EXTON, PA — Megna Health announced that its Rapid COVID-19 IgM/IgG Test, previously authorized for use under the U.S. Food and Drug Administration (FDA) Emergency Use Authorization, is now available for Point of Care Settings. The test can now be administered in CLIA-waived settings using fingerstick whole blood to detect COVID-19 antibodies.
The results of IgM and IgG are produced in 15 minutes using fingerstick whole blood and no additional equipment needed. CLIA-waived facilities may include doctors’ offices, pharmacies, urgent care centers, nursing home facilities, etc.
The product is intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection. At this time it is unknown for how long antibodies persist following infection and if the presence of antibodies confers protective immunity.
“This is the next step of several in the Megna Health pipeline to increase access to affordable rapid testing. Megna Health is proud to be headquartered and manufactured in the United States and employ Americans when the country needs it the most,” said Bret Anderson, Vice President of Sales and Marketing at Megna Health. “Increasing the supply and access to accurate and affordable rapid testing will be one of the keys to safely reopening businesses, schools, travel and entertainment venues.”
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