-positivity-rate-drops-below-3-percent-for-the-first-time

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New York State recorded only one death Sunday to COVID-19, Governor Andrew Cuomo said Monday, making it the lowest one-day death toll from the virus in the state since the start of the pandemic.

Nationwide, ABC News reports there were increases in cases in 29 states, plus Washington DC and Puerto Rico. There were also increases in the daily rate of positivity in 15 states and DC; increases in hospitalizations in 17 states, DC and Puerto Rico; and increases in daily deaths in 16 states and Puerto Rico.

New cases in the U.S. peaked in late July and had been declining steadily ever since.

https://abc7ny.com/health/covid-updates-ny-marks-lowest-1-day-death-toll-since-start-of-pandemic/6478675/

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Silicon Valley medical equipment startup Visby Medical has received Emergency Use Authorization by the U.S. Food and Drug Administration for a portable PCR COVID-19 test kit, the first company to do so, according to the FDA on Thursday.

PCR, or polymerase chain reaction, rapidly replicates DNA or RNA and is considered an accurate diagnostic tool used in labs for infectious diseases. Traditionally, PCR testing uses a machine the size of a large microwave and can cost hundreds of thousands of dollars.

Visby founder and CEO Adam de la Zerda started working at shrinking that machine to a portable size that fits in the palm over seven years ago, initially to use on diagnosing sexually transmitted diseases. But with COVID-19 the company pivoted.

The EUA allows Visby’s kit to be used in clinical labs. A sample taken via a nasal swab is inserted into the kit and produces results in 30 minutes. The company said the goal is to eventually get the test kit sold to consumers to use at home.

https://www.reuters.com/article/us-health-coronavirus-fda-visby/silicon-valley-startup-visbys-portable-covid-19-test-gets-fda-approval-idUSKBN2682XP

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