The Food and Drug Administration (FDA) on Aug. 23 issued an emergency use authorization (EUA) for convalescent plasma — plasma from previously infected patients — to treat hospitalized patients with COVID-19. An EUA enables the temporary use of unapproved medical products or treatments or the unapproved use of approved medical products.
There have been no large-scale, randomized, placebo-controlled trials of convalescent plasma. FDA previously facilitated access to convalescent plasma to treat COVID-19 through an Expanded Access Program (EAP) led by the Mayo Clinic in April. Several essential hospitals participated in this program.
The agency released fact sheets for health care providers and patients about convalescent plasma, noting that potential side effects include allergic reactions, transfusion-associated circulatory overload, and transfusion-associated lung injury.
FDA Guidance on Pooled, Surveillance Testing
A new FDA site includes resources for pooled sample testing, screening asymptomatic individuals, and surveillance testing.
There are two approaches to patient specimen pooling. Sample or media pooling combines aliquots of transport media that each contain a single patient sample, while swab pooling adds swabs from multiple patients into a single volume of transport media.
Because pooled samples are diluted, which can result in the presence of less genetic material to detect, there is a greater likelihood of false negative results, especially if tests are not properly validated. Thus, FDA generally recommends that test performance on a pooled sample includes at least 85 percent positive agreement when compared with the same test performed on individual samples.
Asymptomatic individuals also might yield less viral genetic material for testing; FDA recommends high sensitivity for tests intended for screening asymptomatic individuals, outlined in its EUA templates. If less sensitive tests are used, health care providers should consider serial testing or other approaches to validate results.
FDA does not regulate surveillance testing and encourages health care providers to refer to the Centers for Medicare & Medicaid Services and the Centers for Disease Control and Prevention (CDC) for guidance on testing and reporting.
New Dashboard Shows COVID-19 Testing at Homeless Service Sites
The National Health Care for the Homeless Council has partnered with CDC to collect data from universal COVID-19 testing events at shelter- or encampment-based service sites.
The dashboard shows:
- testing events, number tested, and positivity by state;
- types of shelters where testing occurred;
- whether testing occurred in response to reported cases; and
- testing information by race and ethnicity.
Health care providers who conducted universal testing at homeless service sites can submit data to the CDC’s data collection tool.
Visit the America’s Essential Hospitals coronavirus resource page for more information about the outbreak.
Contact Senior Director of Policy Erin O’Malley at email@example.com or 202.585.0127 with questions.