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Evaluation of three immunochromatographic tests for rapid detection of antibodies against SARS-CoV-2.
Eur J Clin Microbiol Infect Dis. 2020 Dec; 39(12):2289-2297.EJ

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.

Authors+Show Affiliations

Clinical Microbiology Department, Hospital Universitario La Paz, Paseo de La Castellana 261, 28046, Madrid, Spain.Clinical Microbiology Department, Hospital Universitario La Paz, Paseo de La Castellana 261, 28046, Madrid, Spain. marinalguacil11@gmail.com.Clinical Microbiology Department, Hospital Universitario La Paz, Paseo de La Castellana 261, 28046, Madrid, Spain.Clinical Microbiology Department, Hospital Universitario La Paz, Paseo de La Castellana 261, 28046, Madrid, Spain.Rheumatology Department, Hospital Universitario La Paz, Madrid, Spain.Internal Medicine Department, Hospital Universitario La Paz, Madrid, Spain.Clinical Microbiology Department, Hospital Universitario La Paz, Paseo de La Castellana 261, 28046, Madrid, Spain.Clinical Microbiology Department, Hospital Universitario La Paz, Paseo de La Castellana 261, 28046, Madrid, Spain.No affiliation info available

Pub Type(s)

Comparative Study
Journal Article

Language

eng

PubMed ID

32808111

Citation

Guedez-López, Gladys Virginia, et al. "Evaluation of Three Immunochromatographic Tests for Rapid Detection of Antibodies Against SARS-CoV-2." European Journal of Clinical Microbiology & Infectious Diseases : Official Publication of the European Society of Clinical Microbiology, vol. 39, no. 12, 2020, pp. 2289-2297.
Guedez-López GV, Alguacil-Guillén M, González-Donapetry P, et al. Evaluation of three immunochromatographic tests for rapid detection of antibodies against SARS-CoV-2. Eur J Clin Microbiol Infect Dis. 2020;39(12):2289-2297.
Guedez-López, G. V., Alguacil-Guillén, M., González-Donapetry, P., Bloise, I., Tornero-Marin, C., González-García, J., Mingorance, J., & García-Rodríguez, J. (2020). Evaluation of three immunochromatographic tests for rapid detection of antibodies against SARS-CoV-2. European Journal of Clinical Microbiology & Infectious Diseases : Official Publication of the European Society of Clinical Microbiology, 39(12), 2289-2297. https://doi.org/10.1007/s10096-020-04010-7
Guedez-López GV, et al. Evaluation of Three Immunochromatographic Tests for Rapid Detection of Antibodies Against SARS-CoV-2. Eur J Clin Microbiol Infect Dis. 2020;39(12):2289-2297. PubMed PMID: 32808111.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Evaluation of three immunochromatographic tests for rapid detection of antibodies against SARS-CoV-2. AU - Guedez-López,Gladys Virginia, AU - Alguacil-Guillén,Marina, AU - González-Donapetry,Patricia, AU - Bloise,Ivan, AU - Tornero-Marin,Carolina, AU - González-García,Juan, AU - Mingorance,Jesus, AU - García-Rodríguez,Julio, AU - ,, Y1 - 2020/08/17/ PY - 2020/06/09/received PY - 2020/08/11/accepted PY - 2020/8/19/pubmed PY - 2020/11/26/medline PY - 2020/8/19/entrez KW - COVID-19 KW - Immunochromatographic strip assay KW - Lateral flow immunoassays KW - SARS-CoV-2 KW - Serology SP - 2289 EP - 2297 JF - European journal of clinical microbiology & infectious diseases : official publication of the European Society of Clinical Microbiology JO - Eur J Clin Microbiol Infect Dis VL - 39 IS - 12 N2 - 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. SN - 1435-4373 UR - https://www.unboundmedicine.com/medline/citation/32808111/Evaluation_of_three_immunochromatographic_tests_for_rapid_detection_of_antibodies_against_SARS_CoV_2_ L2 - https://dx.doi.org/10.1007/s10096-020-04010-7 DB - PRIME DP - Unbound Medicine ER -