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Performance of a qualitative rapid chromatographic immunoassay to diagnose COVID-19 in patients in a middle-income country

2020; Elsevier BV; Volume: 131; Linguagem: Inglês

10.1016/j.jcv.2020.104592

1873-5967

Sílvia Figueiredo Costa, Lewis Buss, Evelyn Patrícia Sánchez Espinoza, José Mauro Vieira, Léa Campos de Oliveira da Silva, Regina Maia de Souza, Lauro Vieira Perdigão Neto, Ana Paula Matos Porto, Carolina S. Lázari, Vera Aparecida dos Santos, Alberto da Silva Duarte, Ana Catharina de Seixas Santos Nastri, Gabriel Fialkovitz da Costa Leite, Erika R. Manuli, Maura Salaroli de Oliveira, Daniella Bosco Zampelli, Laerte Pastore, Aluísio Augusto Cotrim Segurado, Anna S. Levin, Éster Cerdeira Sabino,

COVID-19 Clinical Research Studies

We evaluated a rapid chromatographic immunoassay (IgG/IgM antibodies) and an ELISA assay to diagnose COVID-19 in patient sat two Brazilian hospitals. A total of 122 subjects with COVID-19 were included: 106 SARS-COV-2 RT-PCR-positive patients and 16 RT-PCR-negative patients with symptoms and chest computed tomography (CT) consistent with COVID-19. Ninety-six historical blood donation samples were used as controls. Demographic and clinical characteristics were retrieved from electronic records. Sensitivity and specificity were calculated, as were their 95% binomial confidence intervals using the Clopper-Pearson method. All analyses were performed in R version 3.6.3. The sensitivity of the chromatographic immunoassay in all RT-PCR-positive patients, irrespective of the timing of symptom onset, was 85.8% (95% binomial CI 77.7% to 91.9%). This increased with time after symptom onset, and at >14 days was 94.9% (85.9% to 98.9%). The specificity was 100% (96.4% to 100%). 15/16 (94%) RT- PCR-negative cases tested positive. The most frequent comorbidities were hypertension and diabetes mellitus and the most frequent symptoms were fever, cough, and dyspnea. All RT-PCR-negative patients had pneumonia. The most frequent thoracic CT findings were ground glass changes (n = 11, 68%), which were bilateral in 9 (56%) patients, and diffuse reticulonodular infiltrates (n = 5, 31%). The COVID-19 rapid chromatographic immunoassay evaluated in this study had a high sensitivity and specificity using plasma, particularly after 14 days from symptom onset. ELISA and qualitative rapid chromatographic immunoassays can be used for the diagnosis of RT-PCR-negative patients.