TY - JOUR
T1 - Retrospective clinical evaluation of 4 lateral flow assays for the detection of SARS-CoV-2 IgG
AU - McAulay, Kathrine
AU - Bryan, Andrew
AU - Greninger, Alexander L.
AU - Grill, Francisca
AU - Lake, Douglas
AU - Kaleta, Erin J.
AU - Grys, Thomas E.
N1 - Publisher Copyright:
© 2020 Elsevier Inc.
PY - 2020/11
Y1 - 2020/11
N2 - 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.
AB - 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.
KW - COVID-19
KW - IgG
KW - Immunoassay
KW - Lateral flow
KW - SARS-CoV-2
KW - Serology
UR - http://www.scopus.com/inward/record.url?scp=85090903058&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85090903058&partnerID=8YFLogxK
U2 - 10.1016/j.diagmicrobio.2020.115161
DO - 10.1016/j.diagmicrobio.2020.115161
M3 - Article
C2 - 32947206
AN - SCOPUS:85090903058
SN - 0732-8893
VL - 98
JO - Diagnostic Microbiology and Infectious Disease
JF - Diagnostic Microbiology and Infectious Disease
IS - 3
M1 - 115161
ER -