Update on Considerations for Tissue Donor Risk Assessment of COVID-19/SARS-CoV-2 Infection
The AATB Physicians Council has updated its recommendations for testing deceased donors for COVID-19/SARS-CoV-2 which was communicated to members of the Physicians Council in a Physicians Advisory Brief on May 17, 2021.
In the beginning of 2020, the world was faced with a rapidly developing pandemic with little to no data available to adequately assess the potential risk of SARS-CoV-2 transmission through human tissue transplantation. Therefore, some tissue processors opted to take a conservative approach to donor selection through screening of donors with PCR-based testing of nasopharyngeal swabs taken at recovery. Consistent with what has been reported in the general population, a number of potential tissue donors have tested positive for the SARS-CoV-2 virus despite the absence of a known risk of exposure or clinical symptoms suggestive of COVID-19 infection. Since the risk of viral transmission through tissues from asymptomatic individuals was unknown, most processors chose to try to identify and defer these donors. However, data reported in the medical literature and unpublished results of AATB sponsored studies conducted over the past year, suggest that the risk of SARS-CoV-2 transmission through tissue transplantation in this setting is very low.
Some of the compelling points that support this conclusion include:
- Routine SARS-CoV-2 PCR-based testing has not been adopted by blood centers. Blood donors are screened only for exposure history and clinical symptoms of COVID-19 infection. To date, there have been no reported cases of SARS-CoV-2 transmission from blood or blood components.
- Preliminary data from a study in progress sponsored by AATB shows that SARS-CoV-2 RNA was undetectable in tissues recovered from asymptomatic deceased donors who tested positive on a post-mortem NP swab.
- There have been no reported cases of SARS-CoV-2 transmission associated with tissue transplantation.
- Guidance published by the FDA April 2020 and updated January 2021 discouraged routine screening of asymptomatic tissue donors.
An array of data should be considered for donor eligibility, and factors for COVID-19 infection should include exposure risk, symptoms, vaccination status, and testing already done, with last 14 days before donation being most relevant. The role of testing symptomatic deceased donors where there is another plausible cause than COVID-19 should be left to the discretion of the medical director.
Consideration should also be given to requirements of international regulatory authorities regarding donor screening and testing.
The following recommendations are based on these current considerations for deceased donors:
- SARS-CoV-2 testing is not recommended for asymptomatic donors.
- Donors who have symptoms possibly consistent with COVID-19 but are reasonably explained by acceptable conditions may be eligible for donation.
- Donors should be considered at risk for COVID-19, who in the last 14 days prior to death have;
- been diagnosed with COVID-19, or
- tested positive for COVID-19 by direct viral testing methods (excluding antibody), or
- been exposed to a person with known COVID-19, or
- experienced unexplained symptoms consistent with COVID-19
- Fully vaccinated donors* are acceptable regardless of close contacts with known or suspected COVID-19 infected individuals.
If you have any questions, please contact Beverly Bliss, VP Accreditation and Standards, at email@example.com.