Virus World

PRNewswire -- SEKISUI Diagnostics, a global medical diagnostics manufacturer, has received EUA clearance for the OSOM Flu SARS-CoV-2 Combo Test for  use in professional and home testing settings.

The OSOM® Flu SARS-CoV-2 Combo Test is a lateral flow immunochromatographic assay intended for in vitro rapid, simultaneous qualitative detection and differentiation of influenza A and influenza B nucleoprotein antigens and SARS-CoV-2 nucleocapsid antigen. As with other OSOM Rapid Tests, it is made in the USA and supported by a highly skilled technical support team of medical technologists/professionals. "The utility of detecting COVID and Flu on one test is now more important than ever having moved into the endemic phase of COVID. The OSOM test is the first antigen, visual, home test to receive EUA status, which allows us to get these diagnostic tools into the hands of healthcare providers and consumers well before the next respiratory season.  This helps minimize the spread of these diseases and allows prescribing appropriate treatments once viruses start circulating.", said Lee Lipski, Sr. VP, Strategy & Business Management.   

SEKISUI Diagnostics is a well-known provider of many rapid diagnostic solutions to the professional and home testing markets through a portfolio of tests under the OSOM® and Acucy® brands. They also supply COVID Ag tests through the HHS/ASPR program (COVIDTests.gov) which delivers tests for free to households across the country. "We first entered the home testing market with our COVID-19 test as we understand these are valuable tools to reduce the spread of respiratory infections and improve the health of all people.  The OSOM Flu SARS-CoV-2 Combo Test takes our offering to the next level with the ability to get two answers with one sample providing fast, actionable results to consumers as well as healthcare professionals.", said Erica Blight, VP, Clinical Research, Customer Care and Marketing.

About SEKISUI Diagnostics:

With over 40 years of experience, SEKISUI Diagnostics' mission is to provide intelligent solutions to enhance life with science and improve the health of all people.  We supply innovative medical diagnostics globally to physicians, hospitals, laboratories and alternate testing locations.   Our product lines include clinical chemistry reagents, point-of-care tests, pre-analytic systems as well as enzymes and specialty biochemicals.    The OSOM® Flu SARS-CoV-2 Combo Test is test is authorized for use at the Point of Care (POC), i.e., in patient care settings operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation and the OSOM® Flu SARS-CoV-2 Combo Home Test is authorized for non-prescription home use with self-collected or adult-collected anterior nares nasal swab samples from individuals aged 14 years or older with signs and symptoms of SARS-CoV-2, influenza A and influenza B. The OSOM Flu SARS CoV-2 Combo Test and the OSOM Flu SARS CoV-2 Combo Home Test are only for in vitro diagnostic use under the Food and Drug Administration's Emergency Use Authorization. This product has not been FDA-cleared or approved.

FDA EUA  letter  (Feb. 29, 2023):

https://www.fda.gov/media/176716/download 

Americans would be able to order the tests at CovidTests.Gov in coming weeks. The federal government program used for the last two winters to send free COVID tests to Americans' homes will get up-and-running once again in the coming days, Health and Human Services Secretary Xavier Becerra said Wednesday. Becerra made the announcement at a CVS drugstore in Washington, D.C., while getting his updated COVID shot and flu shot. The site, CovidTests.Gov, will officially relaunch on Sept. 25 and each household will be able to order four free rapid tests, according to the Administration for Strategic Preparedness and Response. The site has had an on-and-off presence since the winter of 2022, when the omicron variant was ripping across the country...

WASHINGTON, Dec 15 (Reuters) - U.S. households can order four free at-home COVID-19 tests from the government website COVIDTests.gov beginning on Thursday as part of the Biden administration's efforts to tackle coronavirus infections over the winter. The White House said it would use existing funding to pay for the tests since it has been unsuccessful so far in getting Congress to pass a bill to put more money toward the U.S. COVID-19 response. The free tests program was paused because officials wanted to make sure there were enough tests available for a likely spike in COVID cases in the winter, White House COVID-19 response coordinator Ashish Jha said. "We knew there will be a moment later in the year when COVID cases would rise again. So we preserved the tests so we could have them on hand for exactly this moment," White House COVID-19 response coordinator Ashish Jha said on Thursday. "And if we don't get more funding, we won't be able to send more tests out to the American people."

White House Press Release (Dec. 15, 2022):

https://www.whitehouse.gov/briefing-room/statements-releases/2022/12/15/fact-sheet-biden-administration-announces-covid-19-winter-preparedness-plan/ 

Carl Johnson, Cornelius Vanderbilt Professor of Biological Sciences and expert in biological clocks, identifies temporal component to COVID-19 viral shedding. 

THE IDEA

Throughout the COVID-19 pandemic, health care practitioners have relied on COVID-19 testing to tell them what safety precautions to follow with each patient. Carl Johnson, Cornelius Vanderbilt Professor of Biological Sciences, wondered how the virus might act differently depending on the time of day and the body’s circadian rhythms. Johnson collaborated with Candace McNaughton, former adjunct assistant professor of emergency medicine, and Thomas Lasko, associate professor of biomedical informatics at Vanderbilt University Medical Center, to determine if the percentage of people testing positive for COVID-19 varies based on time of day. They found that people were up to two times as likely to have an accurate positive test result if they tested in the middle of the day compared to at night. The data support the hypothesis that COVID-19 acts differently in the body based on our natural circadian rhythm, which has also been implied by studies of other viral and bacterial infections. COVID-19 virus shedding—when infected cells release infectious virus particles into the blood and mucus—appears to be more active in the middle of the day due to modulation of the immune system by our biological clock.

WHY IT MATTERS

“Taking a COVID-19 test at the optimal time of day improves test sensitivity and will help us to be accurate in diagnosing people who may be infected but asymptomatic,” Johnson said. Their results indicate that viral load is lower after 8 p.m. If people choose to get tested at that time, there could be a higher chance of a false-negative result. False negatives can be harmful to the community and for the patient, who might not seek additional care due to their negative test result. A difference in COVID-19 viral shedding throughout the day is important information that may inform how we test for and treat the virus. As Johnson and his co-authors report, the peak shedding in the afternoon, when patients are more likely to interact with others or seek medical care, could play a role in increasing the spread of the virus in hospitals and the wider community.

WHAT’S NEXT

Further research is needed to confirm the diurnal—meaning active during the day—nature of SARS-CoV-2, the virus that causes COVID-19. Experimentally testing patients who are infected with COVID-19 to see if individuals shed the virus differently throughout the day would have important public health implications, Johnson said. Johnson and his co-authors hope this early research can be used to optimize COVID-19 testing and improve test accuracy. The researchers believe temporal considerations may be leveraged to maximize the effectiveness of intervention strategies and even vaccine strategies.

Original Research Published in Journal of Biological Rhythms  (Oct. 26, 2021):

https://doi.org/10.1177/07487304211051841

Unlike similar at-home tests, Ellume’s does not require a prescription.  The Food and Drug Administration on Tuesday issued an emergency authorization for the country’s first coronavirus test that can run from start to finish at home without the need for a prescription. People as young as 2 years old are cleared to use the test, which takes just 15 to 20 minutes to deliver a result. Unlike many similar products, which are only supposed to be used by people with symptoms of Covid-19, this test is authorized for people with or without symptoms. The test, developed by the Australian company Ellume, detects bits of coronavirus proteins called antigens. It’s slightly less accurate than gold standard laboratory tests designed to look for coronavirus genetic material with a technique called polymerase chain reaction, or P.C.R. But in a clinical study of nearly 200 people, Ellume’s product was able to detect 95 percent of the coronavirus infections found by P.C.R., regardless of whether the infected people felt sick. It also correctly identified 97 percent of the people who received negative laboratory test results.

Researchers reveals grocery store workers, particularly ones serving customers, are five times as likely to have COVID-19 than other employees. While workers in all occupations are at risk from coronavirus, there are few who interact with as many people as grocery store workers. A concerning study finds one in five grocery store employees has tested positive for COVID-19. More importantly, researchers say most of these workers have no symptoms. A team of researchers in the Boston area reveals these essential workers, particularly ones serving customers, are five times as likely to have COVID-19 than other employees. Of the 104 workers examined from a Boston grocery, 20 had a positive coronavirus test. Of that group, a staggering 76 percent were asymptomatic. Before testing these grocery workers, the study also gave the employees a questionnaire on their lifestyles, medical histories, job histories, and roles in the store. The worked also supplied data on their commute and social distancing efforts as well. From this information, 91 percent of the workers with COVID-19 had jobs that involving interacting with customers. “This is the first study to demonstrate the significant asymptomatic infection rate, exposure risks, and associated psychological distress of grocery retail essential workers during the pandemic,” researchers say in a media release. “Once essential workers are infected with SARS-CoV-2, they may become a significant transmission source for the community they serve.”..

Study cited published in Occupational and Environmental Medicine (Oct. 30, 2020):

https://doi.org/10.1136/oemed-2020-106774

CRISPR-based approach is much faster than current diagnostics, but does have some limitation. CRISPR diagnostics are just one way researchers are trying to speed coronavirus testing. The new test is the fastest CRISPR-based diagnostic yet. In May, for example, two teams reported creating CRISPR-based coronavirus tests that could detect the virus in about an hour, much faster than the 24 hours needed for conventional coronavirus diagnostic tests.  CRISPR tests work by identifying a sequence of RNA—about 20 RNA bases long—that is unique to SARS-CoV-2. They do so by creating a “guide” RNA that is complementary to the target RNA sequence and, thus, will bind to it in solution. When the guide binds to its target, the CRISPR tool’s Cas13 “scissors” enzyme turns on and cuts apart any nearby single-stranded RNA. These cuts release a separately introduced fluorescent particle in the test solution. When the sample is then hit with a burst of laser light, the released fluorescent particles light up, signaling the presence of the virus. These initial CRISPR tests, however, required researchers to first amplify any potential viral RNA before running it through the diagnostic to increase their odds of spotting a signal. That added complexity, cost, and time, and put a strain on scarce chemical reagents.

Now, researchers led by Jennifer Doudna, who won a share of this year’s Nobel Prize in Chemistry yesterday for her co-discovery of CRISPR, report creating a novel CRISPR diagnostic that doesn’t amplify coronavirus RNA. Instead, Doudna and her colleagues spent months testing hundreds of guide RNAs to find multiple guides that work in tandem to increase the sensitivity of the test. 

In a new preprint, the researchers report that with a single guide RNA, they could detect as few as 100,000 viruses per microliter of solution. And if they add a second guide RNA, they can detect as few as 100 viruses per microliter.  That’s still not as good as the conventional coronavirus diagnostic setup, which uses expensive lab-based machines to track the virus down to one virus per microliter, says Melanie Ott, a virologist at UC San Francisco who helped lead the project with Doudna. However, she says, the new setup was able to accurately identify a batch of five positive clinical samples with perfect accuracy in just 5 minutes per test, whereas the standard test can take 1 day or more to return results.

Starting Wednesday, Finland launches a coronavirus-sniffing-dog pilot program at Helsinki Airport. The voluntary tests will reportedly deliver results in seconds, will require no contact with the dogs and take less than a minute of travelers' time. The voluntary canine tests will deliver results within 10 seconds, and require less than a minute of travelers’ time, said Anna Hielm-Björkman, a researcher at the University of Helsinki who is using the trial to gather data. Researchers in other countries, including the United States and the United Arab Emirates, are studying canine coronavirus tests. But the Finnish trial is among the largest in scale and furthest along. In Dubai, health officials this summer began using dogs to analyze sweat samples from randomly selected air travelers, with more than 90% accuracy, according to initial results.

Changes in health can affect the way people smell, researchers say. Dogs long have been valued for their ability to sniff for drugs and bombs, and have proved able to detect cancers, infections and other health problems. Researchers at the University of Helsinki this year found indications that dogs can detect the virus. Scientists say only large-scale trials, such as the one to begin Wednesday, can demonstrate how effective the method will be in practice. As in Dubai, the dogs to be deployed in Helsinki will sniff sweat samples and will not come into contact with travelers. People who agree to the test will swab their necks to produce a sample, to submit through an opening in a wall, said Hielm-Björkman. Regardless of whether they test positive, they will be urged to take a standard polymerase chain reaction (PCR) COVID-19 test so researchers can monitor the dogs’ accuracy. All tests are free for travelers arriving at the airport. Hielm-Björkman said the dogs, according to preliminary research, may be better at detecting coronavirus infections, which can cause the illness COVID-19, than PCR and antibody tests. They “can also find [people] that are not yet PCR positive, but will become PCR positive within a week,” she said. Virpi Perälä, a representative for Evidensia Elainlaakaripalvelut, a network of veterinary clinics that funded the first stage of the trial, during which the initial cohort of dogs were trained, said more funding would be needed to grow the project, depending on initial results.

Out of the 16 dogs trained, four are ready to work. Six others are still in training, with another six found to be unsuitable for a noisy airport environment. Experts have warned that canine tests, however effective, can be difficult to scale. Training is time-consuming and expensive. Even so, researchers are optimistic that it will come to play a roll, even if it cannot alleviate the demands on the world’s strained testing systems. One of the aims of the upcoming trial, said Hielm-Björkman, is to gather observations on how long the dogs can work in shifts. “You see very easily on a dog when it starts to get tired,” she said.

The YSPH-developed test, called SalivaDirect, has been used as part of an NBA testing program and will now be available to more diagnostic laboratories. A saliva-based laboratory diagnostic test developed by researchers at the Yale School of Public Health to determine whether someone is infected with the novel coronavirus has been granted an emergency use authorization by the U.S. Food and Drug Administration (FDA). The method, called SalivaDirect, is being further validated as a test for asymptomatic individuals through a program that tests players and staff from the National Basketball Association (NBA). SalivaDirect is simpler, less expensive, and less invasive than the traditional method for such testing, known as nasopharyngeal (NP) swabbing. Results so far have found that SalivaDirect is highly sensitive and yields similar outcomes as NP swabbing.  With the FDA’s emergency use authorization, the testing method is immediately available to other diagnostic laboratories that want to start using the new test, which can be scaled up quickly for use across the nation — and, perhaps, beyond — in the coming weeks, the researchers said. A key component of SalivaDirect, they note, is that the method has been validated with reagents and instruments from multiple vendors. This flexibility enables continued testing if some vendors encounter supply chain issues, as experienced early in the pandemic.

“This is a huge step forward to make testing more accessible,” said Chantal Vogels, a Yale postdoctoral fellow, who led the laboratory development and validation along with Doug Brackney, an adjunct assistant clinical professor. “This started off as an idea in our lab soon after we found saliva to be a promising sample type of the detection of SARS-CoV-2, and now it has the potential to be used on a large scale to help protect public health. We are delighted to make this contribution to the fight against coronavirus.” The preprint on the development and validation of SalivaDirect was recently posted on medRxiv. Development of SalivaDirect as a means of rapidly expanding SARS-CoV-2 testing was spearheaded this spring by Nathan Grubaugh and Anne Wyllie, assistant professor and associate research scientist, respectively, at Yale School of Public Health. After finding saliva to be a promising sample type for SARS-CoV-2 detection, they wanted to improve the method further.  “With saliva being quick and easy to collect, we realized it could be a game-changer in COVID-19 diagnostics,” said Wyllie. With testing urgently needed, the Yale team was determined to decrease both testing times and costs, to make testing widely accessible. "Wide-spread testing is critical for our control efforts. We simplified the test so that it only costs a couple of dollars for reagents, and we expect that labs will only charge about $10 per sample. If cheap alternatives like SalivaDirect can be implemented across the country, we may finally get a handle on this pandemic, even before a vaccine,” said Grubaugh. One of the team’s goals was to eliminate the expensive saliva collection tubes that other companies use to preserve the virus for detection. In a separate study led by Wyllie and the team at the Yale School of Public Health, and recently published on medRxiv, they found that SARS-CoV-2 is stable in saliva for prolonged periods at warm temperatures, and that preservatives or specialized tubes are not necessary for collection of saliva....

Validation study available at medRxiv:

https://doi.org/10.1101/2020.08.03.20167791

Test's website and details at:

https://covidtrackerct.com/about-salivadirect/

In a Finnish study, dogs learned to recognize the distinctive odor of a coronavirus infection. In the future, dogs might be able to detect infected people in nursing homes or at airports. In a pilot study at the University of Helsinki, dogs trained as medical diagnostic assistants were taught to recognize the previously unknown odor signature of the COVID-19 disease caused by the novel coronavirus. And they learned with astonishing success: After only a few weeks, the first dogs were able to accurately distinguish urine samples from COVID-19 patients from urine samples of healthy individuals. "We have solid experience in training disease-related scent detection dogs. It was fantastic to see how fast the dogs took to the new smell," says DogRisk group leader Anna Hielm-Björkman. After only a short time, the animals identified the urine of people infected by the novel coronavirus, known as  SARS-CoV-2, almost as reliably as a standard PCR test. The Finnish scientists are now preparing a randomized, double-blind study in which the dogs will sniff a larger number of patient samples. Only then will the scent tests be used in clinical practice.

The very rapid and promising findings from Finland are also important for other research teams, such as those in Great Britain and France, who are training sniffer dogs to detect COVID-19. Fellow researchers from the German Assistance Dog Center (TARSQ) have also benefited from the Finnish results. "No one could tell us with certainty whether training with the aggressive virus is dangerous or not for humans and dogs. We wanted to gather more information first before we started training because the German virologists advised us against it — after all, so little is known about the virus so far," explains Luca Barrett from TARSQ.

It is still unclear which substances in urine produce the apparently characteristic COVID-19 odor. Since SARS-CoV-2 not only attacks the lungs, but also causes damage to blood vessels, kidneys and other organs, it is assumed that the patients' urine odor also changes. This is something which the dogs, with their highly sensitive olfactory organs, notice immediately. Certain diseases appear to have a specific olfactory signature that trained dogs can sniff out with amazing accuracy, Barrett says. "According to one study, dogs can detect breast cancer with a 93% probability, for example. And lung cancer with a 97% probability," she says.

See also study in BMC Inf. Dis. (July 23, 2020):

https://bmcinfectdis.biomedcentral.com/articles/10.1186/s12879-020-05281-3

Illumina has secured an emergency use authorisation (EUA) from the US Food and Drug Administration (FDA) for its sequencing-based Covid-19 diagnostic test. Illumina COVIDSeq test is a high-throughput, sequencing-based and in vitro diagnostic (IVD) workflow test that facilitates the detection of SARS-CoV-2. The sequencing-based diagnostic test, which uses upper respiratory specimens such as nasopharyngeal or oropharyngeal swab, offers sample receipt to result in 24 hours using the NovaSeq 6000 sequencing system. The differentiated diagnostic design is comprised of 98 amplicons, which target the full SARS-CoV-2 genome, enabling to create precise detection and high sensitivity.

Illumina is currently offering COVIDSeq test to a limited number of early access sites, and plans to increase the supply by summer. The workflow holds the capacity to accommodate up to 3,072 samples per NovaSeq run through leveraging the S4 flow cell. It is comprised of steps for viral RNA extraction, RNA-to-CDNA conversion, PCR, library preparation, sequencing and report generation. 

FDA Letter of Approval:

https://www.fda.gov/media/79226/download

The test, developed by Abbott Laboratories, usually still works properly, but initial guidance on how to administer it could have led to false results. Arapid test for the novel coronavirus that was unveiled by President Trump on the White House lawn and has already been used hundreds of thousands of times can falsely produce negative results in patients who are infected, according to clinicians and laboratory experts. 

The 13-minute test, developed by Abbott Laboratories, a major U.S. health care and medical device company, usually still works properly, the company and clinicians say. But Abbott’s initial guidance on how to administer the test — guidance approved by the Food and Drug Administration — could lead to an unspecified number of false negative results. Abbott says changing how samples are collected should fix the problem. The test “performed equivalent to the other platforms with patients that had high and moderate loads of virus,” said Alan Wells, a pathologist who directs the clinical laboratories at the University of Pittsburgh Medical Center. “However, with lower loads of virus, a large fraction of these patients were not detected as positive.” Wells ran a validation of the test compared with stored samples that had been tested on other platforms.

In recent weeks, clinicians have expressed growing concerns about false negative results in testing for the coronavirus, known as SARS-CoV-2. Much of the problem has been blamed on issues with how samples for the main laboratory tests are collected.  Since Abbott’s test, run on its “ID Now” platform, was granted emergency use authorization by the FDA on March 27, the company has shipped 600,000 tests. They are being used at CVS and Walgreens drive-through testing locations, to test nurses and police officers in Detroit, and at urgent care centers in Chicago. They are also being used in hospitals to test surgical candidates to determine if they should be operated on and what level of protective equipment physicians should wear.

The test can be used in two different ways. In one method, a swab that has been rubbed against the nose, throat, or the area deep in the back of the nose is inserted directly into the ID Now platform, a toaster-sized machine. That approach is still seen as effective. But the FDA cleared the test to be used in another way: The swabs could be put in a liquid solution — known as “viral transport media” — and tested, which is the standard way for processing many other kinds of tests and usually allows samples to be stored longer....

How many COVID-19 cases have gone undetected? And are those who had mild cases of the disease—perhaps so mild they dismissed it as a cold or allergies—immune to new infections? If so, they could slow the spread of the burgeoning pandemic. Answering those questions is crucial to managing the pandemic and forecasting its course. But the answers won’t come from the RNA-based diagnostic tests now being given by the tens of thousands. They look for the presence of viral genes in a nose or throat swab, a sign of an active infection. But scientists also need to test a person’s blood for antibodies to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Such tests can detect active infections, too, but more importantly, they can tell whether a person has been infected in the past because the body retains antibodies against pathogens it has already overcome.

Labs and companies around the world have raced to develop antibody tests, and a few have been used in small studies and received commercial approval, including several from China. But so far, large-scale data from such tests—for example showing what fraction of people in the hard-hit city of Wuhan, China, might now be immune—is still lacking or at least not public. Scientists hope that will soon change as more tests become available. A new recipe could offer labs an alternative to waiting for or buying commercial tests. Florian Krammer, a virologist at the Icahn School of Medicine at Mount Sinai, and his colleagues posted a preprint yesterday describing a SARS-CoV-2 antibody test they have developed, and directions for replicating it. It’s one of the first such detailed protocols to be widely distributed, and the procedure is simple enough, he says, that other labs could easily scale it up “to screen a few thousand people a day,” and quickly amass more data on the accuracy and specificity of the test. Together with increased availability of commercial tests, that means some important answers about immunity to COVID-19, the disease caused by the novel coronavirus, may be available soon, he says.

To create the test, the researchers began by designing a slightly altered version of the “spike” protein on SARS-CoV-2’s outer coat. (The alterations made the protein more stable for use in the lab.) That protein helps the virus enter cells, and it is a key target in the immune reaction against the virus, as the body churns out antibodies that recognize the protein and tag the virus for destruction. They also isolated the short piece of the spike protein called the receptor-binding domain (RBD), which the virus uses to attach to cells it tries to invade. They then used cell lines to produce large quantities of the altered spike proteins and RBDs....

Preprint Published in medRxiv (March 18, 2020):

https://doi.org/10.1101/2020.03.17.20037713

At-home testing is becoming a thing not just for COVID-19, but for seasonal flu and other infections. Here's what you need to know. B efore COVID-19, figuring out whether a sore throat, fever, and runny nose were caused by a cold, flu, or strep wasn’t a top priority. You either powered through, knowing you’d be miserable for a few days but would probably feel better soon or you visited the doctor’s office, urgent care, or emergency room where you might get a test to figure out which virus or bacteria was behind your misery, and maybe a prescription to treat it. But even doctors often don’t order tests, preferring instead to make diagnoses based on symptoms. During the pandemic, however, it became more critical to know who was infected with SARS-CoV-2 so those people could isolate and not spread the virus. At-home test kits became household products, and most people are by now adept at squeezing out a few drops of solution onto a card, sticking a swab up their nose, swirling the swab in the testing liquid, and waiting for a result.

Tests for COVID-19

A number of companies, offer at-home test kits for COVID-19 that people can buy without a prescription. Most of these are rapid antigen tests, which pick up antigens, or substances that the SARS-CoV-2 virus makes. While they are relatively accurate, because it takes some time for levels of these antigens to build up after an infection, these tests are less reliable in the day or so immediately after exposure to the virus. That’s why doctors recommend repeating the test a couple of days apart. Then there are PCR, or molecular, tests, that are closer to the gold standard used in laboratories, and rely on finding the smallest genetic signatures of the virus and amplifying them. Cue Health sells a palm-sized COVID-19 PCR device that people can purchase for $300 that allows for 10 at-home tests and doesn’t require a prescription. The device reads a saliva sample and provides results to a smartphone app in 20 minutes. Other testing companies, such as Labcorp and Everlywell, also sell PCR-based tests for COVID-19, but they are technically collection kits, which means that you have to send a saliva sample into a lab to get results, which can mean critical days will pass before you get results.

Tests for seasonal flu

There is only one at-home test authorized by the FDA for influenza: Lucira, now owned by Pfizer, makes a combined flu and COVID-19 molecular test. The kit uses a PCR-related method of amplifying and reading any viral genes in a sample, providing a result in about 30 minutes. In coming months, eMed, a digital health company that sells test kits and telehealth services, plans to offer that kit, as well another that is currently being reviewed by the U.S. Food and Drug Administration. (The combined kit currently available on eMed’s website only tests for COVID-19 and provides a survey to help telemedicine professionals determine if a user likely has the flu.)

Tests for RSV

There currently aren’t at-home tests for RSV, because typically only infants and the elderly are at risk for severe illness. Doctors’ offices, hospitals, and urgent care centers can perform RSV tests that provide results in about 30 minutes.

The advantages of at-home testing

The currently cumbersome journey from symptoms to treatment rests on people making appointments with their doctors or at an urgent care center and could be contributing to the spread of viruses. Self-testing could reduce some of that risk since people are most infectious while they are waiting to get tested and receive treatment. Ideally, if someone tests themselves at home and finds they are positive for influenza or COVID-19, for example, they don’t necessarily have to physically visit their doctor or go into an urgent care or emergency room, where they could spread the virus to others. Instead, they could video conference with a doctor who could assess their symptoms and at-home test results, then write a prescription for, say, oseltamivir if it’s the flu, or Paxlovid if it’s COVID-19. “If you’re trying to minimize morbidity and mortality, and cut down on transmission, then [at-home] testing is an incredible tool to have,” says Thomas Denny, chief operating officer of the Duke University Human Vaccine Institute....

The National Institutes of Health, in collaboration with the Administration for Strategic Preparedness and Response (ASPR) at the U.S. Department of Health and Human Services, has launched the Home Test to Treat program, an entirely virtual community health intervention that will provide free COVID-19 health services—at-home rapid tests, telehealth sessions and at-home treatments—in selected communities. The program, first announced by the White House(link is external) in September 2022, will make antiviral treatment available for eligible individuals who receive a positive test result, which could prevent severe illness, hospitalization or death. “At-home testing for COVID-19 is now widely available in the United States, as are antiviral treatments, and this program combines easy home access to both,” said Bruce Tromberg, Ph.D., director of the National Institute of Biomedical Imaging and Bioengineering (NIBIB) at the National Institutes of Health and leader of the Rapid Acceleration of Diagnostics (RADx®) Tech program. “The Home Test to Treat program allows those who are sick an alternative to venturing out for testing or treatment, potentially reducing the spread of COVID-19 in the community.” Later this month, local and state officials in Berks County, Pennsylvania, will be the first to pilot the Home Test to Treat program. Up to 8,000 eligible residents are anticipated to participate in the program. Program organizers will gather information from participants to identify best practices and make improvements to the Home Test to Treat model that can be used to implement the program on a larger scale. Additional communities across the country will be selected to participate based on level of community need, access to healthcare treatment, expected COVID-19 infection rates and socio-economic factors.

Through collaborations with local health departments, Home Test to Treat aims to offer services to approximately 100,000 people across the United States in the coming year. Telehealth services provider eMed will implement the Home Test to Treat program. Their services are provided under a contract award by NIBIB contractor, VentureWell. Having administered millions of verified at-home telehealth sessions during the pandemic, eMed will host the user-friendly Home Test to Treat website, where participants can sign up for the program, report symptoms, receive telehealth and antiviral treatment delivery, and coordinate telehealth enabled test kits. NIBIB also has issued a contract with UMass Chan Medical School, whose researchers, in collaboration with eMed, will analyze data collected from each participating community, including the impacts of a home-based process for testing and treatment, individual attitudes about the Home Test to Treat program, and clinical outcomes from treatments. HHS, through ASPR, has led a national COVID-19 Test to Treat initiative since March 2022, that includes thousands of treatment access points nationwide. These include CDC’s Increasing Community Access to Testing (ICATT) program, composed of federally funded health centers, long-term care facilities and community-based sites. Participants in the Home Test to Treat program can be tested at local ICATT centers. The Test to Treat initiative has evolved to include more mobile and telehealth-based models that reduce barriers to access for the highest-risk individuals. NIH’s Home Test to treat program will provide an important additional pathway to rapidly access lifesaving treatments for COVID-19 in vulnerable communities.

Home Test to Treat will promote equitable solutions and help to identify best practices that may save lives in this and future pandemics. In each community, the research team will identify and implement improvements that leave us in a much better position to respond to specific needs at the local, state and federal levels. The National Institute of Biomedical Imaging and Bioengineering (NIBIB) has supported development of Home Test to Treat through the RADx Tech program. About the Rapid Acceleration of Diagnostics (RADx®) initiative: The RADx initiative was launched on April 29, 2020, to speed innovation in the development, commercialization, and implementation of technologies for COVID-19 testing. The initiative has four programs: RADx Tech, RADx Advanced Technology Platforms, RADx Underserved Populations and RADx Radical. It leverages the existing NIH Point-of-Care Technology Research Network. The RADx initiative partners with federal agencies, including the Office of the Assistant Secretary of Health, Department of Defense, the Biomedical Advanced Research and Development Authority, and U.S. Food and Drug Administration. Learn more about the RADx initiative and its programs: https://www.nih.gov/radx. 

About the National Institute of Biomedical Imaging and Bioengineering (NIBIB): NIBIB’s mission is to improve health by leading the development and accelerating the application of biomedical technologies. The Institute is committed to integrating the physical and engineering sciences with the life sciences to advance basic research and medical care. NIBIB supports emerging technology research and development within its internal laboratories and through grants, collaborations, and training. More information is available at the NIBIB website: https://www.nibib.nih.gov.

About the National Institutes of Health (NIH): NIH, the nation's medical research agency, includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. NIH is the primary federal agency conducting and supporting basic, clinical, and translational medical research, and is investigating the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit www.nih.gov.

Scientists are trying to develop tests that are just as convenient as antigen tests, but can tell people whether they currently have neutralizing antibodies that protect against SARS-CoV-2. As the world continues to learn how to live with Covid-19 in the long run, scientists are testing ways to quickly tell people how well-protected they are against the virus, and whether they need another booster. A new study, published Monday in Cell Reports Methods, presents a simple test to detect neutralizing antibodies against SARS-CoV-2, using little more than a finger prick and a testing cartridge. The approach, if it bears out in large-scale testing and receives the blessing of regulatory agencies, could one day offer a cheap, easy option to measure protection against the virus. “People want to know, ‘Am I protected today?’ And there isn’t a tool on the market that can facilitate that answer,” said Charles Mace, a chemist at Tufts University who was not involved in the new study. “This has that potential.” Antibodies float around in the bloodstream, waiting for a foreign invader to make it in. When a virus does, some antibodies that are specific for parts of the virus — neutralizing antibodies — recognize and bind to it, which marks the virus for destruction and prevents it from infecting any cells. The body can naturally develop neutralizing antibodies through exposure to the virus after vaccination or an infection. When scientists want to determine whether those neutralizing antibodies are present in a person, they take blood samples, separate out the serum, and mix it with live SARS-CoV-2 virus. They then incubate that mixture with a human cell line and see how many of those cells die off. Scientists can also use other viruses that have been engineered to make the spike protein and a fluorescent molecule. But both of those methods require live virus, which means training and a biosafety lab, and take about 2 days to run. 

Researchers have been developing other, faster methods. But by and large, they either require laboratory equipment or are more complicated to manufacture because they use antibodies. The project started when Hojun Li, a hematologist and investigator at the Koch Institute, saw a bone marrow transplant patient at the Dana-Farber Cancer Institute right around the time that the pandemic hit the U.S. hard. But before the operation, they presented with symptoms for Covid-19. At the time, the only option available for doctors to rule out a Covid-19 infection was to do a blood test and examine the antibody levels. It took a week for the results to come back negative and Li to be able to proceed with the bone marrow transplant. “These are usually very urgent, urgent things to do,” Li said. “The longer you wait, the more likely whatever underlying diseases that come back cannot be cured by the bone marrow transplant.” Li and his colleague at the time, Guinevere Connelly, started talking about how they could close that knowledge gap with Covid. Connelly, a co-first author of the study and now a Ph.D. student at Duke University, said they quickly realized “that what would be really helpful would be a neutralizing antibody test where you could see what level of protection you may have against infection from Covid or from SARS-CoV-2.”  With collaborators, they learned new techniques to make every component of a test, from producing viral proteins at a larger-scale to cycling through a hundred different buffer formulas. It took them a year to collect enough test samples — repeat blood draws from two people before and after vaccination, and single donations from 93 other individuals — to design and validate the test. The result of their work is a device that looks and works like existing rapid antigen tests, which detect protein from the virus when someone is actively infected. The new test uses a small amount of blood, obtained via a finger prick, that gets mixed with a buffer that contains the portion of the SARS-CoV-2 spike protein that binds to the ACE2 receptor on human cells. Where a typical antigen test has two binding sites — a control line that shows the test is working properly and a test line that lights up when a person is positive for the coronavirus — the new one has three: a control line, a line turns an intense red when a person does not have neutralizing antibodies, and a line that appears when they do. “We also like people to think about positive signals as opposed to reduction of signals because there’s just a general feeling that that’s more reliable,” said Angela Koehler, a bioengineer at MIT who worked on the new test. Indicating both the presence and absence of neutralizing antibodies, the researchers said, allows everyday consumers to snap a picture with their mobile app to know their quantitative antibody titer.

“If you have an actual number that you can measure — and neutralizing antibody concentration would be a number that you can actually measure — then you can tell what degree of protection they have and whether or not they might need a subsequent [dose] or a booster sooner rather than later,” said Li. That kind of information could be of interest to a wide range of people, but would be particularly helpful for those who have weaker immune responses, like those Li sees in the clinic. “The vast, vast majority of patients I see get bone marrow transplants,” he added. “Their immune system is just really wiped out.”  Basing booster decisions on antibody levels is not too far-fetched an idea. In Australia, for example, antibody testing is used to determine if someone needs a 4th dose of the hepatitis B vaccine. But Julio Delgado, the clinical pathology chief at the University of Utah School of Medicine, is more skeptical that the new test will find use among the broader population. “Even if I get vaccinated, I’m still going to get infected at some point. That happened to me,” said Delgado, who has developed laboratory-based clinical tests that measure levels of antibodies against SARS-CoV-2. “So the understanding about neutralizing antibodies has really become more of a scientific interest, not necessarily a clinical utility.” Some experts said that any use case was overly optimistic because we don’t yet know what antibody levels translate to optimal protection. This is complicated by the fact that different assays calculate titer levels differently. “There is not an understanding about thresholds above or below which people are going to be prone to getting infected, or prone to develop progressive disease, or prone to die,” said Delgado. “Yes, you get a number, but what does that mean?” In part because the new test can be manufactured for less than a dollar a kit, its developers said that is exactly one of the questions their new product can answer. “It’s really the first one that I’ve seen that can answer that question,” said Hadley Sikes, a chemical engineer at MIT who was a senior author of the research. “If there was a study design where you use this tool — you recruit a cohort, say, 5,000 or 10,000 people, you get these neutralizing antibody tests in their homes, and you follow who gets infected and doesn’t get infected — it’s an answer to a question that a lot of people, a lot of doctors, a lot of articles in the press have been raising.”

The team behind the test said they are interested in pursuing an emergency use authorization down the road and would want to work with an industry partner or foundation that has experience with regulatory applications. But Li acknowledged that the Food and Drug Administration “has a little bit of hesitancy about anything antibody-related,” but attributed this to tests that measured all antibodies, rather than only SARS-CoV-2 neutralizing antibodies. “A lot of those tests flooded the market and a lot of them, frankly, were very, very poorly managed,” he said. Because antibody levels decline gradually, testing once a month would likely be enough. On the flip side, though, such infrequent testing needs might make it less appealing for commercial players to invest in the studies that would be needed to move the tests from a proof-of-concept to an authorized product.  A different approach on the horizon uses a costlier machine called a spectrometer to detect the Covid-fighting antibodies. Cheng-Hao Ko, an engineer at the National Taiwan University of Science and Technology, said this would be “300 to 400 times more accurate” than the rapid test approach. Ko is collaborating with a group at Temple University to seek emergency use authorization from the FDA for that device. That level of accuracy likely wouldn’t be necessary for the general public. “If you have a good indication of low, mid-range, and high level of antibodies, that’s probably good enough for the purpose,” said Jean-François Masson, a biochemist at the Université de Montréal in Canada. Adolfo Garcia-Sastre, a virologist at the Icahn School of Medicine at Mount Sinai, said there’s also a potential to use this type of test as a tool to understand immunity at the population level and help guide public health decisions, for example by routinely testing samples from blood donors. “Surveillance is going to become more important, I hope, in the next year,” he said, “because it gives you an idea of what is the vulnerability.”

See also study (August 22, 2022):

ttps://doi.org/10.1016/j.crmeth.2022.100273

- First at-home, virtually guided service to bring rapid, reliable and affordable testing into the home where the result is delivered in minutes

- Abbott and eMed™ expect to deliver and administer 30 million BinaxNOW™ tests in the first quarter of 2021, with an additional 90 million in the second quarter

- $25 cost for the test and service is the lowest available for at-home testing, which supports the home user to ensure a successful testing process

- BinaxNOW is a highly portable, easy-to-use, 15-minute antigen test with no instrument that detects the virus when people are most infectious, which is critically important in slowing the spread of the virus

- Service uses Abbott's complementary NAVICA™ app to enable the testing process and display authenticated BinaxNOW test results verified by a trained guide - and supports consumer confidence in testing at home

ABBOTT PARK, Ill.,, Dec. 16, 2020 /PRNewswire/ -- Abbott (NYSE: ABT) announced today that the U.S. Food and Drug Administration (FDA) has issued Emergency Use Authorization (EUA) for virtually guided at-home use of its BinaxNOW™ COVID-19 Ag Card rapid test for detection of COVID-19 infection. Abbott is bringing BinaxNOW, the most affordable and widely distributed rapid test into the home, where the result is delivered in minutes without the need to send it out for processing. The $25 cost for the test and service is the lowest currently available for at-home testing.  To facilitate the delivery of the BinaxNOW test to the home and the guided collection and testing process, Abbott has partnered with digital health solutions provider eMed™. This agreement furthers Abbott's vision of making as many tests as possible available in a variety of different settings to improve accessibility, support consumer confidence in testing at home, and help people start returning to living their daily lives with more normalcy. Abbott and eMed expect to deliver and administer 30 million BinaxNOW at-home tests in the first quarter of 2021, with an additional 90 million in the second quarter. Scale is critical to provide broad access to people who need testing and Abbott has scale for all its eight COVID-19 lab and rapid tests. In fact, since launching BinaxNOW in August, Abbott has ramped up capacity to 50 million tests a month in its U.S. facilities that are currently being distributed through the federal government and is expanding further so even more people have access to the tests.

"As the pandemic has evolved, the need for rapid testing has only grown. Unfortunately, we're still hearing that many people can't access testing as quickly as they need it," said Robert B. Ford, Abbott's president and chief executive officer. "That's why Abbott is bringing our rapid BinaxNOW test and NAVICA platform into homes through this partnership with eMed, which allows us to maintain the integrity of the testing process, get even closer to people who need testing and help provide the confidence we need to help get back to living with a bit more normalcy." The eMed service offering costs $25 a test, and eMed takes care of determining eligibility, the guided self-collection process, public health reporting requirements and gets people their results through their NAVICA app in a matter of minutes. The eMed offering could also remove some of the obstacles that individuals, governments and organizations face when seeking to provide or perform testing. These include mobility issues for people with disabilities or who may not have a reliable form of transportation, inconvenient testing windows for people who work non-traditional hours or have childcare or eldercare responsibilities, and discouragingly long lines at testing centers.

FDA Release Dec. 16, 2020:

https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-issues-new-authorization-binaxnow-covid-19-ag-card-home-test

Canines seem to detect coronavirus infections with remarkable accuracy, but researchers say large-scale studies are needed before the approach is scaled up. Asher is an eccentric, Storm likes sunbathing and Maple loves to use her brain. All three could play a part in controlling the COVID-19 pandemic, but they are not scientists or politicians. They are dogs.  And they are not alone. Around the world, canines are being trained to detect the whiff of COVID-19 infections. Dog trainers are claiming extraordinary results — in some cases, they say that dogs can detect the virus with almost perfect accuracy. Scientists involved with the efforts suggest that canines could help to control the pandemic because they can screen hundreds of people an hour in busy places such as airports or sports stadiums, and are cheaper to run than conventional testing methods such as the RNA-amplification technique PCR. But most of these findings have not yet been peer reviewed or published, making it hard for the wider scientific community to evaluate the claims. Researchers working on more conventional viral tests say that initial results from dog groups are intriguing and show promise. But some question whether the process can be scaled up to a level that would allow the animals to make a meaningful impact. On 3 November, groups working with the animals met in an online workshop called International K9 Team to share preliminary results from experiments and to improve how their research is coordinated. “No one is saying they can replace a PCR machine, but they could be very promising,” says veterinary neurologist Holger Volk at the University of Veterinary Medicine Hanover in Germany, who is leading an effort to train and study COVID-sniffing dogs and did not speak at the event.

Sense of wonder

Humans have taken advantage of canines’ superior sense of smell for decades. Dogs’ noses bear 300 million scent receptors, compared with humans’ 5 million or 6 million. That enables them to detect tiny concentrations of odour that people can’t. Sniffer dogs are already a familiar sight in airports, where they detect firearms, explosives and drugs. Scientists have also trained dogs to detect some cancers and malaria, but the animals are not routinely used for this purpose. Researchers don’t know for sure what the dogs are smelling, but many suspect that these illnesses cause the human body to let off a distinct pattern of volatile organic compounds (VOCs). These molecules readily evaporate to create scent that dogs can pick up. Previous work with non-COVID viruses has suggested that viral infections might also cause the body to do this.  Many sniffer-dog scientists turned their attention to COVID-19 early in the pandemic. They have trained their canines to smell samples, most often of sweat, in sterile containers, and to sit or paw the floor when they detect signs of infection. Trials at airports in the United Arab Emirates, Finland and Lebanon are using dogs to detect COVID-19 in sweat samples from passengers; these are then checked against conventional tests. According to data presented at the K9 meeting, dogs in Finland and Lebanon have identified cases days before conventional tests picked up the virus, suggesting that they can spot infection before symptoms start. Riad Sarkis, a surgeon and researcher at Saint Joseph University in Beirut, is part of a French–Lebanese project that has trained 18 dogs. Sarkis used the best two performers for the airport trial in Lebanon. The dogs screened 1,680 passengers and found 158 COVID-19 cases that were confirmed by PCR tests. The animals correctly identified negative results with 100% accuracy, and correctly detected 92% of positive cases, according to unpublished results. “This is very accurate, feasible, cheap and reproducible,” says Sarkis, who has been approached about using the dogs in schools, banks and prisons, and is working with a shopping mall to offer COVID-19 testing using the animals. Low-income countries with limited lab space could particularly benefit from the approach, says Isabella Eckerle, a virologist at the University Hospitals of Geneva in Switzerland....

Published in Nature (Nov. 23, 2020):

https://doi.org/10.1038/d41586-020-03149-9

The president’s result came after he spent months playing down the severity of the outbreak that has killed more than 207,000 in the United States and hours after insisting that “the end of the pandemic is in sight. President Trump said early Friday morning that he and the first lady have tested positive for the coronavirus, throwing the nation’s leadership into uncertainty and escalating the crisis posed by a pandemic that has already killed more than 207,000 Americans and devastated the economy.” “Tonight, @FLOTUS and I tested positive for COVID-19,” Mr. Trump wrote on Twitter shortly before 1 a.m. “We will begin our quarantine and recovery process immediately. We will get through this TOGETHER!”  The president’s physician said Mr. Trump was “well” without saying whether he was experiencing symptoms and added that the president would stay isolated in the White House for now. “The president and first lady are both well at this time, and they plan to remain at home within the White House during their convalescence,” the physician, Sean P. Conley, said in a statement without saying how long that would be. “Rest assured I expect the president to continue carrying out his duties without disruption while recovering, and I will keep you updated on any future developments.” “The president and first lady are both well at this time, and they plan to remain at home within the White House during their convalescence,” the physician, Sean P. Conley, said in a statement without saying how long that would be. “Rest assured I expect the president to continue carrying out his duties without disruption while recovering, and I will keep you updated on any future developments.”

Abbott Laboratories won Food and Drug Administration emergency clearance for its portable test for Covid-19 that will sell for just $5 and allow for “frequent mass testing” in schools and workplaces, the company said. The FDA’s “emergency use authorization” awarded to Abbott’s “BinaxNOW Covid-19 Ag Card” rapid test could be a game-changer given it turns around results within 15 minutes and could be administered in schools, workplaces and other sites. Such a test, which still requires a nasal swab by a health professional, is akin to a pregnancy test in its use of “lateral flow technology” and is about the size of a credit card. “With no equipment required, the device will be an important tool to manage risk by quickly identifying infectious people so they don't spread the disease to others,” Abbott said in announcing the FDA’s emergency use authorization. It’s the latest diagnostic test for Covid-19 that Abbott has developed. The company in March received an FDA emergency use authorization for the Abbott ID NOW Covid-19 rapid molecular “point-of-care” diagnostic test that can be used in temporary screening locations, doctor’s office labs and nursing homes to detect the Coronavirus strain COVID-19 within a half hour. But BinaxNOW is different than IDNow in that it requires “no instrumentation,” Abbott said. And the new BinaxNow includes a companion mobile app Abbott will launch for iPhone and Android devices and make available at no charge called NAVICATM” that quickly displays test results.

"The massive scale of this test and app will allow tens of millions of people to have access to rapid and reliable testing," Joseph Petrosino, professor and chairman or molecular virology and microbiology at the Baylor College of Medicine in Houston said in a statement provided by Abbott. "With lab-based tests, you get excellent sensitivity but might have to wait days or longer to get the results. With a rapid antigen test, you get a result right away, getting infectious people off the streets and into quarantine so they don't spread the virus."  Abbott said the new BinaxNOW tests will begin to be shipped by the end of the month with the company expecting to produce 50 million such tests a month by October. "We intentionally designed the BinaxNOW test and NAVICA app so we could offer a comprehensive testing solution to help Americans feel more confident about their health and lives," Abbott president and chief executive Robert Ford said. "BinaxNOW and the NAVICA app give us an affordable, easy-to-use, scalable test, and a digital health tool to help us have a bit more normalcy in our daily lives."

Early and accurate detection is critical for preventing the spread of COVID-19 and providing appropriate care for patients. Nasopharyngeal (NP) swabs, which require inserting a long shaft into the nasal cavity to collect a sample from the back of the nose and throat, are currently the gold standard for collecting a specimen for diagnosis. But the procedure is technically challenging, often uncomfortable for patients and requires personal protective equipment that may be in short supply. Other approaches to collecting specimens—including from an oropharyngeal swab and sputum—have been tested in small studies, but there is uncertainty about which method is best for detecting the virus. In a new study published in EBioMedicine, investigators from Brigham and Women's Hospital conducted a systematic review and meta-analysis, analyzing data from more than 3,000 specimens to compare the three approaches. The team found that sputum testing detected the RNA of the virus that causes COVID-19 at significantly higher rates while oropharyngeal swab testing had lower rates. Regardless of the collection method, the earlier samples were collected after symptoms began, the higher the detection rate.

"The accurate diagnosis of COVID-19 has implications for health care, return-to-work, infection control and public health," said corresponding author Jonathan Li, MD, a faculty member in the Division of Infectious Diseases at the Brigham. "Our gold standard in and out of the hospital is the nasopharyngeal swab, but there's a lot of confusion about which sampling modality is best and most sensitive. Our study shows that sputum testing resulted in significantly higher rates of SARS-CoV-2 detection and supports the use of this type of testing as a valuable method for the diagnosis and monitoring of COVID-19 patients." Li and his colleagues scoured the literature—both preprints and published papers—for studies that assessed at least two respiratory sampling sites using an NP swab, oropharyngeal swab or sputum. From more than 1,000 studies, they identified 11 that met their criteria. These studies included results from a total of 3,442 respiratory tract specimens. The team examined how often each collection method produced a positive result. For NP swabs, the rate was 54 percent; for oropharyngeal swabs, 43 percent; for sputum, 71 percent. The rate of viral detection was significantly higher in sputum than either oropharyngeal swabs or NP swabs. Detection rates were highest within one week of symptom onset for all three tests.

Study Published in EbioMedicine (July 18, 2020):

https://doi.org/10.1016/j.ebiom.2020.102903

World-first research by Monash University in Australia has been able to detect positive COVID-19 cases using blood samples in about 20 minutes, and identify whether someone has contracted the virus. In a discovery that could advance the worldwide effort to limit the community spread of COVID-19 through robust contact tracing, researchers were able to identify recent COVID-19 cases using 25 microlitres of plasma from blood samples. The research team, led by BioPRIA and Monash University’s Chemical Engineering Department, including researchers from the ARC Centre of Excellence in Convergent BioNano Science and Technology (CBNS),developed a simple agglutination assay – an analysis to determine the presence and amount of a substance in blood – to detect the presence of antibodies raised in response to the SARS-CoV-2 infection. Positive COVID-19 cases caused an agglutination or a clustering of red blood cells, which was easily identifiable to the naked eye. Researchers were able to retrieve positive or negative readings in about 20 minutes.

While the current swab / PCR tests are used to identify people who are currently positive with COVID-19, the agglutination assay can determine whether someone had been recently infected once the infection is resolved – and could potentially be used to detect antibodies raised in response to vaccination to aid clinical trials. Using a simple lab setup, this discovery could see medical practitioners across the world testing up to 200 blood samples an hour. At some hospitals with high-grade diagnostic machines, more than 700 blood samples could be tested hourly – about 16,800 each day. Study findings could help high-risk countries with population screening, case identification, contact tracing, confirming vaccine efficacy during clinical trials, and vaccine distribution....

Original study available at ACS Sensors (July 17, 2020):

https://doi.org/10.1021/acssensors.0c01050

The FDA authorized its first COVID-19 diagnostic test that allows a person to collect a simple saliva sample themselves, without leaving their home, similar to a personal DNA test. The green light expands upon a previous authorization for a test developed by Rutgers University, designed to use a person’s spit instead of a nasal swab. The agency also granted its blessing to LabCorp’s at-home swab test in late April.

“Authorizing additional diagnostic tests with the option of at-home sample collection will continue to increase patient access to testing for COVID-19,” FDA Commissioner Stephen Hahn said in a statement. “This provides an additional option for the easy, safe and convenient collection of samples required for testing without traveling to a doctor’s office, hospital or testing site.” “The FDA has authorized more than 80 COVID-19 tests and adding more options for at-home sample collection is an important advancement in diagnostic testing during this public health emergency,” Hahn added. 

Rutgers’ prescription-only molecular test currently remains as the only diagnostic authorized by the FDA to process saliva samples. After using a collection kit made by Spectrum DNA, the sealed package is then mailed to the New Jersey university’s clinical genomics lab for analysis. Previously, the university said that quickly administered, saliva-based tests could find equally important use in the field—not just in the home—by sparing healthcare workers exposure from collection methods that require them to manually swab a person’s deep nasal cavity....

Abbott on Friday announced it received approval for a test that is capable of delivering positive results of the coronavirus in as little as five minutes, and it will begin making those tests available to health care providers next week. The Food and Drug Administration issued emergency use authorization for the point-of-care test on Friday, the company said in a statement. The test can detect negative results in 13 minutes. The company said it plans to ramp up manufacturing so it can deliver 50,000 tests per day. 

“The COVID-19 pandemic will be fought on multiple fronts, and a portable molecular test that offers results in minutes adds to the broad range of diagnostic solutions needed to combat this virus,” Abbott Chief Operating Officer Robert Ford said in a statement. This is the second Abbott test for the coronavirus to be launched. Between the two, the company expects to produce about 5 million tests per month, the company said in a statement. The Lake Bluff, Illinois, company makes diagnostics, medical devices, nutritionals and medicines.

A challenge might be that clinicians, due to the personal protective equipment shortage, might not feel safe administering these tests to patients, especially those with respiratory symptoms.