Biohit lands EUA approval
CHARLOTTE, N.C., June 23, 2020 /PRNewswire/ -- It's official. Biohit's Sars-CoV-2 IgM/IgG antibody test kit has just been authorized by FDA under a EUA (Emergency Use Authorization) for use in laboratories certified by CLIA (Clinical Laboratory Improvement Amendments of 1988).
EUA authorization is given only to products that have met FDA's rigid criteria showing these tests may be effective in detecting recent or prior infection by identifying individuals with an adaptive immune response to the virus that causes COVID-19 disease.
In an independent study by a FDA-designated agency using frozen positive and negative antibody serum samples, the SARS-CoV-2 IgM/IgG Antibody Test Kit from Biohit Healthcare was estimated to show a very high IgM and IgG sensitivity as well as a very high specificity. It also is a rapid test, giving you results within minutes.
For critically ill COVID-19 patients, the FDA has authorized the transfusion of convalescent plasma (CP) to improve the patient's outcome. CP obtained from former COVID-19 patients who have been free of symptoms for more than 14 days, has shown to be extremely effective in helping the seriously ill recover.
"The utilization of the Biohit SARS-CoV-2 IgM/IgG antibody test kit can play an integral role in the selection of CP donors," says Frederick M. Schaffer M.D., Board certified Immunologist, formerly an Associate Professor at the Medical University of South Carolina. "CP is thought to diminish the morbidity and mortality associated with COVID-19 infections," he adds.
Another advantage of knowing whether you have had COVID-19 (or not) is social interaction. A study completed by Yale University, New Haven, presumes widespread access to diagnostic tests will be critical for restoring social normality and mitigating the harmful impact of the virus. In particular, diagnostic tests for immunological status, which measure IgG and IgM antibody responses, may provide essential information about an individual's past exposure to SARS-CoV-2 while also assessing the risk for subsequent infection.
According to the Yale study most currently available tests require complex laboratory settings; yet because 80% of all infected individuals may be asymptomatic, a reliable and easy-to-use diagnostic test is desirable for deployment among the general population.
Because of these reasons and its strong performance in pilot studies, Yale reported for the American patients studied, an IgM specificity of 97.6% and sensitivity of 100%. The Yale study also reported that the IgG specificity and sensitivity were each 100%.
In respect to Biohit, this study concluded, "Overall, this LFA (lateral flow immunoassay) shows promise for use as a mobile diagnostic tool, and underscores the potential utility of such a simple and cost-effective assay for cataloging epidemiological data like prevalence and past infection status."
More than six million EUA-authorized Biohit test kits are in the pipeline today and ready to go out with delivery within just a few days.
For more information and to order contact: biotestingsupplies.com
* Note: Yale University study: https://www.medrxiv.org/content/10.1101/2020.05.25.20112227v1.full.pdf
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