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EVALUATION OF ELEVEN IMMUNOCHROMATOGRAPHIC ASSAYS FOR SARS-CoV-2 DETECTION: INVESTIGATING DENGUE CROSS-REACTION
Beatriz Araujo Oliveira; Lea Campos de Oliveira; Franciane Mendes de Oliveira; Geovana Maria Pereira; Regina Maia de Souza; Erika Regina Manuli; Fabricio Klerynton Marchini; Evelyn Patrícia Sanchez Espinoza; Marcelo Park; Leandro Taniguchi; Pedro Vitale Mendes; Lucas Augusto Moyses Franco; Ana Catharina Nastri; Maura Salaroli de Oliveira; José Mauro Vieira Junior; Esper Georges Kallas; Anna Sara Levin; Ester Cerdeira Sabino; Silvia Figueiredo Costa.
Affiliation
  • Beatriz Araujo Oliveira; Instituto de Medicina Tropical
  • Lea Campos de Oliveira; Instituto de Medicina Tropical
  • Franciane Mendes de Oliveira; Instituto de Medicina Tropical
  • Geovana Maria Pereira; Instituto de Medicina Tropical
  • Regina Maia de Souza; Instituto de Medicina Tropical
  • Erika Regina Manuli; Instituto de Medicina Tropical
  • Fabricio Klerynton Marchini; Instituto Carlos Chagas, Fiocruz
  • Evelyn Patrícia Sanchez Espinoza; Instituto de Medicina Tropical
  • Marcelo Park; Hospital das Clínicas
  • Leandro Taniguchi; Hospital das Clínicas
  • Pedro Vitale Mendes; Hospital das Clínicas
  • Lucas Augusto Moyses Franco; Instituto de Medicina Tropical
  • Ana Catharina Nastri; Hospital das Clínicas
  • Maura Salaroli de Oliveira; Hospital das Clínicas
  • José Mauro Vieira Junior; Hospital Sírio Libanês
  • Esper Georges Kallas; Faculdade de Medicina da Universidade de São Paulo
  • Anna Sara Levin; Faculdade de Medicina da Universidade de São Paulo
  • Ester Cerdeira Sabino; Instituto de Medicina Tropical
  • Silvia Figueiredo Costa; Instituto de Medicina Tropical
Preprint in English | medRxiv | ID: ppmedrxiv-20210039
ABSTRACT
BackgroundCOVID-19 disease (Coronavirus disease 2019) caused by SARS-CoV-2 (Severe acute respiratory syndrome coronavirus 2) is widespread worldwide, affecting more than 11 million people globally (July 6th, 2020). Diagnostic techniques have been studied in order to contain the pandemic. Immunochromatographic (IC) assays are feasible and low cost alternative for monitoring the spread of COVID-19 in the population. MethodsHere we evaluate the sensitivity and specificity of eleven different immunochromatographic tests in 98 serum samples from confirmed cases of COVID-19 through RT-PCR and 100 negative serum samples from blood donors collected in February 2019. Considering the endemic situation of Dengue in Brazil, we also evaluated the cross-reactivity with Dengue using 20 serum samples from patients with confirmed diagnosis for Dengue collected in early 2019 through four different tests. ResultsOur results demonstrated agreement between immunochromatographic assays and RT-PCR, especially after 10 days since the onset of symptoms. The evaluation of IgG and IgM antibodies combined demonstrated a strong level of agreement (0.85) of IC assays and RT-PCR. It was observed cross-reactivity between Dengue and COVID-19 using four different IC assays for COVID-19 diagnosis. The specificity of IC assays to detected COVID-19 IgM antibodies using Dengue serum samples varied from 80% to 85%; the specificity of IgG detection was 100% and total antibody was 95%. ConclusionsWe found high sensitivity, specificity and good agreement of IC assays, especially after 10 days onset of symptoms. However, we detected cross-reactivity between Dengue and COVID-19 mainly with IgM antibodies demonstrating the need for better studies about diagnostic techniques for these diseases. HighlightsO_LIImmunochromatographic assays demonstrated high sensitivity and specificity and good agreement with the gold-standard RT-PCR; C_LIO_LIIncrease in sensitivity and specificity of assays using samples collected after the 10th day of symptoms; C_LIO_LICross-reaction with Dengue serology in evaluation of IgM. C_LI
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Full text: Available Collection: Preprints Database: medRxiv Type of study: Diagnostic study / Experimental_studies / Rct Language: English Year: 2020 Document type: Preprint
Full text: Available Collection: Preprints Database: medRxiv Type of study: Diagnostic study / Experimental_studies / Rct Language: English Year: 2020 Document type: Preprint
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