ABSTRACT Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has spread rapidly worldwide since it was confirmed as the causative agent of COVID-19. Molecular diagnosis of the disease is typically performed via nucleic acid-based detection of the virus from swabs, sputum or bronchoalveolar lavage fluid (BALF). However, the positive rate from the commonly used specimens (swabs or sputum) was less than 75%. Immunological assays for SARS-CoV-2 are needed to accurately diagnose COVID-19. Sera were collected from patients or healthy people in a local hospital in Xiangyang, Hubei Province, China. The SARS-CoV-2 specific IgM antibodies were then detected using a SARS-CoV-2 IgM colloidal gold immunochromatographic assay (GICA). Results were analysed in combination with sera collection date and clinical information. The GICA was found to be positive with the detected 82.2% (37/45) of RT-qPCR confirmed COVID-19 cases, as well as 32.0% (8/25) of clinically confirmed, RT-qPCR negative patients (4–14 days after symptom onset). Investigation of IgM-negative, RT-qPCR-positive COVID-19 patients showed that half of them developed severe disease. The GICA was found to be a useful test to complement existing PCR-based assays for confirmation of COVID-19, and a delayed specific IgM antibody response was observed among COVID-19 patients with severe progression.
【저자키워드】 COVID-19, severity, IgM antibody, Delayed, GICA, 【초록키워드】 SARS-CoV-2, coronavirus, antibody, hospital, Antibody Response, Diagnosis, Local, complement, progression, sputum, virus, Spread, China, RT-qPCR, Bronchoalveolar lavage fluid, sera, swabs, Patient, immunochromatographic assay, BALF, positive rate, diagnose, SARS-CoV-2 IgM, Combination, investigation, severe disease, COVID-19 cases, COVID-19 patient, colloidal gold, symptom onset, acute respiratory syndrome, clinical information, specimen, positive, specific IgM, Result, performed, collected, healthy, clinically, the disease, analysed, less, PCR-based assay, 【제목키워드】 Antibody Response, progression, COVID-19 patient, specific IgM,