• Eur. J. Clin. Microbiol. Infect. Dis. · Dec 2020

    Comparative Study

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

    • Gladys Virginia Guedez-López, Marina Alguacil-Guillén, Patricia González-Donapetry, Ivan Bloise, Carolina Tornero-Marin, Juan González-García, Jesus Mingorance, Julio García-Rodríguez, and SARS-CoV-2 Working Group.
    • Clinical Microbiology Department, Hospital Universitario La Paz, Paseo de La Castellana 261, 28046, Madrid, Spain.
    • Eur. J. Clin. Microbiol. Infect. Dis. 2020 Dec 1; 39 (12): 2289-2297.

    AbstractLateral 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.

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