Regiocit EUA Letter of Authorization 08132020

Regiocit EUA Letter of Authorization 08132020

Emergency Use Authorization (EUA) updates

EUA for REGIOCIT replacement solution FDA issued an EUA (PDF) for the emergency use of Baxter Healthcare Corporation’s REGIOCIT for adult patients being treated with continuous renal replacement therapy (CRRT) and for whom regional citrate anticoagulation is appropriate. The use of this product under the EUA is limited to critical care settings. CRRT is a “dialysis” treatment that provides renal support for critically ill patients with acute kidney injury. Baxter Healthcare Corporation’s REGIOCIT is available for use only in healthcare facilities that the company has qualified for receiving this product. (August 14, 2020)

FDA issues EUA to Yale School of Public Health for SalivaDirect, which uses a new method of saliva sample processing FDA issued an EUA (PDF) to Yale School of Public Health for its SalivaDirect COVID-19 diagnostic test, which uses a new method of processing saliva samples when testing for COVID-19 infection. SalivaDirect does not require any special type of swab or collection device; a saliva sample can be collected in any sterile container. This test is also unique because it does not require a separate nucleic acid extraction step. This is significant because the extraction kits used for this step in other tests have been prone to shortages in the past. (August 15, 2020) Risk of inaccurate results with Thermo Fisher Scientific TaqPath COVID-19 Combo Kit FDA is alerting clinical laboratory staff and health care providers of a risk of false results with the Thermo Fisher Scientific TaqPath COVID-19 Combo Kit. This alert addresses two issues: The first is about the instructions for vortexing and centrifugation of RT-PCR reaction plates, which Thermo Fisher Scientific has updated.   The second is related to the assay Internal Positive Control (IPC) and requires laboratory staff to upgrade software to resolve the issue. (August 17, 2020) Diagnostic test EUAs To date, FDA has currently authorized 217 tests under EUAs, which include 176 molecular tests, 39 antibody tests, and 2 antigen tests. Also see: Coronavirus Testing Basics

Related links: FAQs on Testing for SARS-CoV-2 (frequently updated) Coronavirus Disease 2019 (COVID-19) Emergency Use Authorizations for Medical Devices