FDA releases guidance on viral transport media for labs, manufacturers

2020 07 22 00 08 9493 Regulation Wheel 400

The U.S. Food and Drug Administration (FDA) has issued guidance for clinical laboratories and commercial manufacturers on transport media for specimens being tested with molecular or antigen assays for the novel coronavirus during the pandemic.

The agency explained that the guidance, which includes recommendations for validation of products, will help expand the availability of transport media for clinical specimens. It comes as laboratories are continuing to report shortages of the supplies needed to conduct diagnostic testing for the novel coronavirus. Some labs have reported that they were migrating to normal saline as a transport media, due to the problems in the supply chain.

The guidance applies to products used to stabilize and transport clinical specimens, usually obtained on swabs, and used with molecular or antigen assays designed to measure nucleic acids, antigens, and other viral markers. It addresses viral transport media, sterile phosphate buffered saline, and sterile normal saline.

Policy outlined in the document will stay in effect for the public health emergency, the duration of which is determined by the U.S. Department of Health and Human Services. The agency has also added information about viral transport media on a list of frequently asked questions on its website.

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