Subject matter experts from the Informatics Committee compiled some resources that may be helpful for your practice during the COVID-19 pandemic.
Alliance for Digital Pathology (https://digitalpathologyalliance.org/)
The Alliance for Digital Pathology, of which the CAP is a member, is a collaborative and voluntary group interested in the evolution of regulatory science as it applies to digital pathology. The Alliance is actively collaborating to help understand and combat COVID-19.
The Alliance recently highlighted one project in a recent update: the COVID-19 Worldwide Digital Repository. The Alliance requests that if you have access to COVID-19 tissue samples and the ability to digitize samples in the form of whole slide imaging, please contact: firstname.lastname@example.org.
The project aims to apply a standardized specimen preparation protocol and use an international ISO standard for communication of digital images and related information to ensure digital slides can be interpreted reliably and compared across institutions. As a proof of principle, the goal is to establish a standard data repository of digital images of postmortem lung specimens together with relevant metadata and make these data sets available to pathologists and scientists around the world.
New FDA email addresses for specific COVID-19 inquiries:
There are new FDA mailboxes on its Emergency Preparedness and Response website (https://www.fda.gov/emergency-preparedness-and-response/counterterrorism-and-emerging-threats/coronavirus-disease-2019-covid-19) that might be of interest to members.
- CDRH-EUA-Templates@fda.hhs.gov for diagnostic inquiries and EUAs
- CDRH-NondiagnosticEUA-Templates@fda.hhs.gov for non-diagnostic inquiries and EUAs
- DeviceShortages@fda.hhs.gov is the industry hotline for shortages
The FDA’s website contains its latest COVID-19 information and that of the federal government, including a daily roundup https://www.fda.gov/news-events/fda-newsroom/press-announcements.
COVID-19 Decentralized Testing Proposal
This white paper at Ruleout.org, from two CAP members, proposes a highly specific “Rule-Out” Laboratory Developed Test (LDT), an information technology structure, and a procedural framework which are readily implementable and scalable. Current RNA testing is a “rule-in” test (high sensitivity). To deal with the vast number of people needing testing, this group proposes an approach to rule out true negatives (highly specific). The solution, modified from the successful South Korean model, leverages existing laboratory capabilities and can scale testing capacity exponentially. If you work in a laboratory possessing highly skilled personnel and equipment, your help is requested to scale COVID-19 Testing.