The US Department of Health and Human Services on Sunday said that it is investigating a manufacturing defect in some initial COVID-19 test kits that prompted some US states to seek emergency approval to use their own test kits.
On Saturday, New York Governor Andrew Cuomo said that his state would immediately begin using its own test kit developed in-state after asking the US Food and Drug Administration (FDA) on Friday for permission to do so.
The FDA on Saturday said that it would allow some laboratories to immediately use tests they have developed and validated to achieve more rapid testing capacity for the coronavirus.
On Sunday, New York confirmed its first case of the disease.
FDA Commissioner Stephen Hahn said in a statement on Sunday that “upon learning about the test issue from CDC [the US Centers for Disease Control and Prevention], FDA worked with CDC to determine that problems with certain test components were due to a manufacturing issue. We worked hand in hand with CDC to resolve the issues with manufacturing.”
US Health and Human Services Secretary Alex Azar on Sunday told ABC’s This Week that the US has 75,000 test kits on hand “and over the next week that will expand radically.”
More than 3,600 people in the US have been tested, Azar said.
Hahn said that the “FDA has confidence in the design and current manufacturing of the test that already have [been] and are continuing to be distributed.”
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