Evaluation of SARS-CoV-2 serology assays reveals a range of test performance.
Adult
Aged
Aged, 80 and over
Antibodies, Viral
/ blood
Betacoronavirus
/ genetics
Biotechnology
COVID-19
COVID-19 Testing
Chromatography, Affinity
Clinical Laboratory Techniques
/ methods
Coronavirus Infections
/ diagnosis
Enzyme-Linked Immunosorbent Assay
Female
Humans
Immunoglobulin G
/ blood
Immunoglobulin M
/ blood
Male
Middle Aged
Pandemics
Pneumonia, Viral
/ diagnosis
Point-of-Care Testing
Reverse Transcriptase Polymerase Chain Reaction
SARS-CoV-2
Sensitivity and Specificity
Young Adult
Journal
Nature biotechnology
ISSN: 1546-1696
Titre abrégé: Nat Biotechnol
Pays: United States
ID NLM: 9604648
Informations de publication
Date de publication:
10 2020
10 2020
Historique:
received:
09
06
2020
accepted:
29
07
2020
pubmed:
29
8
2020
medline:
21
10
2020
entrez:
29
8
2020
Statut:
ppublish
Résumé
Appropriate use and interpretation of serological tests for assessments of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) exposure, infection and potential immunity require accurate data on assay performance. We conducted a head-to-head evaluation of ten point-of-care-style lateral flow assays (LFAs) and two laboratory-based enzyme-linked immunosorbent assays to detect anti-SARS-CoV-2 IgM and IgG antibodies in 5-d time intervals from symptom onset and studied the specificity of each assay in pre-coronavirus disease 2019 specimens. The percent of seropositive individuals increased with time, peaking in the latest time interval tested (>20 d after symptom onset). Test specificity ranged from 84.3% to 100.0% and was predominantly affected by variability in IgM results. LFA specificity could be increased by considering weak bands as negative, but this decreased detection of antibodies (sensitivity) in a subset of SARS-CoV-2 real-time PCR-positive cases. Our results underline the importance of seropositivity threshold determination and reader training for reliable LFA deployment. Although there was no standout serological assay, four tests achieved more than 80% positivity at later time points tested and more than 95% specificity.
Identifiants
pubmed: 32855547
doi: 10.1038/s41587-020-0659-0
pii: 10.1038/s41587-020-0659-0
pmc: PMC7740072
mid: NIHMS1616808
doi:
Substances chimiques
Antibodies, Viral
0
Immunoglobulin G
0
Immunoglobulin M
0
Types de publication
Evaluation Study
Journal Article
Research Support, N.I.H., Extramural
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
1174-1183Subventions
Organisme : NHLBI NIH HHS
ID : R38 HL143581
Pays : United States
Organisme : U.S. Department of Health & Human Services | National Institutes of Health (NIH)
ID : F30AI150061
Pays : International
Organisme : U.S. Department of Health & Human Services | National Institutes of Health (NIH)
ID : T32GM007618
Pays : International
Organisme : U.S. Department of Health & Human Services | National Institutes of Health (NIH)
ID : 1F31NS106868-01
Pays : International
Organisme : NINDS NIH HHS
ID : F31 NS106868
Pays : United States
Organisme : NIAID NIH HHS
ID : F30 AI147364
Pays : United States
Organisme : NIAID NIH HHS
ID : R01 AI040098
Pays : United States
Organisme : NIAID NIH HHS
ID : T32 AI007334
Pays : United States
Organisme : U.S. Department of Health & Human Services | NIH | National Heart, Lung, and Blood Institute (NHLBI)
ID : R38HL143581
Pays : International
Organisme : NIGMS NIH HHS
ID : T32 GM007618
Pays : United States
Organisme : U.S. Department of Health & Human Services | National Institutes of Health (NIH)
ID : 1F30HD093116
Pays : International
Organisme : NIAID NIH HHS
ID : U19 AI135990
Pays : United States
Organisme : NIAID NIH HHS
ID : L40 AI140341
Pays : United States
Organisme : NIAID NIH HHS
ID : F30 AI150061
Pays : United States
Organisme : NCEZID CDC HHS
ID : U01 CK000490
Pays : United States
Organisme : NHLBI NIH HHS
ID : K38 HL154203
Pays : United States
Organisme : ACL HHS
ID : U01CK000490
Pays : United States
Organisme : NICHD NIH HHS
ID : F30 HD093116
Pays : United States
Commentaires et corrections
Type : UpdateOf
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