How we secured a COVID‐19 convalescent plasma procurement scheme in Japan

Background In order to tackle the COVID‐19 pandemic, a COVID‐19 convalescent plasma (CCP) procurement program was initiated in Japan in April 2020. The program was a collaboration between a government‐managed national hospital, an infectious disease research institute, and a blood banking organizati...

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Published in:	Transfusion (Philadelphia, Pa.) Vol. 61; no. 7; pp. 1998 - 2007
Main Authors:	Terada, Mari, Kutsuna, Satoshi, Togano, Tomiteru, Saito, Sho, Kinoshita, Noriko, Shimanishi, Yumiko, Suzuki, Tetsuya, Miyazato, Yusuke, Inada, Makoto, Nakamoto, Takahito, Nomoto, Hidetoshi, Ide, Satoshi, Sato, Mitsuhiro, Maeda, Kenji, Matsunaga, Akihiro, Satake, Masahiro, Matsubayashi, Keiji, Tsuno, Hirokazu, Kojima, Makiko, Kuramistu, Madoka, Tezuka, Kenta, Ikebe, Emi, Okuma, Kazu, Hamaguchi, Isao, Shiratori, Katsuyuki, Sato, Motohiko, Kawakami, Yuiko, Inaba, Kumi, Igarashi, Saori, Yamauchi, Reina, Matsumura, Mina, Ishimaru, Keiko, Zhang, Bijuan, Kuge, Chika, Ishihara, Maiko, Gouda, Miho, Tanaka, Keiko, Ishizaka, Yukihito, Ohmagari, Norio
Format:	Journal Article
Language:	English
Published:	Hoboken, USA John Wiley & Sons, Inc 01-07-2021 Wiley Subscription Services, Inc
Subjects:	Antibodies antibody Apheresis Blood Blood & organ donations blood donation Blood donors convalescent plasma COVID-19 How Do I Infectious diseases Pandemics Plasmapheresis Procurement Public concern Public health SARS‐CoV‐2 Severe acute respiratory syndrome Severe acute respiratory syndrome coronavirus 2 Spike protein Viral diseases Japan
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Summary:	Background In order to tackle the COVID‐19 pandemic, a COVID‐19 convalescent plasma (CCP) procurement program was initiated in Japan in April 2020. The program was a collaboration between a government‐managed national hospital, an infectious disease research institute, and a blood banking organization. Each party assumed different responsibilities: recruitment, SARS‐CoV‐2 antibody profiling, and plasmapheresis; conduction of screening tests; and SARS‐CoV‐2 blood testing, respectively. Methods We adopted a two‐point screening approach before the collected CCP was labeled as a CCP product for investigational use, for which we mainly tested anti‐SARS‐CoV‐2 antibody eligibility and blood product eligibility. Anti‐SARS‐CoV‐2 spike protein titer was measured using enzyme‐linked immunosorbent assay, and the IC50 value was denoted as the neutralizing activity. Blood donor eligibility was extended beyond the normal blood donation guidelines to include a broader range of participants. After both eligibility criteria were confirmed, participants were asked to revisit the hospital for blood donation, which is a unique aspect of the Japanese CCP program, as most donations are taking place in normal blood donation venues in other countries. Some donors were re‐scheduled for repeat plasma donations. As public interest in anti‐SARS‐CoV‐2 antibodies increased, test results were given to the participants. Results As of September 17, 2020, our collection of CCP products was sufficient to treat more than 100 patients. As a result, projects for administration and distribution are also being conducted. Conclusions We successfully implemented a CCP procurement scheme with the goal to expand to other parts of the country to improve treatment options for COVID‐19.
Bibliography:	Funding information Health, Labor and Welfare Policy Research Grants for Research on Emerging and Re‐emerging Infectious Diseases and Immunization, Grant/Award Number: 20HA1006; Ministry of Health, Labour and Welfare, Japan ObjectType-Article-1 SourceType-Scholarly Journals-1 ObjectType-Feature-2 content type line 23 Funding information Health, Labor and Welfare Policy Research Grants for Research on Emerging and Re‐emerging Infectious Diseases and Immunization, Grant/Award Number: 20HA1006; Ministry of Health, Labour and Welfare, Japan
ISSN:	0041-1132 1537-2995
DOI:	10.1111/trf.16541