Abstract
Standard tests for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) detect the presence of viral RNA using real-time reverse transcription (rRT)-PCR. Recently, convenient, rapid, and relatively inexpensive SARS-CoV-2 antigen (Ag) detection methods have been developed. The STANDARD Q COVID-19 Ag test (SD Biosensor, Inc., Suwon, Korea) is a rapid immunochromatography test that qualitatively detects the nucleocapsid protein of SARS-CoV-2 using gold conjugated antibodies. We evaluated its performance in comparison with that of Allplex 2019-nCoV Assay (Seegene, Seoul, Korea) in a retrospective case-control study using residual samples. The sensitivity and specificity of the STANDARD Q COVID-19 Ag test were 89.2% (58/65) and 96.0% (96/100), respectively. Cycle threshold (Ct) values for the three target SARS-CoV-2 genes (envelope, RNA-dependent RNA polymerase, and nucleocapsid genes) included in Allplex 2019-nCoV Assay were significantly lower in Ag test-positive patients than in Ag test-negative patients ( P <0.001). The Ag test sensitivity was higher in samples with Ct≤30 and those collected one to five days post symptom onset. In conclusion, the STANDARD Q COVID-19 Ag test can serve as an alternative in high-prevalence settings, when the low sensitivity is compensated or when rRT-PCR tests are limited.
Keywords: Allplex 2019-nCoV Assay; Antigen; Immunochromatography; Nucleocapsid protein; Performance; STANDARD Q COVID-19 Ag test; Severe Acute Respiratory Syndrome Coronavirus 2.
【저자키워드】 severe acute respiratory syndrome coronavirus 2, immunochromatography, nucleocapsid protein, Antigen, performance, Allplex 2019-nCoV Assay, STANDARD Q COVID-19 Ag test, 【초록키워드】 COVID-19, severe acute respiratory syndrome coronavirus 2, antibodies, immunochromatography, SARS-CoV-2, coronavirus, 2019-nCoV, severe acute respiratory syndrome Coronavirus, coronavirus 2, respiratory syndrome coronavirus 2, nucleocapsid protein, Antigen, Severe acute respiratory syndrome, sensitivity, Sensitivity and specificity, cycle threshold, nucleocapsid, Patient, gold, RNA-dependent RNA polymerase, envelope, reverse transcription, Viral RNA, SARS-CoV-2 antigen, respiratory, threshold, case-control study, retrospective, Standard, symptom onset, acute respiratory syndrome, acute respiratory syndrome coronavirus, acute respiratory syndrome coronavirus 2, alternative, cycle, SARS-CoV-2 genes, SD Biosensor, rRT-PCR test, rRT-PCR tests, significantly lower, Genes, FIVE, detect, collected, evaluated, compensated, Inc., SARS-CoV-2 gene, 【제목키워드】 COVID-19, Test, coronavirus 2, Screening, clinical, Rapid, respiratory,