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 - Funding Information:
We would like to thank the Mayo Clinic Center for Individualized Medicine for their continued support and the Mayo Clinic Arizona Department of Laboratory Medicine and Pathology staff for all their hard work supporting this study and the care of our patients during this pandemic. We would also like to thank the manufacturers for supplying some of the kits (ACON and BTNX kit 1). We also thank Safe Health Systems who supplied some kits (SD and BTNX kit 2) as part of a joint partnership with Mayo Clinic. TEG represents Mayo Clinic in a joint venture with Safe Health Systems and has shared intellectual property that may result in royalty sharing. This research did not receive any specific grant from funding agencies in the public, commercial, or not-for-profit sectors.
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
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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 -