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February 4, 2023

Health Ministry completes methodology for collection, use of plasma from COVID-19 cured donors

A methodology for collecting, testing, processing, storing and distributing plasma from donors cured of the infection with the novel coronavirus and the monitored use for COVID-19 critically ill patients in intensive care has been completed, the Romanian Health Ministry announced on Wednesday.

Currently, there are three devices for plasma treatment of coronavirus patients donated to the Ministry of Health in Bucharest, Iasi and Timisoara.

According to the ministry, plasma will be administered by the RT-PCR method, subject to certain conditions, only to critically ill patients confirmed as infected with COVID-19, who are at least 18 years of age and consent to this procedure.

“The minister’s order establishes the manner of collection, testing, processing, storage and distribution of blood plasma from COVID-19-cured donors and the monitored use for critically ill COVID-19 patients in intensive care, in accordance with the national legislation on blood transfusion and the technical guide drawn up by the European Commission on the collection, testing, processing, storage, distribution and monitored use of plasma from persons cured of COVID-19 for the treatment of COVID-19,” the ministry said in a press release.

Potential donors will be selected from among patients who have been hospitalized for COVID-19, cured and discharged.

Plasma donation, like blood donation, is voluntary and unpaid, under the conditions provided by Law 282/2005 on the organisation of blood transfusion and donation of blood and blood components of human origin, as well as ensuring medical quality and safety for therapeutic care.

“For the selection of the cured patients, the blood transfusion centres will conclude protocols with the hospitals that treat COVID-19 patients in order to identify potential donors in compliance with the national and EU rules for the protection of personal data, by signing by the patient signing an informed consent form. Blood Transfusion Centers will also contact potential donors and schedule them for examination, analysis and donation. Healed patients may also contact blood transfusion centres to schedule for donation,” the release reads.

Eligible donors will donate to blood transfusion centres.

“For the biological qualification of the blood components, the testing protocol is applied according to the legislation in force and the testing algorithm developed by the National Institute of Transfusion Hematology (INHT) for the biological control of blood donations and blood components,” according to the release.

The blood transfusion centres will send eligible samples to INHT for further testing.

Following the tests performed, the INHT will submit to the blood transfusion centres the results that confirm or deny the eligibility of the fresh frozen plasma for distribution and experimental administration to COVID-19 patients.

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