TY - JOUR
T1 - Feasibility of a pilot program for COVID-19 convalescent plasma collection in Wuhan, China
AU - Li, Ling
AU - Yang, Ru
AU - Wang, Jue
AU - Lv, Qilu
AU - Ren, Ming
AU - Zhao, Lei
AU - Chen, Hanwei
AU - Xu, Haixia
AU - Xie, Songli
AU - Xie, Jin
AU - Lin, Hui
AU - Li, Wenjuan
AU - Fang, Peng
AU - Gong, Li
AU - Wang, Lan
AU - Wu, Yanyun
AU - Liu, Zhong
N1 - Funding Information:
: This work was supported by the CAMS Innovation Fund for Medical Sciences (CIFMS) (Grant Nos. 2020‐I2M‐CoV19‐006, 2016‐I2M‐3‐024, and 2017‐I2M‐1‐009). Non‐profit Central Research Institute Fund of Chinese Academy of Medical Sciences (Grant No. 2018PT32016). Financial support
Funding Information:
We would like to thank the following individuals for their guidance, expertise, and assistance with the study design: Peter W. Marks, MD, PhD, Center for Biologics Evaluation and Research, FDA; Anne Eder, MD, PhD, Center for Biologics Evaluation and Research, FDA; Nicole Verdun, MD, Center for Biologics Evaluation and Research, FDA; Tim Uyeki, MD, MPH, MPP, National Center for Immunization and Respiratory Diseases, Centers for Disease Control and Prevention (CDC), USA; Scott Koepsell MD, PhD, University of Nebraska Medical Center; Annie Winkler, MD, Instrumentation Laboratory; Xuan Qin, PhD, D(ABMM), Seattle Children?s Hospital and University of Washington; Toby L. Simon, MD, CSL Behring; Richard J Benjamin, MD, PhD, CERUS Corporation; Jerry A Holmberg, Grifols S A; Vicente Blanquer, Grifols S A; Daniel Fleta, Grifols S A; Amarant Martinez, Grifols S A; and Liu Yang, Grifols S A.
Publisher Copyright:
© 2020 AABB
PY - 2020/8/1
Y1 - 2020/8/1
N2 - BACKGROUND: A novel coronavirus has caused an international outbreak. Currently, there are no specific therapeutic agents for coronavirus infections. Convalescent plasma (CP) therapy is a potentially effective treatment option. METHODS: Patients who had recovered from COVID-19 and had been discharged from the hospital for more than 2 weeks were recruited. COVID-19 convalescent plasma (CCP)-specific donor screening and selection were performed based on the following criteria: 1) aged 18-55 years; 2) eligible for blood donation; 3) diagnosed with COVID-19; 4) had two consecutive negative COVID-19 nasopharyngeal swab tests based on PCR (at least 24 hr apart) prior to hospital discharge; 5) had been discharged from the hospital for more than 2 weeks; and 6) had no COVID-19 symptoms prior to convalescent plasma donation. In addition, preference was given to CCP donors who had a fever lasting more than 3 days or a body temperature exceeding 38.5°C (101.3°F), and who donated 4 weeks after the onset of symptoms. CCP collection was performed using routine plasma collection procedures via plasmapheresis. In addition to routine donor testing, the CCP donorsʼ plasma was also tested for SARS-CoV-2 nucleic acid and S-RBD-specific IgG antibody. RESULTS: Of the 81 potential CCP donors, 64 (79%) plasma products were collected. There were 18 female donors and 46 male donors. There were 34 first-time blood donors and 30 repeat donors. The average time between CCP collection and initial symptom onset was 49.1 days, and the average time between CCP collection and hospital discharge was 38.7 days. The average volume of CCP collected was 327.7 mL. All Alanine transaminase (ALT) testing results met blood donation requirements. HIV Ag/Ab, anti-HCV, anti-syphilis, and HBsAg were all negative; NAT for HIV, HBV, and HCV were also negative. In addition, all of the CCP donorsʼ plasma units were negative for SARS-CoV-2 RNA. Of the total 64 CCP donors tested, only one had an S-RBD-specific IgG titer of 1:160, all others had a titer of ≥1:320. CONCLUSION: Based on a feasibility study of a pilot CCP program in Wuhan, China, we demonstrated the success and feasibility of CCP collection. In addition, all of the CCP units collected had a titer of ≥1:160 for S-RBD-specific IgG antibody, which met the CCP quality control requirements based on the Chinese national guidelines for CCP.
AB - BACKGROUND: A novel coronavirus has caused an international outbreak. Currently, there are no specific therapeutic agents for coronavirus infections. Convalescent plasma (CP) therapy is a potentially effective treatment option. METHODS: Patients who had recovered from COVID-19 and had been discharged from the hospital for more than 2 weeks were recruited. COVID-19 convalescent plasma (CCP)-specific donor screening and selection were performed based on the following criteria: 1) aged 18-55 years; 2) eligible for blood donation; 3) diagnosed with COVID-19; 4) had two consecutive negative COVID-19 nasopharyngeal swab tests based on PCR (at least 24 hr apart) prior to hospital discharge; 5) had been discharged from the hospital for more than 2 weeks; and 6) had no COVID-19 symptoms prior to convalescent plasma donation. In addition, preference was given to CCP donors who had a fever lasting more than 3 days or a body temperature exceeding 38.5°C (101.3°F), and who donated 4 weeks after the onset of symptoms. CCP collection was performed using routine plasma collection procedures via plasmapheresis. In addition to routine donor testing, the CCP donorsʼ plasma was also tested for SARS-CoV-2 nucleic acid and S-RBD-specific IgG antibody. RESULTS: Of the 81 potential CCP donors, 64 (79%) plasma products were collected. There were 18 female donors and 46 male donors. There were 34 first-time blood donors and 30 repeat donors. The average time between CCP collection and initial symptom onset was 49.1 days, and the average time between CCP collection and hospital discharge was 38.7 days. The average volume of CCP collected was 327.7 mL. All Alanine transaminase (ALT) testing results met blood donation requirements. HIV Ag/Ab, anti-HCV, anti-syphilis, and HBsAg were all negative; NAT for HIV, HBV, and HCV were also negative. In addition, all of the CCP donorsʼ plasma units were negative for SARS-CoV-2 RNA. Of the total 64 CCP donors tested, only one had an S-RBD-specific IgG titer of 1:160, all others had a titer of ≥1:320. CONCLUSION: Based on a feasibility study of a pilot CCP program in Wuhan, China, we demonstrated the success and feasibility of CCP collection. In addition, all of the CCP units collected had a titer of ≥1:160 for S-RBD-specific IgG antibody, which met the CCP quality control requirements based on the Chinese national guidelines for CCP.
UR - http://www.scopus.com/inward/record.url?scp=85088792871&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85088792871&partnerID=8YFLogxK
U2 - 10.1111/trf.15921
DO - 10.1111/trf.15921
M3 - Article
C2 - 32491199
AN - SCOPUS:85088792871
VL - 60
SP - 1773
EP - 1777
JO - Transfusion
JF - Transfusion
SN - 0041-1132
IS - 8
ER -