COVID-19 Business Intelligence and Analysis for Clinical Laboratories, Pathology Groups and Hospital Administration

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FDA Releases Update of Test Substitution Tool Identifying Validated Supply Alternatives for SARS-CoV-2 Testing

FDA updates direction on alternative COVID-19 testing supplies
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The FDA updated its resource for clinical laboratories in response to SARS-CoV-2 testing supply chain deficiencies.

The US Food and Drug Administration (FDA) updated its tool identifying substitute reagents and supplies that clinical laboratories can use in SARS-CoV-2 testing. Supply chain issues have reemerged as testing rates for COVID-19 have increased across the United States. 

In an apparent response to the continued strain on SARS-CoV-2 testing supply chains, the FDA released the update July 23, 2020, to its Testing Supply Substitution Strategies tool. 

“This presentation includes validated supply alternatives that labs can use to continue performing testing when there is a supply issue with some components of a molecular test,” stated the FDA as part of this, the tool’s first update.

Supplies identified for substitution include:

  • Swabs
  • Collection media
  • Primers and probes
  • Master mixes
  • PCR systems
  • Controls
  • Extraction systems or kits
  • General consumables 

The layout for this update is similar to the initial June 3 release of the Testing Supply Substitution Strategies tool, but the information has been updated to reflect the increased understanding of effective and useful substitutions. The “Additional Resources” slide includes more up-to-date resources.

Clinical laboratories that need a resource indicating possible substitution of test supplies or that are using the first version of this tool can find the link to the updated version in the FDA press release here.

As of July 23, the FDA had authorized 187 tests for SARS-CoV-2 under emergency use authorization (EUAs). These include 154 molecular tests, 31 antibody tests, and 2 antigen tests.

Related Resources:

FDA Coronavirus (COVID-19) Update: Daily Roundup July 23, 2020

FDA Announces New Tool for Clinical Laboratories to Identify Validated Supply Alternatives for SARS-CoV-2 Testing

COVID-19 TESTING DATA