Abstract
Here, we aimed to evaluate the clinical performance of a novel automated immunoassay HISCL SARS-CoV-2 Antigen assay kit designed to detect the nucleocapsid (N) protein of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). This kit comprises automated chemiluminescence detection systems. Western blot analysis confirmed that anti-SARS-CoV antibodies detected SARS-CoV-2N proteins. The best cut-off index was determined, and clinical performance was tested using 115 nasopharyngeal swab samples obtained from 46 patients with coronavirus disease 2019 (COVID-19) and 69 individuals who tested negative for COVID-19 through reverse transcription quantitative polymerase chain reaction (RT-qPCR). The HISCL Antigen assay kit showed a sensitivity of 95.4% and 16.6% in samples with copy numbers > 100 and < 99, respectively. The kit did not cross-react with human coronaviruses causing seasonal common cold and influenza, and none of the 69 individuals without COVID-19 were diagnosed with positive results. Importantly, 81.8% of the samples with low virus load (< 50 copy numbers) were diagnosed as negative. Thus, using HISCL antigen assay kits may reduce overdiagnosis compared with RT-qPCR tests. The rapid and high-throughput HISCL SARS-CoV-2 Antigen assay kit developed here proved suitable for screening infectious COVID-19 and may help control the pandemic.
Highlights
We aimed to evaluate the clinical performance of a novel automated immunoassay HISCL SARSCoV-2 Antigen assay kit designed to detect the nucleocapsid (N) protein of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)
Low, clinically insignificant amounts of viral RNAs can still be detected when the cycle threshold (Ct) is set to more than 35, suggesting a positive result. This indicates that the relationship between Ct values and infectious status is debatable[12,13,14] since non-infectious COVID-19 individuals can be labeled as positive due to overdiagnosis by reverse transcription quantitative polymerase chain reaction (RT-qPCR) tests[15,16,17]
We developed an automated antigen detection system, which we termed as the HISCL SARS-CoV-2 Antigen assay kit that can detect the N protein of SARS-CoV-2 using enzyme-linked immunosorbent assay (ELISA)
Summary
We aimed to evaluate the clinical performance of a novel automated immunoassay HISCL SARSCoV-2 Antigen assay kit designed to detect the nucleocapsid (N) protein of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). This kit comprises automated chemiluminescence detection systems. Low, clinically insignificant amounts of viral RNAs can still be detected when the Ct is set to more than 35, suggesting a positive result This indicates that the relationship between Ct values and infectious status is debatable[12,13,14] since non-infectious COVID-19 individuals can be labeled as positive due to overdiagnosis by RT-qPCR tests[15,16,17]. In June 2020, LUMIPULSE G1200 using a chemiluminescence enzyme immunoassay became available (Fujirebio, Tokyo, Japan), and its overall sensitivity and specificity in Japanese patients was 55.2% and 99.6%, r espectively[23]
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