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FDA issues warning letters to four companies for sale of HIV self-collection blood tests

Photo of a finger prick blood test with blood drop on thumb
Photo: Smith Collection/Gado/Getty Images

Kevin Kinsella

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The federal regulator contends the four biologics firms lack appropriate testing and marketing authorization.

The US Federal Drug Administration (FDA) has issued near-identical warning letters to four biologics companies regarding their at-home blood testing kits, citing concerns over safety and reliability.

The agency alleges that the businesses were providing human immunodeficiency virus (HIV) serological diagnostic dried blood spot (DBS) card self-collection kits (HIV DBS

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