Carolina Liquid Chemistries Corp. Continues to Add to its Point-of-Care Product Offering with the FDA Emergency Use Authorized Status™ COVID-19/Flu A&B Combo Test
23 Mar, 2021, 12:10 ET
GREENSBORO, N.C., March 23, 2021 /PRNewswire/ -- Carolina Liquid Chemistries Corp. announces the most recent addition to their Point-of-Care product line. Carolina Liquid Chemistries Corp. now has the Emergency Use Authorized Status™ COVID-19/Flu A&B Combo Test from LifeSign, a Princeton BioMeditech Group Company. The Status™ COVID-19/Flu A&B Combo Test is a lateral flow immunoassay intended for the in vitro rapid, simultaneous qualitative detection and differentiation of nucleocapsid antigen from SARS-CoV-2, Influenza A, and Influenza B directly from nasopharyngeal swab specimens obtained from individuals, who are suspected of respiratory viral infection consistent with COVID-19 and/or influenza by their healthcare provider, within the first five days of onset of symptoms. It is intended to aid in the rapid differential diagnosis of SARS-CoV-2, Influenza A, and B viral infections.
Influenza is a highly contagious acute viral infection of the respiratory tract. It is a communicable disease easily transmitted from person to person through aerosol droplets excreted when sneezing or coughing. An accurate diagnosis of influenza based on clinical symptoms is difficult because the initial symptoms of influenza are similar to those of numerous other illnesses. Early differential diagnosis of Influenza type A or type B can allow for proper treatment with appropriate antiviral therapy while reducing the incidence of inappropriate treatment with antibiotics. Early diagnosis and treatment are of particular value in a clinical setting where an accurate diagnosis can assist the healthcare professional with the management of influenza patients who are at risk for complications.
The ongoing COVID-19 pandemic has infected millions of people worldwide. To respond effectively to the COVID-19 outbreak, rapid detection of cases, stringent performance assessment, and increase in the current diagnostic capacity are still urgently needed. As the early symptoms of COVID-19 are similar to those of seasonal Influenza A or B, a rapid detection test to specifically diagnose symptomatic patients is urgently needed. The Status™ COVID-19/Flu A&B Combo Test is intended to aid in the rapid differential diagnosis of Influenza A, B, and SARS-CoV-2 viral infection.
Phil Shugart, CEO of Carolina Liquid Chemistries Corp., comments, "I am so proud of our business development team for continuing to onboard excellent products. The Status™ COVID-19/Flu A&B Combo Test is a vital combination test for the current market. Anytime we can make testing easier, faster, less expensive, and more efficient for the patient and provider, we know we are doing our job."
This test has not been FDA cleared or approved, but has been authorized by FDA under an EUA for use by authorized laboratories; This test has been authorized only for the detection of proteins from SARSCoV-2, influenza A and influenza B, not for any other viruses or pathogens; and, The emergency use of this test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), unless the declaration is terminated or authorization is revoked sooner.
About Carolina Liquid Chemistries Corp.
Headquartered in Greensboro, NC, Carolina Liquid Chemistries Corp. (CLC) is an FDA registered manufacturer, re-packager, re-labeler and value-added reseller of chemistry systems and reagents, as well as COVID-19 tests and supplies. CLC helps clinical laboratories of all sizes reduce chemistry analyzer and reagent costs, while also receiving accurate and timely results. The company has responded to the COVID-19 pandemic by providing various testing products and supplies to market under the FDA's Emergency Use Authorization. For more information, visit carolinachemistries.com or email [email protected].
SOURCE Carolina Liquid Chemistries
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