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 

The emergence of the SARS-CoV-2 Omicron variant has motivated a re-evaluation of the test characteristics for lateral flow immunochromatographic assays (LFIAs), commonly referred to as rapid antigen tests. To address this need, we evaluated the analytic sensitivity of one of the most widely used LFIAs in the US market, the Abbott BinaxNOW COVID-19 Ag At-Home Card using 32 samples of Omicron and 30 samples of the Delta variant. Samples were chosen to intentionally over-represent the range of viral loads where differences are most likely to appear. We found no changes in the analytic sensitivity of the BinaxNOW assay by variant even after controlling for variation in cycle threshold values in the two populations. Similar to prior studies, the sensitivity of the assay is highly dependent on the amount of virus present in the sample. While the analytic sensitivity of the BinaxNOW LFIA remains intact versus the Omicron variant, its clinical sensitivity is influenced by the interaction between viral replication, the dynamics of tissue tropism and the timing of sampling. Further research is necessary to optimally adapt current testing strategies to robustly detect early infection by the Omicron variant to prevent transmission.

Preprint available in medRxiv (Jan. 11, 2022):

https://doi.org/10.1101/2022.01.10.22269033 

A new study raises significant doubts about whether at-home rapid antigen tests can detect the Omicron variant before infected people can transmit the virus to others. The study looks at 30 people from settings including Broadway theaters and offices in New York and San Francisco where some workers were not only being tested daily but were, because of rules at their workplaces, receiving both the antigen tests and a daily test that used the polymerase chain reaction, or PCR, which is believed to be more reliable. On days 0 and 1 following a positive PCR test, all of the antigen tests used produced false-negative results, even though in 28 of the 30 cases, levels of virus detected by the PCR test were high enough to infect other people. In four cases, researchers were able to confirm that infected people transmitted the virus to others during the period before they had a positive result on the rapid antigen test. “I think that with every new variant that comes, scientists have to question whether the things that were previously true are still true,” said Blythe Adamson, the lead author of the paper and the principal epidemiologist at Infectious Economics in New York. “This one has a different way it travels, a different mechanism of action of symptoms, it has different windows of transmission.”  Adamson, who is also an employee of Flatiron Health, an affiliate of Roche, said that it was also possible there were more cases of transmission than the authors were able to confirm.

“It’s absolutely likely there were many more than four transmissions,” Adamson said. “We named four because there were four that were confirmed through contact tracing and epidemiology investigation. There were likely many more.” The study included both the Abbott BinaxNOW and Quidel QuickVue rapid antigen tests, both of which are authorized by the Food and Drug Administration. The results were published in a preprint, meaning they have not yet been reviewed by outside researchers.  The results mean that rapid tests — both Abbott BinaxNOW and Quidel QuickVue — aren’t catching people during their first couple days of infection. “We know that PCR tests are more sensitive than antigen tests — this is not new information,” Abbott Laboratories said in a statement.  “We also know that PCR tests are so sensitive that they do not indicate infectiousness and thus are not a practical tool for keeping the workforce and economy moving.” Despite its small size, the results in the study are remarkably consistent. Not a single rapid antigen test detected the virus until nearly two days after the initial positive PCR result. Additionally, the cases of infection from people who had received false negative results could raise alarm bells. Daniel Larremore, an assistant professor of computer science at the University of Colorado Boulder who has studied Covid testing, said the results show rapid tests are not catching cases during the first days of infection.

Meanwhile, people are facing hour-long lines for PCR tests and multiple-day waits for results. “[The] results strongly suggest that we will be unable to effectively test our way out of the current surge, even if we each had a week’s supply of rapid tests on the counter,” Larremore said. He was not involved with this study. Other data from the group indicate that viral loads peaked in saliva one to two days before they peaked in tests taken from nasal swabs, adding to evidence that swabs taken from the mouth or throat may detect the SARS-CoV-2 that causes Covid better than the nasal swabs used for many PCR and antigen tests. “The major unknown is what it has been for weeks now: Are the [rapid antigen tests] inherently less able to detect Omicron, or is there less Omicron to detect on nasal swabs?” asked John Moore, a professor of microbiology and immunology at Weill Cornell Medical College. He noted that a paper from South Africa had also shown that there was more virus in saliva than in the nose. “Does it replicate more in the throat/mouth and hence accumulates in saliva, more than it does in the nose and is present on nasal swabs?” Moore asked. “Remember that Omicron infections are not generally causing loss of smell, which happens when the virus damages nasal tissue and the nerves within the tissues. Is that another indicator of less replication in the nose?” At this point, researchers see riddles, not solutions. However, many emphasize, this does not mean that rapid antigen tests are not useful. The tests also detected the virus in every case – it just took longer than with PCR. So while the tests may not work as an early warning, a positive test result at home does likely mean that the person taking the test has Covid-19.

Anne Wyllie, a researcher at the Yale School of Public Health and a co-author on the paper, said that the reports she is seeing from the general public on social media also raise her level of concern. “If the general public is seeing this and reporting on it, you know, this is also a lot of evidence for me,” Wyllie said. “Like they’re actually seeing it. This is a lot more widespread than just this one outbreak that we were observing.” During the pandemic, Adamson and Infectious Economics became consultants to many Broadway productions that were trying to keep their staffs safe from Covid. The risk to audiences was relatively easy to control, but cast and crew members worked in cramped quarters where lots of safety precautions, including vaccination, masking, and the use of rapid tests were all necessary to keep people safe. She said that as soon as Omicron hit, there were anecdotes about rapid antigen tests remaining negative until days after the infected people had already developed symptoms. She said she started to feel anxiety about whether precautions to keep cast members safe would be enough. Since then, numerous Broadway shows, including “Waitress” and “Jagged Little Pill,” have announced Covid-related closures.

Cited Findings Available at medRxiv (Jan. 5, 2022):

https://doi.org/10.1101/2022.01.04.22268770 

Rapid antigen tests for the coronavirus are faster, cheaper and more user-friendly than standard diagnostic assays. An assessment now shows that some antigen tests — but not all — can tell with high accuracy who is likely to be most infectious. Antigen-based assays detect specific proteins, or antigens, on the surface of SARS-CoV-2 particles. Christian Drosten at the Charité — University Hospital Berlin and his colleagues analysed the performance of seven commercially available rapid antigen tests. The researchers applied the tests to a range of samples, including dozens of swabs from people who had already tested positive for SARS-CoV-2 or for other respiratory viruses using the gold-standard polymerase chain reaction test (V. M. Corman et al. Preprint at medRxiv https://doi.org/ghj3wt; 2020).

The five most sensitive antigen assays detected the presence of SARS-CoV-2 on 95% of the test runs for samples with concentrations of viral genetic material that ranged between the equivalent of 3.4 million and 74 million copies per millilitre of swab. Such high viral levels are observed during the first week of symptoms, when people are likely to spread the virus to others. The findings have not yet been peer reviewed.

Study cited available as preprint in medRxiv (November 13, 2020):

 https://doi.org/10.1101/2020.11.12.20230292

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....

The US Food and Drug Administration announced it has authorized the use of the first rapid diagnostic test that could detect the novel coronavirus in approximately 45 minutes. The authorization was made Friday and tests will begin shipping next week, according to a statement from California-based Cepheid, the company manufacturing the tests. "During this time of increased demand for hospital services, Clinicians urgently need an on-demand diagnostic test for real-time management of patients being evaluated for admission to health-care facilities," said Dr. David Persing, MD, Ph.D., chief medical and technology officer at Cepheid.

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....

A new study adds to evidence that common rapid tests may fail to detect some Omicron cases in the first days of infection.  A small, new real-world study suggests that two widely used at-home antigen tests, the Abbott BinaxNOW and Quidel QuickVue, may fail to detect some Omicron infections even when people are carrying high levels of the coronavirus. The study, which has not yet been peer-reviewed, focused on 30 people infected with the virus at five workplaces that experienced what were most likely outbreaks of the Omicron variant in December. The people received both saliva-based P.C.R. tests and rapid antigen tests using nasal swabs. It took three days, on average, for people to test positive on a rapid antigen test after their first positive P.C.R. result. In four cases, people transmitted the virus to others while the rapid test showed the negative result, according to the study, which was conducted by several members of the Covid-19 Sports and Society Working Group. It is not clear whether the infections were missed because the antigen tests are inherently less sensitive to Omicron or because saliva tests may be better at detecting the new variant. But the results are consistent with other preliminary evidence that the at-home tests that many Americans have come to rely on — at least as currently administered, with a nasal swab — may fail to detect some Omicron cases in the first days of infection. The researchers said they shared their results with federal officials — including at the White House, the Food and Drug Administration and the Centers for Disease Control and Prevention — in real-time, as the outbreaks were occurring last month. “They’re aware that there are flaws with antigen testing,” said Dr. Robby Sikka, an author of the study and chair of the working group. The study comes a week after the Food and Drug Administration released its own update on the effectiveness of the rapid antigen tests. “Early data suggests that antigen tests do detect the Omicron variant but may have reduced sensitivity,” the agency said. Many of the studies are early and small, and much more data is needed. The tests, which can deliver results at home in minutes, remain an important public health tool, and positive results are especially likely to be informative, many scientists said. (The wait for P.C.R. results can stretch for days.) “The message is not that we should stop using these tests,” said Isabella Eckerle, a clinical virologist at the University of Geneva in Switzerland. But people should be cautious about interpreting negative results, especially when they have symptoms or believe they may have been exposed to the virus. “It’s not a ticket that allows you to go back to normal or to drop any other measures,” Dr. Eckerle said.

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.

The rapid tests for hospitals and care homes will distinguish between Covid-19 and seasonal illness. The "on-the-spot" swab and DNA tests will help distinguish between Covid-19 and other seasonal illnesses, the government said. The health secretary said this would be "hugely beneficial" over the winter.

Currently, a third of tests take longer than 24 hours to process. The announcement comes as the government pushed back a July target to regularly test all care home staff and residents - a key move to identify so-called silent spreaders, those who are infected but do not show symptoms. This is unlikely to be achieved until September because the number of testing kits has become more limited. The government said almost half a million of the new rapid swab tests, called LamPORE, will be available from next week in adult care settings and laboratories, with millions more due to be rolled out later in the year. Additionally, thousands of DNA test machines, which have already been used in eight London hospitals and can analyse nose swabs, will be available across NHS hospitals from September.

Around 5,000 machines, supplied by DnaNudge, will provide 5.8 million tests in the coming months, the Department for Health said. There is currently no publicly available data on the accuracy of the new tests. But Sir John Bell, Regius Professor of Medicine at Oxford University, who has been advising the government on tests, said they produced the same "sensitivity" as the current lab-based tests. The breakthrough on testing is important for a number of reasons - not just because one has the ability to test for flu and other viruses too. Firstly, speed. The fact the tests do not have to be sent off to a lab means the processing times are much quicker. In hospital, most tests - 9 in 10 - are currently turned around in 24 hours. But those done in the community via regional drive-through centres, using postal kits and mobile units, tend to take longer because they have to be sent away to labs for processing...

The startup says its compact, point-of-care test can deliver rapid results, compared with hours or days at centralized labs. Mesa Biotech, a privately held San Diego startup that designs point-of-care flu tests, has received emergency authorization from federal authorities to provide a molecular test for the COVID-19 coronavirus. The company, which employs 50 workers, said its palm-size COVID-19 tests deliver results in as little as 30 minutes. That is significantly faster than the hours or days it can take to get results from centralized labs. The U.S. Food and Drug Administration authorized Mesa’s test for use in moderate to highly complex medical labs, as well as other health settings with trained professionals such as emergency rooms or clinics, said Steven Sepulveda, a vice president of global business development. “What they wanted to do was really broaden where (testing) is done,” said Sepulveda. “Now it is done in central labs. This gets it closer to the patient, in the ER, etc.”

Mesa is the second point-of-care test provider to receive FDA emergency authorization for COVID-19. Cepheid, a Bay Area subsidiary of global life sciences firm Danaher, gained approval for its a 45-minute test last week. Delays in testing have hindered the fight against the coronavirus pandemic in the U.S. Efforts to break the bottleneck include bringing more coronavirus tests from private companies to the fight. Several diagnostic companies with operations in the San Diego region, including GenMark Diagnostics, Quidel Corp., Hologic and Thermo Fisher, recently received emergency approval to provide coronavirus tests to labs. Mesa designed its rapid test with the help of a $561,000 contract from the U.S. Department of Health and Human Services. The company already has approved point-of-care tests for Flu A/B available in the U.S. through a distribution partnership with Sekisui Diagnostics. Mesa said it is ready to ship coronavirus tests immediately under the Accula brand name, though the volume of available tests was not disclosed....

Company's Press Release (March 24, 2020):

https://www.mesabiotech.com/news/euacoronavirus

FDA Approval Letter (March 23, 2020):

https://www.fda.gov/media/136345/download