COVID-19 Business Intelligence and Analysis for Clinical Laboratories, Pathology Groups and Hospital Administration

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FDA Tightens Requirement for COVID-19 Convalescent Plasma Testing and Use

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New changes to FDA guidelines for convalescent plasma eliminate the use of low-titer COVID-19 convalescent plasma

The US Food and Drug Administration (FDA) issued a revision of the emergency use authorization (EUA) for the use of COVID-19 convalescent plasma. The initial EUA, released in August 2020, allowed for the use of both high-titer and low-titer plasma, although plasma testing was required to distinguish between the different antibody levels. The revision now only permits the use of high-titer convalescent plasma when treating COVID-19

“Based upon data from new clinical trials analyzed or reported since the original EUA was issued in August 2020, we have revised the EUA to limit the authorization to the use of high titer COVID-19 convalescent plasma for the treatment of hospitalized patients early in the disease course,” said Peter Marks, MD, PhD, Director of the FDA’s Center for Biologics Evaluation and Research. “This and other changes to the EUA represent important updates to the use of convalescent plasma for the treatment of COVID-19 patients.

“Issuance of, and updates to, EUAs are based on a thorough evaluation of currently available scientific evidence about medical products,” Marks continued. “In this case, as additional scientific evidence about COVID-19 convalescent plasma emerged, we revised the EUA to reflect the updated evidence.”

The FDA revised its Letter of Authorization for COVID-19 convalescent plasma Feb. 4, 2021, allowing clinicians to only use high-titer convalescent plasma. The authorization continues to apply only to the treatment of hospitalized patients with COVID-19 early in the disease course and to hospitalized patients who are unable to produce an adequate antibody response to COVID-19.

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