United States – Vitalant

Mark Yazer & Darrell Triulzi

Question 1

Vitalant in Pittsburgh administers a centralized transfusion service that provides transfusion medicine expertise and blood products to about 24 area hospitals. Between these hospitals, virtually all medical and surgical services are provided from neonatal to geriatric care, including several Level 1 trauma hospitals. Vitalant Pittsburgh is also the regional blood collector, collecting approximately 87 000 RBCs, 25 000 platelets, and 31 000 plasma units per year.

Question 2

CCP is collected at Vitalant by apheresis. Our collection of CCP is the same as for routine plasma apheresis donations in that, according to the US FDA, plasma can be donated every 28 days, up to 13 times per year. While the FDA allows donors to give plasma more frequently, as soon as 48 h apart, these are considered frequent plasma donors and require close monitoring. The FDA waived the frequent donor requirements temporarily during the pandemic. The Vitalant blood donor medical director can give medical approval for donation more frequently than 28 days on a donor-by-donor basis.

Question 3

CCP is collected for transfusion to patients with dyspnoea and a positive COVID-19 diagnosis. Initially, we provided CCP for use in both compassionate and study protocols, in particular the Mayo Clinic study. However, since the Mayo Clinic IND was completed, all of the CCP is provided as an investigational new drug and the physician who orders it is required to explain the investigational nature of the product to the patient and document the patient’s understanding of this fact in the consent note.

Question 4

Yes, a donor must have a positive test indicating that they were infected with COVID-19. We accept the results of either the PCR or the antibody test as proof that they were infected.

The donor must wait 28 days after resolution of their last sign or symptom before they can donate CCP.

Question 5

No.

Question 6

As a service to the community, and as a means of identifying potential CCP donors, Vitalant tests all donors who donate whole blood or apheresis products for these antibodies. This testing is performed after the donation is made and the donor can check their results on the website. Similarly, potential donors who are referred to the blood centre by the hospital to donate CCP once they have recovered from their infection are also tested for antibodies after the donation is made. Thus, having a high titre antibody is not an exclusion criteria as the titre is determined after the donation is made.

Question 7

Vitalant uses the Euroimmun IgG/IgA immunoassay, with the donor plasma diluted 1:100.

Yes, samples are frozen for future assessment.

Question 8

No, our CCP does not undergo pathogen inactivation.

Question 9

No.

Question 10

Yes, individuals who have recovered from COVID-19 can donate standard blood products 28 days after resolution of their last sign or symptom.

Question 11

No.

Question 12 Substantial coordination was needed between hospitals, testing sites, in order to streamline the referral of potential donors to the blood centre. Donor recruitment is still a challenge Educating the ordering physicians about clinical criteria, dose, and what is required in order to obtain informed consent is a challenge given the wide range of physicians who treat COVID-19 patients. We found it best to have a small group of hospital-based clinicians who were trained in the appropriate and up-to-date use of, and consent for, CCP approve its use and ensure that the proper documentation has been obtained on each patient. Turkey – Bursa Transfusion Centre

Levent Tufan Kumaş

Question 1 Type of institution ○ Hospital-based Blood Services (a hospital unit performing the functions of blood establishment and transfusion services at a hospital level) Institution demographics

For hospital

▪ Number of in-patient beds: 900 ▪ Approximate number of RBCs transfused/year: 22 000 ▪ Age group of patients treated: Neonates, paediatrics <18 years, adults >18 years. ▪ Type of patients treated: Both medical and surgical.

For blood establishments and blood services

Whole blood donation number: 20 000/year Apheresis donation number for platelets: 1700/year (3300 units of apheresis platelet concentrates prepared totally) Question 2

We perform plasmapheresis for collection of CCP.

Donation frequency permitted for routine plasma donation by apheresis: 48 h (Max. twice a week, totally 33 donations/year).

Donation frequency permitted for CCP donation by apheresis: 10 days (Max. 8 donations in a 3 months period).

Question 3

CCP is collected for transfusion, and for compassionate use.

Question 4

Yes. Diagnosis of COVID-19 infection by a laboratory test result (Either PCR test positivity studied from the nasopharynx swab sample or serologically test positivity for SARS-CoV-2 antibodies) is considered acceptable.

In addition to general blood donor selection criteria:

28 days after complete cessation of COVID-19 symptoms donors considered to be acceptable for CCP donation

Or, 14 days after complete cessation of COVID-19 symptoms with 2 negative PCR test results (One of the tests must have been done within the last 48 h).

Question 5

No.

Question 6

Yes. SARS-CoV-2 IgG assay (Abbott Architect). Chemiluminescent microparticle immunoassay. Predefined index value threshold of 1·4 signal-to-cut-off (S/C) ratio for seropositivity. (Tests are run just before each donation process).

Question 7

No. The samples are collected from the CCP unit and freezed/archived for future assessment.

Question 8

No.

Question 9

No.

Question 10

Yes. The minimum deferral period after recovery before whole blood or apheresis donation is 28 days.

Question 11

No. According to our regulations; these people are considered to be people who have received a blood transfusion, so they cannot donate blood or plasma at least 12 months.

Question 12 In the first step, we had difficulties in supplying an antibody test that meets the national guideline requirements to be used in our institution to select available donors for CCP apheresis. At the beginning of the pandemic (April to June), the donor organization and the referral of suitable donors to our blood centre was done by the local health authority. However, as this organization is not maintained and there are not enough volunteer donors at the moment, most of our CCP donors are replacement donors. High donor deferral rate (General blood donor selection criteria, negative anti-SARS-CoV-2 antibody test results, and deferral of female donors due to pregnancy history) and short donation period (Max. 3 months) make it difficult to prepare sufficient number of products. Another challenge is not measuring the neutralizing antibody titre in the prepared products before transfusion. Turkey – Turkish Red Crescent

Levent Sağdur

Question 1 Type of institution National Blood Services/Blood Centre (responsible for recruiting donors; screening and selecting blood donors; blood collection; testing and processing blood units; transporting; receiving and storage of blood units; pre-transfusion testing, and issuing blood for clinical transfusion at a national level) Institution demographics ▪ Year 2019: ○ Blood Donation Number: 2·766·581 ○ Apheresis Donation Number: 42·656 ○ RBC production: 2·738·117 ○ Fresh Frozen Plasma (FFP)Production: 1·390·223 ○ Pooled platelet production: 281·327 ○ Apheresis Platelet Production: 44·726 ▪ Year 2020 (11 month): ○ Blood Donation Number: 2·126·279 ○ Apheresis Donation Number: 55·247 ○ Convalescent Plasma (CP): 35·383 ○ RBC production: 2·110·140 ○ Fresh Frozen Plasma (FFP)Production: 1·098·723 ○ Pooled platelet production: 244·554 ○ Apheresis Platelet Production: 77·429 ○ Apheresis CP Production: 63·145 Question 2 ▪ Immune plasma donation can be done within a minimum of 14 days and a maximum of 3 (three) months after recovery. The date of the first donation is accepted as the starting date and it can be made 8 times in 3 months with a minimum of 10 days intervals and a maximum of 3 times in a month. A maximum of 1800 ml of plasma can be collected from a donor in one month. ▪ No Question 3 ▪ Turkish Red Crescent is responsible for procurement. Indications for use should be taken from the Ministry of Health or from faults. Question 4 ▪ In order for individuals caught and recovered from COVID-19 virus infection to become donors: • The diagnosis of COVID-19 infection was made according to the results of the laboratory test (PCR test positivity from the nasopharynx swab sample or the test positivity of SARS-CoV-2 antibodies serologically) AND • At least 14 days have passed since clinical recovery (cough, fever, shortness of breath, weakness, etc.) AND • At least 2 PCR test results from nasopharyngeal swab samples must be negative (one of the tests must have been done in the last 48 h). • If 28 days have passed since clinical recovery, PCR test negativity is not required. The records of these people should be complete, documented and traceable. Question 5

No

Question 6

No

Question 7

Yes. ELISA (17 Regional Blood Center) and CLIA (1 regional blood center) (Euroimmun/Roche)

If yes/no, are samples collected from the CCP unit and freezed/archived for future assessment? YES

Question 8

Yes. Mirasol® Pathogen Reduction Technology - Terumo BCT

Question 9

No. These people are considered to be people who have received a blood transfusion, so they cannot donate blood or plasma

Question 10

Yes. 28 days.

Question 11

No. These people are considered to be people who have received a blood transfusion, so they cannot donate blood or plasma.

Turkey – Acıbadem Health Group Hospitals

Nil Banu Pelit

Question 1 Type of institution Hospital-based blood transfusion service/blood bank (a hospital unit responsible for pre-transfusion and compatibility testing, and issuing blood for clinical transfusion exclusively for use within hospital facilities) Institution demographics ○ For hospital ▪ Number of in-patient beds: 2129/16 hospitals ▪ Approximate number of RBCs transfused/year: 44 465 between Nov 2019–2020 ▪ Age group of patients treated (neonates, paediatrics <18 years, adults >18 years): <18 y: 19 500 >18 y: 72 000 ▪ Type of patients treated (medical or surgical): M:68500; S: 23000 ○ For blood establishments and blood services ▪ Approximate number of whole blood and apheresis collections made/year for RBCs, platelets and plasma (as applicable): WB: 1080; Aph: 5800 Question 2

Immune plasma donation can be done within a minimum of 28 days and a maximum of 3 (three) months after recovery. The date of the first donation is accepted as the starting date and it can be made eight times in 3 months with a minimum of 10 days intervals and a maximum of three times in a month.

Question 3

Both.

Question 4

The diagnosis of COVID-19 infection was made according to the results of the laboratory test (PCR test positivity from the nasopharynx swab sample or the test positivity of SARS-CoV-2 antibodies serologically) AND.

At least 28 days have passed since clinical recovery (cough, fever, shortness of breath, weakness, etc.) AND.

At least 2 PCR test results from nasopharyngeal swab samples must be negative (one of the tests must have been done just before donation) AND.

The result of Anti-SARS-Cov-2 antibodies is IgG Positive but IgM Negative.

If there is no symptoms (weakness, cough, shortness of breath, etc.), he/she is accepted for donation.

Question 5

Yes, patients with negative nasopharyngeal swab test were accepted as a suitable donor.

Question 6

Yes, the donors are screened with rapid card tests for anti-SARS-CoV-2 IgG and IgM in donor serum/plasma. The donors who are IgG positive and IgM negative were accepted as donors.

Question 7

No.

Yes.

Question 8

Yes: Cerus Corporation, Intercept Blood System.

Question 9

No. According to our regulations, these people are considered to be people who have received a blood transfusion, so they cannot donate blood or plasma at least 12 months.

Question 10

Yes, at least 28 days have passed since clinical recovery (cough, fever, shortness of breath, weakness, etc.)

Question 11

No. According to our regulations, these people are considered to be people who have received a blood transfusion, so they cannot donate blood or plasma at least 12 months.

Question 12

We had developed a project for CCP collection soon after first case in Turkey was defined. In addition to the described criteria, we also prepared cryopoor plasma and pooled plasma from them in order to decrease the coagulation factors and the effect of antibody-dependent enhancement of infection. We screened the isohemagglutinin titres before pooling. We pooled 8 units in order to have the titres below 1:32. We divided this pooled plasma into 200 ml bags. By this way, we made a composition that can be used by each patient without blood group match. We will soon publish the results of this project. At the beginning of the pandemic the CCP was used in ICU patients who had pneumonia according the MoH guidelines, however the guideline was reviewed and CCP was advised during the first 7–10 days of the infection. We think that immune plasma is more useful at initial days in order to prevent the development of pneumonia or in patients in risk groups such as medical staff and close contacts to infected people.

Saudi Arabia

Salwa I. Hindawi & Maha A. Badawi

Question 1 Hospital-based blood services Institution demographics: ▪ Number of in-patient beds: 780 beds ▪ Approximate number of RBCs transfused/year: 12 000 ▪ Age group of patients treated (neonates, paediatrics < 18 years, adults > 18 years) All age groups ▪ Type of patients treated (medical or surgical): Medical and surgical for all age groups but without transplant or trauma. ▪ Approximate number of whole blood and apheresis collections made/year for whole blood: 12 500, which processed to blood components, apheresis platelets donation around 100 Question 2

Type of CCP donations in our institution is performed through plasmapheresis and donor can donate once or twice one week apart.

Question 3

Collected CCP is intended for transfusion of COVID-19 patients only under clinical trial and only few have been used as compassionate use.

Question 4

The CCP donor eligibility criteria used in our institution are as follow:

Donor should match routine donor eligibility criteria; donors should have history of SARS-CoV-2 infection with positive confirmation for SARS-CoV-2 by PCR testing and complete recovery from symptoms of at least 2 weeks before donation.

There is no need to have a confirmatory test result status of past COVID-19 infection before CCP donation but anti-SARS-CoV-2 neutralizing antibodies titre regularly done for all donors at time of donation.

Question 5

No need to test the CCP donor for SARS-CoV-2 by PCR before donation as he should have complete clinical recovery for 2 weeks before CCP donation.

Question 6

To date, we are testing all donors for SARS-CoV-2 neutralizing antibodies titre before donation through in-house neutralization test using live virus. No other antibody testing is done.

Question 7

We are testing only donors at time of CCP donation for SARS-CoV-2 neutralizing antibody titre testing.

Question 8

At our institution, CCP subjected to a pathogen reduction treatment and we use Intercept system (Amotosalen and UV light treatment).

Question 9

At the current time, the protocol does not clearly exclude recipients of CCP from CCP donation. However, we did not have come across any recipients of CCP whom like to donate. At our institution recipients of blood or blood components are deferred from donating any blood components for 3 months (new policy).

Question 10

Individuals recovered from COVID-19 infection can donate if 28 days have passed since resolution of symptoms, or 28 days after the date of the positive swab if they were asymptomatic.

Question 11

Recipients of blood or blood components (including recipient of CCP) are deferred from donating any blood components for 3 months. This change from the previous policy of deferral for 12 months was based on FDA guidance https://www.fda.gov/media/92490/download

Question 12

We faced few challenges as convincing recovered patients to donate CCP after their discharged from the hospital, as they seem to be worried about their health and contracting infection again. The other challenges are the transfusion protocol, dosing and frequency of treatment.

An important lesson we learned that the recruitment of CCP donors should be started shortly after diagnosis by healthcare professionals in contact with the patient at that early stage and before discharge from the hospital. Awareness and education to the patients and society on the importance of CCP donation and its implication through distribution of educational materials and discussion with patients, through donor campaigns and social media are essential. We should be prepared with effective plan for future pandemics if any.

India – New Delhi

Gopal K Patidar, Hem Chandra Pandey & Rahul Chaurasia

Question 1

We are a hospital-based blood transfusion service within All India Institute of Medical Sciences (AIIMS), New Delhi, India, that is one of the largest tertiary care academic hospital in North India. Our hospital has more than 2000 in-patient’s hospital beds, catering to patients of all age groups i.e. neonates, paediatrics, adults and geriatrics, across all medical and surgical specialties. We received approximately 1 50 000 blood component transfusion requests form annually from various departments out of them around 75 000 red blood cell units issued annually for transfusion. At our institution, there are three blood centres under the purview of Department of Transfusion Medicine, which collects more than 80 000 of whole blood units annually and fully process it into blood components like red blood cells, platelet concentrates and plasma. We also perform pre-transfusion testing and issue the blood components within our hospital and outsource excess plasma for fractionation. We also have apheresis facilities which mainly focuses on platelet (apheresis) collection and peripheral blood stem collection accounting for collection of 2000 apheresis units. Therapeutic procedures such as plasma exchanges are also quite frequent (400–500 plasma exchanges are performed annually). Apheresis plasma collection was not performed routinely in the pre-COVID-19 period.

Question 2

At our institution CCP donation is done by plasmapheresis, as per the regulations mandated under the Drugs and Cosmetic Act (second amendment) 2020, India [1]. The act recommends “The quantity of plasma separated from the blood of donor shall not exceed 500 ml per sitting and once in a fortnight or shall not exceed 1000 ml per month”. Thus, allowing a CCP donor to donate twice a month with maximum collection of 500 ml in each donation.

Question 3

At our institute, CCP collected is intended for transfusions only. During the initial phases of COVID-19 pandemic, CCP transfusions were performed as a part of clinical trial to evaluate its safety and efficacy. Later on, its use was restricted for off label indication or transfused on compassionate grounds.

Question 4

CCP donor eligibility criteria at our institution were in accordance with national guidelines issued by Indian Council of Medical Research (ICMR) [2] and National Blood Transfusion Council (NBTC) [3], India.

Our donor eligibility criteria are as following:

Donor age should be 18–60 years. Males or nulliparous female donors of weight >50 Kg. Laboratory confirmed COVID-19 either by RT-PCR OR Rapid antigen test. Recovered patient (CCP donor) preferably symptomatic during illness (fever, cold, cough, etc.) and demonstrable anti-SARS-CoV-2 IgG antibodies by available immunoassay. Complete resolution of symptoms at least 14 days prior to donation, RT-PCR negative report is not mandated in this situation. If RT-PCR negative report is available, then the period can be reduced to 14 days from the negative RT-PCR report. Asymptomatic donors may be accepted, if anti-SARS-CoV-2 IgG antibodies are present and verified by two different approved test. In addition, donor eligibility criteria for whole blood donation is being followed in accordance with Drugs and Cosmetics (Second Amendment) Rules, 2020 [1]. Complete blood count including Haemoglobin (Hb), Haematocrit (HCT), Platelet count, Total leucocyte count (TLC) and differential leucocyte count (DLC). Donors with Hb > 12·5 g/dl, platelet count >1 50 000 per microlitre of blood and TLC within normal limits are accepted. Donors negative for screening test of human immunodeficiency virus (HIV), hepatitis B virus (HBV), hepatitis C virus (HCV), syphilis and malaria are accepted. Donors with total serum protein >6 gm/dl are accepted. Titration of anti-SARS-CoV-2 neutralizing antibodies may be done depending on availability of facilities at the time of testing. Unavailability of antibody titres is not preclude convalescent plasma transfusion. Desired titres for IgG antibodies is 1:640 by enzyme-linked immunosorbent assay (ELISA) method OR 13 arbitrary unit (AU) by chemiluminescence method OR for neutralizing antibodies titre of 1:80 (Plaque reduction neutralization test (PRNT)/microneutralization test (MNT). Blood group (ABO grouping and Rh phenotyping) and antibody screening for clinically significant antibodies (Extended Rh, Kell, Duffy, Kidd, MNS) – Antibody screen positive donors are deferred. Question 5

At our institution CCP donors are not tested for SARS-CoV-2 by PCR method to confirm clearance of the infection before donation.

Question 6

Yes, we do test the CCP donors for presence of IgG anti-SARS-CoV-2 antibodies using chemiluminescence assay in Abbott platform (i1000SR) before donation. We were using all the CCP above the cut-off recommended by the manufacturer (1·4) for differentiating positive and negative samples.

Question 7

Pre-donation testing of blood donors for presence of IgG anti-SARS-CoV-2 antibodies is being done and repeat testing of the collected units is not done. The unit is collected either on the same day of testing or the next day. As we did not have facility for testing neutralizing titre, we do store the frozen sample of CCP for testing in future.

Question 8

Pathogen reduction treatment for plasma is still not in use in our country, so collected CCP units were not subjected to pathogen reduction treatment.

Question 9

As per the regulations laid out in the Drug and Cosmetic Act (Second Amendment), 2020 [1], any blood and blood component recipient should be deferred for any donation until 12 months. Accordingly, we also do not accept recipients of CCP for convalescent plasma donation.

Question 10

At our institution, we accept whole blood or apheresis donation after 28 days of complete recovery after COVID-19 infection as per the guidelines issued by the National Blood Transfusion Council, India [3].

Question 11

As per the regulations laid out in the Drug and Cosmetic Act (Second Amendment), 2020 [1], any blood and blood component recipient should be deferred for any donation until 12 months. Accordingly, we also do not accept recipients of CCP for whole blood and apheresis donation until 12 months after receipt of transfusion.

Question 12

Blood collection by apheresis is not a routine procedure in our country and is limited to only platelet collections at most of the blood centres. Thus, general public in our country is less aware and motivated towards blood component donations through apheresis procedure. Motivating individuals who have recently recovered from severe mental stress due to COVID-19 for apheresis donation was a daunting task. This was subdued by continuous motivation of potential donors, especially by treating clinicians during treatment or recovery and follow-up by the blood centre staff.

Since recruiting donors for CCP donation was difficult amid the national lockdown, we had to modify our approach towards recruitment and screening of the blood donors. A telephonic screening of potential donors by asking the health related questions or sending questionnaire by digital means, allowed only the eligible donors to come at the blood centre. This not only reduced the hardships faced by the donors during travel restrictions but also helped in maintaining social distance. At times, incentivizing the donor in the form of transportation through hospital/medical vehicle, also aided them to come and donate CCP.

Since plasma donation was new procedure for most donors, the total time taken for CCP donation, including waiting time required for testing and due to the limited apheresis equipment was also a demotivating factor for many donors. This was improved by allotting time slots for sample collection and procedure to donors and demarcating dedicated space and equipment for CCP donation.

Apart from donor-related issues, we also faced issues related to the availability of quality antibody assays to screen donors for presence of SARS-CoV-2 antibodies. The availability of neutralizing assays remains a challenge.

However, stringent CCP donor selection criterion remained a major hurdle in the overall process as it reduced the number of eligible donors significantly. A careful analysis of risk vs. benefit of certain less innocuous conditions in the donors and relaxing them, during the pandemic situation can further improve the overall recruitment of donors for CCP.

Section References Brazil

Roberta Maria Fachini, Patrícia Scuracchio & Silvano Wendel

Question 1 Type of institution: Hospital-based blood service Institution demographics:

The Hospital Sírio-Libanês is a not for profit private hospital with 510 in-patient beds that transfuses an average of 6000 red blood cells (RBCs)/year. The hospital receives paediatric and adult patients affected by clinical or surgical diseases. It is a national reference institution for oncological and critical patients, including those that need to be submitted to bone marrow transplantation, solid organ transplants, cardiovascular, orthopaedic, neurological and extensive oncological surgeries.

The Hospital Sírio-Libanês Blood Bank collects approximately 5500 whole blood units and 1750 apheresis, rendering additional 2300 components per year.

Question 2

As no specific single therapeutic measure has been proven efficient for COVID-19 treatment yet, the transfusion of SARS-CoV-2 convalescent plasma (CCP) has been studied through clinical trials.

Only male candidates, who had a moderate/mild disease, and full clinical recovery at least for ≥14 days, with a previous positive RT-PCR, age ranging from 18 to 60 years and body weight >55 kg were accepted as potential CCP donors, according to national guidelines [1, 2]. Those approved by a medical interview, were submitted to a second RT-PCR (whose result had to be negative), and had their neutralizing antibodies (nAb) tested by a virus neutralization test (VNT), and anti-nucleocapsid (NP) SARS-CoV-2 IgM, IgG and IgA ELISAs, as described elsewhere [3]. CCP units were collected only via plasmapheresis with a standard 600 mL plasma collection. According to Brazilian guidelines, each apheresis donor is allowed to donate plasma up to four times by apheresis in a two-month period; however, in specific situations, they can donate in shorter period in order to supply the transfusion demand for special patients, as COVID-19 [2].

Question 3

All the collected CCP is intended for transfusion, mostly for clinical trials, and in lesser amount as compassionate use, depending on the medical request. For clinical trial use, admitted patients were confirmed by RT-PCR, being ≥18 years old, and with criteria for severe pneumonia (defined by respiratory distress: oxygen saturation of 93% or less on room air, respiratory rate >30 breaths/min and/or arterial partial pressure of oxygen (PaO2)/fraction of inspired oxygen (FiO2) of 300 or less). Patients with preexisting history of anaphylactic transfusion reaction, pregnant or lactating women were excluded from trials [4]. No CCP units were intended as prophylaxis or fractionation use at this moment.

Question 4

Donors had to present a previous positive molecular test (SARS-CoV-2 RT-PCR) collected by nasopharyngeal swab at the time of the diagnosis, and full clinical recovery for at least 14 days after the beginning of their symptoms.

Question 5

Donors approved by the medical examination underwent a second molecular test (SARS-CoV-2 RT-PCR by nasopharyngeal swab), which had to be non-reactive in order to be accepted for donation. Donors who remain reactive by the RT-PCR were invited to perform a third RT-PCR test after additional 14 days. If the subsequent RT-PCR test is non-reactive, the donor was accepted; otherwise, rejected from the CCP collection program [3].

Additionally, donors were tested for blood typing (ABO and RhD), irregular antibodies to red blood cell antigens (immunohematologic tests), and infectious diseases markers (hepatitis B and C virus, human immunodeficiency virus, human T-lymphotropic virus-1/2, syphilis and Chagas disease).

Question 6

Serum samples were collected for a cytopathic effect (CPE)-based virus neutralization test (VNT) carried out with SARS-CoV-2 (Gen-Bank: MT MT350282) and for immunoglobulins (IgA, IgM and IgG) nucleocapsid protein (NP)-based SARS-CoV-2 enzyme-linked immune-sorbent assays (ELISA) [3] at the moment of the first medical interview, together with the second RT-PCR. Only donors with nAb titre ≥160 and a negative RT-PCR were later accepted for donation, regardless of anti-NP results.

Question 7

Likewise, the same tests for anti-SARS-CoV-2 antibodies (nAbs and immunoglobulins) were carried out on donated CCP units, using the same criteria described above.

Question 8

All CCP units were treated with INTERCEPT® (Cerus Corporation, Concord, USA), according to manufacturer’s instructions, either individually or pooled two by two. After treatment, units are separated into 200 ml doses. Pre- and post-treatment samples were tested for nAb titres and specific anti-NP antibodies, with no considerable change both in nAb or anti-NP levels before or after pathogen reduction [5].

Question 9

The answer is no, based on our current protocol, which establishes that only individuals who had mild/moderate SARS-CoV-2 infections can be candidate for donations. In addition, the Brazilian legislation [2], defines that anyone who has received a transfusion of any blood component, could donate blood only after a minimum period of 1 year.

Question 10

Yes, we accept individuals recovered from COVID-19 infection for standard whole blood or apheresis donation, as long as they have had the mild form of the disease and only after 60 days of complete recovery of all symptoms.

Question 11

See question 9.

Question 12

The implementation of a CCP collection program in our blood service was a very important action in order to provide spec