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Comparative Study
. 2020 Dec;39(12):2289-2297.
doi: 10.1007/s10096-020-04010-7. Epub 2020 Aug 17.

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

Gladys Virginia Guedez-López  1 , Marina Alguacil-Guillén  2 , Patricia González-Donapetry  1 , Ivan Bloise  1 , Carolina Tornero-Marin  3 , Juan González-García  4 , Jesus Mingorance  1 , Julio García-Rodríguez  1 ; SARS-CoV-2 Working Group
Collaborators, Affiliations
Comparative Study

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

Gladys Virginia Guedez-López et al. Eur J Clin Microbiol Infect Dis. 2020 Dec.

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: 64.4%, 75%, 85.5% and 47.8% with Sienna®; 45.2%, 81.8%, 80.5% and 47.4% with Wondfo® and 75.5%, 12.5%, 51.4% and 29.4% with Prometheus®. The accuracy of the test for Sienna®, Wondfo® and Prometheus® was 67.6%, 59% and 47.2%, with a prevalence of COVID-19 of 69.7%, 62.4% and 55.1% respectively. Sensitivity of the three tests (Sienna®, Wondfo® and Prometheus® respectively) along the three different stages was 36.6%, 18.8% and 68.6% in the early stage (first week); 81.3%, 74.1% and 90.9% in the intermediate stage (second week) and 100%, 83.3% and 100% in the late stage (third week). The results demonstrate that even though Prometheus® presented a high sensitivity, the specificity was notably lower than the other two tests. Sienna® showed the greatest contrast between sensitivity and specificity, achieving the best accuracy, followed by Wondfo®. The sensitivity of the three ICT assays was higher in late stages of the disease.

Keywords: COVID-19; Immunochromatographic strip assay; Lateral flow immunoassays; SARS-CoV-2; Serology.

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Conflict of interest statement

The authors declare that they have no conflict of interest.

Figures

Fig. 1
Fig. 1
Diagnostic test parameters of Sienna® broken down into early, intermediate and late stage
Fig. 2
Fig. 2
Diagnostic test parameters of Prometheus® broken down into early, intermediate and late stage
Fig. 3
Fig. 3
Diagnostic test parameters of Wondfo® broken down into early, intermediate and late stage
See this image and copyright information in PMC

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