Retrospective clinical evaluation of 4 lateral flow assays for the detection of SARS-CoV-2 IgG.
Diagn Microbiol Infect Dis
; 98(3): 115161, 2020 Nov.
Article
in English
| MEDLINE | ID: covidwho-776481
ABSTRACT
In a Clinical Laboratory Improvement Amendments laboratory setting, we evaluated severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) IgG detection with 4 lateral flow immunoassays [LFIAs; 2 iterations from BTNX Inc. (nâ¯=â¯457) and 1 each from ACON Laboratories (nâ¯=â¯200) and SD BIOSENSOR (nâ¯=â¯155)]. In a cohort of primarily hospitalized, reverse-transcription polymerase chain reaction-confirmed coronavirus disease 2019 cases, sensitivity at ≥14â¯days from symptom onset was BTNX kit 1, 95%; BTNX kit 2, 91%; ACON, 95%; and SD, 92%. All assays showed good concordance with the Abbott SARS-CoV-2 IgG assay at ≥14â¯days from symptom onset BTNX kit 1, 99%; BTNX kit 2, 94%; ACON, 99%; and SD, 100%. Specificity, measured using specimens collected prior to SARS-CoV-2 circulation in the United States and "cross-reactivity challenge" specimens, was 98% for BTNX kit 1 and ACON and 100% for BTNX kit 2 and SD. These results suggest that LFIAs may provide adequate results for rapid detection of SARS-CoV-2.
Keywords
Full text:
Available
Collection:
International databases
Database:
MEDLINE
Main subject:
Pneumonia, Viral
/
Immunoglobulin G
/
Immunoassay
/
Coronavirus Infections
/
Betacoronavirus
/
Antibodies, Viral
Type of study:
Cohort study
/
Diagnostic study
/
Experimental Studies
/
Observational study
/
Prognostic study
/
Randomized controlled trials
Limits:
Humans
Language:
English
Journal:
Diagn Microbiol Infect Dis
Year:
2020
Document Type:
Article
Affiliation country:
J.diagmicrobio.2020.115161
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