key: cord-252273-mykwzlsu authors: Politis, Constantina; Papadaki, Maria; Politi, Lida; Kourti, Georgia; Richardson, Clive; Asariotou, Marina; Tsakris, Athanassios; Mentis, Andreas title: Post-donation information and haemovigilance reporting for COVID-19 in Greece: information supporting the absence of SARS-CoV-2 possible transmission through blood components date: 2020-10-20 journal: Transfus Clin Biol DOI: 10.1016/j.tracli.2020.10.007 sha: doc_id: 252273 cord_uid: mykwzlsu Background. Although the SARS-CoV-2 virus is transmitted mainly through the respiratory tract, possible transmission by transfusion from asymptomatic carriers should be explored. As yet there are no reports of transfusion transmission of COVID-19. Haemovigilance findings within a three-month surveillance period during the new coronavirus pandemic are presented. Materials and methods. Due to great demand and shortage, blood sessions in outpatient facilities were organized during the high prevalence period of COVID-19, alongside a national plan to monitor the evolving public health situation by random molecular screening of high-risk groups of the population. Haemovigilance protocols were implemented as well as surveillance for any COVID-19 case reported post-transfusion. A 14-day quarantine and follow-up molecular and antibody testing of any COVID-19 positive case was obligatory. Results. Post-donation, post-transfusion information and molecular testing of swab samples collected from three asymptomatic donors at risk for COVID-19, revealed the case of an immunosupressed patient who had been transfused with whole blood derived platelets from a donor subsequently diagnosed with COVID-19. The recipient exhibited no symptoms of the disease. Molecular and antibody testing results were negative. Conclusion. Haemovigilance provided information supporting the absence of transfusion transmission of COVID-19, thus strengthening the hypothesis that, even if it cannot yet be definitively ruled out, COVID-19 is not transmitted through blood transfusion. As of early June 2020, a perfect test does not exist, therefore haemovigilance along with the implementation of strict proactive measures is crucial to identify eluding asymptomatic individuals and ensure blood safety during the pandemic. The recent outbreak of the novel coronavirus disease 2019 (COVID-19) was officially reported in December 2019 in China and spread quickly around the globe, resulting in its declaration as a pandemic by the World Health Organization [1] [2] [3] [4] [5] [6] [7] . As with all respiratory viruses, the COVID-19 virus is primarily transmitted by the respiratory route [8] [9] [10] [11] [12] . Because respiratory viruses have never been reported to be transmitted through blood or blood components, any potential risk of transmission by transfusion of blood collected from asymptomatic individuals remains theoretical 13 . According to the case report described for the first time by Cho et al., the transfusion of apheresis platelets to a patient diagnosed with severe aplastic anaemia from a donor who was subsequently diagnosed with COVID-19 did not result in the transmission of the disease 14 . Any reports indicating possible transmission through transfusion of blood components have not received confirmation and therefore have been discounted. Due to the urgent requirement for blood, it remains critically important to know whether the COVID-19 virus can be transmitted by blood transfusion, because asymptomatic carriers may donate blood and therefore blood donation could be an unidentified route of transmission. The pandemic has the potential to reduce the supply of blood and blood components by affecting blood system activities, which has led to the publication by authorities worldwide of a variety of statements, precautionary J o u r n a l P r e -p r o o f measures, interim guidelines and risk assessments concerning blood safety and sustainability [15] [16] [17] [18] [19] [20] [21] [22] . Following the first confirmed COVID-19 case in Greece in late February 23 Greek cities in safe outpatient facilities. In our study we describe the haemovigilance data over a surveillance period of three months (March to May 2020) when prevalence of the virus was high, focusing on post-donation and post-transfusion information regarding the transfusion to an immunocompromised patient of whole blood derived platelets from a donor who was subsequently diagnosed with COVID-19. In Greece, a system for monitoring, reporting, investigating and analyzing any adverse events related to donations, processing and transfusion of blood, is constantly in use; however, during the high prevalence period of the disease period. Further investigation showed that she had returned from an 11-day trip to Bali 33 days before blood donation, travelling via Singapore. She did not report contact with suspected or confirmed COVID-19 cases during her trip. After diagnosis, she stayed indoors in self-isolation for 14 days. She remained asymptomatic during quarantine. All her close contacts were tested for COVID-19 and self-isolated as a precautionary measure. Moreover, her colleagues who donated blood in the same session were subjected to molecular testing and 14 days' quarantine. All contacts and colleagues tested negative for COVID-19. The blood establishment where the blood session was performed on April 8 th was informed on April 12 th of a confirmed COVID-19 case among the donors. Haemovigilance protocols were triggered and information about the confirmed COVID-19 case was requested. Investigations showed that the whole blood derived platelet unit from this donation had been transfused into an immunocompromised male diagnosed with acute myeloid leukemia. Red cells and plasma processed from the same blood unit had not been used, and were discarded, according to blood safety protocols. being in the same room as a subsequently confirmed COVID-19 case for ten minutes the day before the blood donation. She was advised to remain selfisolated as a precautionary measure and monitor her health closely. The donated whole blood unit was discarded. The result of her molecular testing for COVID 19 was negative. The second donor reported close contact with a subsequently confirmed COVID-19 person, twelve days before blood donation. Haemovigilance protocols revealed that the processed RBCs had already been transfused into an elderly patient admitted to the ICU due to a herpetic encephalitis infection. This donor was also advised to self-isolate and monitor his health closely. Donor and recipient both tested negative for COVID-19. Transfusion of platelet rich plasma obtained from an asymptomatic infected individual did not result in disease transmission, even though the platelet recipient was diagnosed with myeloid leukaemia and was taking immunosuppressive drugs. This is the second report described globally, 26--30 . In general, the sicker one becomes due to an infection, the more robust is the immune response that is triggered, and consequently more robust immunity is acquired. Serological screening of the donor was performed approximately 4-8 weeks after the assumed date of exposure to the virus and the result was negative. That the donor remained asymptomatic throughout suggests that either she failed to produce antibodies, or antibody secretion was below the detection limit, or she had not yet seroconverted at the time of sampling. There are as yet no data regarding the extent and duration of immunity to the virus and it might be a long time before such information becomes available. We should accept the fact that at that time a perfect test did not exist [28] [29] [30] [31] [32] , and therefore consider the addition of more stringent criteria to the existing ones to avoid the potential transmission of this infection by blood transfusion, such as precautionary deferral from blood donation based on the profession and place of work of candidate donors, as well as the extension of exclusion periods after travelling. Asymptomatic transmission of SARS-CoV-2 remains the Achilles' heel of public health strategies for COVID-19 pandemic control. Symptom-based J o u r n a l P r e -p r o o f screening is useful, but epidemiological evaluation of COVID-19 data strongly demonstrates that COVID-19 transmission from asymptomatic individuals may play a critical role in this pandemic status. In order to ensure blood safety, most blood transfusion services implement precautionary measures during an outbreak, which involve: a) body In such circumstances of great demand and shortage, along with all the limitations and "lists of unknowns" in serological and molecular testing, the fact remains that haemovigilance is the essential tool for blood safety. 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