A critical point in the management of the SARS-CoV-2 pandemic is the need to promptly identify the greatest number of infected people and to implement strict public health measures. In this study, the performance of a rapid serological test in a clinical setting was evaluated. Samples from 819 consecutive patients (with or without respiratory symptoms) admitted to a large Emergency Department were tested between 23 March and 21 April 2020. Patient samples were tested in a real-time PCR assay and a serological assay. In total, 148/819 patients (18.1%) tested positive for SARS-CoV-2 by real-time PCR. The serological test revealed that 70/819 patients (8.5%) had anti-SARS-CoV-2 IgM and/or IgG. The prevalence of anti-SARS-CoV-2 antibodies was significantly higher in patients with respiratory symptoms lasting for >7 days than in those with respiratory symptoms lasting for 0–7 days ( p < 0.001). The serological assay had an overall sensitivity of 35.1% and an overall specificity of 97.3%. A high negative predictive value (96.7%) was reported for patients without respiratory symptoms. The results confirm that rapid serological assays alone are not sufficient for diagnosis of SARS-CoV-2 infection but can be incorporated into large-scale screening programs during periods in which the virus circulation is low.
【저자키워드】 COVID-19, serological test, SARS-COV-2 infection, Real-time PCR, Laboratory test, 【초록키워드】 SARS-CoV-2, IgG, pandemic, Infection, virus, Prevalence, sensitivity, specificity, Serological assay, anti-SARS-CoV-2 antibody, management, Patient, circulation, Critical, anti-SARS-CoV-2 IgM, Emergency, Negative predictive value, respiratory symptoms, greatest number, public health measures, respiratory symptom, clinical setting, Department, positive, real-time PCR assay, tested, identify, Sample, reported, evaluated, significantly higher, consecutive patient, diagnosis of SARS-CoV-2, the SARS-CoV-2, 【제목키워드】 SARS-CoV-2, Test, Rapid, Emergency, LIGHT, Department, shadow, Result,