No evidence of SARS‐CoV‐2 RNA among blood donors: A multicenter study in Hubei, China

Chang, Le; Yan, Ying; Zhao, Lei; Hu, Guibin; Deng, Lijuan; Su, Dan; Peng, Dongju; Nie, Xinjiao; Wang, Song; Li, Yuanyuan; Wang, Jundao; Ruan, Zhong; Gao, Shouliang; Yang, Huasong; Guo, Fei; Wang, Lunan

Severe acute respiratory syndrome coronavirus 2 (SARS‐CoV‐2) RNA could be detected in the blood of infected cases. From February 9, all blood establishments in Hubei province, China, implemented nucleic acid testing (NAT) for SARS‐CoV‐2 RNA among blood donors to ensure blood safety. STUDY DESIGN AND METHODS: Nucleic acid test screening individually (ID) or by minipool (MP) testing was performed according to the manufacturerʼs instructions. Inactivated culture supernatant of SARS‐CoV‐2–infected Vero cells was quantified by droplet digital polymerase chain reaction (ddPCR) and series diluted with negative plasma to evaluate the assayʼs performance. RESULTS: The limit of detection of the kit for MP testing was 62.94 and 33.14 copies/mL for N and ORF1ab region, respectively. ID testing could achieve 3.87 and 4.85 copies/mL for two regions using 1600 μL of plasma. Coefficients of variations of two different concentrations of reference samples were all less than 5% in MP testing. As of April 30, 2020, a total of 98,342 blood donations including 87,095 whole blood donations and 11,247 platelet donations were tested by ID or MP testing, and no RNAemia was found. In addition, Hubei province suffered precipitously decreased blood supply, especially in February: 86% reduction compared with the same period of 2019. CONCLUSION: Nucleic acid test screening of SARS‐CoV‐2 on blood donations is suitable in blood establishments using the commercial real‐time PCR detection kit based on available instruments. The negative result indicated that SARS‐CoV‐2 appears to be no direct threat to blood safety but raises some serious issues for general blood supply.