Evaluation of three immunochromatographic tests for rapid detection of antibodies against SARS-CoV-2

Abstract

Lateral flow immunoassays (LFIA) for rapid detection of specific antibodies (IgM and IgG) against SARS-CoV-2 in different human specimens have been developed in response to the pandemic. The aim of this study is to evaluate three immunocromathographic assays (Sienna®, Wondfo® and Prometheus®) for detection of antibodies against SARS-CoV-2 in serum samples, considering RT-qPCR as a reference. A total of 145 serum samples from 145 patients with clinical suspicion of COVID-19 were collected: all of the samples were tested with Sienna®, 117 with Wondfo® and 89 with Prometheus®. The overall results of sensitivity, specificity, positive predictive value and negative predictive value obtained were as follows: 64.

Accurate point-of-care serology tests for COVID-19

“…The test that lost EUA during the course of our study demonstrates that effective corrective action has been taken. These data suggest that regulatory agencies are now appropriately approving these tests but may not indicate that all LFA assays are accurate when using finger-stick blood [19]. Importantly, data are emerging that individuals with antibodies against COVID-19 may be at lower risk of infection [20].…”

“…Coronavirus disease 2019 (COVID- 19), caused by severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2), has caused a pandemic with millions of cases and deaths [1]. As effective vaccines become available, the question of screening individuals for prior COVID-19 infection has become relevant.…”

Large-scale IgM and IgG SARS-CoV-2 serological screening among healthcare workers with a low infection prevalence based on nasopharyngeal swab tests in an Italian university hospital: Perspectives for public health

“…Recently, high sensitivity rates were described in IgM and IgG CLIA determination (88% and 100% after 12 days of symptom onset) ( Padoan et al, 2020 ; Nicol et al, 2020 ). On the other hand, rapid detection SARS-CoV-2 antibody tests, e.g., lateral flow immunoassays (LFIAs), seem to have lower accuracy ( Guedez-López et al, 2020 ; Zhang et al, 2020 ); in particular, the immunochromatographic antibody test is burdened by the high incidence of false positive results of IgG ( Shibata et al, 2020 ).…”

Evaluation of SARS-CoV-2 total antibody detection via a lateral flow nanoparticle fluorescence immunoassay

“…These rapid assays provide a low-throughput antibody testing option for laboratories with limited resources and are particularly useful for epidemiologic field studies. However, a meta-analysis evaluating the diagnostic accuracy of SARS-CoV-2 serologic testing concluded that LFIAs were consistently less sensitive than ELISA or CLIA methods [ 9 ], and subsequent studies have reported a wide range of sensitivities and specificities [ [10] , [11] , [12] , [13] , [14] , [15] , [16] , [17] , [18] , [19] , [20] , [21] , [22] , [23] , [24] ]. Nevertheless, the Infectious Diseases Society of America (IDSA) recommends against the use of IgG or IgM antibody combination tests, where detecting either antibody isotype is used to define a positive result [ 7 ].…”