Sensitivity of three commercial tests for SARS-CoV-2 serology in children: an Italian multicentre prospective study.

BACKGROUND: US Food and Drug Administration has issued Emergency Use Authorizations for hundreds of serological assays to support Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) diagnosis. The aim of this study is to evaluate, for the first time in children, the performance of three widely utilized SARS-CoV-2 serology commercial assays, Diesse Diagnostics (IgG, IgA, IgM) and Roche Diagnostics, both Roche Nucleocapsid (N) IgG and Roche Spike (S) IgG assays. METHODS: Sensitivity and 95% confidence intervals (CIs) were estimated for each of the three different serological tests and mixed and direct comparison were performed. Univariate and multivariate Poisson regression models were fitted to calculate incidence rate ratios and 95% CIs as estimate of the effects of age, gender, time on the serology title. A p-value < 0.05 indicated statistical significance. RESULTS: Overall, 149 children were enrolled in the study. A low sensitivity was found for Diesse IgA, IgM and IgG. Compare to Diesse, Roche S had a higher sensitivity at 15-28 days from infection (0.94, 95%CI: 0.73-1.0) and Roche N at 28-84 days (0.78, 95%CI: 0.58-0.91). When a direct comparison of IgG tests sensitivity was feasible for patients with pairwise information, Roche S and Roche N showed a statistically significant higher sensitivity compared to Diesse in all the study periods, whereas there was no difference between the two Roche tests. CONCLUSION: Roche S and Roche N serology tests seem to better perform in children. Large prospective studies are needed to better define the characteristics of those tests.

Eligibility criteria for pediatric patients who may benefit from anti SARS-CoV-2 monoclonal antibody therapy administration: an Italian inter-society consensus statement.

The fast diffusion of the SARS-CoV-2 pandemic have called for an equally rapid evolution of the therapeutic options.The Human recombinant monoclonal antibodies (mAbs) have recently been approved by the Food and Drug Administration (FDA) and by the Italian Medicines Agency (AIFA) in subjects aged ≥12 with SARS-CoV-2 infection and specific risk factors.Currently the indications are specific for the use of two different mAbs combination: Bamlanivimab+Etesevimab (produced by Eli Lilly) and Casirivimab+Imdevimab (produced by Regeneron).These drugs have shown favorable effects in adult patients in the initial phase of infection, whereas to date few data are available on their use in children.AIFA criteria derived from the existing literature which reports an increased risk of severe COVID-19 in children with comorbidities. However, the studies analyzing the determinants for progression to severe disease are mainly monocentric, with limited numbers and reporting mostly generic risk categories.Thus, the Italian Society of Pediatrics invited its affiliated Scientific Societies to produce a Consensus document based on the revision of the criteria proposed by AIFA in light of the most recent literature and experts' agreement.This Consensus tries to detail which patients actually have the risk to develop severe disease, analyzing the most common comorbidities in children, in order to detail the indications for mAbs administration and to guide the clinicians in identifying eligible patients.

Impact of SARS-CoV-2 Pandemic on Bronchiolitis Hospitalizations: The Experience of an Italian Tertiary Center.

SARS-CoV-2 pandemic restrictions have deeply altered the common respiratory illnesses burden. The aim of this paper was to clarify how these measures may have influenced bronchiolitis epidemiology, exploring possible explanations. We studied 342 infants hospitalized for bronchiolitis at our center from four different epidemic seasons (October-April 2017-2018, 2018-2019, 2019-2020 and 2020-2021). March-April hospitalization rate, RSV (respiratory syncytial virus) infection, pediatric intensive care unit (PICU) admission and oxygen therapy administration data were compared among different seasons to outline any changes during the SARS-CoV-2 outbreak. In March-April, 30 (23.1%), 28 (24.6%) and 5 (5.1%) infants were hospitalized for bronchiolitis, respectively, in 2017-2018, 2018-2019 and 2019-2020, with a lower rate in March-April 2020 (p < 0.001). No hospitalizations for bronchiolitis occurred during the epidemic season of 2020-2021. No significant differences in RSV infections, oxygen therapy administration and PICU admissions across seasons were outlined. In conclusion, we report a severe decrease in hospitalizations for bronchiolitis at our center throughout the entire SARS-CoV-2 outbreak rather than only during the lockdown periods. This seems to suggest a pivotal role for the systematic implementation of cost-effective non-pharmaceutical interventions (NPIs) such as compulsory face masks and hand hygiene, which were deployed for the entire pandemic, in reducing the circulation of infectious agents.