2026-04-29T04:17:39Zhttps://repisalud.isciii.es/rest/oai/request

oai:repisalud.isciii.es:20.500.12105/236322024-11-28T19:44:19Zcom_20.500.12105_15322com_20.500.12105_2051col_20.500.12105_16967

00925njm 22002777a 4500 dc Gallardo-Alfaro, Laura author Lorente Montalvo, Patricia author Cañellas, Margarita A author Carandell Jöger, Eugenia author Oliver, Antonio author Rojo Molinero, Estrella author Riera, Beatriz author Llobera Cánaves, Joan author Bulilete, Oana author Leiva Rus, Alfonso author Obieta, Anaida author Pascual, Victoria author Pericàs Pulido, Pau author Raduán de Páramo, Carlos author Segura, Elsa author Vega, Verónica author Balearic COVID-19 Pediatric Primary Care Research Group author 2023-08-29 Background: Rapid antigen-detection tests (Ag-RDTs) are used to diagnose SARS-CoV-2 infection. Real-world studies of Ag-RDTs are necessary to evaluate their diagnostic yield in paediatric patients. Our aim was to evaluate the accuracy of the Panbio™ Rapid Antigen Test for SARS-CoV-2 in the setting of a primary health care centre (PHC), with use of the Reverse Transcription-Polymerase Chain Reaction (RT-PCR) as gold standard. Methods: This prospective diagnostic study was conducted at PHCs in Mallorca, Spain. Patients were ≤ 18 years-old that attended sites for RT-PCR testing due to symptoms suggestive of infection (fever, headache, nasal congestion and dry cough, among others) or epidemiological exposure (close contacts). Two samples were collected: a nasal mid-turbinate sample for Ag-RDTs and a nasopharyngeal swab for RT-PCR testing. The sensitivity, specificity, and predictive values of the AgRDT were calculated using the RT-PCR results as the reference. Results: We examined 1142 participants from 0 to 18 years (47.5% female, mean age 8.9 ± 4.8 years, median 9.0 [5.0-13.0]). There were 84 positive RT-PCR results (pre-test probability of 7.3%) and 52 positive Ag-RDT results. The sensitivity of the Ag-RDT was 59.5% (95% Confidence Interval (CI): 48.2-69.9%), the specificity was 99.8% (95%CI: 99.2-99.9%), the positive predictive value was 96.1% (95%CI: 85.6-99.4%), and the negative predictive value was 96.8% (95%CI: 95.6-97.7%). The sensitivity for individuals referred by a general practitioner (GP) or paediatrician due to symptoms was 71.4% (95%CI: 51.5-86.0%) and for asymptomatic individuals was 50.0% (95%CI: 9.1-90.8%). The specificity was greater than 98.9% overall and in all subgroups. The sensitivity was 73.0% (95%CI: 52.0-87.5%) for referred patients due to symptoms and who were tested within 5 days since symptom onset. No significant statistical differences between any groups were found. There were 34 false-negative Ag-RDT results (40.5%) and 2 false-positive Ag-RDT results (0.2%). Conclusion: The sensitivity of the Panbio™ Test in paediatric individuals is below the minimum of 80% recommended by the World Health Organization for Ag-RDTs. This test had better accuracy in individuals referred by a GP or paediatrician due to symptoms, rather than those who were asymptomatic or referred due to epidemiological exposure. The RT-PCR test using a nasopharyngeal swab is accurate, but a less invasive alternative that has better sensitivity than the Panbio™ Test is needed for paediatric populations. Gallardo-Alfaro L, Lorente-Montalvo P, Cañellas M, Carandell E, Oliver A, Rojo E, et al. Diagnostic accuracy of PanbioTM rapid antigen test for SARS-CoV-2 in paediatric population. BMC Pediatrics. 2023 Aug 29;23(1):433. 1471-2431 https://hdl.handle.net/20.500.13003/19328 https://hdl.handle.net/20.500.12105/23632 37644389 10.1186/s12887-023-04201-z BMC Pediatrics COVID-19 Rapid antigen test SARS-CoV-2 Primary care Paediatric Diagnostic accuracy of Panbio™ rapid antigen test for SARS-CoV-2 in paediatric population