• Meng Li, Yuwei Zhao, Ying Li, Xue Chen, Dongxia Luo, Mei Luo, Jue Hou, Juan Liu, Humin Liu, Huan Wang, Yufang Dong, Lanjiang Zhang, Maosheng Ji, Xin Zhao, Caibing Wei, Wen Li, Jialiang Gao, Hua Shan, and Xuemei Fu.
• Blood Research Laboratory, Chengdu Blood Center, Chengdu, China.
• Transfusion. 2020 Dec 1; 60 (12): 2952-2961.

BackgroundThe ongoing outbreak of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has caused great global concerns. In contrast to SARS, some SARS-CoV-2-infected people can be asymptomatic or have only mild nonspecific symptoms. Furthermore, there is evidence that SARS-CoV-2 may be infectious during an asymptomatic incubation period. With the discovery that SARS-CoV-2 can be detected in plasma or serum, blood safety is worthy of consideration.Study Design And MethodsWe developed a nucleic acid test (NAT) screening system for SARS-CoV-2 targeting nucleocapsid protein (N) and open reading frame 1ab (ORF 1ab) gene that could screen 5076 samples every 24 hours. The 2019 novel coronavirus RNA standard was used to evaluate linearity of standard curves. Diagnostic sensitivity and reproducibility were evaluated using artificial SARS-CoV-2. Specificity was evaluated with 61 other respiratory pathogens. Diagnostic performance was evaluated by testing two sputum and nine oropharyngeal swab specimens. The reverse transcription polymerase chain reaction (RT-PCR) assay was used to screen SARS-CoV-2 RNA in blood donor specimens collected during the outbreak of SARS-CoV-2 in Chengdu.ResultsLimits of detection of the SARS-CoV-2 RT-PCR assay for N and ORF 1ab gene were 12.5 and 27.58 copies/mL, respectively. Intra-assay and interassay for the SARS-CoV-2 RT-PCR assay based on cycle threshold were acceptably low. No cross-reactivity was observed with other respiratory virus and bacterial isolates. The overall agreement value between the SARS-CoV-2 RT-PCR assay and clinical diagnostic results was 100%. A total of 16 287 blood specimens collected from blood donors during SARS-CoV-2 surveillance were tested negative.ConclusionsA high-throughput NAT screening system was developed for SARS-CoV-2 screening of blood donations during the outbreak of SARS-CoV-2.© 2020 AABB.

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