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

Autor: Vera Aparecida dos Santos, Regina Maia de Souza, Evelyn Patricia Sanchez Espinoza, Erika R. Manuli, Anna S. Levin, Daniella Bosco Zampelli, Jose Mauro Vieira, Laerte Pastore, Maura Salaroli de Oliveira, Ana Paula Matos Porto, Alberto José da Silva Duarte, Lauro Vieira Perdigão Neto, Silvia Figueiredo Costa, Gabriel Fialkovitz Leite, Aluísio Augusto Cotrim Segurado, Lea Campos de Oliveira da Silva, Ester Cerdeira Sabino, Carolina S. Lazari, Lewis F Buss, Ana Catharina de Seixas Santos Nastri
Rok vydání: 2020
Předmět:
Male
0301 basic medicine
Antibodies
Viral
COVID-19 Testing
0302 clinical medicine
SARS-cov-2
Prospective Studies
030212 general & internal medicine
Young adult
Prospective cohort study
Aged
80 and over
Immunoassay
Chromatography
medicine.diagnostic_test
food and beverages
qualitative rapid chromatographic immunoassays
Middle Aged
Hospitalization
Infectious Diseases
ELISA
Female
Coronavirus Infections
Brazil
Adult
Coronavirus disease 2019 (COVID-19)
Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)
Pneumonia
Viral
030106 microbiology
Sensitivity and Specificity
Article
Betacoronavirus
Young Adult
03 medical and health sciences
Virology
Diabetes mellitus
medicine
Humans
In patient
Pandemics
Aged
Clinical Laboratory Techniques
business.industry
fungi
COVID-19
medicine.disease
Pneumonia
Immunoglobulin G
business
Zdroj: Journal of Clinical Virology
ISSN: 1386-6532
DOI: 10.1016/j.jcv.2020.104592
Popis: Highlights • COVID-19 diagnosis; high sensitivity and specificity qualitative rapid chromatographic immunoassays; can be used for the diagnosis of RT-PCR-negative patients.
Objectives We evaluated a rapid chromatographic immunoassay (IgG/IgM antibodies) and an ELISA assay to diagnose COVID-19 in patient sat two Brazilian hospitals. Methods 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. Results 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%). Conclusions 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.
Databáze: OpenAIRE
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