8th April 2020 Editorial by: Paul Carton
10-minute Point-Of-Care Serology Test used by China CDC will be sold in US
A handheld serological test that was used by the Chinese Centre of Disease Control to aid in the diagnosis of suspected COVID-19 patients is to be sold in the U.S. after a change in FDA Guidelines.
The FDA has been reluctant to give Emergency Use Authorisation (EUA) for serology tests, to prevent the tests be used as the sole basis for diagnosis. However, they are allowing the sale of such kits, without EUA, as long as they are used as an aid for diagnosis and not standalone.
The BioMedomic's point-of-care IgM-IgG Combined Antibody Test for COVID-19 is an immunochromatography-based lateral flow assay that takes human serum, plasma or whole blood in vitro.
It requires no special equipment and will be distributed by Becton Dickinson (BD). BioMedomics has notified the FDA of its intention to market the test in the U.S. without seeking an official emergency authorization.
BD said it will make the test available this month and plans to supply more than 1 million tests in the future. BioMedomics described the test's accuracy as having a sensitivity of 88.66%, and a specificity of 90.63%.
Date Published: 8th April 2020
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