1. Low performance of a SARS-CoV-2 point-of-care lateral flow immunoassay in symptomatic children during the pandemic
- Author
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Marcelo Comerlato Scotta, Caroline Nespolo de David, Fernanda Hammes Varela, Ivaine Tais Sauthier Sartor, Márcia Polese-Bonatto, Ingrid Rodrigues Fernandes, Gabriela Oliveira Zavaglia, Charles Francisco Ferreira, Luciane Beatriz Kern, Amanda Paz Santos, João Ronaldo Mafalda Krauzer, Paulo Márcio Pitrez, Walquiria Aparecida Ferreira de Almeida, Victor Bertollo Gomes Porto, and Renato T. Stein
- Subjects
Children ,SARS-CoV-2 ,COVID-19 ,Lateral flow immunoassay ,Point-of-Care Testing ,Pediatrics ,RJ1-570 - Abstract
Objective: to evaluate the accuracy of an antibody point-of-care lateral flow immunoassay (LFI - Wondfo Biotech Co., Guangzhou, China) in a pediatric population. Methods: children and adolescents (2 months to 18 years) with signs and symptoms suggestive of acute SARS-CoV-2 infection were prospectively investigated with nasopharyngeal RT-PCR and LFI at the emergency room. RT-PCR was performed at baseline, and LFI at the same time or scheduled for those with less than 7 days of the clinical picture. Overall accuracy, sensitivity and specificity were assessed, as well as according to the onset of symptoms (7-13 or ≥14 days) at the time of the LFI test. Results: In 175 children included, RT-PCR and LFI were positive in 51 (29.14%) and 36 (20.57%), respectively. The overall sensitivity, specificity, positive and negative predictive value was 70.6% (95%CI 56.2-82.5), 96.8% (95%CI 91.9-99.1), 90.0% (95%CI 77.2-96.0), and 88.9% (95%CI 83.9-92.5), respectively. At 7-13 and ≥14 days after the onset of symptoms, sensitivity was 60.0% (95%CI 26.2-87.8) and 73.2% (95%CI 57.1-85.8) and specificity was 97.9% (95%CI 88.7-99.9) and 96.1% (95%CI 89.0-99.2), respectively. Conclusion: Despite its high specificity, in the present study the sensitivity of LFI in children was lower (around 70%) than most reports in adults. Although a positive result is informative, a negative LFI test cannot rule out COVID-19 in children.
- Published
- 2022
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