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

Diagn Microbiol Infect Dis. 2020 Nov;98(3):115161. doi: 10.1016/j.diagmicrobio.2020.115161. Epub 2020 Aug 2.

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.

Keywords: COVID-19; IgG; Immunoassay; Lateral flow; SARS-CoV-2; Serology.

Publication types

  • Evaluation Study

MeSH terms

  • Antibodies, Viral / blood*
  • Betacoronavirus / immunology*
  • COVID-19
  • Coronavirus Infections / diagnosis*
  • Humans
  • Immunoassay / methods*
  • Immunoglobulin G / blood*
  • Pandemics
  • Pneumonia, Viral / diagnosis*
  • Retrospective Studies
  • Reverse Transcriptase Polymerase Chain Reaction / methods
  • SARS-CoV-2
  • Sensitivity and Specificity

Substances

  • Antibodies, Viral
  • Immunoglobulin G