4.1 Article

Time-dependent decay of detectable antibodies against SARS-CoV-2: A comparison of ELISA with two batches of a lateral-flow test

Journal

BRAZILIAN JOURNAL OF INFECTIOUS DISEASES
Volume 25, Issue 4, Pages -

Publisher

ELSEVIER BRAZIL
DOI: 10.1016/j.bjid.2021.101601

Keywords

SARS-CoV-2; Rapid test; ELISA; PCR; Validation; Epidemiological serosurvey

Funding

  1. Todos Pela Saude initiative
  2. Instituto Serrapilheira
  3. Brazilian Ministry of Health
  4. Brazilian Collective Health Association (ABRASCO)
  5. JBS S.A. initiative 'Fazer o Bem Faz Bem'

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The study found that ELISA tests showed high sensitivity and stability of results over the five months of the study, while the two batches of the rapid test showed substantial declines, with one batch consistently showing lower sensitivity levels than the other.
Background: Large-scale epidemiological studies of seroprevalence of antibodies against SARS-CoV-2 often rely on point-of-care tests that provide immediate results to participants. Yet, little is known on how long rapid tests remain positive after the COVID-19 episode, or how much variability exists across different brands and even among batches of the same test. Methods: In November 2020, we assessed the sensitivity of three tests applied to 133 individuals with a previous positive PCR result between April and October. All subjects provided finger prick blood samples for two batches (A and B) of the Wondfo lateral -flow IgG/IgM test, and dried blood spot samples for the S-UFRJ ELISA test. Results: Overall sensitivity levels were 92.5% (95% CI 86.6-96.3), 63.2% (95% CI 54.4-71.4) and 33.8% (95% CI 25.9-42.5) for the S-UFRJ test, Wondfo A and Wondfo B tests, respectively. There was no evidence of a decline in the positivity of S-UFRJ with time since the diagnosis, but the two Wondfo batches showed sharp reductions to as low as 41.9% and 19.4%, respectively, for subjects with a positive PCR in June or earlier. Positive results for batch B of the rapid test were 35% to 54% lower than for batch A at any given month of diagnosis. Interpretation: Whereas the ELISA test showed high sensitivity and stability of results over the five months of the study, both batches of the rapid test showed substantial declines, with one of the batches consistently showing lower sensitivity levels than the other. ELISA tests based on dried-blood spots are an inexpensive alternative to rapid lateral-flow tests in large-scale epidemiological studies. Funding: The study was funded by the Todos Pela Saude initiative, Instituto Serrapilheira, Brazilian Ministry of Health, Brazilian Collective Health Association (ABRASCO) and the JBS S.A. initiative 'Fazer o Bem Faz Bem'. (C) 2021 Sociedade Brasileira de Infectologia. Published by Elsevier Espana, S.L.U.

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