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Retrospective clinical evaluation of 4 lateral flow assays for the detection of SARS-CoV-2 IgG.
McAulay, Kathrine; Bryan, Andrew; Greninger, Alexander L; Grill, Francisca; Lake, Douglas; Kaleta, Erin J; Grys, Thomas E.
  • McAulay K; Department of Laboratory Medicine and Pathology, Mayo Clinic, Phoenix, AZ, USA.
  • Bryan A; Department of Laboratory Medicine, University of Washington School of Medicine, Seattle, WA, USA.
  • Greninger AL; Department of Laboratory Medicine, University of Washington School of Medicine, Seattle, WA, USA; Vaccine and Infectious Disease Division, Fred Hutchison Cancer Research Center, Seattle, WA, USA.
  • Grill F; School of Life Sciences, Arizona State University, Tempe, AZ, USA.
  • Lake D; School of Life Sciences, Arizona State University, Tempe, AZ, USA.
  • Kaleta EJ; Department of Laboratory Medicine and Pathology, Mayo Clinic, Phoenix, AZ, USA.
  • Grys TE; Department of Laboratory Medicine and Pathology, Mayo Clinic, Phoenix, AZ, USA. Electronic address: Grys.Thomas@mayo.edu.
Diagn Microbiol Infect Dis ; 98(3): 115161, 2020 Nov.
Article in English | MEDLINE | ID: covidwho-776481
Semantic information from SemMedBD (by NLM)
1. Assay METHOD_OF Detection
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Assay
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METHOD_OF
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Detection
2. Assay METHOD_OF Detection
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METHOD_OF
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Detection
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.
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Full text: Available Collection: International databases Database: MEDLINE Main subject: Pneumonia, Viral / Immunoglobulin G / Immunoassay / Coronavirus Infections / Betacoronavirus / Antibodies, Viral Type of study: Diagnostic study / Evaluation study / Observational 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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Full text: Available Collection: International databases Database: MEDLINE Main subject: Pneumonia, Viral / Immunoglobulin G / Immunoassay / Coronavirus Infections / Betacoronavirus / Antibodies, Viral Type of study: Diagnostic study / Evaluation study / Observational study / Randomized controlled trials Limits: Humans Language: English Journal: Diagn Microbiol Infect Dis Year: 2020 Document Type: Article Affiliation country: J.diagmicrobio.2020.115161