Diagnostic accuracy of sars-cov-2 antigen rapid test compared to real time pcr in ped

Abstract:

Background: The accuracy of rapid antigen tests (RAT) SARS-CoV-2 for in children is unknown. Our aim was to determine the diagnostic accuracy and concordance of the RAT PanBioTM (Abbott) compared to RT-PCR in nasopharyngeal smear (NPS) samples, in symptomatic pediatric population. Methods: This is a descriptive, retrospective, multicentre clinical study nested in a prospective, observational, multicenter cohort study. We included pediatric patients aged 0 to 16 years with symptoms consistent with COVID-19 of≤ 5 days of evolution, attended in the Emergency Departments of the seven centers involved. A total of two consecutive NPS were obtained from each patient one was employed to perform the RAT and the other to perform RT-PCR. Sample size for a non-inferiority study was calculated considering 80% power, for a 5% prevalence and a 90% sensitivity, using RT-PCR as the gold standard reference. A confusion matrix was displayed. Non-inferiority of sensitivity and specificity between diagnostic tests was assessed using the McNemar's test. The agreement between the two methods was calculated using Cohen's kappa index. Results: A total of 1620 patients were tested in 7 hospitals. The overall sensitivity for RAT PanBioTM was 45.4%(95% CI, 34.1-57.2), and specificity was 99.8%(95% CI, 99.4-99.9)(Figure 1). The positive pbkp_redictive value (PPV) for this 4.8% prevalence was 92.5%(95% CI, 78.6-97.4). The negative pbkp_redictive value was 97.3%(95% CI, 96.8-97.8). Positive likelihood ratio (PLR) was high-233.8 (IC 95%, 73.5-743.3), and negative likelihood ratio (NLR) was low-0.54 (95% CI, 0.44-0.67). Conclusion: Compared to RT …

Año de publicación:

2021

Keywords:

Fuente:

google