TY - JOUR T1 - Low performance of a SARS-CoV-2 point-of-care lateral flow immunoassay in symptomatic children during the pandemic JO - Jornal de Pediatria (English Edition) T2 - AU - Scotta,Marcelo Comerlato AU - David,Caroline Nespolo de AU - Varela,Fernanda Hammes AU - Sartor,Ivaine Tais Sauthier AU - Polese-Bonatto,Márcia AU - Fernandes,Ingrid Rodrigues AU - Zavaglia,Gabriela Oliveira AU - Ferreira,Charles Francisco AU - Kern,Luciane Beatriz AU - Santos,Amanda Paz AU - Krauzer,João Ronaldo Mafalda AU - Pitrez,Paulo Márcio AU - Almeida,Walquiria Aparecida Ferreira de AU - Porto,Victor Bertollo Gomes AU - Stein,Renato T. SN - 00217557 M3 - 10.1016/j.jped.2021.04.010 DO - 10.1016/j.jped.2021.04.010 UR - https://jped.elsevier.es/en-low-performance-sars-cov-2-point-of-care-lateral-articulo-S0021755721000838 AB - Objectiveto evaluate the accuracy of an antibody point-of-care lateral flow immunoassay (LFI - Wondfo Biotech Co., Guangzhou, China) in a pediatric population. Methodschildren 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. ResultsIn 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. ConclusionDespite 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. ER -