FDA provides resource for clinical laboratories seeking to accommodate supply chain deficiencies for SARS-CoV-2 testing.
As supply chain issues continue to affect clinical laboratories performing SARS-CoV-2 testing, many laboratories have found it necessary to substitute the reagents or supplies used in tests. This substitution can be complex, as clinical laboratories must consider what supply alternatives have been validated.
The US Food and Drug Administration (FDA) has recently released a tool that clinical laboratories can use to understand permitted substitutions. According to the FDA press release, “This 22-slide PowerPoint file contains detailed information to help support labs performing authorized COVID-19 tests. This interactive tool includes validated supply alternatives that labs can use to continue performing testing when there is a supply issue with some components of a test.”
The tool is easy to navigate and includes information about supplies that can be substituted including:
- Collection media
- Primers and probes
- Master mixes
- PCR systems
- Extraction systems or kits
- General consumables
The first page of this tool states, “This resource is intended for labs performing COVID-19 tests that are authorized. This resource includes validated supply alternatives that labs can use to continue performing testing when there is a supply issue with some components of a test.”
As of June 12, 2020, the FDA had authorized 135 COVID-19 tests under emergency use authorization (EUA), which include 114 molecular tests, 20 antibody tests, and 1 antigen test.
Clinical laboratories may find the new FDA tool useful in accommodating supply chain deficiencies.