Retrospective clinical evaluation of 4 lateral flow assays for the detection of SARS-CoV-2 IgG

Kathrine McAulay, Andrew Bryan, Alexander L. Greninger, Francisca Grill, Douglas Lake, Erin J. Kaleta, Thomas E. Grys

Research output: Contribution to journalArticlepeer-review

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. (n = 457) and 1 each from ACON Laboratories (n = 200) and SD BIOSENSOR (n = 155)]. In a cohort of primarily hospitalized, reverse-transcription polymerase chain reaction–confirmed coronavirus disease 2019 cases, sensitivity at ≥14 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 ≥14 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.

Original languageEnglish (US)
Article number115161
JournalDiagnostic Microbiology and Infectious Disease
Volume98
Issue number3
DOIs
StatePublished - Nov 2020

Keywords

  • COVID-19
  • IgG
  • Immunoassay
  • Lateral flow
  • SARS-CoV-2
  • Serology

ASJC Scopus subject areas

  • Microbiology (medical)
  • Infectious Diseases

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