期刊
JORNAL DE PEDIATRIA
卷 98, 期 2, 页码 136-141出版社
SOC BRASIL PEDIATRIA
DOI: 10.1016/j.jped.2021.04.010
关键词
Children; SARS-CoV-2; COVID-19; Lateral flow immunoassay; Point-of-Care Testing
类别
资金
- Ministry of Health of Brazil, through the Institutional Development Program of the Brazilian National Health System (PROADI-SUS)
- Hospital Moinhos de Vento
This study evaluated the accuracy of an antibody point-of-care lateral flow immunoassay in a pediatric population and found that the sensitivity was lower in children, indicating that it cannot fully rule out COVID-19 infection in this population.
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 83.992.5), 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. (C) 2021 Published by Elsevier Editora Ltda. on behalf of Sociedade Brasileira de Pediatria.
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