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

Autor: 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
Přispěvatelé: 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, Other Research
Rok vydání: 2021
Předmět:
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
Zdroj: Journal of clinical virology, 139:104821. Elsevier
Journal of Clinical Virology
Amsterdam UMC Covid-19 Biobank 2021, ' Head-to-head validation of six immunoassays for SARS-CoV-2 in hospitalized patients ', Journal of Clinical Virology, vol. 139, 104821 . https://doi.org/10.1016/j.jcv.2021.104821
Journal of Clinical Virology, 139:104821. Elsevier
ISSN: 1386-6532
Popis: 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.
Databáze: OpenAIRE