Prior AATB Bulletins provided recommendations solely applicable to deceased donors; recommendations in this Bulletin apply to both living and deceased donors.
This information will continue to be provided through Bulletins and by shared communications with the Physicians Council and tissue bank medical directors.
BACKGROUND
Since the beginning of the COVID-19 Pandemic, the AATB PC Subgroup has carefully assessed available data regarding the risks of tissue donation, applied the precautionary principle, and now has formally reassessed the available data. During that 2+ year interval, there has been no known transmission via (deceased or living donor) tissue or ocular transplantation1 or blood transfusion2, and the only verified organ transmission was via lung transplantation3. Furthermore, some organ transplant centers are transplanting non-lung organs from individuals known to have tested positive for SARS-CoV-2 just prior to death without reported transmissions to date4. The lack of known tissue transmission is reassuring, even in light of precautions taken by the tissue industry to avoid transmission of the emerging SARS-CoV-2 virus while scientific data on this emerging pathogen could be collected and evaluated.
AATB has sponsored two research studies of SARS-CoV-2 related to tissue transplantation. One study tested blood from deceased donors to determine whether SARS-CoV-2 RNA could be detected in donor blood specimens in January – June 2020. This study found a low rate of detectable RNA, which does not equate to infectiousness5. While further research is needed to
confirm a lack of transmissible virus in the blood of tissue donors, such studies in blood donors have been reassuring6,7,8. Another study tested tissue and blood specimens from deceased tissue donors with positive nasopharyngeal swabs; the results of this study are pending publication.
The most recent Centers for Disease Control and Prevention (CDC) recommendations to healthcare providers9 regarding recommendations for isolation following COVID-19:
KEY POINTS FOR HEALTHCARE PROFESSIONALS
• Children and adults with mild, symptomatic COVID-19: Isolation can end at least 5 days after symptom onset and after fever ends for 24 hours (without the use of fever-reducing medication) and symptoms are improving, if these people can continue to properly wear a well-fitted mask around others for 5 more days after the 5-day isolation period. Day 0 is the first day of symptoms.
• People who are infected but asymptomatic (never develop symptoms): Isolation can end at least 5 days after the first positive test (with day 0 being the date their specimen was collected for the positive test), if these people can continue to wear a properly well-fitted mask around others for 5 more days after the 5-day isolation period. However, if symptoms develop after a positive test, their 5-day isolation period should start over (day 0 changes to the first day of symptoms).
• People who have moderate COVID-19 illness: Isolate for 10 days.
• People who are severely ill (i.e., requiring hospitalization, intensive care, or ventilation support): Extending the duration of isolation and precautions to at least 10 days and up to 20 days after symptom onset, and after fever ends (without the use of fever-reducing medication) and symptoms are improving, may be warranted.
• People who are moderately or severely immunocompromised might have a longer infectious period: Extend isolation to 20 or more days (day 0 is the first day of symptoms or a positive viral test). Use a test-based strategy and consult with an infectious disease specialist to determine the appropriate duration of isolation and precautions.
• Recovered patients: Patients who have recovered from COVID-19 can continue to have detectable SARS-CoV-2 RNA in upper respiratory specimens for up to 3 months after illness onset. However, replication-competent virus has not been reliably recovered from such patients, and they are not likely infectious.
The Food and Drug Administration (FDA) last published updated information for HCT/P establishments regarding COVID 19 on January 4, 2021. The considerations provided:
• FDA does not recommend using laboratory tests to screen asymptomatic HCT/P donors.
• FDA is aware that some HCT/P establishments in the U.S. are considering additional donor screening and testing measures in response to the COVID-19 pandemic.
• The HCT/P establishment’s responsible person must determine and document the eligibility of a cell or tissue donor (21 CFR 1271.50). Based on information available at this time, establishments may wish to consider, whether, in the 28 days prior to HCT/P recovery, the donor
– cared for, lived with, or otherwise had close contact with individuals diagnosed with or suspected of having COVID-19 infection; or
– had been diagnosed with or suspected of having COVID-19 infection; or
– had a positive diagnostic test (e.g., nasopharyngeal swab) for SARS-CoV-2 but never developed symptoms.
• COVID-19 vaccines hold the promise to alter the course of this pandemic and are complex biological products intended to be administered to millions of individuals to prevent COVID-19. Recently, vaccines for the prevention of COVID-19 have become available under emergency use authorization (EUA) issued by the FDA. Based on information available at this time, those who have received non-replicating, inactivated, or RNA-based COVID-19 vaccines are not precluded from donating HCT/Ps.
Furthermore, FDA published updated information for blood establishments regarding COVID-19 on January 11, 2022. The considerations provided:
• FDA does not recommend using COVID-19 laboratory tests to screen routine blood donors.
• The blood establishment’s responsible physician must evaluate prospective donors and determine eligibility (21 CFR 630.5). The donor must be in good health and meet all donor eligibility criteria on the day of donation (21 CFR 630.10). The responsible physician may wish to consider the following:
– individuals diagnosed with COVID-19 or who are suspected of having COVID-19, and who had symptomatic disease, refrain from donating blood for at least 10 days after complete resolution of symptoms,
– individuals who had a positive diagnostic test for SARS-CoV-2 (e.g., nasopharyngeal swab), but never developed symptoms, refrain from donating at least 10 days after the date of the positive test result,
– individuals who are tested and found positive for SARS-CoV-2 antibodies, but who did not have prior diagnostic testing and never developed symptoms, can donate without a waiting period and without performing a diagnostic test (e.g., nasopharyngeal swab),
– individuals who received a nonreplicating, inactivated, or mRNA-based COVID-19 vaccine can donate blood without a waiting period,
– individuals who received a live-attenuated viral COVID-19 vaccine, refrain from donating blood for a short waiting period (e.g., 14 days) after receipt of the vaccine,
– individuals who are uncertain about which COVID-19 vaccine was administered, refrain from donating for a short waiting period (e.g., 14 days) if it is possible that the individual received a live-attenuated viral vaccine.
All laboratory tests for SARS-CoV-2 currently remain available only through Emergency Use Authorization (EUA) by FDA.
UPDATE ON TRAVEL RECOMMENDATIONS
As described in the April 2, 2020, Bulletin No.20-10, recommendations made early in the SARS-CoV-2 pandemic regarding travel deferral were no longer relevant. No new information since that time indicates that there is any utility to considering donor travel history to help inform risk of COVID-19 infection.
UPDATE ON DONOR SCREENING RECOMMENDATIONS
It is the responsibility of the tissue establishment’s medical director to evaluate donors regarding the possibility for communicable disease transmission via HCT/Ps. HCT/P donors may or may not be tested for SARS-CoV-2 upon recovery, while most individuals admitted to a hospital are tested for SARS-CoV-2. In light of recommendations from FDA, CDC, and currently available literature, medical directors should consider the following regarding donor screening related to COVID:
1. Exclusion of prospective donors who in the last 10 days prior to donation tested positive for COVID-19 (SARS-CoV2) and
0. had symptoms of a primary respiratory condition OR
1. had symptoms or signs suggesting a systemic infectious process OR
2. have circumstances suggesting unknown/pending cause of death and no autopsy to follow OR
3. have pathology suggestive of viral etiology found at autopsy
2. Asymptomatic individuals dying of other known causes may be considered acceptable (MD discretion) even with
recovery positive NAT or antigen tests for SARS-CoV-2.
3. Caution should be taken with respect to donors who are immunocompromised because they can harbor the virus longer than immunocompetent individuals.
UPDATE ON DONOR TESTING
Currently, there are no data available to suggest that blood carries infectious particles, so the utility of testing donor blood specimens with SARS-CoV-2 NAT assays is unclear at this time, and furthermore there is no utility to testing donors for antibodies to SARS-CoV-2. The utility of NAT testing can be reconsidered if additional concerning information becomes available.
FDA does not recommend use of laboratory tests “to screen asymptomatic [HCT/P] donors” at this time. These recommendations do not appear to apply to symptomatic HCT/P donors, and recommendations would not be made for testing using assays under EUA. At this time, the PC subgroup continues to recommend that it would be up to the medical director responsible for donor eligibility determination to choose the risk mitigation methods and criteria for donors presenting with symptoms that may be attributed to COVID-19, which might include use of nasal swab NAT testing for
SARS-CoV-2.
MEDICAL DIRECTOR’S DISCRETION
As previously emphasized, the ultimate selection of risk-mitigation criteria pertaining to COVID-19, e.g., travel evaluation, symptomatology, exposure, close contact, infection status, and testing for COVID-19, is in the sole discretion of the medical director of the tissue bank responsible for donor eligibility determination as long as the intent of relevant standards, e.g. D4.120, D4.150, F1.120 and Appendix II is met.
AATB will inform its members if any material changes require additional measures. For additional information, please contact Beverly Bliss, MBA, CTBS, Vice President of Accreditation and Standards.
– FDA. Information for Human Cell, Tissue, or Cellular or Tissue-based Product (HCT/P) Establishments Regarding the COVID-19 Pandemic. 1/4/2021
– FDA. Updated Information for Blood Establishments Regarding the COVID-19 Pandemic and Blood Donation. 1/11/2022
– Kaul DR, Valesano AL, Petrie JG, et al. Donor to recipient transmission of SARS-CoV-2 by lung transplantation despite negative donor upper respiratory tract testing. Am J Transplant. 2021;21(8):2885–9.
– Koval CE, Poggio ED, Lin YC, Kerr H, Eltemamy M, Wee A. Early success transplanting kidneys from donors with new SARS-CoV-2 RNA positivity: a report of 10 cases. Am J Transplant. 2021. https://doi.org/10.1111/ajt. 16765.
– Greenwald MA, Grebe E, Green V, Jones AL, Williamson P, Busch M, Kuehnert MJ. Detection of SARS-CoV-2 RNAemia in Deceased Tissue Donors. In: ID Week 2021; 29 September – October 3, 2021; Virtual Event.
– Cappy P, Candotti D, Sauvage V, et al. No evidence of SARS-CoV-2 transfusion transmission despite RNA detection in blood donors showing symptoms after donation. Blood. 2020;136(16):1888-1891. doi:10.1182/blood.2020008230
– Corman VM, Rabenau HF, Adams O, Oberle D, Funk MB, Keller-Stanislawski B, Timm J, Drosten C, Ciesek S. SARS-CoV-2 asymptomatic and symptomatic patients and risk for transfusion transmission. Transfusion. 2020 Jun;60(6):1119-1122. doi: 10.1111/trf.15841. Epub 2020 May 27. PMID: 32361996; PMCID: PMC7267331.
– Bakkour S, Saá P, Groves JA, Montalvo L, Di Germanio C, Best SM, Grebe E, Livezey K, Linnen JM, Strauss D, Kessler D, Bonn M, Green V, Williamson P, Kleinman S, Stramer SL, Stone M, Busch MP; NHLBI Recipient Epidemiology and Donor Evaluation Study-IV-Pediatric (REDS-IV-P). Minipool testing
for SARS-CoV-2 RNA in United States blood donors. Transfusion. 2021 Aug;61(8):2384-2391. doi: 10.1111/trf.16511. Epub 2021 May 27. PMID: 34046906.
– Centers for Disease Control and Prevention. Ending Isolation and Precautions for People with COVID-19: Interim Guidance. January 14, 2022.
As the designated AATB MwER, Medical Director, and/or Bulletin Contact, you are receiving this communication for your organization. Please distribute this message to other members of your organization that may find this information relevant and important. Thank you in advance for your attention to this matter.
