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Comparison of 16 Serological SARS-CoV-2 Immunoassays in 16 Clinical Laboratories.
Harritshøj, Lene H; Gybel-Brask, Mikkel; Afzal, Shoaib; Kamstrup, Pia R; Jørgensen, Charlotte S; Thomsen, Marianne Kragh; Hilsted, Linda; Friis-Hansen, Lennart; Szecsi, Pal B; Pedersen, Lise; Nielsen, Lene; Hansen, Cecilie B; Garred, Peter; Korsholm, Trine-Line; Mikkelsen, Susan; Nielsen, Kirstine O; Møller, Bjarne K; Hansen, Anne T; Iversen, Kasper K; Nielsen, Pernille B; Hasselbalch, Rasmus B; Fogh, Kamille; Norsk, Jakob B; Kristensen, Jonas Henrik; Schønning, Kristian; Kirkby, Nikolai S; Nielsen, Alex C Y; Landsy, Lone H; Loftager, Mette; Holm, Dorte K; Nilsson, Anna C; Sækmose, Susanne G; Grum-Schwensen, Birgitte; Aagaard, Bitten; Jensen, Thøger G; Nielsen, Dorte M; Ullum, Henrik; Dessau, Ram B.
  • Harritshøj LH; Department of Clinical Immunology, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark Lene.holm.harritshoej@regionh.dk.
  • Gybel-Brask M; Department of Clinical Immunology, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark.
  • Afzal S; Department of Clinical Biochemistry, Copenhagen University Hospital, Herlev and Gentofte Hospital, Herlev, Denmark.
  • Kamstrup PR; Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.
  • Jørgensen CS; Department of Clinical Biochemistry, Copenhagen University Hospital, Herlev and Gentofte Hospital, Herlev, Denmark.
  • Thomsen MK; Department of Virus & Microbiological Special Diagnostics, Statens Serum Institut, Copenhagen, Denmark.
  • Hilsted L; Department of Clinical Microbiology, Aarhus University Hospital, Aarhus, Denmark.
  • Friis-Hansen L; Department of Clinical Biochemistry, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark.
  • Szecsi PB; Department of Clinical Biochemistry, Copenhagen University Hospital, Bispebjerg, and Frederiksberg Hospital, Copenhagen, Denmark.
  • Pedersen L; Department of Clinical Biochemistry, Holbæk Hospital, Holbæk, Denmark.
  • Nielsen L; Department of Clinical Biochemistry, Holbæk Hospital, Holbæk, Denmark.
  • Hansen CB; Department of Clinical Microbiology, Copenhagen University Hospital, Herlev and Gentofte Hospital, Copenhagen, Denmark.
  • Garred P; Laboratory of Molecular Medicine, Department of Clinical Immunology, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark.
  • Korsholm TL; Laboratory of Molecular Medicine, Department of Clinical Immunology, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark.
  • Mikkelsen S; Department of Clinical Medicine, Faculty of Health Sciences, University of Copenhagen, Copenhagen, Denmark.
  • Nielsen KO; Department of Clinical Immunology, Aarhus University Hospital, Aarhus, Denmark.
  • Møller BK; Department of Clinical Immunology, Aarhus University Hospital, Aarhus, Denmark.
  • Hansen AT; Department of Clinical Immunology, Aarhus University Hospital, Aarhus, Denmark.
  • Iversen KK; Department of Clinical Immunology, Aarhus University Hospital, Aarhus, Denmark.
  • Nielsen PB; Department of Clinical Immunology, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark.
  • Hasselbalch RB; Department of Cardiology, Herlev og Gentofte Hospital, University of Copenhagen, Herlev, Denmark.
  • Fogh K; Department of Emergency Medicine, Herlev og Gentofte Hospital, University of Copenhagen, Herlev, Denmark.
  • Norsk JB; Department of Cardiology, Herlev og Gentofte Hospital, University of Copenhagen, Herlev, Denmark.
  • Kristensen JH; Department of Emergency Medicine, Herlev og Gentofte Hospital, University of Copenhagen, Herlev, Denmark.
  • Schønning K; Department of Cardiology, Herlev og Gentofte Hospital, University of Copenhagen, Herlev, Denmark.
  • Kirkby NS; Department of Emergency Medicine, Herlev og Gentofte Hospital, University of Copenhagen, Herlev, Denmark.
  • Nielsen ACY; Department of Cardiology, Herlev og Gentofte Hospital, University of Copenhagen, Herlev, Denmark.
  • Landsy LH; Department of Emergency Medicine, Herlev og Gentofte Hospital, University of Copenhagen, Herlev, Denmark.
  • Loftager M; Department of Cardiology, Herlev og Gentofte Hospital, University of Copenhagen, Herlev, Denmark.
  • Holm DK; Department of Emergency Medicine, Herlev og Gentofte Hospital, University of Copenhagen, Herlev, Denmark.
  • Nilsson AC; Department of Cardiology, Herlev og Gentofte Hospital, University of Copenhagen, Herlev, Denmark.
  • Sækmose SG; Department of Emergency Medicine, Herlev og Gentofte Hospital, University of Copenhagen, Herlev, Denmark.
  • Grum-Schwensen B; Department of Clinical Microbiology, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark.
  • Aagaard B; Department of Clinical Microbiology, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark.
  • Jensen TG; Department of Clinical Microbiology, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark.
  • Nielsen DM; Department of Nonclinical and Clinical Assay Sciences in Global Discovery & Development Sciences, Novo Nordisk A/S, Måløv, Denmark.
  • Ullum H; Department of Nonclinical and Clinical Assay Sciences in Global Discovery & Development Sciences, Novo Nordisk A/S, Måløv, Denmark.
  • Dessau RB; Department of Clinical Immunology, Odense University Hospital, Odense, Denmark.
J Clin Microbiol ; 59(5)2021 04 20.
Article in English | MEDLINE | ID: covidwho-1081941
Semantic information from SemMedBD (by NLM)
1. Antigens PART_OF 2019 novel coronavirus
Subject
Antigens
Predicate
PART_OF
Object
2019 novel coronavirus
2. Assay METHOD_OF Detection
Subject
Assay
Predicate
METHOD_OF
Object
Detection
3. Laboratory LOCATION_OF Assay
Subject
Laboratory
Predicate
LOCATION_OF
Object
Assay
4. Nucleic Acid Amplification Tests DIAGNOSES Patient in hospital
Subject
Nucleic Acid Amplification Tests
Predicate
DIAGNOSES
Object
Patient in hospital
5. Epidermal cGVHD Score 2 PROCESS_OF Persons
Subject
Epidermal cGVHD Score 2
Predicate
PROCESS_OF
Object
Persons
6. COVID-19 PROCESS_OF Persons
Subject
COVID-19
Predicate
PROCESS_OF
Object
Persons
7. Autoimmune Diseases PROCESS_OF Blood donor
Subject
Autoimmune Diseases
Predicate
PROCESS_OF
Object
Blood donor
8. Autoimmune Diseases PROCESS_OF Patients
Subject
Autoimmune Diseases
Predicate
PROCESS_OF
Object
Patients
9. Total immunoglobulin measurement USES Enzyme-Linked Immunosorbent Assay
Subject
Total immunoglobulin measurement
Predicate
USES
Object
Enzyme-Linked Immunosorbent Assay
10. Total immunoglobulin measurement USES VSIR gene|VSIR
Subject
Total immunoglobulin measurement
Predicate
USES
Object
VSIR gene|VSIR
11. Antigens PART_OF 2019 novel coronavirus
Subject
Antigens
Predicate
PART_OF
Object
2019 novel coronavirus
12. Assay METHOD_OF Detection
Subject
Assay
Predicate
METHOD_OF
Object
Detection
13. Laboratory LOCATION_OF Assay
Subject
Laboratory
Predicate
LOCATION_OF
Object
Assay
14. Nucleic Acid Amplification Tests DIAGNOSES Patient in hospital
Subject
Nucleic Acid Amplification Tests
Predicate
DIAGNOSES
Object
Patient in hospital
15. Epidermal cGVHD Score 2 PROCESS_OF Persons
Subject
Epidermal cGVHD Score 2
Predicate
PROCESS_OF
Object
Persons
16. COVID-19 PROCESS_OF Persons
Subject
COVID-19
Predicate
PROCESS_OF
Object
Persons
17. Autoimmune Diseases PROCESS_OF Blood donor
Subject
Autoimmune Diseases
Predicate
PROCESS_OF
Object
Blood donor
18. Autoimmune Diseases PROCESS_OF Patients
Subject
Autoimmune Diseases
Predicate
PROCESS_OF
Object
Patients
19. Total immunoglobulin measurement USES Enzyme-Linked Immunosorbent Assay
Subject
Total immunoglobulin measurement
Predicate
USES
Object
Enzyme-Linked Immunosorbent Assay
20. Total immunoglobulin measurement USES VSIR gene|VSIR
Subject
Total immunoglobulin measurement
Predicate
USES
Object
VSIR gene|VSIR
ABSTRACT
Serological assays for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) are needed to support clinical diagnosis and epidemiological investigations. Recently, assays for large-scale detection of total antibodies (Ab), immunoglobulin G (IgG), and IgM against SARS-CoV-2 antigens have been developed, but there are limited data on the diagnostic accuracy of these assays. This study was a Danish national collaboration and evaluated 15 commercial and one in-house anti-SARS-CoV-2 assays in 16 laboratories. Sensitivity was evaluated using 150 samples from individuals with asymptomatic, mild, or moderate COVID-19, nonhospitalized or hospitalized, confirmed by nucleic acid amplification tests (NAAT); samples were collected 13 to 73 days either from symptom onset or from positive NAAT (patients without symptoms). Specificity and cross-reactivity were evaluated in samples collected prior to the SARS-CoV-2 epidemic from >586 blood donors and patients with autoimmune diseases, cytomegalovirus or Epstein-Barr virus infections, and acute viral infections. A specificity of ≥99% was achieved by all total-Ab and IgG assays except one, DiaSorin Liaison XL IgG (97.2%). Sensitivities in descending order were Wantai ELISA total Ab (96.7%), CUH-NOVO in-house ELISA total Ab (96.0%), Ortho Vitros total Ab (95.3%), YHLO iFlash IgG (94.0%), Ortho Vitros IgG (93.3%), Siemens Atellica total Ab (93.2%), Roche Elecsys total Ab (92.7%), Abbott Architect IgG (90.0%), Abbott Alinity IgG (median 88.0%), DiaSorin Liaison XL IgG (median 84.6%), Siemens Vista total Ab (81.0%), Euroimmun/ELISA IgG (78.0%), and Snibe Maglumi IgG (median 78.0%). However, confidence intervals overlapped for several assays. The IgM results were variable, with the Wantai IgM ELISA showing the highest sensitivity (82.7%) and specificity (99%). The rate of seropositivity increased with time from symptom onset and symptom severity.
Subject(s)
Keywords

Full text: Available Collection: International databases Database: MEDLINE Main subject: Immunoassay / COVID-19 Serological Testing / COVID-19 / Antibodies, Viral Type of study: Diagnostic study / Randomized controlled trials Limits: Humans Language: English Year: 2021 Document Type: Article Affiliation country: JCM.02596-20

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Full text: Available Collection: International databases Database: MEDLINE Main subject: Immunoassay / COVID-19 Serological Testing / COVID-19 / Antibodies, Viral Type of study: Diagnostic study / Randomized controlled trials Limits: Humans Language: English Year: 2021 Document Type: Article Affiliation country: JCM.02596-20