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

Owen SI., Williams CT., Garrod G., Fraser AJ., Menzies S., Baldwin L., Brown L., Byrne RL., Collins AM., Cubas-Atienzar AI., de Vos M., Edwards T., Escadafal C., Ferreira DM., Fletcher T., Hyder-Wright A., Kay GA., Kontogianni K., Mason J., Mitsi E., Planche T., Sacks JA., Taylor J., Todd S., Tully C., Cuevas LE., Adams ER.

BackgroundThere 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.MethodsSera 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.ResultsAt presentation sensitivity against RT-PCR ranged from 37.4 to 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 to 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 to 95.4% and 85.4-100%, respectively.ConclusionThere 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.

DOI

10.1016/j.jinf.2021.12.007

Type

Journal article

Publication Date

2022-03-01T00:00:00+00:00

Volume

84

Pages

355 - 360

Total pages

5

Addresses

Centre for Drugs and Diagnostics Research, Liverpool School of Tropical Medicine (LSTM), Liverpool, United Kingdom.

Keywords

Humans, Immunoglobulin G, Immunoglobulin M, Antibodies, Viral, Immunoassay, Sensitivity and Specificity, COVID-19, SARS-CoV-2

Permalink More information Close