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Twelve lateral flow immunoassays (LFAs) to detect SARS-CoV-2 antibodies

Owen, Sophie ORCID:, Williams, Chris, Garrod, Gala, Fraser, Alice, Baldwin, Lisa, Brown, Charlotte, Byrne, Rachel, Collins, Andrea ORCID:, CubasAtienzar, Ana, de Vos, Margaretha, Edwards, Thomas, Escadafal, Camille, Ferreira, Daniela ORCID:, Fletcher, Tom, Hyder-Wright, Angela, Kay, Grant Alistair, Kontogianni, Konstantina, Mason, Jenifer, Menzies, Stefanie ORCID:, Mitsi, Elena, Planche, Tim, Sacks, Jilian A., Taylor, Joseph, Todd, Stacy, Tully, Caroline, Cuevas, Luis ORCID: and Adams, Emily ORCID: (2022) 'Twelve lateral flow immunoassays (LFAs) to detect SARS-CoV-2 antibodies'. Journal of Infection, Vol 84, Issue 3, pp. 355-360.

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There are an abundance of commercially available lateral flow assays (LFAs) that detect antibodies to SARS-CoV-2. Whilst these are usually evaluated by the manufacturer, externally performed diagnostic accuracy studies to assess performance are essential. Herein we present an evaluation of 12 LFAs.
Sera from 100 SARS-CoV-2 reverse-transcriptase polymerase chain reaction (RT-PCR) positive participants were recruited through the FASTER study. A total of 105 pre-pandemic sera from participants with other infections were included as negative samples.
At presentation sensitivity against RT-PCR ranged from 37.4-79% for IgM/IgG, 30.3-74% for IgG, and 21.2-67% for IgM. Sensitivity for IgM/IgG improved ≥21 days post symptom onset for 10/12 tests. Specificity ranged from 74.3-99.1% for IgM/IgG, 82.9-100% for IgG, and 75.2-98% for IgM. Compared to the EuroImmun IgG enzyme-linked immunosorbent assay (ELISA), sensitivity and specificity ranged from 44.6-95.4% and 85.4-100%, respectively.
There are many LFAs available with varied sensitivity and specificity. Understanding the diagnostic accuracy of these tests will be vital as we come to rely more on the antibody status of a person moving forward, and as such manufacturer-independent evaluations are crucial.

Item Type: Article
Subjects: QW Microbiology and Immunology > Antigens and Antibodies. Toxins and Antitoxins > QW 575 Antibodies
QW Microbiology and Immunology > Immune Responses > QW 700 Infection. Mechanisms of infection and resistance.
QW Microbiology and Immunology > Immunotherapy and Hypersensitivity > QW 805 Vaccines. Antitoxins. Toxoids
WC Communicable Diseases > Virus Diseases > Viral Respiratory Tract Infections. Respirovirus Infections > WC 506 COVID-19
WF Respiratory System > WF 140 Diseases of the respiratory system (General)
Faculty: Department: Biological Sciences > Department of Tropical Disease Biology
Digital Object Identifer (DOI):
Depositing User: Cathy Waldron
Date Deposited: 17 Jan 2022 12:33
Last Modified: 05 May 2022 14:08


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