By Gretchen Morgenson
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.
But some COVID-19 antibody tests, including those being used by public health departments in Denver and Los Angeles and provided to urgent care centers in Maryland and North Carolina, were supplied by Chinese manufacturers that are not approved by China's Center for Medical Device Evaluation, a unit of the National Medical Product Administration, or NMPA, the country's equivalent of the U.S. Food and Drug Administration, NBC News has found.
Two U.S. companies — Premier Biotech of Minneapolis and Aytu Bioscience of Colorado — have been distributing the tests from unapproved Chinese manufacturers, according to health officials, FDA filings and a spokesman for one of the Chinese manufacturers. Many of the unapproved tests appear to have been shipped to the U.S. after the FDA relaxed its guidelines for tests in mid-March and before the Chinese government banned their export just over two weeks later.
If COVID-19 antibody tests are unreliable, they can produce false results, either negative or positive, health officials said. The use of such tests has been widely discussed as a way to ensure that employees are healthy enough to go back to work and to find COVID-19 survivors who may be able to provide blood plasma to severely ill patients.
Officials at the Association of Public Health Laboratories have expressed concern about the reliability of the numerous antibody tests being sold or used across the country with little scrutiny. Scott Becker, the association's chief executive, told NBC News that FDA officials are working with the Centers for Disease Control and Prevention, the National Institutes of Health and the Biomedical Advanced Research and Development Authority to evaluate the performance of the tests.
In 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.
Not on the list
The FDA moved to accelerate and expand the availability of COVID-19 diagnostic tests after coming under criticism for the slow pace of test approval in the U.S.
On March 16, after the Department of Health and Human Services said the pandemic justified the authorization of emergency use of diagnostics for detection and diagnosis, the FDA relaxed its policies, allowing tests to be sold even if it had not approved them.
In China, the NMPA has been reviewing COVID-19 test kits since January to ensure that they "meet the requirements of 'safety, effectiveness and quality control,'" according to the NMPA website. A U.S. expert said the Chinese agency is considered "rigorous" and "demanding" in its oversight of products.
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."
Tests made by two Chinese manufacturers, Hangzhou Biotest Biotech Co. and Zhejiang Orient Gene Biotech, are not on the approved list, but they are being sold in the U.S.
There is no indication that either test is unreliable.
Hangzhou Biotest Biotech, for example, provides U.S.-based Premier Biotech's COVID-19 tests, according to the FDA website. Premier supplied tests to the Los Angeles County Public Health Department, which teamed up with the University of Southern California for a comprehensive antibody testing study that began this month.County officials hope the study will show how deadly the coronavirus is and demonstrate the effectiveness of strategies like social distancing and wearing masks.
Julie Labich, a spokeswoman for USC, did not provide a comment when asked about the Premier test's lack of approval by the NMPA. A spokesman for Los Angeles County did not respond to a request for comment.
Zhejiang Orient Gene Biotech supplies U.S.-based Aytu Bioscience with a COVID-19 test that has not been approved, according to Bryan Fang, a spokesman for Healgen Scientific, the U.S. subsidiary of Zhejiang Orient in Houston.
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.
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While that study showed a satisfactory performance of the test, the researchers said that their findings were limited and that results for the Zhejiang Orient tests needed to be compared with results from other antibody tests to gauge performance.
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