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

Abstract

Background 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. Methods 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. Results 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. Conclusion 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.

Diagnostic performance of lateral flow immunoassays for COVID-19 antibodies in Peruvian population

“…Still, much information about immunity remains unknown. Future studies and LFIA point-of-care test manufacturers could aim to the identification of neutralizing antibodies, local accuracy considering endemic diseases, and its ability to detect and differentiate vaccinated and previously infected people, in order to find more and better uses for the serological COVID-19 tests (32,(43)(44)(45).…”

An updated review of SARS‐CoV‐2 detection methods in the context of a novel coronavirus pandemic

“…The sensitivity and specificity of the 12 LFAs were low 21 days prior to symptom onset; however, they all increased 21 days after the onset of symptoms, with specificities ranging from 74.3% to 99.1% for IgM/IgG, 82.9% to 100%, and IgM specificity ranged from 75.2% to 98%. The Bionote had the highest overall sensitivity (79.0%) and its sensitivity for IgM/IgG response reached 88.2% after >21 days of symptom onset 89 . With the emergence of variant strains, Pickering et al investigated the specificity and LoD of six rapid test kits, such as the Innova Rapid SARS‐CoV‐2 antigen test, and the Spring Healthcare SARS‐CoV‐2 antigen rapid test Cassette, the SureScreen‐V kit, the Encode kit, and the E25Bio rapid diagnostic test.…”

“…The Bionote had the highest overall sensitivity (79.0%) and its sensitivity for IgM/IgG response reached 88.2% after >21 days of symptom onset. 89 With the emergence of variant strains, Pickering et al investigated the specificity and LoD of six rapid test kits, such as the Innova Rapid SARS‐CoV‐2 antigen test, and the Spring Healthcare SARS‐CoV‐2 antigen rapid test Cassette, the SureScreen‐V kit, the Encode kit, and the E25Bio rapid diagnostic test. The specificity, LoD, and sensitivity were measured for the assay kits, with both SureScreen‐V and Encode achieving 100% specificity and Innova achieving the highest overall sensitivity (89%) for clinical samples, rising to 95.5% and 98.6% when used on specimens with Ct values below 28 and Ct values below 25, respectively.…”

Potential of vibrational spectroscopy coupled with machine learning as a non-invasive diagnostic method for COVID-19

“…However, some technical shortcomings such as long processing time, laborious, involving specialized instruments and skilled personal encourage the further efforts to develop more reliable diagnosis strategy. Hence, some other testing methods including chest computed tomography (CT) [4] , [5] , chest X-ray images [6] , [7] , [8] , enzyme-linked immunosorbent assays [9] , chemiluminescence immunoassays [10] , lateral flow immunoassays [11] , electrochemical biosensor [12] , and mass spectrometry [13] , [14] , [15] , were presented as an alternative method for SARS-CoV-2 detection. Though these assays have been effective in reducing transmission rate, it is imperative to develop individual-friendly biofluids such as saliva or serum for COVID-19 patients screening and diagnosis.…”