UK: Confirmatory PCR tests temporarily suspended for positive lateral flow test results

 From 11 January in England, people who receive positive lateral flow device (LFD) test results for coronavirus (COVID-19) will be required to self-isolate immediately and won’t be required to take a confirmatory PCR test.

This is a temporary measure while COVID-19 rates remain high across the UK. Whilst levels of COVID-19 are high, the vast majority of people with positive LFD results can be confident that they have COVID-19.

Lateral flow tests are taken by people who do not have COVID-19 symptoms. Anyone who develops 1 of the 3 main COVID-19 symptoms should stay at home and self-isolate and take a PCR test. They must self-isolate if they get a positive test result, even if they have had a recent negative lateral flow test – these rules have not changed.

The new approach reflects similar changes made this time last year in January 2021, when there was also a high prevalence of infection meaning it was highly likely that a positive LFD COVID-19 result was a true positive. This meant confirmatory PCRs were temporarily paused and reintroduced in March 2021 following a reduction in prevalence.

The UK’s testing programme is the biggest in Europe with over 400 million tests carried out since the start of the pandemic. Since mid-December, 100,000 more PCR booking slots have been made available per day and capacity continues to be rapidly expanded, with delivery capacity doubled to 900,000 PCR and LFD test kits a day.

Under this new approach, anyone who receives a positive LFD test result should report their result on GOV.UK and must self-isolate immediately but will not need to take a follow-up PCR test.

After reporting a positive LFD test result, they will be contacted by NHS Test and Trace so that their contacts can be traced and must continue to self-isolate.

There are a few exceptions to this revised approach.

First, people who are eligible for the £500 Test and Trace Support Payment (TTSP) will still be asked to take a confirmatory PCR if they receive a positive LFD result, to enable them to access financial support.

Second, people participating in research or surveillance programmes may still be asked to take a follow-up PCR test, according to the research or surveillance protocol.

Finally, around one million people in England who are at particular risk of becoming seriously ill from COVID-19 have been identified by the NHS as being potentially eligible for new treatments. They will be receiving a PCR test kit at home by mid-January to use if they develop symptoms or if they get a positive LFD result, as they may be eligible for new treatments if they receive a positive PCR result. This group should use these priority PCR tests when they have symptoms as it will enable prioritised laboratory handling.

In line with the reduced self-isolation approach announced on 22 December, anyone who tests positive will be able to leave self-isolation 7 days after the date of their initial positive test if they receive 2 negative LFD results, 24 hours apart, on days 6 and 7.

Rapid lateral flow tests are most useful at identifying COVID-19 in people without any symptoms. The tests are over 80% effective at finding people with high viral loads who are most infectious and most likely to transmit the virus to others.

Analysis by NHS Test and Trace shows LFD tests to have an estimated specificity of at least 99.97% when used in the community. This means that for every 10,000 lateral flow tests carried out, there are likely to be fewer than 3 false positive results. LFD tests identify the most infectious people. These people tend to spread the virus to many people and so identifying them remains important.

Secretary of State for Health and Social Care Sajid Javid said:

We have built a world-leading testing system and our testing capacity is the largest in Europe. This has helped save lives and protect millions of people from COVID-19. It forms a crucial line of defence alongside vaccines and antivirals.

As Omicron cases continue to rise the demand for tests has grown rapidly across the globe. We’re putting plans in place to manage the demand for PCR tests in the UK so we can ensure that those who most need tests can continue to access them.

Chief Executive of UKHSA, Dr Jenny Harries, said:

While cases of COVID-19 continue to rise, this tried-and-tested approach means that LFDs can be used confidently to indicate COVID-19 infection without the need for PCR confirmation.

It remains really important that anyone who experiences COVID-19 symptoms self-isolates immediately.  They should also order a PCR test on GOV.UK or by phoning 119.

I’m really grateful to the public and all of our critical workers who continue to test regularly and self-isolate when necessary, along with other practical and important public health behaviours, as this is the most effective way of stopping the spread of the virus and keeping our friends, families and communities safe.

Yesterday the Prime Minister announced the government will provide 100,000 critical workers in England with free lateral flow tests to help keep essential services and supply chains running.

Critical workers will be able to take a test on every working day and the provision of precautionary testing will be for an initial 5 weeks.  This will help to isolate asymptomatic cases and limit the risk of outbreaks in workplaces, reducing transmission while COVID-19 cases remain high.

The full range of critical workers have been identified by the relevant departments and government will contact these organisations directly on the logistics of the scheme this week. Roll-out will start from Monday 10 January.

Tests will be separate from public sectors who already have a testing allocation with UKHSA, such as adult social care or education, and separate to those delivered to pharmacies and homes, so those channels will not be impacted by the new scheme.

We are now distributing around 600,000 packs of LFD tests (each containing 7 tests) on GOV.UK directly to homes every day (more than 50% higher than last week).

https://www.gov.uk/government/news/confirmatory-pcr-tests-to-be-temporarily-suspended-for-positive-lateral-flow-test-results

Mass Seattle Schools COVID tests show 4% positive rate

 Officials say around 4% of more than 14,000 Seattle Public Schools students and staff who participated in the district’s rapid testing clinics this week tested positive for COVID-19.

Volunteers and district staff administered the tests in pop-up clinics on Sunday and Monday after the state’s largest district received a shipment of 60,000 rapid tests from the state health department. Seattle has about 50,000 students and 7,800 staff.

Testing was intended to help build a forecast of how many staff might be out for quarantine periods and need substitutes, and to slow virus transmission in classrooms after winter break.

Carri Campbell, the district’s assistant deputy superintendent, said in-person instruction is the district’s priority and the primary reason for the pop-up test sites.

The district sent a message to families two weeks ago warning that if cases spiked after the holidays, classes could be moved online temporarily.

Officials were not able to provide a breakdown of the positive cases by staff and students on Tuesday, but Campbell noted that the staff absence rates on Tuesday, the first day of school in the new year, looked typical.

No other school district in Washington state has administered rapid tests in such a manner and scale.

https://www.q13fox.com/news/mass-seattle-schools-covid-tests-show-4-positive-rate

Up to 80% of Fla. will have caught COVID-19 by end of omicron wave: report

 According to a new report from the University of Florida, most of the state’s population will become infected with coronavirus in the latest omicron wave.

UF biostatisticians have been studying the way that the omicron variant behaves. They say data shows that omicron is twice as infectious as delta and spreads quicker, too.

“So you combine those two things and you get a very fast, large epidemic,” said Ira Longini.

Longini is a UF professor and one of the researchers who worked on the report. So how large of an epidemic are they predicting? This large:

“Probably 70 to 80% of the state will either get infected in this wave or have been infected in a prior wave,” Longini said.

Researchers said the most recent wave is likely to cause many more infections in part because of the variant’s shorter incubation period compared to delta.

“If you get infected with omicron, you start infecting other people about two days after you’re infected,” said Longini.

With delta, he said it usually took about five days to spread. The quick transmission means an earlier peak.

Last month, UF researchers predicted that the omicron wave would peak in February. Because of the significant growth in cases, they updated their prediction to next week.

“It’s good news in the sense that the wave will be over certainly by the end of January,” said Longini. “The bad news it’s going to be very intense for the next couple weeks with lots of cases and it probably will put a strain on our hospital resources.”

With the peak just days away, Longini said it is not too late to take precautions.

“We may get more variants in the future,” he said. “So I think the more people we can vaccinate and keep vaccinating, especially our children who need to be vaccinated, especially the younger children, to keep doing that. Not let up is going to be very important going forward.”

While researchers warn most of the state could become infected by the end of this wave, they add that majority of people will either be asymptomatic or have a mild case. They estimate that omicron will cause substantially fewer deaths, about a third as many deaths caused by delta.

https://www.wesh.com/article/watch-house-holds-moment-of-silence-as-congress-marks-1-year-since-capitol-riot/38686184

Former Biden transition advisors call for change in COVID-19 strategy

 Several health advisers to President Biden’s transition team are calling on the administration to revamp its COVID-19 pandemic strategy and set clear goals for what the “new normal” of living with the virus will look like.

In three separate op-eds published in the Journal of the American Medical Association, the authors recommended dozens of strategies that go above and beyond what the Biden administration is currently doing. 

The authors include Luciana Borio, a former acting chief scientist at the Food and Drug Administration; Ezekiel Emanuel, an oncologist and University of Pennsylvania professor; Michael Osterholm of the University of Minnesota; and Rick Bright of the Rockefeller Foundation. 

The authors made clear that COVID-19 is not endemic yet, and that the U.S. is far from that point. But they said the administration needs to clearly communicate the current goals and strategies, instead of shifting from one crisis to another.

For instance, they said it was shortsighted for Biden to declare last summer that the U.S. has “gained the upper hand against this virus."

“By September 2021, the Delta variant proved these steps to be premature, and by late November, the Omicron variant created concern about a perpetual state of emergency,” they wrote. “In delineating a national strategy, humility is essential.”

Neither COVID-19 vaccination nor infection appear to confer lifelong immunity, and the current vaccines do not offer protection against infection either. The goal for the “new normal” with COVID-19 does not include eradication or elimination, they wrote.

The appropriate risk threshold should reflect peak weekly deaths, hospitalizations, and community prevalence of viral respiratory illnesses during high-severity years, such as 2017-2018. That year had approximately 41 million symptomatic cases of influenza, 710,000 hospitalizations and 52,000 deaths

“Today, the U.S. is far from these thresholds,” they said, and getting to that point will take effort. 

For instance, they said the U.S. needs to invest in a public health data infrastructure 

“As Omicron has reemphasized, the US is operating with imprecise estimates of disease spread, limited genomic surveillance, projections based on select reporting sites, and data from other countries that may not be generalizable. These shortcomings are threatening lives and societal function,” the authors wrote.

They also called for better investment in testing.

“Every person in the US should have access to low-cost testing to determine if they are infected and infectious. The Biden administration’s plan to distribute 500 million at-home rapid tests and ramp up production using the Defense Production Act is an important step in the right direction but many more are needed,” they wrote.

The authors also said that vaccine mandates should be imposed more broadly, including for children in schools, and that the government should make high quality masks like N95 available for free for all Americans.

“It appears that SARS-CoV-2 will persist, and the COVID-19 pandemic will continue for some time. Consequently, to achieve a sustainable ‘new normal’ with substantially lower virus transmission and mortality from COVID-19, testing, surveillance, masking, and ventilation all need significant improvement,” the authors wrote.

https://thehill.com/policy/healthcare/588651-former-biden-transition-advisors-call-for-change-in-covd-strategy

Chicago Public Schools reports record-high COVID-19 infections

 The Chicago Public Schools (CPS) system reported 417 students and 270 adults had COVID-19 on Tuesday, a new daily case record as the district grapples with canceled classes and returning to school after the holiday break. 

Tuesday's infections were double the numbers seen last month before the two-week holiday break, according to data provided by the school system.

Now, the district has a total of 5,178 coronavirus cases among students and 1,988 for adults, while 9,000 students and 2,377 adults were in isolation as of Wednesday evening, the school system said.

CPS also reported that more than 90 percent of teachers and staffers are fully vaccinated.

The record-setting numbers come as Chicago's teachers union voted on Tuesday to teach remotely unless they reached a safety agreement with CPS or the uptick in infections lessened.

But on Thursday, schools in Chicago were closed for the second day after 73 percent of Chicago Teachers Union members voted to switch to remote learning, a move criticized by some school and local leaders.

“We know that our schools are safe. Yes. Do we have challenges across individual schools? Absolutely. Do we respond? Absolutely,” schools CEO Pedro Martinez said at a press conference Wednesday.

“There is no basis in the data, the science or common sense for us to shut an entire system down when we can surgically do this at a school level," Chicago Mayor Lori Lightfoot (D) has also said of the decision.

Both CPS and the teachers union have filed charges regarding unfair labor against each other, according to The Chicago Tribune.

https://thehill.com/homenews/state-watch/588649-chicago-public-schools-reports-record-high-covid-19-infections

'Massive Meltdown': 40% Of Nasdaq Companies Down More Than Half From Their Highs

 In a testament to the narrow breadth of the Nasdaq, and the broader market in general, where as a reminder 51% of all market gains from April through December were just from the five most popular tech names - AAPL, MSFT, NVDA, TSLA, GOOGL - Sundial Research notes that a near-record number of tech stocks have plunged by some 50%, a number that was only surpassed by the March 2021 crash and the global financial crisis.

Roughly four in every 10 companies on the Nasdaq Composite have seen their market values cut by 50% or more from their 52-week highs, while a vast majority of index constituents are mired in bear markets, according to Jason Goepfert, chief research officer at Sundial.

"Whatever the fundamental and macro considerations, there is no doubt that investors have been selling first and trying to figure out the rest later," Goepfert said in a note and first noted by Bloomberg.

It's also why hedge fund holding all but the largest companies have had a miserable year, and why as we noted earlier, hedge funds had already undergone some of the biggest selling and degrossing in the past decade ahead of yesterday's FOMC minutes rout.

“Valuations are at historical highs, companies are raising billions based on fairy dust, and the Fed is signaling a tightening cycle,” Goepfert said. “All of these are scaring investors that we’re on the cusp of a repeat of 1999-2000.”

Tech stocks have been under especially heavy selling pressure since the start of the year amid a bond-market rout that’s sent 10Y TSY surging as high as 1.75% on Thursday, surpassing the highest level of 2021. The carnage accelerated after the latest FOMC minutes pointed to earlier and faster rate hikes, suggesting to some that the central bank became more hawkish quicker than many had expected. As a result, traders were quick to dump high-duration tech shares, whose high valuations become harder to justify in a rising-rate environment.

The Nasdaq index is on pace for its biggest weekly decline since November, even as it rose in the New York afternoon trading session Thursday. A 3.3% fall Wednesday marked its worst single-day session since February last year. However, the drop has been relatively contained thanks to the continued support of the big five generals, which have so far been resistant to wholesale selling.

https://www.zerohedge.com/markets/massive-meltdown-40-nasdaq-companies-are-down-more-half-their-highs

Quidel Preliminary Revenue for Q4 2021

 Quidel Corporation (NASDAQ: QDEL) ("Quidel"), a provider of rapid diagnostic testing solutions, cellular-based virology assays and molecular diagnostic systems, announced today that it expects total revenues in the fourth quarter of 2021 to be in the range of $633 million to $637 million and full year total revenues to be in the range of $1,695 million to $1,699 million. COVID-19 revenues in the fourth quarter of 2021 are expected to be approximately $510 million.

"The fourth quarter of 2021 put the final exclamation point on a truly outstanding and transformational year for Quidel," said Douglas Bryant, President and Chief Executive Officer of Quidel. "From the opening of our largest American immunoassay manufacturing facility to date in just nine months, to shipping nearly 77 million total rapid immunoassay tests in the quarter, to announcing our definitive agreement to acquire Ortho Clinical Diagnostics Holdings plc ("Ortho"), Quidel emerged from a challenging year with the strongest portfolio of physical, financial, and intellectual assets in our history. Quidel has never been more capable, more consequential or more committed than we are today – which only fuels our confidence for the successes ahead."

Mr. Bryant added, "We’ve always believed that rapid tests are critical for both peace of mind and improved public health. That’s why we never wavered in our drive to maximize test development and manufacturing capacity, which proved to be the right decision with the rise of both Delta and Omicron variants. In the fourth quarter of 2021, we sold approximately 65 million QuickVue® COVID-19 antigen tests and over 4 million Sofia® SARS antigen tests – the highest quarterly sales volume for tests for Quidel. We continue to work diligently to meet demand from government, retail, employers and distributors for our QuickVue At-Home OTC COVID-19 test. We’ve also expanded our installed base of Sofia analyzers to over 76,000 instrument placements, further broadening our footprint at the point of care and increasing opportunities in the professional setting to introduce our full portfolio of assays to patients and providers."

Quidel to Present at 40th Annual J.P. Morgan Healthcare Conference

Quidel will present at the 40th Annual J.P. Morgan Healthcare Conference to be held virtually on Wednesday, January 12, 2022.

Douglas Bryant will present that day at 1:30 p.m. Eastern time (10:30 a.m. Pacific time) with a question-and-answer session scheduled immediately following the presentation. During the presentation, Quidel will discuss business and financial developments and trends. Quidel's statements may contain or constitute material information that has not been previously disclosed.

A live webcast and audio archive of the presentation will be available via the Investor Relations section of Quidel’s Web site at https://ir.quidel.com, or by clicking on the link below:

https://jpmorgan.metameetings.net/events/healthcare22/sessions/40551-quidel-corporation/webcast?gpu_only=true&kiosk=true

Participants should allow approximately five to ten minutes prior to the presentation's start time to visit the site and download any streaming media software needed to listen to the Internet webcast. A replay of the webcast will also be available on Quidel’s Web site for 14 days.

https://finance.yahoo.com/news/quidel-announces-preliminary-revenue-fourth-211000208.html