Paul-Ehrlich-Institut

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How safe are tissue preparations in the context of SARS-CoV-2?

A transmission of respiratory viruses by implantation, transplantation, infusion or transfer of human cells or tissues has not yet been described. The potential for transmission of SARS-CoV-2 through tissue preparations is currently unknown.

No cases of transmission of SARS-CoV-2 via tissue preparations have been reported.

Clinical signs of infection in tissue donors are already being recorded as part of routine screening measures.

In principle, the eligibility for donation is assessed by a doctor (section 3 (1) and section 3 (2) TPG). Specific adjustments to donor screening and the donor eligibility-assessment process, including clinical evaluation and decision-making in specific cases, are at the discretion of the tissue establishment.

As there is currently no evidence that SARS-CoV-2 can be transmitted through the transplantation of tissue preparations, the PEI proposes the following precautionary measures:

  1. Exclusion of potential tissue donors upon contact with people with confirmed SARS-CoV-2 infection within 14 days before the donation
  2. Exclusion of potential tissue donors with confirmed SARS-CoV-2 infection within 14 days after completion of the recovery.

Contrary to the updated recommendations of the ECDC on donor selection from April 29, 2020, the recommendations of the PEI remain unchanged.

An obligatory screening test of deceased donors of tissue where no validated pathogen reduction method for enveloped viruses is used is currently not recommended due to the data available, analogous to the procedure for donating blood.
Tissue establishments can establish donor screening at any time that goes beyond the recommendations of the PEI.

Tissue preparations that undergo a validated pathogen reduction process for enveloped viruses are not affected by these precautionary risk-minimizing measures.

Further information on SARS-CoV-2 in relation to blood, blood products and stem cell preparations can be found in the publication by Corman et al, "SARS-CoV-2 asymptomatic and symptomatic patients and risk for transfusion transmission". The Paul Ehrlich Institute press release "No virus detection in the blood of asymptomatic SARS-CoV-2 patients" and the SARS-Coronavirus 2 Announcement of the National Advisory Committee Blood (AK Blut) provides details on this.

The PEI continues to monitor the situation and will post updates as new information becomes available.