Some Chinese-made COVID-19 antibody tests being used in the U.S. were not approved by China's FDA. China has now barred their export.
Officials across the country are racing to provide coronavirus tests to diagnose infections and to identify recovered patients with antibodies that may help others battle COVID-19, the disease it causes.
Story continuesIn the meantime, Becker said, any U.S. companies that are selling tests to public health agencies should push to have the FDA evaluate them in the multi-agency study. On April 2, the NMPA published its most recent list of approved COVID-19 test manufacturers after a March 31 announcement from China's Commerce Ministry restricted the export of medical materials. The ministry said its restrictions aimed"to strictly control quality, maintain export order, and crack down on counterfeit and shoddy products."
Josh Disbrow, chief executive of Aytu, confirmed by phone that Zhejiang Orient's tests have not been approved by the NMPA. He emphasized that the tests have been validated in a study by third-party clinical researchers. After publication of this article, a lawyer for Premier contacted NBC News to stress that the tests were lawfully exported from China and are “lawfully on the U.S. market under FDA’s COVID-19 policy.” The lawyer also said that the “diagnostic has been validated by testing as per FDA’s policy.”
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