Analytical performance of lateral flow immunoassay for SARS-CoV-2 exposure screening on venous and capillary blood samples

Margaret A. Black, Guomiao Shen, Xiaojun Feng, Wilfredo F. Garcia Beltran, Yang Feng, Varshini Vasudevaraja, Douglas Allison, Lawrence H. Lin, Tatyana Gindin, Michael Astudillo, Diane Yang, Mandakolathur Murali, A. John Iafrate, George Jour, Paolo Cotzia, Matija Snuderl

Research output: Contribution to journalArticlepeer-review

Abstract

Objectives: We validate the use of a lateral flow immunoassay (LFI) intended for rapid screening and qualitative detection of anti-SARS-CoV-2 IgM and IgG in serum, plasma, and whole blood, and compare results with ELISA. We also seek to establish the value of LFI testing on blood obtained from a capillary blood sample. Methods: Samples collected by venous blood draw and finger stick were obtained from patients with SARS-CoV-2 detected by RT-qPCR and control patients. Samples were tested with Biolidics 2019-nCoV IgG/IgM Detection Kit lateral flow immunoassay, and antibody calls were compared with ELISA. Results: Biolidics LFI showed clinical sensitivity of 92% with venous blood at 7 days after PCR diagnosis of SARS-CoV-2. Test specificity was 92% for IgM and 100% for IgG. There was no significant difference in detecting IgM and IgG with Biolidics LFI and ELISA at D0 and D7 (p = 1.00), except for detection of IgM at D7 (p = 0.04). Capillary blood of SARS-CoV-2 patients showed 93% sensitivity for antibody detection. Conclusions: Clinical performance of Biolidics 2019-nCoV IgG/IgM Detection Kit is comparable to ELISA and was consistent across sample types. This provides an opportunity for decentralized rapid testing and may allow point-of-care and longitudinal self-testing for the presence of anti-SARS-CoV-2 antibodies.

Original languageEnglish (US)
Article number112909
JournalJournal of Immunological Methods
Volume489
DOIs
StatePublished - Feb 2021

Keywords

  • COVID-19
  • Lateral flow immunoassay
  • SARS-CoV-2
  • Serology
  • Validation

ASJC Scopus subject areas

  • Immunology and Allergy
  • Immunology

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