FDA posts Independent Evaluations of COVID-19 Serological Tests

Attention: Clinical Laboratories Please share this announcement with the following:              Medical Director, Laboratory Services              Administrative Director and Managers, Laboratory Services On Thursday, June 4, 2020, the U.S. Food and Drug Administration (FDA) posted Independent Evaluations of COVID-19 Serological Tests. Key points: The document includes performance data for COVID-19 serology tests that have been…

Read more

CDC Lab Alert: Molecular Transport Media (MTM) and Cyanide Gas

PrimeStore MTM transport media contains guanidine thiocyanate, which produces a dangerous chemical reaction that releases cyanide gas when exposed to bleach (sodium hypochlorite). Do not use PrimeStore MTM with platforms that include a disinfecting step that uses bleach (e.g., Hologic Panther, Panther Fusion Systems). Other MTM may contain guanidine thiocyanate, and ingredients in MTM may not be…

Read more

COVID-19 Update: FDA Provides Promised Transparency for Antibody Tests

Coronavirus (COVID-19) Update: FDA Provides Promised Transparency for Antibody Tests (from CDC, updated May 22, 2020) Key points: On May 21, 2020, the U.S. Food and Drug Administration (FDA) announced that it has removed a number of antibody tests from the “notification list” of tests offered under the Policy for Coronavirus Disease-2019 Tests During the…

Read more

Interim Laboratory Biosafety Guidelines for Handling and Processing Specimens Associated with COVID-19 (updated May 11, 2020)

Attention: Acute Care Hospital, Critical Access Hospital, Clinical Laboratory, Ambulatory Surgery Center Please share this with: Accreditation Coordinator Quality Director Medical Director – Laboratory services Administrative Director – Laboratory Laboratory Manager Point of Care Coordinator The CDC has updated Interim Laboratory Biosafety Guidelines for Handling and Processing Specimens Associated with COVID-19 Key points: This is…

Read more