Rapid Serological Test for COVID-19, One-Step-COVID-2019: Accuracy and Implications for Pandemic Control
Luiz Antônio Alves de Menezes-Júnior,
Aline Priscila Batista,
Luciano Garcia Lourenção,
Ana Maria Sampaio Rocha,
Nara Nunes Lage,
Keila Furbino Barbosa,
George Luiz Lins Machado-Coelho,
Adriana Lúcia Meireles
Affiliations
Luiz Antônio Alves de Menezes-Júnior
Post-Graduate Program in Health and Nutrition, Department of Clinical and Social Nutrition, School of Nutrition, Federal University of Ouro Preto (UFOP), Campus Universitário Morro do Cruzeiro, Bauxita, Ouro Preto 35402-139, MG, Brazil
Aline Priscila Batista
Department of Biological Sciences/Institute of Exact and Biological Sciences/Laboratory of Genomics and DNA Repair, Federal University of Ouro Preto (UFOP), Ouro Preto 35402-139, MG, Brazil
Luciano Garcia Lourenção
Nursing School, Federal University of Rio Grande, Rio Grande 96200-400, RS, Brazil
Ana Maria Sampaio Rocha
School of Medicine, Federal University of Ouro Preto (UFOP), Campus Universitário Morro do Cruzeiro, Bauxita, Ouro Preto 35402-139, MG, Brazil
Nara Nunes Lage
Department of Clinical and Social Nutrition, School of Nutrition, Federal University of Ouro Preto (UFOP), Campus Universitário Morro do Cruzeiro, Bauxita, Ouro Preto 35402-139, MG, Brazil
Keila Furbino Barbosa
School of Medicine, Federal University of Ouro Preto (UFOP), Campus Universitário Morro do Cruzeiro, Bauxita, Ouro Preto 35402-139, MG, Brazil
George Luiz Lins Machado-Coelho
School of Medicine, Federal University of Ouro Preto (UFOP), Campus Universitário Morro do Cruzeiro, Bauxita, Ouro Preto 35402-139, MG, Brazil
Adriana Lúcia Meireles
Post-Graduate Program in Health and Nutrition, Department of Clinical and Social Nutrition, School of Nutrition, Federal University of Ouro Preto (UFOP), Campus Universitário Morro do Cruzeiro, Bauxita, Ouro Preto 35402-139, MG, Brazil
Background: Accurate and rapid testing for COVID-19 is critical for effective disease management and control. The One-Step-COVID-2019-Test was developed as a rapid serological test to detect antibodies against SARS-CoV-2. Objective: To estimate the accuracy of the rapid serological test for COVID-19 using One-Step-COVID-2019. Methods: We conducted a population-based serological survey with a stratified sampling of 593 adults between October and December 2020, prior to mass vaccination and during a period of limited availability of rapid tests. Participants provided 7.5 mL of serum, which was tested using the One-Step-COVID-2019-Test for IgM-IgG antibodies without distinction, as well as an in-house ELISA for IgG against the spike protein. Statistical analysis accounted for sampling weights, with accuracy assessed through sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), Youden index, and kappa coefficient, using ELISA as the reference standard. McNemar’s test identified significant differences between the test results. Results: The ELISA-based prevalence of infection was 11.1%. The One-Step-COVID-2019-Test showed low sensitivity (27.0–30.8%) but high specificity (89.9–96.6%), with poor agreement (kappa: 0.290–0.337), particularly among asymptomatic individuals. Conclusions: The One-Step-COVID-2019 rapid test for COVID-19 demonstrated inadequate performance, characterized by low sensitivity and poor reliability, making it unsuitable for effective serological surveillance.
