Abstract

BACKGROUND: The ongoing outbreak of SARS-CoV-2 has caused great global concerns. In contrast to SARS, some SARS-CoV-2 infected people can be asymptomatic or only have mild non-specific 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 METHODS: We developed a NAT screening system for SARS-CoV-2 targeting nucleocapsid protein (N) and open reading frame 1ab (ORF 1ab) gene which could screen 5076 samples every 24hours. 2019-nCoV RNA standard was used to evaluate linearity of standard curves. Diagnostic sensitivity and reproducibility were evaluated using artificial SARS-CoV-2 virus. Specificity was evaluated with 61 other respiratory pathogens. Diagnostic performance was evaluated by testing 2 sputum and 9 oropharyngeal swab specimens. The RT-PCR assay was used to screen SARS-CoV-2 RNA in blood donors specimens collected during the outbreak of SARS-CoV-2 in Chengdu.RESULTS: LOD 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 inter-assay for SARS-CoV-2 RT-PCR assay based on Ct were acceptably low. No cross-reactivity was observed with other respiratory virus and bacterial isolates. The overall agreement value between SARS-CoV-2 RT-PCR assay and clinical diagnostic results were 100%. A total of 16287 blood specimens collected from blood donors during SARS-CoV-2 surveillance were tested negative.CONCLUSIONS: A high throughput NAT screening system was developed for SARS-CoV-2 screening of blood donations during the outbreak of SARS-CoV-2.

View details for DOI 10.1111/trf.16049

View details for PubMedID 32798248