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New blood test is designed to reduce the number of false positive results and provide improved diagnostic guidance in Systemic Lupus Erythematosus [26-August-2021] PORTAGE, Mich., Aug. 26, 2021 /PRNewswire/ -- Thermo Fisher Scientific EliA SmDP-S test has been cleared by the U.S. Food & Drug Administration (FDA) for aiding the diagnosis of Systemic Lupus Erythematosus (SLE), the most common type of lupus. This new test enhances specificity without sacrificing sensitivity, leading to a more precise diagnosis while also reducing the number of false positives1. "Diagnosing autoimmune diseases is often challenging," said Dr. Henry Homburger, Professor Emeritus of Laboratory Medicine at Mayo Clinic College of Medicine. "Existing serologic tests have less than ideal diagnostic specificity for SLE. With the new EliA SmDP-S assay, clinicians can have greater confidence for differentiating SLE from mixed connective tissue disease, because of the improved immuno-chemical specificity. This innovative test in turn, has the potential to improve treatment and outcomes for patients with SLE." The EliA SmDP-S utilizes an advanced coating technique optimized for binding the synthetic SmD3 peptide antigen, which contains the most specific epitope for Sm peptide antibodies. Antibodies that react with SmD3 peptide do not cross react with other Sm peptides, which improves the specificity of this test for distinguishing SLE from MCTD2. "The new EliA SmDP-S replaces the former SmDP test to become a best-in-class test for the detection of Sm antibodies, providing clinicians with a higher degree of diagnostic confidence," said Dr. Homburger. "With its improved specificity, EliA SmDP-S could be used to further evaluate potential associations with systemic complications, including nephritis." For more information on the Thermo Scientific EliA SmDP-S test, please visit A bou t Thermo Fisher Scientific Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $30 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, improving patient diagnostics and therapies or increasing productivity in their laboratories, we are here to support them. Our global team of more than 80,000 colleagues delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services and Patheon. For more information, please visit . Mahler M et al. Improved Serological Differentiation between Systemic Lupus Erythematosus and Mixed Connective Tissue Disease by Use of an SmD3 Peptide-Based Immunoassay. Clin and Diag Lab Immunol. Jan. 2005, p. 107-113. (LINK) Mahler M et al. Identification of a SmD3 epitope with a single symmetrical dimethylation of an arginine residue as a specific target of a subpopulation of anti-Sm antibodies. Arthritis Res Ther 2005, 7:R19-R29. (LINK) Media Contact Information Angela Christoforos Greenough (for Thermo Fisher) 508-801-2391 achristoforos@greenough.biz

BinaxNOW is the most studied and widely available rapid antigen test in the U.S. Abbott headquarters. (Credit: Abbott.) Abbott (NYSE: ABT) announced today it began shipping its BinaxNOW™ COVID-19 Ag Self Test to retailers across the country. Consumers can expect the test to be available in the next few days online and in some stores. Broader nationwide availability is expected in the next two weeks as tests work their way through distribution channels. The BinaxNOW Self Test initially will be available at CVS Pharmacy, Walgreens and Walmart as part of Abbott’s commitment to get the country’s most studied COVID-19 rapid test to as many Americans as possible. The test, which can be purchased over the counter without a prescription, will then roll out to other major food, drug and mass merchandisers in the weeks ahead. “Over the past year, Abbott has developed high-quality rapid testing and invested in U.S. facilities to scale up manufacturing so we could bring affordable testing to Americans on a mass scale,” said Robert B. Ford, president and chief executive officer, Abbott. “We’re pleased to be working with the country’s leading retailers to provide broad access to this affordable test so that it gets out into the communities that need it most.” Abbott will manufacture tens of millions of BinaxNOW Self Tests per month and can further scale capacity based on demand. Abbott can also work with retailers to prioritize distribution to areas of the country where the virus is surging as additional supply comes online. The BinaxNOW Self Test will be sold in 2-count packs for an MSRP of $23.99, making it the most affordable OTC COVID-19 rapid test available in the U.S. Abbott is the only manufacturer in the U.S. that has Emergency Use Authorization (EUA) for a COVID-19 self test that can provide tests immediately at this scale. “Let’s not back down on testing, let’s double down on it,” said Thomas Quinn, M.D., professor of medicine and pathology at the Johns Hopkins School of Medicine. “As long as COVID remains unpredictable, there’s an important role for the corner pharmacy and the central lab to tackle this virus in tandem, which gives this country the best chance to detect and screen for COVID-19.” The CDC advises that “a robust and responsive testing infrastructure is essential to our success in stopping the spread of SARS-CoV-2” and provides guidance on the important role both PCR tests and rapid antigen tests play in detecting infections and screening individuals. Abbott will continue bringing accessible testing options and lead the U.S. in supplying COVID-19 tests for use in labs, at the point of care, and now over the counter. Proven testing technology now broadly available On March 31, Abbott announced that it received FDA EUA for over-the-counter, non-prescription, symptomatic and asymptomatic use of its BinaxNOW™ COVID-19 Ag Self Test for detection of COVID-19 infection. This new indication allows individuals with or without symptoms to have access to this test without a prescription, bringing the country’s most extensively studied and widely used rapid antigen test to nearly everyone in the U.S. The test will come in a two-count pack to meet serial (frequent) testing requirements. The BinaxNOW Self Test uses the same technology as the existing BinaxNOW test that has been available since August 2020 but is now indicated by the FDA for serial symptomatic and asymptomatic testing, meaning that people should test themselves frequently. The test can be used on children as young as two years old when samples are collected by an adult and for all people aged 15 years or older. Using the BinaxNOW Self Test will be simple, even for people who have never tested themselves. People will only need to perform a minimally invasive nasal swab (not the deep nasopharyngeal swab) and all materials required to perform the test (swab, test card, and reagent solution) will come in the box. With results in just 15 minutes, the BinaxNOW Self Test lets people who test positive immediately isolate so that they do not infect others, rather than waiting days for results from a lab or send-away at-home tests. Abbott launched the BinaxNOW professional test nationwide in August 2020 and scaled up production at its new U.S. manufacturing facilities to produce 50 million tests per month. The U.S. Department of Health and Human Services (HHS) purchased the company’s first 150 million tests, sending them to K-12 schools, nursing homes, historically black colleges and universities, and underserved communities, where they remain in use today and serve as a powerful tool to help prevent the virus from spreading. Since its original authorization in August 2020, the BinaxNOW COVID-19 professional use test has gone on to be used by workplaces, additional universities and other organizations throughout the country. Source: Company Press Release