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1. Head-to-head validation of six immunoassays for SARS-CoV-2 in hospitalized patients

Author

Menno D. de Jong, MJ Schultz, Charlotte E. Teunissen, Marry Smit, Marianna Bugiani, Cornelis S. Stijnis, Janke Schinkel, H J C de Vries, Jan M. Prins, Godelieve J. de Bree, Harm Jan Bogaard, Paul Elbers, D. van de Beek, Frans Martens, Anne Geke Algera, Martijn Beudel, Rutger Koning, Armand Girbes, Robert Hemke, Diane Bax, Michiel Schinkel, Thecla A.M. Hekker, Suzanne Jurriaans, Jorinde Raasveld, Robin van Houdt, Leo Heunks, Willemke Stilma, Florianne Hafkamp, Denise Veelo, Janneke Horn, Esther Bulle, Pien Defoer, Suzanne Geerlings, Osoul Chouchane, Jeannine Nellen, Lieuwe D. J. Bos, B. Geerts, T. van der Poll, S. de Bruin, Patrick Thoral, Lynn Boonkamp, N. van Mourik, Michela Botta, Sabine M. Hermans, Aeilko H. Zwinderman, Edgar Peters, F. van Baarle, M. van der Valk, Lucas Fleuren, Dorien Wouters, Frederique Paulus, Tom van Gool, Martin P. Grobusch, Joppe W. Hovius, Michèle van Vugt, W.J. Wiersinga, Patricia E. Broekhuizen-van Haaften, Bennedikt Preckel, J. de Brabander, Alex R. Schuurman, M.A. van Agtmael, A. Goorhuis, M. W. Hollmann, Alexander P.J. Vlaar, Rens Zonneveld, Kim C. E. Sigaloff, Ellen Wentink-Bonnema, Anissa M. Tsonas, Jörg Hamann, Matthijs C. Brouwer, Marije K. Bomers, Laura Hagens, Tom Reijnders, Alex Cloherty, Annemieke C. Heijboer, Theo Geijtenbeek, Vanessa Harris, Jorrit J. Hofstra, Medical Microbiology and Infection Prevention, AII - Amsterdam institute for Infection and Immunity, Endocrinology Laboratory, AGEM - Amsterdam Gastroenterology Endocrinology Metabolism, Infectious diseases, AII - Infectious diseases, APH - Aging & Later Life, APH - Global Health, APH - Quality of Care, Graduate School, Intensive Care Medicine, Neurology, ANS - Neurodegeneration, Center of Experimental and Molecular Medicine, ANS - Neuroinfection & -inflammation, ACS - Pulmonary hypertension & thrombosis, Experimental Immunology, Radiology and Nuclear Medicine, AMS - Musculoskeletal Health, AMS - Sports, Global Health, APH - Methodology, Anesthesiology, ACS - Heart failure & arrhythmias, Nursing, ACS - Diabetes & metabolism, General Paediatrics, ACS - Microcirculation, Epidemiology and Data Science, APH - Health Behaviors & Chronic Diseases, APH - Digital Health, APH - Personalized Medicine, Laboratory Medicine, Amsterdam Neuroscience - Neurodegeneration, Amsterdam Neuroscience - Neuroinfection & -inflammation, Amsterdam Reproduction & Development (AR&D), Amsterdam Gastroenterology Endocrinology Metabolism, Internal medicine, Pulmonary medicine, Pathology, Amsterdam Neuroscience - Cellular & Molecular Mechanisms, Amsterdam Neuroscience - Complex Trait Genetics, Intensive care medicine, Radiology and nuclear medicine, VU University medical center, General practice, and Other Research

Subjects
Adult, Male, 0301 basic medicine, CLIA, chemiluminescence immunoassay, medicine.medical_specialty, Coronavirus disease 2019 (COVID-19), Head to head, Hospitalized patients, Rapid immunoassay, Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), 030106 microbiology, Enzyme-Linked Immunosorbent Assay, Antibodies, Viral, Sensitivity and Specificity, ECLIA, electrochemiluminescence immunoassay, SIMOA, single molecule array assay, Gastroenterology, Article, COVID-19 Serological Testing, Serology, 03 medical and health sciences, 0302 clinical medicine, Virology, Internal medicine, medicine, Automated analyzer, Humans, 030212 general & internal medicine, Aged, Aged, 80 and over, Immunoassay, medicine.diagnostic_test, SARS-CoV-2, business.industry, COVID-19, Middle Aged, Infectious Diseases, Female, ELISA, CMIA, chemiluminescence microparticle immunoassay, business, RIA, rapid immunoassay
Abstract

Background: Detecting SARS-CoV-2 antibodies may help to diagnose COVID-19. Head-to-head validation of different types of immunoassays in well-characterized cohorts of hospitalized patients remains needed. Methods: We validated three chemiluminescence immunoassays (CLIAs) (Liaison, Elecsys, and Abbott) and one single molecule array assay (SIMOA) (Quanterix) for automated analyzers, one rapid immunoassay RIA (AllTest), and one ELISA (Wantai) in parallel in first samples from 126 PCR confirmed COVID-19 hospitalized patients and 158 pre-COVID-19 patients. Specificity of the AllTest was also tested in 106 patients with confirmed parasitic and dengue virus infections. Specificity of the Wantai assay was not tested due to limitations in sample volumes. Results: Overall sensitivity in first samples was 70.6 % for the Liaison, 71.4 % for the Elecsys, 75.4 % for the Abbott, 70.6 % for the Quanterix, 77.8 % for the AllTest, and 88.9 % for the Wantai assay, respectively. Sensitivity was between 77.4 % (Liaison) and 94.0 % (Wantai) after 10 dpso. No false positive results were observed for the Elecsys and Abbott assays. Specificity was 91.1 % for the Quanterix, 96.2 % for the Liaison, and 98.1 % for the AllTest assay, respectively. Conclusion: We conclude that low sensitivity of all immunoassays limits their use early after onset of illness in diagnosing COVID-19 in hospitalized patients. After 10 dpso, the Wantai ELISA has a relatively high sensitivity, followed by the point-of-care AllTest RIA that compares favorably with automated analyzer immunoassays.

Published
2021
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2. Clinical features and prognostic factors in Covid-19: A prospective cohort study

Author

Sanne de Bruin, Lieuwe D. Bos, Marian A. van Roon, Anita M. Tuip-de Boer, Alex R. Schuurman, Marleen J.A. Koel-Simmelinck, Harm Jan Bogaard, Pieter Roel Tuinman, Michiel A. van Agtmael, Jörg Hamann, Charlotte E. Teunissen, W. Joost Wiersinga, A.H. (Koos) Zwinderman, Matthijs C. Brouwer, Diederik van de Beek, Alexander P.J. Vlaar, Michiel van Agtmael, Anne Geke Algera, Brent Appelman, Frank van Baarle, Diane Bax, Martijn Beudel, Marije Bomers, Peter Bonta, Lieuwe Bos, Michela Botta, Justin de Brabander, Godelieve de Bree, David T.P. Buis, Marianna Bugiani, Esther Bulle, Osoul Chouchane, Alex Cloherty, Maurits C.F.J. de Rotte, Mirjam Dijkstra, Dave A. Dongelmans, Romein W.G. Dujardin, Paul Elbers, Lucas Fleuren, Suzanne Geerlings, Theo Geijtenbeek, Armand Girbes, Bram Goorhuis, Martin P. Grobusch, Florianne Hafkamp, Laura Hagens, Jorg Hamann, Vanessa Harris, Robert Hemke, Sabine M. Hermans, Leo Heunks, Markus Hollmann, Janneke Horn, Joppe W. Hovius, Menno D. de Jong, Rutger Koning, Endry H.T. Lim, Niels van Mourik, Jeannine Nellen, Esther J. Nossent, Frederique Paulus, Edgar Peters, Dan A.I. Piña-Fuentes, Tom van der Poll, Bennedikt Preckel, Jan M. Prins, Jorinde Raasveld, Tom Reijnders, Michiel Schinkel, Femke A.P. Schrauwen, Marcus J. Schultz, Alex Schuurmans, Jaap Schuurmans, Kim Sigaloff, Marleen A. Slim, Patrick Smeele, Marry Smit, Cornelis S. Stijnis, Willemke Stilma, Charlotte Teunissen, Patrick Thoral, Anissa M. Tsonas, Pieter R. Tuinman, Marc van der Valk, Denise Veelo, Carolien Volleman, Heder de Vries, Lonneke A. Vught, Michèle van Vugt, Dorien Wouters, A.H (Koos) Zwinderman, Pulmonary medicine, ACS - Pulmonary hypertension & thrombosis, Intensive care medicine, Internal medicine, AII - Infectious diseases, Amsterdam Neuroscience - Complex Trait Genetics, Amsterdam Neuroscience - Cellular & Molecular Mechanisms, Pathology, ACS - Diabetes & metabolism, Graduate School, Intensive Care Medicine, Pulmonology, ACS - Heart failure & arrhythmias, Experimental Immunology, Center of Experimental and Molecular Medicine, Infectious diseases, Neurology, ANS - Neuroinfection & -inflammation, ACS - Microcirculation, APH - Quality of Care, Anesthesiology, AII - Amsterdam institute for Infection and Immunity, APH - Global Health, APH - Health Behaviors & Chronic Diseases, Global Health, APH - Digital Health, and APH - Personalized Medicine

Subjects
0301 basic medicine, Medicine (General), medicine.medical_specialty, Pathway analysis, medicine.medical_treatment, General Biochemistry, Genetics and Molecular Biology, Procalcitonin, 03 medical and health sciences, R5-920, 0302 clinical medicine, Internal medicine, Fibrinolysis, medicine, Prospective cohort study, business.industry, Proportional hazards model, Mortality rate, COVID-19, Clinical features, Biomarker, General Medicine, Prognosis, 030104 developmental biology, 030220 oncology & carcinogenesis, Medicine, Biomarker (medicine), business, Complement component 5a, Blood sampling
Abstract

Background Mortality rates are high among hospitalized patients with COVID-19, especially in those intubated on the ICU. Insight in pathways associated with unfavourable outcome may lead to new treatment strategies. Methods We performed a prospective cohort study of patients with COVID-19 admitted to general ward or ICU who underwent serial blood sampling. To provide insight in the pathways involved in disease progression, associations were estimated between outcome risk and serial measurements of 64 biomarkers in potential important pathways of COVID-19 infection (inflammation, tissue damage, complement system, coagulation and fibrinolysis) using joint models combining Cox regression and linear mixed-effects models. For patients admitted to the general ward, the primary outcome was admission to the ICU or mortality (unfavourable outcome). For patients admitted to the ICU, the primary outcome was 12-week mortality. Findings A total of 219 patients were included: 136 (62%) on the ward and 119 patients (54%) on the ICU; 36 patients (26%) were included in both cohorts because they were transferred from general ward to ICU. On the general ward, 54 of 136 patients (40%) had an unfavourable outcome and 31 (23%) patients died. On the ICU, 54 out of 119 patients (45%) died. Unfavourable outcome on the general ward was associated with changes in concentrations of IL-6, IL-8, IL-10, soluble Receptor for Advanced Glycation End Products (sRAGE), vascular cell adhesion molecule 1 (VCAM-1) and Pentraxin-3. Death on the ICU was associated with changes in IL-6, IL-8, IL-10, sRAGE, VCAM-1, Pentraxin-3, urokinase-type plasminogen activator receptor, IL-1-receptor antagonist, CD14, procalcitonin, tumor necrosis factor alfa, tissue factor, complement component 5a, Growth arrest–specific 6, angiopoietin 2, and lactoferrin. Pathway analysis showed that unfavourable outcome on the ward was mainly driven by chemotaxis and interleukin production, whereas death on ICU was associated with a variety of pathways including chemotaxis, cell-cell adhesion, innate host response mechanisms, including the complement system, viral life cycle regulation, angiogenesis, wound healing and response to corticosteroids. Interpretation Clinical deterioration in patients with severe COVID-19 involves multiple pathways, including chemotaxis and interleukin production, but also endothelial dysfunction, the complement system, and immunothrombosis. Prognostic markers showed considerable overlap between general ward and ICU patients, but we identified distinct differences between groups that should be considered in the development and timing of interventional therapies in COVID-19. Funding Amsterdam UMC, Amsterdam UMC Corona Fund, and Dr. C.J. Vaillant Fonds.

Published
2021
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