COVID-19 Tests | Wish List

Posts: 1537
Joined: Fri Jun 26, 2020 5:22 am

Re: COVID-19 Tests | Wish List

Post by trader32176 »

3D printed nanoparticle biosensing platform detects SARS-CoV-2 antibodies within seconds

9/14/20 ... conds.aspx

Pandemics caused by novel infectious agents like the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), Zika, or Ebola virus seriously impact human health and lives while also overwhelming health care systems all over the world. Early detection and diagnosis allow isolation of the infected patients and contact tracing, which can mitigate the spread of the virus and save lives, especially when a significant number of the patients are asymptomatic.

Current methods used in SARS-CoV-2 detection

Developing low-cost and rapid testing methods for early detection of infection has always been a challenge while dealing with the current COVID-19 pandemic. Presently, two approaches are being used for the detection of COVID-19 infection.

The first one detects the viral genome and uses techniques such as genomic sequencing, CRISPR, and reverse transcription real-time quantitative polymerase chain reaction (PCR). While these methods are relatively accurate, they are slow because there are multiple steps involved in sample processing, and the samples need to be shipped to a laboratory for testing. The accuracy of these methods is also affected by the high mutation rate in the viral genome.

A second approach involves the detection of antibodies specific to the viral antigens using serological methods such as lateral flow immunoassay and enzyme-linked immunosorbent assay (ELISA). These assays have a long sample preparation time (0.5-2 hrs) and are based on structural proteins like the nucleocapsid protein (N-protein) or the spike protein (S-protein). Their sensitivity is relatively low, and false-positive rates are about 5-11%.

The shortfalls of both testing methods show that there is an urgent need for the development of a faster, more sensitive, and specific assay for the detection of SARS-CoV-2 infection.

The authors say, “Hence, there is an urgent need to develop a sensitive and specific assay for rapid detection of SARS-CoV-2 infection within minutes or if possible, seconds; ideally within days of infection, which could particularly be useful for medically underserved areas if a smartphone enables the readout.”

A New Rapid Testing Platform

In a paper published on the preprint server medRxiv*, researchers from the Carnegie Mellon University and University of Pittsburgh School of Medicine discuss a newly developed 3D printed biosensing platform called the 3DcC that can sense SARS-CoV-2 antibodies within seconds.

The platform was developed by using aerosol jet nanoparticle 3D printing method to produce gold micropillar array electrodes, which was followed by functionalization of rGO and antigen immobilization on the electrode surface with the help of an EDC: NHS chemistry.

The device is capable of detecting antibodies produced against the S1 protein and receptor-binding-domain (RBD) of SARS-CoV-2 at very low concentrations (1pM) using electrochemical impedance spectroscopy. The results can be read on a smartphone-based user interface. Moreover, the sensor used in the device can be regenerated in under a minute at a low-pH that elutes the antigens from the antibodies. This allows using the same sensor to test multiple samples. In this work, two antibodies were tested within 11.5 seconds.

Significance of this biosensing platform

In electrochemical sensing, the antibody-antigen complex is detected through electrochemical transduction. The specificity, sensitivity, and speed of detection depend on the electrochemical cell, the surface chemistry of the electrodes, the antigen, and the type of assay.

This work aimed at utilizing advanced techniques such as nanoparticle 3D printing for microelectronic fabrication and using electrochemical transduction in the rapid detection of COVID-19 antibodies. Combined with a regeneration capability and smartphone-supported design, the new platform offers a rapid, hi-tech, and much-needed solution to early diagnosis of COVID-19.

The signal obtained using this device was very selective and repeatable. Antibodies produced against spike S1 and RBD viral antigens were detected at concentrations as low as 1 pM and 1 fM, respectively. The regeneration of the sensor in less than a minute allowed up to 10 successive, accurate readings using the same sensor.

“These results are highly encouraging and a device for field use, after appropriate human trials, will have a significant positive impact on public health and the course of the current as well as future pandemics.”, write the authors.

This biosensing system will make rapid detection and early diagnosis possible, thus saving lives. Moreover, as this platform is generic, it can find more uses in detecting biomarkers specific to a variety of other pathogens such as HIV, Ebola, and Zika, which makes it a significant advancement in biotechnology that has a very positive impact on public health.
Posts: 1537
Joined: Fri Jun 26, 2020 5:22 am

Re: COVID-19 Tests | Wish List

Post by trader32176 »

Lack of antigen test reporting leaves country ‘blind to the pandemic’

9/16/20 ... 28099.aspx

More than 20 states either don't release or have incomplete data on the rapid antigen tests now considered key to containing the coronavirus, which has sickened more than 6 million Americans. The lapses leave officials and the public in the dark about the true scope of the pandemic as untold numbers of cases go uncounted.

The gap will only widen as tens of millions of antigen tests sweep the country. Federal officials are prioritizing the tests to quickly detect COVID-19's spread over slower, but more accurate, PCR tests.

Relying on patchy data on COVID testing carries enormous consequences as officials decide whether to reopen schools and businesses: Go back to normal too quickly and risk even greater outbreaks of disease. Keep people at home too long and risk an even greater economic crisis.

"The absence of information is a very dangerous thing," said Janet Hamilton, executive director of the Council for State and Territorial Epidemiologists, which represents public health officials. "We will be blind to the pandemic. It will be happening around us and we will have no data."

The states that don't report antigen test results or don't count antigen positives as COVID cases are California, Colorado, Georgia, Illinois, Maryland, Minnesota, Missouri, Montana, New Hampshire, New Jersey, North Carolina, North Dakota, Ohio, Pennsylvania, South Dakota, Tennessee, Texas, Vermont, Virginia, Washington, Wisconsin and Wyoming, as well as the District of Columbia.

So far, most of the COVID tests given in the U.S. have been PCR tests, which are processed in medical labs and can take days to return results. By contrast, antigen tests offer results in minutes outside of labs, appealing to everyone from medical clinics to sports teams and universities.

Each relies on swabs to test patients. But unlike using tests run through labs, many providers who would use antigen tests don't have an easy way to send data electronically to public health authorities.

Since July, though, the federal government has pushed roughly 5 million antigen tests into nearly 14,000 nursing homes to contain outbreaks among staff members and residents. The Department of Health and Human Services also awarded a $760 million contract to buy 150 million rapid antigen tests from Abbott, the Illinois-based diagnostics behemoth. It plans to send 750,000 of those to nursing homes starting this week, Brett Giroir, the HHS official heading the Trump administration's testing efforts, told industry executives on Sept. 8. Federal officials have not elaborated on how many tests will be sent elsewhere but have suggested many will go to governors to distribute as schools reopen.

The rush of antigen tests, however, won't be particularly useful to officials if the results are not publicly and uniformly reported.

KHN surveyed 50 states and the District of Columbia on their collection of antigen test results and what is reported publicly. Forty-eight responded between Sept. 3 and 10, revealing significant variation over whether people who test positive for COVID-19 with an antigen test are counted as cases and whether states even publicly report antigen data in their testing numbers:

21 states and D.C. do not report all antigen test results.
15 states and D.C. do not count positive results from antigen tests as COVID cases.
Two states do not require antigen test providers to report results, and five others require only positive results to be reported.
Nearly half of states believe their antigen test results are underreported.

Consequently, many state counts of infected people could be artificially low. For instance, the lack of reporting could imply infection rates are declining because the virus isn't spreading as widely — when really more antigen tests are being used and not counted, public health officials and experts say.

"It's going to look like your cases are coming down when they're not," said Jeffrey Morris, a biostatistics professor at the University of Pennsylvania.

HHS recognizes that antigen tests are underreported but maintained that officials are not missing the full scale of the pandemic, an agency spokesperson said.

"There is sufficient testing to achieve all objectives outlined in the testing strategy, including identifying newly emergent outbreaks, supporting public health isolation and contact tracing, protecting the vulnerable, supporting safe reopening of schools and businesses, and enabling state testing plans," spokesperson Mia Heck said.

Part of the problem on antigen test reporting stems from what counts as a COVID case. Guidance from the Centers for Disease Control and Prevention defines a "confirmed" COVID case as one that is determined from a PCR test. Positive results from antigen tests are considered "probable" cases because the tests can be less accurate.

Months after the first COVID antigen test received emergency authorization from the Food and Drug Administration, the CDC revised its COVID case definition in early August to allow a positive antigen test to count as a probable case without assessing whether a person had clinical symptoms or was in close contact with a confirmed infected person.

That prompted many states — including Arkansas, starting Sept. 2 — to adjust how they report cases.

"It's easy for people to think since we use the word 'probable' that maybe it's a case, maybe it isn't. But that's not how we think of it," said Dr. Jennifer Dillaha, medical director for the Arkansas Department of Health. "It is a real case in the same way that a PCR is a real case."

Dr. Karen Landers, an assistant state health officer for the Alabama Department of Public Health, said her biggest concern was the potential undercounting of antigen test results as they continue to grow in popularity. While the state has been trying to work with each urgent care or other medical provider, some struggle to submit the results.

"We can't afford to miss a case," she said.

The CARES Act, which Congress passed in March, requires a broad range of health care providers to report any COVID test result to state or local health departments. Nonetheless, two states — Montana and New Jersey — said they weren't requiring antigen test providers to report results, positive or negative. Colorado, Maine, Mississippi, New Hampshire and Wyoming require only positive results to be reported, which can distort the positivity rate.

Sara Mendez, the support services manager for the Brazos County Health Department in Texas, said the department saw an increase of antigen tests being administered as Texas A&M University students returned. Even though the state health department was not including positive COVID cases from antigen tests in its public reports, the local health department felt obligated to do so.

"A lot of the college students will just go and get those done as opposed to the PCR tests," Mendez said, "so we felt like we were missing out."

Indiana University undertook a massive antigen testing operation for students living on campus in August, administering 14,870 antigen tests across four campuses through drive-thrus, according to Graham McKeen, an assistant university director for public health. The test results were delivered while students waited in cars for about 30 minutes, with 159 coming back positive. Each night, a university staff member would manually download the spreadsheet off each of the test machines and securely email it to the state health department.

But Indiana began reporting antigen testing only on Aug. 24, adding over 16,000 antigen tests into its public dashboard that day and saying in a news release that it plans to retroactively add in earlier antigen testing figures.

McKeen said that, even though the state is now reporting some antigen data, tests are still missed under the cumbersome reporting system. The state said some of the data is being sent by fax.

"It doesn't give the community a good handle on the infection in the community," McKeen said.

Heck, the HHS spokesperson, said that federal agencies are working to improve the reporting of results and that problems were likely to be eased in the future, citing that Abbott's antigen test includes an electronic reader for automated reporting. By October, 48 million of those tests will be in circulation each month, she said.

Still, to date, "what this is exposing is the antiquated systems that public health agencies have had for years," said Scott Becker, executive director of the Association of Public Health Laboratories. "So much of the data we've gotten is incomplete."

That data barrier is playing out in nursing homes as well.

Victoria Crenshaw is holding off on using antigen tests to screen residents and staff members at Westminster Canterbury on Chesapeake Bay nursing home in Virginia Beach, Virginia. As senior director, she sees one major holdup: No technology platform is in place to easily send results to health officials. Instead, she and colleagues would need to resort to taping pieces of paper together to deliver details of who was tested, and hope local officials would accept it.

The Trump administration is pushing for nursing homes to use the tests for required screenings at least once a month and as often as twice a week. Under new federal regulations, nursing homes that don't comply with regular testing and reporting requirements are subject to citations or fines.

"We have no technology today to submit this information," Crenshaw said, "which leaves us in a vulnerable position."
Posts: 1537
Joined: Fri Jun 26, 2020 5:22 am

Re: COVID-19 Tests | Wish List

Post by trader32176 »

Study: 90-minute COVID-19 test has high sensitivity and specificity

9/18/20 ... icity.aspx

A 90-minute COVID-19 test has been shown to have over 94 per cent sensitivity, and 100 per cent specificity in a new study.

The work, published in the journal The Lancet Microbe, was ledby scientists from Imperial College London.

In the research, the high-speed tests, which do not require a laboratory and can be performed in cartridges smaller than a mobile phone, were used on 386 NHS staff and patients.

The Lab-in-Cartridge rapid testing device, which can be performed at a patient's bedside, was shown to have over 94% sensitivity and 100% specificity, which meant it had a high level of accuracy and produced very few false negatives and no false positives.

The test is currently being used successfully across eight London hospitals, and due to be rolled out at a national level, and data continues to be gathered from the testing device for continual assessment. The UK government recently placed an order for 5.8 million of the testing kits.

To perform the test, a paediatric-sized nose swab from a patient is inserted into the device, which then looks for traces of genetic material belonging to the SARS-CoV-2 virus, which causes COVID-19.
A result is available within 90 minutes, compared to conventional COVID-19 testing which delivers a result in 24 hours. The test is now being developed for assessing simultaneously Flu-A, Flu-B, and RSV as well as COVID19.

" These results suggest the test, which can be performed at a patient's bedside without the need to handle any sample material, has comparable accuracy to standard laboratory testing. Many tests involve a trade-off between speed and accuracy, but this test manages to achieve both. Developing an effective bedside test in under three months has been an incredible collaboration between teams of engineers, clinicians and virologists."

-Graham Cooke, Study Lead Author and Professor, Department of Infectious Disease, Imperial College London

The device, produced by DnaNudge, an Imperial start-up headquartered in White City, was used on 280 NHS staff members with suspected COVID-19, 15 patients in A&E with suspected COVID-19, and 91 hospital in-patients (some of who were not displaying COVID-19 symptoms).

The samples from all individuals in the study were analysed on both the rapid-testing device, called the CovidNudge test, and standard hospital laboratory equipment - and then the results compared.

The research team, which included scientists and clinicians from Imperial, Imperial College Healthcare NHS Trust, DnaNudge,Chelsea & Westminster Hospital NHS Foundation Trust and Oxford University Hospitals NHS Trust, assessed sensitivity and specificity.

Sensitivity is a measure of how well a test gives a positive result for people who have disease, and is an indication of how likely a test will produce false negative results. Specificity, on the other hand, is a measure of a test's ability to give a negative result for a people who don't have the disease, and is an indication of the likelihood of false positive results.

The percentage of those found to be positive for COVID-19 was 18 per cent (the study was conducted in the peak of COVID-19). The results showed 67 samples tested positive on the CovidNudge test, compared with 71 positive results against a range of NHS standard laboratory machines,which represents the value of 94 per cent sensitivity.

The study was supported by the National Institute for Health Research Imperial Biomedical Research Centre.

Regius Professor Chris Toumazou, CEO and co-founder of DnaNudge and founder of theInstitute of Biomedical Engineeringat Imperial, said: "The DnaNudge test was developed as a lab-free, on-the-spot consumer service that can be delivered at scale,so we clearlybelieve it offers very significant potentialin terms ofmasspopulation testing during theCOVID-19 pandemic."

"The platform is well suited to testing in primary care and community settings with potential for use in non-healthcare settings such as care homes, schools, transport hubs, offices, and, to help bring the arts back, in theatres and venues. However, further studies of real-world effectiveness in non-clinical settings would be required prior to widespread deployment."

The research team add the device recently obtained a CE mark, enabling its additional use in non-clinical locations (it has been previously approved by the UK Medicines and Healthcare Regulatory Agency).
The team explain each device is wi-fi enabled, allowing the test result to be securely sent to a hospital's record system.

Testing for this study took place between 10th April and 12th May at three NHS sites: St Mary's Hospital, Imperial College Healthcare NHS Trust, London; Chelsea & Westminster Hospital NHS Foundation Trust, London and the John Radcliffe Hospital, Oxford University Hospitals NHS Foundation Trust, Oxford.

Dr Bob Klaber, director of strategy, research and innovation at Imperial College Healthcare NHS Trust said. "As an organisation we are focused on using research and innovation to continuously drive improvements to care.

It's been brilliant to work so closely with scientists, clinicians and innovators from DnaNudge, Imperial CollegeLondonand the Trust, alongside many of our patients and staff, to assess the practicality and validity of this exciting test.

Getting accurate results back to clinicians and their patients as quickly as possible makes a huge difference to how we safely manage clinical pathways and we are very much looking forward torolling this out more widely."
Posts: 1537
Joined: Fri Jun 26, 2020 5:22 am

Re: COVID-19 Tests | Wish List

Post by trader32176 »

New Canadian Covid-19 gargle test is "one of the first of its kind" in the world

9/18/20 ... index.html

Most children in British Columbia can now say goodbye to those icky swabs and uncomfortable Covid-19 tests as the province launches a new gargle method for students ages 4 to 19.

“It is one of the first of its kind around the world,” said Dr. Bonnie Henry, British Columbia's provincial health officer at a news conference Thursday.

The BC Centre for Disease Control said the new test is just as accurate as tests using a nasal swab and is much easier to administer for children.

“This is a new saline gargle where you put a little bit of normal saline, so sterile water, in your mouth and you swish it around a little bit and you spit it into a little tube and that’s an easier way to collect it for young people,” said Henry.

Public health officials in British Columbia say they compared test results in both children and adults and found the rate of Covid-19 detection was very similar between the nasal swab and the new gargle test.

British Columbia is prioritizing children for the new test but hopes to expand to adults in the coming weeks.

While the sample will still have to be taken to a lab for processing, the test does not have to be administered by a health care professional.

With the majority of students in Canada are now attending school in person, Covid-19 testing is in high demand as Canada has seen a doubling of new daily cases in the last month.
Posts: 1537
Joined: Fri Jun 26, 2020 5:22 am

Re: COVID-19 Tests | Wish List

Post by trader32176 »

Expanded screening of asymptomatic people could reduce COVID-19 infections and deaths

9/22/20 ... eaths.aspx

New research suggests when the COVID-19 pandemic is slowing, low-cost, recurring screening of asymptomatic people - at an expense of approximately $3 or less per test every two weeks - could decrease COVID-19 infections and deaths and be cost-effective. When the pandemic is surging, screening can be cost-effective when done more often, even if tests costs are higher. The report - led by researchers at Massachusetts General Hospital (MGH) - was recently published in Clinical Infectious Diseases.

COVID-19 testing refers generally to testing of people with symptoms of the illness, while screening refers to testing of individuals who do not have symptoms of the infection. In the United States, restricted testing capacity early in the pandemic led states such as Massachusetts to test only severely symptomatic people and those with a known exposure to someone with COVID-19. However, making COVID-19 testing available to all people with symptoms suggestive of the illness, as well as expanding to screening programs for the entire population - including those who are without symptoms - could reduce hospitalizations and deaths, allowing for safe resumption of economic and social activity.

" Massachusetts experienced a major COVID-19 outbreak beginning in March 2020, and while the outbreak is now under reasonably good control, questions remain about how to optimally deploy COVID testing, both in our current situation and in other settings - and communities - where new infections continue to rise. While some have argued testing must be highly sensitive to be of value, others suggest that sensitivity can be sacrificed if tests are rapid, low-cost, frequent and widely available."

- Anne Neilan, MD, MPH, Investigator, MGH Divisions of General Pediatrics and Infectious Diseases and the Medical Practice Evaluation Center

The study used a dynamic transmission model developed by members of the research team (the "CEACOV model") to analyze the outcomes anticipated from several different strategies for COVID-19 testing and screening for the entire population of Massachusetts, using laboratory-based polymerase chain reaction (PCR) tests. The PCR test uses a sample taken from the nose or mouth (usually a nasal swab or a saliva sample), which is then sent to a laboratory that tests for the virus causing COVID-19. The model-based analysis revealed that repeated screening of the entire population would lead to the most favorable clinical outcomes, preventing the greatest number of infections, hospitalizations, and, ultimately, deaths. This was true in a wide range of scenarios, ranging from decreasing to rapidly rising numbers of new cases per day. Such a screening strategy could also be cost-effective, depending on the cost of the test and the frequency of screening.

"Based on the prices that most laboratories are now charging for the PCR test, with our current levels of new COVID-19 cases in Massachusetts, the most cost-effective strategy remains testing only people with symptoms of COVID-19. Importantly, for Massachusetts as of now, this includes testing all people with symptoms, and not only people whose symptoms are severe," says study co-senior author Andrea Ciaranello, MD, MPH, investigator in the Division of Infectious Diseases at MGH. "However, in locations where cases are rising, regular screening of the entire population, while expensive, will actually be of very good value.

"Based on the prices that most laboratories are now charging for the PCR test, with our current levels of new COVID-19 cases in Massachusetts, the most cost-effective strategy remains testing only people with symptoms of COVID-19. Importantly, for Massachusetts as of now, this includes testing all people with symptoms, and not only people whose symptoms are severe," says study co-senior author Andrea Ciaranello, MD, MPH, investigator in the Division of Infectious Diseases at MGH. "However, in locations where cases are rising, regular screening of the entire population, while expensive, will actually be of very good value.

"When the pandemic is slowing, if testing costs can come down to $5 or less, repeat screening of people without COVID symptoms would decrease infections and deaths, and be cost-effective," adds Neilan. "Our data suggest that even now, expanding testing and screening capacity must remain a focus of national efforts." Because the study modeled the use of the laboratory-based PCR tests, the investigators did not evaluate the possible use of even less sensitive and less expensive tests, such as rapid tests used on-site at healthcare facilities (like urgent care locations), schools, or places of employment. Several such tests have been brought to market but are not yet widely available for use in these settings.

Adds Ciaranello, "It is important to note that these strategies involve repeated screening. Screening a group of people just one time, while an interesting snapshot, is an approach that will miss many people who will become able to infect others in the future. Because of this, we also found that screening just once was a less efficient use of healthcare resources under most circumstance than strategies using repeat testing."

"There is also a price to not being able to rapidly deploy testing," says Nielan. "Early in the pandemic, we struggled to provide testing even for people with symptoms of COVID-19. If expanded PCR testing had been widely available in Massachusetts from April to May 2020, our model suggests that more than 100,000 infections and approximately 100 deaths would have been averted during that month alone."

"Expanding testing and screening capacity will require careful logistical planning, and also responsiveness to changes in the numbers of new infections that we are seeing. This needs to be a priority for policymakers seeking to utilize available resources in the most efficient way," says Ciaranello.
Posts: 1537
Joined: Fri Jun 26, 2020 5:22 am

Re: COVID-19 Tests | Wish List

Post by trader32176 »

Researchers develop a cheaper, faster and accurate COVID-19 test

9/24/20 ... -test.aspx

Researchers at Karolinska Institutet have developed a method for fast, cheap, yet accurate testing for COVID-19 infection. The method simplifies and frees the testing from expensive reaction steps, enabling upscaling of the diagnostics.

This makes the method particularly attractive for places and situations with limited resources. It is equally interesting for repeated testing and for moving resources from expensive diagnostics to other parts of the care chain. The study is published in Nature Communications.

" We started working on the issue of developing a readily available testing method as soon as we saw the developments in Asia and southern Europe, and before the situation reached crisis point in Sweden. Our method was effectively finished already by the end of April, and we then made all the data freely available online."

-Bjorn Reinius, Principal Investigator and Research Leader, Department of Medical Biochemistry and Biophysics, Karolinska Institutet

The spread of the new coronavirus at the end of 2019 in China's Wuhan region quickly escalated into a global pandemic.

The relatively high transmission rate and the large number of asymptomatic infections led to a huge, world-wide need for fast, affordable and effective diagnostic tests that could be performed in clinical as well as non-clinical settings.

Established diagnostic tests for COVID-19 are based on the detection of viral RNA in patient samples, such as nasal and throat swabs, from which RNA molecules must then be extracted and purified.

RNA purification constitutes a major bottleneck for the testing process, requiring a great deal of equipment and logistics as well as expensive chemical compounds.

Making the current methods simpler without markedly compromising their accuracy means that more and faster testing can be carried out, which would help to reduce the rate of transmission and facilitate earlier-stage care.

The cross-departmental research group at Karolinska Institutet has now developed methods that completely circumvent the RNA-extraction procedure, so that once the patient sample has been inactivated by means of heating, rendering the virus particles no longer infectious, it can pass straight to the diagnostic reaction that detects the presence of the virus.

According to the researchers, the most important keys to the method's success are both the above virus inactivation procedure and a new formulation of the solution used to collect and transport the sample material taken from the patients.

"By replacing the collection buffer with simple and inexpensive buffer formulations, we can enable viral detection with high sensitivity directly from the original clinical sample, without any intermediate steps," says Dr Reinius.

Institutions and research groups around the world have shown great interest in the method since a first version of the scientific article was published on the preprint server medRxiv.

The article was read more than 15,000 times even before it was peer-reviewed by other researchers in the field and officially published in Nature Communications.

"Thanks to the low cost and the simplicity of the method, it becomes a particularly attractive option at sites and in situations with limited resources but a pressing need to test for COVID-19," he says and adds: "I would certainly like to see that this test used in Sweden too, for example for cheap periodic testing of asymptomatic people to eliminate the spread of infection."
Posts: 1537
Joined: Fri Jun 26, 2020 5:22 am

Re: COVID-19 Tests | Wish List

Post by trader32176 »

FDA issues emergency use authorization for first serology point-of-care test for COVID-19

9/24/20 ... ID-19.aspx

Today, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the first serology (antibody) point-of-care (POC) test for COVID-19. The Assure COVID-19 IgG/IgM Rapid Test Device was first authorized for emergency use by certain labs in July 2020 to help identify individuals with antibodies to SARS-CoV-2, indicating recent or prior COVID-19 infection.

Today, that EUA is being reissued to authorize the test for POC use using fingerstick blood samples. This authorization means that fingerstick blood samples can now be tested in POC settings like doctor's offices, hospitals, urgent care centers and emergency rooms rather than having to be sent to a central lab for testing.

" Authorizing point-of-care serology tests will enable more timely and convenient results for individuals who want to understand if they have previously been infected with the virus that causes COVID-19."

-Stephen M. Hahn, M.D, Commissioner, Food and Drug Administration

"Until today, serology test samples were generally only able to be evaluated in a central lab, which can be time consuming and use additional resources to transport samples and run the test. As more and more point-of-care serology tests are authorized, they will help conserve those resources and may help reduce processing time for other types of COVID-19 tests, as less time is spent on serology tests."

Nearly 50 serology tests have been granted an EUA since the start of the pandemic. The Assure test is a lateral flow assay and is authorized for use with venous whole blood, serum, plasma and fingerstick whole blood. This serology POC test, unlike POC COVID-19 diagnostic tests, uses a blood sample from the fingertip to run the test.

The FDA wants to remind patients that it is unknown how long antibodies persist following infection and if the presence of antibodies confers protective immunity, so they should not interpret results from a serology test as telling them they are immune, or have any level of immunity, from the virus.

Due to these unknowns, the FDA cautions patients against using the results from these tests, or any serology test, as an indication that they can stop taking steps to protect themselves and others, such as stopping social distancing, discontinuing wearing masks or returning to work.

The FDA also wants to remind the public that serology tests should not be used to diagnose an active infection, as they only detect antibodies the immune system develops in response to the virus - not the virus itself.

It is also important to remember that in a population with low prevalence, even high-performing antibody tests may produce as many or more false results as true results because the likelihood of finding someone who has been infected is very small. Thus, it is necessary to consider that the results from two serology tests may be needed to generate reliable results.

The Assure COVID-19 IgG/IgM Rapid Test Device is currently the only FDA authorized COVID-19 POC serology test and is available by prescription only. The FDA continues to work with test developers to expand access to COVID-19 testing.
Posts: 1537
Joined: Fri Jun 26, 2020 5:22 am

Re: COVID-19 Tests | Wish List

Post by trader32176 »

United Airlines to offer Covid-19 testing for passengers

9/24/20 ... index.html

United Airlines will become the first US airline to offer coronavirus testing to its passengers.

It will offer the testing for Hawaii-bound passengers beginning October 15 out of San Francisco. The testing will help passengers avoid an otherwise mandatory 14-day quarantine.

United said it will use a rapid, 15-minute test from Abbott, and will also offer customers a mail-in option that can be completed in the days before departure.

The normally tourism-driven island state is currently seeing 70% fewer flights, 91% less TSA checkpoint traffic, and 94% less travel into the state compared to usual, according to numbers from Airlines for America.

The International Air Transport Association on Tuesday called for coronavirus testing at the airport as a requirement for all passengers and airplane crew members before international flights. The group, which represents about 290 airlines worldwide, called on governments to set up and fund the testing regimen.
Posts: 1537
Joined: Fri Jun 26, 2020 5:22 am

Re: COVID-19 Tests | Wish List

Post by trader32176 »

3D-printed alternative performs as well as the standard nasal swabs for COVID-19 testing

9/25/20 ... sting.aspx

As COVID-19 quickly spread worldwide this spring, shortages of supplies, including the nasopharyngeal (nasal) swabs used to collect viral samples, limited diagnostic testing.

Now, a multisite clinical trial led by the University of South Florida Health (USF Health) Morsani College of Medicine and its primary hospital affiliate Tampa General Hospital (TGH) provides the first evidence that 3D-printed alternative nasal swabs work as well, and safely, as the standard synthetic flocked nasal swabs.

The results were published online Sept. 10 in Clinical Infectious Diseases. A commentary accompanying the paper cites the authors' timely, collaborative response to supply chain disruptions affecting testing capacity early in the pandemic.

Seeking a solution to an unprecedented demand for nasal swabs at their own institution and others, USF Health researchers in the Departments of Radiology and Infectious Diseases reached out to colleagues at TGH; Northwell Health, New York's largest health care provider; and leading 3D-printer manufacturer Formlabs.

Working around the clock, this multidisciplinary team rapidly designed, tested and produced a 3D printed nasal swab prototype as a replacement for commercially-made flocked nasal swabs. Bench testing (24-hour, 3-day, and leeching) using respiratory syncytial virus as a proxy for SARS-CoV-2, as well as local clinical validation of the final prototype (fabricated with FDA-approved nontoxic, surgical grade materials), was successfully completed in mid-March 2020.

The larger-scale clinical trial began in late March at three sites: TGH, Northwell Health, and Philadelphia-based Thomas Jefferson University Hospital. (Other sites joined later.)

Although USF Health held a provisional patent on the concept and design of the new 3D printed swab, they freely shared the information with hospitals, clinics, governments and international agencies experiencing supply chain shortages.

Since the first batches of 3D printed swabs were processed, tens of millions of the USF Health-invented devices have been used in 22 countries, said lead author Summer Decker, PhD, an associate professor of radiology at the USF Health Morsani College of Medicine. Dr. Decker directs the USF Health Radiology-TGH Division of 3D Clinical Applications, a group with expertise in creating and printing 3D anatomical models for surgeons and other clinicians as well as designing medical devices.

"In the midst of a pandemic, our team of experts representing academic medicine, health care delivery systems, and the medical device industry put aside boundaries to quickly work together toward a common purpose. It's rewarding that the novel design for a 3D swab we created has been adopted around the world, equipping more providers to diagnose COVID-19 and hopefully help prevent its spread."

-Summer Decker, PhD, Associate Professor of Radiology, USF Health Morsani College of Medicine

The gold standard for diagnosing respiratory infections is to look for viral genetic material found in mucosal fluid collected with a long, slender swab inserted into the patient's nose and back of the throat. The nasal swab is put into a plastic tube with chemicals that stabilize the sample until the virus-specific genetic material can be extracted and amplified by polymerase chain reaction (PCR) in a diagnostics laboratory. Conventional swabs feature a bushy tip coated with nylon flock; the USF Health doctors designed a tip with a 3D printed textured pattern able to capture a sufficient sample for COVID testing while keeping patient safety and comfort in mind.

The clinical trial fully tested the safety and effectiveness of this 3D printed swab in 291 symptomatic adults undergoing COVID-19 screening at the TGH, Northwell Health and Thomas Jefferson University Hospital sites. The 3D printed nasal swab was compared to the standard synthetic nasal swab across three SARS-CoV-2 testing platforms FDA-authorized for emergency use -- a modified version of the Center for Disease Control and Prevention's real-time reverse transcriptase PCR diagnostic panel, and two commercial molecular diagnostic tests.

"This trial provided the first rigorous head-to-head comparison to make sure that the 3D swab performed as well as the standard," said principal investigator Kami Kim, MD, professor and division director for infectious disease at the USF Health Morsani College of Medicine. "Across all three platforms used in our study, we demonstrated that the commercial swab and the 3D printed swab were comparable for accurate detection of COVID-19 infection."

For both swabs, the only adverse patient reaction documented during the trial was a few instances of slight nasal bleeding. The cost of materials per 3D printed nasal swab ranges from 26-to 46-cents, while commercial swabs cost about $1 each, the authors reported.

Given the ongoing need for widespread COVID-19 testing, the study authors concluded that 3D printing technology offers a viable, cost-efficient option to address swab supply shortages, particularly when local hospitals or other clinical sites already have 3D printing labs equipped to print and process the devices.

Frank Rybicki, MD, PhD, vice chair of operations and quality at the University of Cincinnati College of Medicine's Department of Radiology, wrote a commentary on 3D printing in medicine to accompany the Clinical Infectious Diseases paper. The article frames the contributions of Decker et. al. in the context of the larger 3D manufacturing community.

"Among all parts 3D printed during COVID-19, nasopharyngeal swabs have received the most attention, with participants ranging from humanitarians to charlatans," Dr. Rybicki wrote in his summary. "The authors should be congratulated for staying on the right side of the curve, and for their perseverance, leadership, scientific rigor, and good will."
Posts: 1537
Joined: Fri Jun 26, 2020 5:22 am

Re: COVID-19 Tests | Wish List

Post by trader32176 »

Yale designates three independent laboratories to perform SalivaDirect COVID-19 test

9/26/20 ... -test.aspx

Yale has designated three independent laboratories to perform the university-developed SalivaDirect™ COVID-19 test. Along with Yale Pathology Labs — the first to offer the test — Access Medical Laboratories, Hennepin County Medical Center (HCMC), and Mirimus, Inc., represent the initial wave of providers for the innovative testing method. They will make SalivaDirect™ available to people in Florida, Minnesota and New York by late September.

SalivaDirect™ was developed by a Yale School of Public Health research team led by Nathan Grubaugh, assistant professor, and Anne Wyllie, associate research scientist. Their method is less prone to supply chain bottlenecks, more economical, and less invasive than nasopharyngeal (NP) swabbing, the most common form of testing available currently. The test received FDA Emergency Use Authorization on Aug. 15.

After discovering saliva is a promising sample type for SARS-CoV-2 detection, we have made it our mission to develop a testing method that is accurate, affordable, and accessible to all. Our hope is that eventually every person that needs a COVID-19 test will be able to get one. Our laboratory partners are instrumental in ensuring schools and other essential institutions can remain open and healthy."

Anne Wyllie, Associate Research Scientist, Yale University

In a spring 2020 pilot program led by the Yale School of Public Health, The National Basketball Association (NBA), and the National Basketball Players Association (NBPA), SalivaDirect™ was used to successfully test asymptomatic people within the NBA. This success attracted the attention of laboratories nationwide.

“Having seen the ease and effectiveness of using SalivaDirect™ to test our players and staff for COVID-19 firsthand, I am looking forward to seeing these laboratories help us achieve the overall mission of rolling out an affordable test to the masses, especially those in our most vulnerable communities,” said Robby Sikka, vice president of basketball performance and technology for the Minnesota Timberwolves. “We are proud and excited to see these labs partner with schools and other area organizations to help reduce the spread of COVID-19.”

SalivaDirect™ does not require any special type of swab or collection device; a saliva sample can be collected in any sterile container. As stated by the U.S. Food and Drug Administration, “this test is also unique because it does not require a separate nucleic acid extraction step. This is significant because the extraction kits used for this step in other tests have been prone to shortages in the past. Being able to perform a test without these kits enhances the capacity for increased testing, while reducing the strain on available resources.”

“We are so grateful to extend SalivaDirect™ to these laboratory partners, and because our test does not rely on any proprietary equipment it can be assembled and used in most high-complexity labs across the country. As such, our hope is that many other labs will follow suit,” said Grubaugh. “While we are not looking to commercialize the method, we absolutely want it to be widely available; the only way we will see this pandemic in the rearview mirror is to increase testing in every single neighborhood across the country, regardless of economics.”

High-complexity CLIA labs need to apply for designation from Yale and more information on that process can be found on the SalivaDirect website.
Post Reply