Table 2.

Regional variation in criteria for COVID‐19 convalescent plasma procurement

Geographical distribution	Country	Definition of diagnosis*	Definition of donor recovery for eligibility							Acceptable Cut off for sero‐positivity OR SARS‐CoV‐2 Antibody titres (if applicable)						Accepted interval for Repeat Donation and Total Number of Donations				Gender‐Specific Criteria as TRALI mitigation strategy			Pathogen Inactivation
			At least 14 days since resolution of symptoms without additional testing	14–28 days from resolution of symptoms with negative results for COVID‐19 on donated plasma	>28 days post symptom resolution	>28 days post‐symptom resolution OR >14 days negative result of a NAT testing on NP swab	>14 days post symptom resolution and 1 negative results for SARS‐CoV‐2 PCR or by a molecular diagnostic test from blood	Symptom free for more than 14 days AND 2 negative SARS‐CoV‐2 PCR tests on 2 different days	Negative result of a NAT testing on NP swab and molecular diagnostic test from blood, performed 14 days after the first test	NAT titre >1:160	NAT titre >1:80	NAT titre >1:40	ELISA signal specification only	positive testing for anti‐SARS‐CoV‐2 antibodies	No antibody tests approved currently, samples will be stored for retrospective testing	Every 7 days (%)	Every 2 weeks	Every 4 weeks	min. 2 donation free days between 2 plasmaphereses; max. 60 plasmaphereses per year;	Male donors or female nulliparous donors or negative for HLA antibodies	Male donors or nulliparous female donors	Male Donors Only
AMERICAS	United States	√			√		√			√	√**					√				√
	Canada	√	√		√^						√^		√			√				√		√^
	Brazil	√					√			√	√**					√&				√	√
EUROPE	Italy	√						√	√	√											√		√
	UK	√			√						√ ‡						√			√
	Netherlands	√	√												√	√				√
	France	√	√									√		√*****			√			√			√
	Spain	√						√							√						√
	Germany	√				√								√					√	√			(√)
	Belgium	√			√					√						√					√		√
Asia	Singapore	√			√							√						√		√
	Hong Kong	√			√					√												√
	China	√					√						√				√#				√
	Taiwan*****	√			√		√								√
	India(fx)	√			√			√				√			√			√			√
	UAE	√			√			√							√	√				√			√
	Oman	√			√		√								√	√					√		√
	Saudi	√			√			√							√	once					√	√£	√
	Qatar	√			√				√						√	√						√	√
Africa	South Africa	√			√		√								√
	Nigeria	√			√		√								√			√				√
Australia	Australia	√			√						√					√						√

Pathogen inactivation is NOT intended for the SARS‐CoV‐2 inactivation.

(fx) In India: donors who have had COVID diagnosis more than 4 months will be excluded from donation.

^*Prior diagnosis of COVID‐19 documented by a PCR test at time of infection OR by positive anti‐SARS‐CoV‐2 serology following infection.

^**Neutralizing antibody titre >1:80 by AABB). A titre of 1:80 may be considered acceptable if an alternative matched unit is not available (per FDA)

^***Cut‐off for sero‐positivity will be set as the mean value +3 SD of the ELISA signal obtained with SARS‐ CoV‐2 negative plasma (pool of plasma samples collected before 2020) at a 1:100 plasma dilution. NAT will not be used as a criteria to release CP (%%) Every 7 days as permitted by allogeneic donor eligibility criteria. Maximum number of donations are limited by the annual limit on volume of donation.

^****France: testing has evolved over time: initially a systematic seroneutralization titre (+ an ELISA), more recently a systematic ELISA and seroneutralization titre when ELISA values are within a range of values associated with insufficient negative or positive predictive value a seroneutralization titre >40.

^*****Data for Taiwan are based on optimal understanding of the situation as the low number of cases did not justify so far the transfusion of convalescent plasma.

^† Highlights practices for Canadian Blood Services versus Hema‐Quebec.

^‡ Performed neutralising antibody titres and now performs Euroimmun tests that equate to a neutralising antibody titre of >1:100.

^# if asked for the second time, usually only one donation per donor.