ASM Thanks FDA for Clarifying SARS-CoV-2 Serology Test Guidance
On May 4, 2020, ASM submitted the following letter to the U.S. Food and Drug Administration.
Dear Commissioner Hahn:
On behalf of the American Society for °®¶¹´«Ã½, which includes thousands of public health and clinical laboratory microbiologists, we thank the FDA for clarifying its current online guidance that serology tests for SARS-CoV-2 that have not received Emergency Use Authorization (EUA) must be conducted in CLIA or CAP-certified high complexity labs. This policy helps ensure quality testing of serologic testing for SARS-CoV-2 in the °®¶¹´«Ã½ States.
We support the FDA’s current position that the only tests allowed to voluntarily submit to the EUA process are those that are to be conducted in CLIA- or CAP-certified high complexity laboratories. We appreciate FDA’s recognition that testing in these settings is overseen by highly trained, board-certified doctoral-level directors of clinical laboratories that follow strict procedures for validating tests for accuracy and reliability before offering them to patients and/or the public.
Our leadership appreciates the ongoing, open dialogue you and your staff have had with us since the pandemic began. As we look to the next phase of addressing the impact of the virus, which includes widespread adoption of antibody testing, ASM urges you to do everything you can to ensure that these tests are accurate, reliable and provide meaningful information; and prevent unauthorized testing.
We recognize that this continues to be a complex and evolving situation. ASM looks forward to working with you to ensure millions of Americans will have greater access to antibody tests at this critical juncture in the pandemic, and that these tests are accurate and reliable.
Sincerely,
Robin Patel, M.D.
President
Stefano Bertuzzi, Ph.D.
Chief Executive Officer
Melissa Miller, Ph.D.
Chair, ASM Clinical and Public Health °®¶¹´«Ã½ Committee
Dear Commissioner Hahn:
On behalf of the American Society for °®¶¹´«Ã½, which includes thousands of public health and clinical laboratory microbiologists, we thank the FDA for clarifying its current online guidance that serology tests for SARS-CoV-2 that have not received Emergency Use Authorization (EUA) must be conducted in CLIA or CAP-certified high complexity labs. This policy helps ensure quality testing of serologic testing for SARS-CoV-2 in the °®¶¹´«Ã½ States.
We support the FDA’s current position that the only tests allowed to voluntarily submit to the EUA process are those that are to be conducted in CLIA- or CAP-certified high complexity laboratories. We appreciate FDA’s recognition that testing in these settings is overseen by highly trained, board-certified doctoral-level directors of clinical laboratories that follow strict procedures for validating tests for accuracy and reliability before offering them to patients and/or the public.
Our leadership appreciates the ongoing, open dialogue you and your staff have had with us since the pandemic began. As we look to the next phase of addressing the impact of the virus, which includes widespread adoption of antibody testing, ASM urges you to do everything you can to ensure that these tests are accurate, reliable and provide meaningful information; and prevent unauthorized testing.
We recognize that this continues to be a complex and evolving situation. ASM looks forward to working with you to ensure millions of Americans will have greater access to antibody tests at this critical juncture in the pandemic, and that these tests are accurate and reliable.
Sincerely,
Robin Patel, M.D.
President
Stefano Bertuzzi, Ph.D.
Chief Executive Officer
Melissa Miller, Ph.D.
Chair, ASM Clinical and Public Health °®¶¹´«Ã½ Committee
