ABSTRACT
BACKGROUND: The coronavirus disease 2019 (COVID-19) has become a major health threat. To overcome COVID-19, appropriate diagnosis methods are urgently needed. The aim of this study was to clinically evaluate the colloidal gold immunochromatography assay for SARS-Cov-2 IgM/IgG antibody (Ab). METHODS: Patients confirmed COVID-19 (n = 51) were recruited prospectively from the Musashino Red Cross hospital and Tokyo Medical and Dental University Medical Hospital, between March and May 2020. And the analytical specificity was assessed with serum samples of patients without COVID-19 (n = 100) collected between August to September 2019 before SARS-CoV-2 was first reported in China. RESULTS: Among COVID-19 patients, a total of 87 serum samples were tested for SARS-Cov-2 IgM/IgG Ab assay. IgM was detected 71.0 %, 86.9 %, and 83.3 % at day8-14, 15-28, >29 after symptom onset and IgG was detected in 81.6 %, 87.0 %, and 94.4 %, respectively. The sensitivity of IgM and IgG Ab after day8 assay was significantly higher than before day7, respectively (p=0.0016, 0.0003). There were no positive results in 100 serum samples from patients without COVID-19. CONCLUSION: The SARS-Cov-2 IgM/IgG Ab assay had 79.7% / 86.1% sensitivity (the 8 days after from onset) and 100% specificity in this population.
Subject(s)
COVID-19 Serological Testing/methods , COVID-19/diagnosis , Immunoassay/methods , SARS-CoV-2 , Adult , Aged , Aged, 80 and over , COVID-19/epidemiology , COVID-19/immunology , Cohort Studies , Female , Humans , Immunoglobulin G/blood , Immunoglobulin M/blood , Japan/epidemiology , Male , Middle Aged , SARS-CoV-2/immunology , Sensitivity and SpecificityABSTRACT
BACKGROUND/AIM: The coronavirus disease 2019 (COVID-19) had become a big threat worldwide. Liver injury is not uncommon in patients with COVID-19, and clarifying its characteristics is needed. This study aimed to identify factors associated with liver injury and to develop a new classification of predictive severity in patients with COVID-19. METHODS: Confirmed patients with COVID-19 (n = 60) were recruited retrospectively from Musashino Red Cross Hospital. The factors of liver injury especially on the elevation of liver enzymes (aspartate aminotransferase [AST] and alanine aminotransferase [ALT]) were analyzed. Grading was assessed according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. RESULTS: During a median hospitalization follow-up of 15 (4-41) days, 51 (85.0%) patients had COVID-19 pneumonia. In clinical courses, oxygenation was needed for 25 (41.6%) patients and intubation was needed for 9 (15.0%) patients. A total of 27 (45.0%) patients had gastrointestinal symptoms (GS), such as appetite loss, diarrhea, and nausea. A logistic regression analysis revealed that C-reactive protein (CRP) at baseline, oxygenation, intubation, and GS were significant factors of liver injury. Based on these results, patients were classified into three groups: group 1, no oxygenation pneumonia; group 2, pneumonia with oxygenation or GS; and group 3, intubation. We classified 25 (41.7%), 26 (43.3%), and 9 (15.0%) patients into mild, moderate, and severe groups, respectively. The peak of AST and ALT levels was significantly stratified with this criteria (mild [median AST, 28 IU/L; median ALT, 33 IU/L], moderate [median AST, 48 IU/L; median ALT, 47.5 IU/L], and severe [median AST, 109 IU/L; median ALT, 106 IU/L]; P<0.001 and P = 0.0114, respectively). CONCLUSION: COVID-19-related liver injury was significantly stratified based on GS and severity of pneumonia.
Subject(s)
Coronavirus Infections/pathology , Digestive System Diseases/pathology , Digestive System Diseases/virology , Liver Diseases/pathology , Liver Diseases/virology , Pneumonia, Viral/pathology , Pneumonia/pathology , Pneumonia/virology , Alanine Transaminase/metabolism , Aspartate Aminotransferases/metabolism , C-Reactive Protein/metabolism , COVID-19 , Digestive System Diseases/metabolism , Female , Follow-Up Studies , Humans , Liver/metabolism , Liver/pathology , Liver/virology , Liver Diseases/metabolism , Male , Middle Aged , Pandemics , Pneumonia/metabolism , Retrospective Studies , Severity of Illness IndexABSTRACT
We examined anti-SARS-CoV-2 IgG and IgM antibodies in 45 serum samples from 26 patients with COVID-19, who were admitted in our hospital by using three different ELISA kits. All patients had pneumonia at admission, and 7 patients required mechanical ventilator support and grouped in severe case. Anti-SARS-CoV-2 IgG and IgM antibodies turned to be partially positive between the 6th and 10th days, more than 84% positive between the 11th and 15th days, and 100% after the 16th day. One ELISA kit revealed poorer sensitivity for anti-SARS-CoV-2 IgM antibody. Negative conversion of IgM antibody was not observed in the 30th day in our cohort. All three ELISA kits showed no false positive reaction for negative serum samples. Between severe and moderate cases, there was no significant difference in the trends of anti-SARS-CoV-2 IgG and IgM antibody.