ABSTRACT
INTRODUCTION: In order to deal with the current pandemic caused by the novel SARS-CoV-2 coronavirus several serological immunoassays have been recently developed with the objective of being used as a complementary diagnostic tool and to support the RT-PCR technique currently considered the "gold-standard" method. However, these new assays need to be evaluated and validated. The purpose of this study was to assess the performance of five immunoassays (two ELISA and three CLIA assays) and one rapid immunochromatographic test for the detection of anti-SARS-CoV-2 antibodies. METHODS: Five semiquantitative immunoassays (MENARINI®, PALEX®, VIRCLIA®, ROCHE® and SIEMENS®) and one lateral flow rapid test (WONDFO®) were performed. A total of 124 samples were studied. Case serum samples (n=78) were obtained from COVID-19 patients confirmed by real-time RT-PCR/epidemiological-clinical-radiological criteria, and control non-SARS-CoV-2 samples (n=46) belonged to healthy healthcare workers involved in a seroprevalence study. RESULTS: Overall, the tests showed sensitivities around 70-90% and specificities greater than 95%, including the immunochromatographic test. In addition, we observed very good agreements among them, being better for the detection of IgG than for IgM antibodies (Cohen's kappa index of 0.95 for VIRCLIA® IgG with ROCHE®), as well as good diagnostic power of the tests as determined by the ROC curves. CONCLUSIONS: This study demonstrates the proper performance of the different immunoassays in order to be applied in the clinical practice as support in the diagnostic approach and in the development of vaccines and seroepidemiological studies of COVID-19.
ABSTRACT
INTRODUCTION: In order to deal with the current pandemic caused by the novel SARS-CoV-2 coronavirus several serological immunoassays have been recently developed with the objective of being used as a complementary diagnostic tool and to support the RT-PCR technique currently considered the "gold-standard" method. However, these new assays need to be evaluated and validated. The purpose of this study was to assess the performance of five immunoassays (two ELISA and three CLIA assays) and one rapid immunochromatographic test for the detection of anti-SARS-CoV-2 antibodies. METHODS: Five semiquantitative immunoassays (MENARINI®, PALEX®, VIRCLIA®, ROCHE® and SIEMENS®) and one lateral flow rapid test (WONDFO®) were performed. A total of 124 samples were studied. Case serum samples (n=78) were obtained from COVID-19 patients confirmed by real-time RT-PCR/epidemiological-clinical-radiological criteria, and control non-SARS-CoV-2 samples (n=46) belonged to healthy healthcare workers involved in a seroprevalence study. RESULTS: Overall, the tests showed sensitivities around 70-90% and specificities greater than 95%, including the immunochromatographic test. In addition, we observed very good agreements among them, being better for the detection of IgG than for IgM antibodies (Cohen's kappa index of 0.95 for VIRCLIA® IgG with ROCHE®), as well as good diagnostic power of the tests as determined by the ROC curves. CONCLUSIONS: This study demonstrates the proper performance of the different immunoassays in order to be applied in the clinical practice as support in the diagnostic approach and in the development of vaccines and seroepidemiological studies of COVID-19.
Subject(s)
COVID-19 , SARS-CoV-2 , Humans , COVID-19/diagnosis , Seroepidemiologic Studies , Immunoglobulin G , Sensitivity and Specificity , Antibodies, Viral , Immunoassay/methods , Chromatography, AffinityABSTRACT
INTRODUCTION AND OBJECTIVES: The cardiac sequelae of SARS-CoV-2 infection are still poorly documented. We conducted a cross-sectional study in healthcare workers to report evidence of pericardial and myocardial involvement after SARS-CoV-2 infection. METHODS: We studied 139 healthcare workers with confirmed past SARS-CoV-2 infection. Participants underwent clinical assessment, electrocardiography, and laboratory tests, including immune cell profiling and cardiac magnetic resonance (CMR). Clinically suspected pericarditis was diagnosed when classic criteria were present and clinically suspected myocarditis was based on the combination of at least 2 CMR criteria. RESULTS: Median age was 52 (41-57) years, 71.9% were women, and 16.5% were previously hospitalized for COVID-19 pneumonia. On examination (10.4 [9.3-11.0] weeks after infection-like symptoms), participants showed hemodynamic stability. Chest pain, dyspnea or palpitations were present in 41.7% participants, electrocardiographic abnormalities in 49.6%, NT-proBNP elevation in 7.9%, troponin in 0.7%, and CMR abnormalities in 60.4%. A total of 30.9% participants met criteria for either pericarditis and/or myocarditis: isolated pericarditis was diagnosed in 5.8%, myopericarditis in 7.9%, and isolated myocarditis in 17.3%. Most participants (73.2%) showed altered immune cell counts in blood, particularly decreased eosinophil (27.3%; P<.001) and increased cytotoxic T cell numbers (17.3%; P <.001). Clinically suspected pericarditis was associated (P <.005) with particularly elevated cytotoxic T cells and decreased eosinophil counts, while participants diagnosed with clinically suspected myopericarditis or myocarditis had lower (P <.05) neutrophil counts, natural killer-cells, and plasma cells. CONCLUSIONS: Pericardial and myocardial involvement with clinical stability are frequent after SARS-CoV-2 infection and are associated with specific immune cell profiles.
Subject(s)
COVID-19 , Myocarditis , Pericarditis , Arrhythmias, Cardiac/complications , COVID-19/complications , COVID-19/epidemiology , Cross-Sectional Studies , Female , Health Personnel , Humans , Male , Middle Aged , Myocarditis/diagnosis , Myocarditis/epidemiology , Myocarditis/etiology , Pericarditis/diagnosis , Pericarditis/epidemiology , Pericarditis/etiology , SARS-CoV-2ABSTRACT
OBJECTIVE: To describe the planning and execution process of a massive seroprevalence study for SARS-CoV-2 in professionals of the Hospital Universitario Fundación Alcorcón (HUFA) (Spain). METHODS: A description is presented of the plan designed and developed at the HUFA for the execution of the extraction of the samples for serology from all the professionals who worked in the hospital between 14 and 29 April 2020. A descriptive analysis of the participation of the professionals in the study is carried out. Extraction areas, health personnel, and execution times were planned. A total of 2326 extractions were assigned to health personnel, the remaining extractions were assigned to workers from external companies. RESULTS: A total of 2641 workers (90.5%) out of 2918 candidates participated in the study. The professional category most analysed was nursing with 28.3% (n = 590). The percentage of compliance with schedule planning was 28.6%. Up to a maximum of 298 daily extractions were planned. The busiest day was the 4th day of the study with 399 extractions. CONCLUSIONS: The organising of such a large study, with a 100% coverage of those who worked in the hospital, and with such a great response from the workers involved, has led to obtaining results of high reliability in the seroprevalence study carried out. Although the percentage of participation was very high, the level of compliance with the planning was low.
Subject(s)
Antibodies, Viral/blood , COVID-19/blood , COVID-19/epidemiology , Occupational Diseases/blood , Occupational Diseases/epidemiology , Personnel, Hospital , SARS-CoV-2/immunology , Adult , Female , Hospitals, Teaching , Humans , Male , Middle Aged , Occupational Diseases/virology , Seroepidemiologic Studies , Spain/epidemiologyABSTRACT
The appearance of a new coronavirus disease called COVID-19 at the end of 2019 and its pandemic expansion in the world has changed the usual practice of the specialty of Otorhinolaryngology (ENT). After a phase of exponential growth of infections, it has been possible to enter a phase of control of the spread of the disease in which the possibility of infection persists, and the appearance of new cases is considered acceptable by the health system. The aim of this document is to review the available evidence and propose strategies and recommendations for the medical-surgical practice of otorhinolaryngology and head and neck surgery, which allow establishing the usual activity, adapting the safety and efficacy standards to the current situation. Therefore, it is required to identify and classify patients according to criteria of infectious-immunological status, and to establish recommendations for protection in consultations, hospitalization and the operating room, which avoid the transmission of the disease to other users and healthcare personnel, in the specific context of the development of our specialty. This document is the result of the collaboration of all the scientific commissions and the SEORLCCC COVID-19 committee.