UChicago Medicine and UIC researchers to study expanded access to rapid COVID-19 testing

Researchers at the University of Chicago Medicine and the University of Illinois at Chicago (UIC) are launching an investigational study to determine the effects of increased education and access to rapid, FDA-approved COVID-19 testing on community perceptions, access, and use of COVID-19 testing resources.

The study will be funded by $2M in support from the National Institutes for Health RADx-UP program. A part of the Rapid Acceleration of Diagnostics (RADx) initiative, the RADx Underserved Populations (RADx-UP) program supports research that aims to better understand COVID-19 testing patterns among underserved and vulnerable populations; strengthen the data on disparities in infection rates, disease progression and outcomes; and develop strategies to reduce the disparities in COVID-19 testing.

The research will be led by Ayman Al-Hendy, MD, professor of obstetrics and gynecology at UChicago Medicine, and Renee Taylor, PhD, professor of occupational therapy and Nahed Ismail MD, PhD, D(ABMM), D(ABMLI), professor of pathology and medical director of clinical microbiology at the University of Illinois at Chicago. The investigators plan to leverage existing university-community partnerships and expertise in clinical microbiology, community engagement, and epidemiological infrastructures to expand access to rapid COVID-19 testing.

“There are testing deserts in Chicago, where many people don’t have easy or affordable access to testing,” said Taylor. “We can reach individuals who maybe don’t have health insurance or are concerned about having a COVID-19 test on their medical record and provide them with an easy and private opportunity to get tested.”

The project includes collaboration with community members to co-create advertisements to recruit other participants into the trial as well as a mobile health web app, called the mHealth Literacy and Outreach Suite, that will allow individuals to not only privately order testing, but also learn how to prevent the spread of COVID-19 and care for themselves if they fall ill.

Investigators are also sending out kits so participants can collect their own samples and send them to be tested at UIC. Sample collection can be performed rapidly at home with a nasal swab, without the discomfort of the typical nasopharyngeal swab, before sending the sample to the central lab for testing.

The team hopes that the privacy offered by these options, as well as the community advocacy, will help improve the public perception of receiving a COVID-19 test.

“Many people don’t trust the test, are concerned about the expense, or are worried that they’ll be forced out of work or forced to isolate if they have a positive test, which is creating a lot of stigma,” said Ismail. “We need to expand our testing in a community setting where people have some privacy, and the mHealth Suite provides that, as well as overcoming issues of cost.”

Al-Hendy credits the skills of the interdisciplinary team and their pooled community networks for making this collaborative effort possible. “The collaboration between UIC and UChicago Medicine will allow this project to reach many underserved populations,” he said. “Our two institutions already both have robust relationships within our local communities, which will help expand the

Read more

A Rapid Virus Test Falters in People Without Symptoms, Study Finds

Mr. Bryant, of Quidel, who received an early copy of the University of Arizona study, praised the results as “very, very good,” citing the Sofia’s ability to root out “people who are infectious.”

Quidel, which is running several studies of its own, does not yet have definitive results that show the Sofia works in people without Covid-19 symptoms. But “based on the data so far, it seems to be applicable to that population,” Mr. Bryant said of his company’s results.

Other experts advised caution.

Although C.T. values do tend to increase as virus levels diminish, exceptions to this trend exist — and there is no universal “magic-number cutoff” for infectiousness, Dr. Dien Bard said.

Failing to grow the coronavirus out of a person’s sample also does not guarantee that individual is not contagious to others, said Omai Garner, the associate director of clinical microbiology in the UCLA Health System, who was not involved in the study.

Several experts noted that the University of Arizona study did not track transmission among its participants, making it impossible to draw conclusions about how, and from whom, the virus spread.

Dr. Harris said that some of the concerns about the Sofia’s accuracy could be overcome with repeat testing. Screened frequently enough with a rapid test, infected people missed by one Sofia would probably be detected with the next, especially if the levels of virus in their bodies were rising, Dr. Harris said. He and his colleagues are now gathering data on University of Arizona athletes, who are tested daily, to investigate this possibility. Quidel has also partnered with the Pac-12 and Big Ten Conferences to conduct daily tests.

People with symptoms or known exposures to the coronavirus should still get the most precise and reliable tests available — those that use P.C.R., said Susan Butler-Wu, a clinical microbiologist at the University of Southern California who was not involved in the study. More data, she added, would be needed to figure out how rapid tests fit into the larger diagnostic landscape.

Source Article

Read more

Doubts over ‘rapid turnaround’ Covid tests pledged by Johnson

The “rapid turnaround” coronavirus tests the prime minister announced on Saturday are not approved for the public to interpret themselves without an expert’s help and so will not provide results in the promised 15 minutes, the Guardian has learned.



Boris Johnson wearing a suit and tie: Photograph: WPA/Getty Images


© Provided by The Guardian
Photograph: WPA/Getty Images

Boris Johnson’s briefing about this week’s national lockdown in England included the promise of a mass rollout of “tests that you can use yourself to tell whether or not you are infectious and get the result within 10 to 15 minutes”, which would be made available at universities and across whole cities.

He said the army would be deployed to roll out the “many millions of cheap, reliable and above all rapid turnaround tests” everywhere they were needed.

Three of these rapid antigen tests, called lateral flow tests, have passed an assessment by Porton Down with Oxford University. The government has bought one of them. The health secretary, Matt Hancock, announced the government had signed a deal for 20 million, from the company Innova Tried and Tested, on 19 October.

But the Innova tests are not for people without symptoms, such as university students or people wanting to get on a plane or go to the theatre. They are designed for people who already have Covid symptoms. And the devices, which look like a pregnancy test, are intended to be read by a healthcare professional.

The company is clear about their limitations on the instructions for use, which can be found on its website. The tests analyse throat and nose swabs “from individuals who are suspected of Covid-19 by their healthcare provider, within the first five days of the onset of symptoms”. The test is designed for use by trained lab and healthcare staff, it says.



Boris Johnson wearing a suit and tie: Boris Johnson announced the promise of a mass rollout of the tests, to be made available at universities and across cities.


© Photograph: WPA/Getty Images
Boris Johnson announced the promise of a mass rollout of the tests, to be made available at universities and across cities.

Johnson hopes the tests will help show the way out of the pandemic. They will be deployed in a wide range of situations, he said, “from helping women to have their partners with them in labour wards when they’re giving birth, to testing whole towns and even whole cities.

“The army has been brought in to work on the logistics and the programme will begin in a matter of days, working with local communities, local government, public health directors and organisations of all kinds to help people discover whether or not they are infectious, and then immediately to get them to self-isolate and to stop the spread.”

Prof Jon Deeks from Birmingham University and a member of a working group of the Royal Statistical Society, which is looking at coronavirus tests, said they were not ready for this type of use.

“At the moment, if you were bought this test, you would not be using it for this purpose,” he told the Guardian.

Lateral flow tests are now being offered to students at two universities – Durham and De Montfort – in

Read more

Organised ‘overkill’: China shows off rapid lockdown system after latest outbreak

BEIJING (Reuters) – Days after a 17-year-old girl tested positive for COVID-19 in a remote part of western China last week, health authorities said they had tested over 4.7 million people in the region.

FILE PHOTO: Chinese Foreign Ministry spokesman Wang Wenbin speaks during a news conference in Beijing, China July 27, 2020. REUTERS/Tingshu Wang

China’s strict formula of immediate lockdowns and mass testing even at the first signs of infection has been vital to its success in controlling the disease, allowing its economy to quickly recover from the crisis, officials say.

The highly orchestrated strategy – described as “overkill” even by its own proponents – is unique among major economies at a time when Europe and the United States are facing a massive surge of new cases and often chaotic policies.

At the time the girl was diagnosed, the Kashgar region of Xinjiang had reported no new cases for almost 70 days.

“China has taken the most comprehensive, strictest and most thorough control and prevention measures since the COVID-19 pandemic started,” foreign ministry spokesman Wang Wenbin said on Wednesday.

“The facts show China’s measures are effective.”

Key to the programme are factors unique to China, including the Communist Party’s tight grip on all aspects of society.

Authorities have unimpeded access to personal information as part of an expansive surveillance network, which has played a major role in tracing infections.

The government has also quickly enlisted the help of businesses, which are churning out tens of millions of test kits, and tightly controls their pricing and distribution, issues which have severely set back efforts to contain the disease in other countries.

China has reported just 2,382 cases since June. By contrast, Germany and France are set to follow Italy and Spain back into partial lockdowns, as Europe reported a record 230,000 cases in one day earlier this week, while U.S. cases are set to hit 9 million soon.

MASS TESTINGS

In August, Beijing ordered all major hospitals in the country to offer testing, and said there should be one urban testing base constructed for every million residents, with the capacity to scale up to 30,000 tests a day in a local outbreak.

Regions are also required to share resources, in sharp contrast to the early days of the outbreak, when several cities were accused of stealing equipment from each other.

The system, like all Chinese Communist blueprints, is highly structured around specific targets; testing teams should be able to complete a campaign within seven days.

Earlier this month, almost 11 million test results were delivered in around five days in the eastern port city of Qingdao. In Wuhan, the initial epicentre of the pandemic, over 9 million samples were taken over 10 days in May.

The mass testings are mandatory. Some are held in outdoor sporting venues and city parks, with hundreds of people lining up.

PUTTING PEOPLE AT EASE

Epidemiologists have called into question the efficacy of the mass testing events, noting some patients require multiple tests over time

Read more

Georgia infections show sharper rise if rapid tests included

ATLANTA (AP) — COVID-19 infections are rising more rapidly in Georgia, in line with a national trend of increasing cases.

The broadest measure of COVID-19 cases, which includes rapid antigen tests as well as the more precise genetic tests, shows the number of confirmed and probable cases was 18% higher in the week that ended Friday compared to the week before, according to a report issued Monday by the Georgia Department of Public Health.

The state recorded 10,086 genetic positives and 2,564 antigen positives last week, tipping Georgia back above 100 weekly cases per 100,000 people, one measure of rapid spread.


Georgia still remains far off its July peaks, when it was averaging 3,700 cases per day, worst in the nation at the time. Because the respiratory illness is now spreading so rapidly in other regions, Georgia ranks only 34th among the states, according to numbers tracked by The Associated Press. Many more cases, per capita, are being recorded in some Midwestern and Western states.

The share of positive genetic tests has risen above 7% statewide in Georgia from a low of 5.5% as late as Oct. 15, suggesting more rapid spread in communities. Experts say that if more than 5% of tests are coming back positive, it suggests that too few tests are being done and many infections may be going undetected.

Public Health Commissioner Kathleen Toomey said earlier this month that the state was planning to include positive rapid antigen tests in its daily report, but has not yet done so. Many other states count those tests no differently than genetic tests, but Georgia officials said they’re worried about the higher rate of false results on the antigen tests.

Despite those concerns, the state publishes antigen numbers in once-weekly county-level reports that are issued on Mondays.

But even just counting genetic tests, the rise in cases in Georgia is increasingly clear. The state’s seven-day daily average of positive tests is up 30% since hitting a low on Oct. 8, according to AP numbers. The seven-day average of hospitalizations is up 7% since hitting a low on Oct. 12.

Deaths, which usually lag behind hospitalizations, have mounted more slowly in recent days. Georgia has recorded 7,827 confirmed deaths from COVID-19 and more than 326,000 cases confirmed through genetic tests. While most people who contract the coronavirus recover after suffering only mild to moderate symptoms, it can be deadly for older patients and those with other health problems.

The numbers are rising as millions of Georgians cast their votes for president and federal and state offices. Democrats have heavily criticized President Donald Trump and Gov. Brian Kemp, both Republicans, for their actions during the pandemic. Kemp has said he’s striking the right balance between health and making sure restrictions don’t choke off economic growth.

Public health officials count 39 high transmission counties, with a group in northwest Georgia that includes the Carrollton, Cartersville, Rome and Dalton areas, parts of rural northeast Georgia north of Athens, and a belt running east

Read more

New rapid tests a ‘game changer’ against COVID

GENEVA (AP) — Health officials in Africa say the rollout of rapid diagnostic tests for COVID-19 could be a “game changer” for their fight against the coronavirus but also warned Thursday that increased testing could drive up confirmed cases on a continent that has seen them decline or plateauing as case numbers soar in the West.

Some experts worry that Africa so far has lacked the ability to test widely enough, especially in hard-to-reach rural areas, and that its case counts therefore don’t reflect reality and impede tracking the virus.

“African countries are gearing up to introduce antigen-based rapid diagnostic tests on a large scale, and this will be a game changer, we think, in the fight against COVID-19,” Dr. Matshidiso Moeti, the World Health Organization’s regional director for Africa, said. “These high-quality rapid tests will help meet the huge unmet need for testing in Africa.”

Speaking from Brazzaville, Congo, at an online news conference, Moeti noted that WHO Africa region comprising sub-Saharan Africa plus Algeria – has seen a downward trend from a daily average of more than 15,000 cases in July to less than 4,000 in the past month -– prompting some governments to pull back from their toughest containment measures.

“As countries ease restrictions on movement, some increase in cases is expected, but preventing an exponential rise is absolutely critical,” she said.


From early on in the pandemic, officials at WHO headquarters in Geneva, including the U.N. health agency’s Ethiopian director-general, Tedros Adhanom Ghebreyesus, have expressed concerns that COVID-19 could have a big impact on weaker health systems like those in Africa.

However, developed countries with world-class health systems so far have been among the ones hardest hit by virus outbreaks. WHO’s 54-nation European region tallied 927,000 cases in its latest weekly count, a new record high.

Dr. Susan Ndidde Nabadda, head of the Ugandan National Health Laboratory Services and Central Public Health Laboratory, suggested that it could take some time to ensure proper authorizations and a high-quality process before rapid diagnostic tests on a broader scale because “there is no longer really a lot of emergency” in Africa.

Nabadda cited reports indicating that the identification of COVID-19 cases increased in Guinea once the west African country started rolling out the RDTs, noting that “we might see more numbers coming on board” as the tests are deployed more widely.

She said the relative lack of testing in Africa could be one of the reasons why African case counts were lower than in developed countries.

WHO announced last month that it and leading partners have agreed on a plan to roll out 120 million rapid diagnostic tests for COVID-19 to help lower- and middle-income countries make up ground in a testing gap with richer countries.

The antigen-based rapid diagnostic tests for which WHO issued an emergency use listing are intended to provide better testing access to areas where it is harder to distribute the PCR tests often in many wealthier nations.

The rapid tests look for antigens, or

Read more

Covid cases increase across US as upper midwest sees rapid rise

Covid-19 cases are increasing across the United States and surging in the upper midwest, in what appears to be a third pandemic peak. In North Dakota, cases are increasing at a higher and faster rate per capita than in any other state throughout the pandemic so far.



a group of people performing on a counter in a store: Photograph: Bing Guan/Reuters


© Provided by The Guardian
Photograph: Bing Guan/Reuters

Experts have long predicted cooler weather and pandemic fatigue would increase the spread of Covid-19 this fall. That now appears to be coming to pass, coupled with the longer and higher levels of death and disease the US has seen throughout the pandemic compared to peer countries.



a group of people performing on a counter in a store: Jake’s Deli in Milwaukee, Wisconsin. Widespread distribution of an approved vaccine is unlikely to take place before the middle or third quarter of next year.


© Photograph: Bing Guan/Reuters
Jake’s Deli in Milwaukee, Wisconsin. Widespread distribution of an approved vaccine is unlikely to take place before the middle or third quarter of next year.

Related: Republican senator ‘personally benefited from tax change he sought’

“Everyone who knew anything about infectious disease and epidemiology predicted this six to eight months ago,” said Dr Ezekiel Emanuel, vice-provost for global initiatives at the Perelman School of Medicine at the University of Pennsylvania.

“Yes, it will surge in the fall, and the reason it will surge is because we are moving indoors,” said Emanuel. “Our surge is much higher than the surges in general,” he said, because the US has started, “from a higher baseline”.

Surges are especially pronounced in Montana, North Dakota and South Dakota, according to the Covid Tracking Project, but states from Wisconsin to Kentucky to Massachusetts are also seeing the curve bend upwards.

Last week, the Democratic governor of Wisconsin, Tony Evers, activated a field hospital on state fairgrounds to expand treatment capacity. Kentucky’s Democratic governor, Andy Beshear, called increasing cases “grim” and said officials were now revisiting surge plans made last spring.

“We are now going back to our plans about capacity in hospitals, looking if we have to at hotel options and the use of state parks,” Beshear said during a press briefing. “Ensuring that we have the operational plans to stand up the field hospital, if necessary.”

In Massachusetts, Boston’s mayor, Marty Walsh, said children would return to virtual learning until the city’s positivity rate – the percentage of all Covid tests that come back positive – decreased for two weeks in a row.

But far and away North Dakota leads in increasing Covid-19. The state has the highest per-capita rate of Covid-19 infections anywhere in the nation, at 1,350 cases per 1 million residents. That is nearly double the rate of the second hardest-hit state, Wisconsin, where there are 805 new cases per 1 million residents.

Video: Pandemic Caused ‘A Lot of Consumer-Driven Innovation’: Harvard’s Herzlinger (Bloomberg)

Pandemic Caused ‘A Lot of Consumer-Driven Innovation’: Harvard’s Herzlinger

UP NEXT

UP NEXT

Nearly three weeks ago, the state loosened public health guidance, telling residents they no longer needed to

Read more

Primo Nutraceuticals Inc. signs a Memorandum of Understanding for Exclusive Rights to Sell Rapid (Colloidal Gold Method) COVID-19 Test Kits in Canada

COVID-19 Test Kits

COVID-19 Test Kits
COVID-19 Test Kits
COVID-19 Test Kits

VANCOUVER, British Columbia, Oct. 21, 2020 (GLOBE NEWSWIRE) — PRIMO NUTRACEUTICALS INC. (CSE: PRMO) (OTC: BUGVF ) (FSE: 8BV) (DEU: 8BV) (MUN: 8BV) (STU: 8BV) (” PRIMO ” or the “Company”) announces the signing of a Memorandum of Understanding (MOU) with Neo-Nostics (Suzhou) Bioengineering Co. Ltd. Of Su Zhou City, China (“Neo-Nostics”) as the official trade representative for Neo-Nostics ™ with the exclusive rights to apply for licensing and to market and sell the following COVID-19 production Canada: Neo-Nostics 2019-nCoV IgG/IgM Rapid Test Kit (Colloidal Gold Method) (Test Kit).

The Memorandum of Understanding between Primo and Neo-Nostics ™, is effective as of October 13, 2020. Upon successfully receiving product license and approval by Health Canada, Neo-Nostics ™ will grant Primo with “Official Dealer/Distributor Status” in Canada.

The Neo-Nostics 2019-nCoV IgG/IgM Rapid Testing Kit is currently registered with the FDA. Primo will be submitting the application for approval to Health Canada immediately. Neo-Nostics ™ has committed to supporting Primo’s efforts to obtain and maintain all necessary certifications and approvals for the sale and marketing of the Test Kits in Canada by granting access to all necessary documentation and clinical studies concerning the Test Kits.

Follow the link for a video demonstration: http://www.neo-nostics.com/skin/images/mp40.mp4

About the Neo-NosticsRapid Test Kits

The Neo-Nostics 2019-nCoV Antibody Detection Reagent Kit (Colloidal Gold Method) has the advantage of rapidity, convenience, high accuracy, and can make up for the shortcomings of professional requirements, time consumption and low positive detection rate of PCR nucleic acid detection, and can be used as an important supplementary detection method for the diagnosis of coronal pneumonia.

Through detection and calculation, it is found that the comprehensive accuracy rate of the Neo-Nostics2019-nCoV IgM Detection Reagent is higher than 95%.

During the worst period of the epidemic in China, the reagent kit was donated to hospitals and the CDC in the most severely infected areas of Hubei for clinical auxiliary diagnosis. At present, the verification reports made by three clinical units prove that the positive detection rate of clinically confirmed cases has reached 92%, which has exceeded the general detection effect. Not only negative or positive results can be detected, but also the early, middle and or recovery period of virus infection can be distinguished by the positive strength of IgM or IgG.
Source: Clinical study report conducted by the Institute of Virology, in the capital city of Hubei, China and The Chinese Academy of Sciences in Beijing, China.

DISCLAIMER: “The Company is not making any express or implied claims that it has the ability to eliminate, cure or contain the Covid-19 (or SARS-2 Coronavirus) at this time”.

Clinical Applications of Reagents

This reagent has been used by professionals in China since February 2020 in an area that was the hardest hit and impacted most severely by COVID-19, in the form of clinical auxiliary diagnosis.

The reagent kit was clinically verified by several professionals, hospitals, and universities

Read more

US is nearing ‘rapid acceleration’ of Covid-19 cases, expert warns, as daily infections top 60,000

A leading health expert says US Covid-19 cases will begin to rapidly accelerate in a week as the country topped 60,000 new infections Tuesday — triple what the daily average was back in June, when restrictions had begun to ease.



a car parked in a parking lot: People in cars wait in line for Covid-19 testing in Reading, Pennsylvania, on Tuesday morning, October 13.


© Ben Hasty/MediaNews Group/Reading Eagle/Getty Images
People in cars wait in line for Covid-19 testing in Reading, Pennsylvania, on Tuesday morning, October 13.

The prediction comes after several state leaders reimposed some measures to help curb the spread of the virus, fueled by small gatherings increasingly moving indoors with the colder weather, as well as other factors such as college and school reopenings. The national seven-day case average has increased at least 18% since the previous week and is now a staggering 61% higher than what it was five weeks ago. And as multiple experts have warned, things will likely get worse before they get better.

“It’s going to be a difficult fall and winter,” Dr. Scott Gottlieb, former commissioner of the US Food and Drug Administration, told CNBC Monday. “I think we’re about two or three weeks behind Europe — so we’re about a week away from starting to enter a period where we’re going to see a rapid acceleration in cases.”

The difference is many European countries were able to suppress their numbers of new cases over the summer, but the US entered the fall season with a relatively high baseline average of new infections — something experts warned wouldn’t help in containing another surge of cases. Dr. Anthony Fauci said earlier this week European Union countries were able to bring their baseline down because of strict and stringent lockdowns, adding the US did not “shut down nearly as much as our colleagues in Italy and Spain.”

Ahead of bleak outlooks of the coming weeks, hospitalizations in the US have also began to rise, with more than 39,000 Covid-19 patients nationwide, according to the COVID Tracking Project.

“We’re seeing hospitalizations go up in 42 states right now, cases are going up in 45 states, and there really is no backstop,” Gottlieb said. “This fall and winter season is when the coronavirus is going to want to spread.”

‘Get ready:’ 70,000 new infections daily

At least 26 US states are reporting more new Covid-19 cases than the previous week, according to data from Johns Hopkins University. And no states are trending in the right direction, according to the data.

By next week or the week after that, the US could be recording up to 70,000 new cases daily, Dr. Peter Hotez, dean of the National School of Tropical Medicine at Baylor College of Medicine, said Tuesday. And the numbers could keep rising after that, he said.

“Look out for your mental health, because the normal response to this is people are going to get sad and upset, and maybe even depressed, so have access to mental health counseling,” Hotez said. “In other words, put those belts and suspenders in and get ready.”

Video: Infectious diseases expert blasts

Read more