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Juan Lama
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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
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Juan Lama
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Background Early in the COVID-19 pandemic, peak viral loads coincided with symptom onset. We hypothesized that in a highly immune population, symptom onset might occur earlier in infection, coinciding with lower viral loads. Methods We assessed SARS-CoV-2 and influenza A viral loads relative to symptom duration in symptomatic adults (>16y) presenting for testing in Georgia (4/2022-4/2023; Omicron variant predominant). Participants provided symptom duration and recent testing history. Nasal swabs were tested by Xpert Xpress SARS-CoV-2/Flu/RSV assay and Ct values recorded. Nucleoprotein concentrations in SARS-CoV-2 PCR-positive samples were measured by Single Molecule Array. To estimate hypothetical antigen rapid diagnostic test (Ag RDT) sensitivity on each day after symptom onset, percentages of individuals with Ct value <30 or <25 were calculated. Results Of 348 newly-diagnosed SARS-CoV-2 PCR-positive individuals (65.5% women, median 39.2y), 317/348 (91.1%) had a history of vaccination, natural infection, or both. By both Ct value and antigen concentration measurements, median viral loads rose from the day of symptom onset and peaked on the fourth/fifth day. Ag RDT sensitivity estimates were 30.0-60.0% on the first day, 59.2-74.8% on the third day, and 80.0-93.3% on the fourth day of symptoms. In 74 influenza A PCR-positive individuals (55.4% women; median 35.0y), median influenza viral loads peaked on the second day of symptoms. Conclusions In a highly immune adult population, median SARS-CoV-2 viral loads peaked around the fourth day of symptoms. Influenza A viral loads peaked soon after symptom onset. These findings have implications for ongoing use of Ag RDTs for COVID-19 and influenza. Published in Clinical Infectious Diseases (Sept. 28, 2023): https://doi.org/10.1093/cid/ciad582
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Juan Lama
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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....
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Juan Lama
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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. Ellume, which was awarded a $30 million grant from the National Institutes of Health, said it planned to manufacture and deliver about 20 million home coronavirus tests to the United States within the first half of 2021. Each kit, which tests a single swab sample, is expected to cost about $30 or less, said Bella Zabinofsky, a spokeswoman for the company. In a statement, the F.D.A. commissioner Dr. Stephen M. Hahn called Ellume’s authorization “a major milestone in diagnostic testing for Covid-19” in light of the coronavirus’s persistent grip on the nation. The product will be available in drugstores, Dr. Hahn noted, and gives Americans “more testing options from the comfort and safety of their own homes.” Ellume’s test works best in people with Covid symptoms. In people without symptoms, the product’s accuracy dropped a bit, finding 91 percent of the coronavirus infections discovered by P.C.R. Dr. Valerie Fitzhugh, a pathologist at Rutgers University, noted that all of the study’s false positives occurred in the asymptomatic group. That “does make me a little nervous,” Dr. Fitzhugh said. False positives could send people into unnecessary periods of isolation or erode trust in testing, among other issues. In a statement announcing Ellume’s emergency clearance, the F.D.A. underscored the importance of recognizing false positive and false negative results, both of which are more common with antigen tests. People without symptoms who test positive, the agency said, should confirm their results with another test, especially if the coronavirus is scarce in their community. When very few people in a region are infected, the number of false positives yielded by tests can outnumber true positives. Still, in broad strokes, “the performance looks better than what we’ve seen for other antigen tests,” said Susan Butler-Wu, a clinical microbiologist at the University of Southern California’s Keck School of Medicine. The test’s price tag — compared with some competitors that cost just $5, for example — and limited availability will likely restrict it from very frequent use, Dr. Butler-Wu said. But in single-use contexts, “what’s really exciting is, it allows me to get a really quick answer if I’m feeling unwell. To me, that’s the most powerful thing.” FDA EUA Letter (Dec. 15, 2020): https://www.fda.gov/media/144457/download
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