Departamento de Urgencia, Hospital de Niños R. Gutiérrez, Ciudad Autónoma de Buenos Aires, Argentina.
Unidad Febril de Urgencia, Hospital de Niños R. Gutiérrez, Ciudad Autónoma de Buenos Aires, Argentina.
Arch Argent Pediatr. 2022 Oct;120(5):325-331. doi: 10.5546/aap.2022.eng.325. Epub 2022 Aug 16.
Rapid antigen tests (RAgTs) for SARS-CoV-2 are considered adequate for diagnosis at the point of care. Our objective was to establish the agreement between reverse transcription-quantitative polymerase chain reaction (RT-qPCR) and RAgTs in the pediatric population.
All patients aged 1 month to 17 years and 11 months seen at the Emergency Fever Unit of a children's hospital between 6-11-2021 and 10-3-2021 were recruited. The Panbio COVID-19 Ag® test (Abbott Diagnostic) was compared to the reference method RT-qPCR (as per the protocol suggested by the United States Centers for Disease Control and Prevention).
A total of 6491 patients were included. The prevalence of COVID-19 was 2.8%. Symptoms were observed in 92.1%. Sensitivity, specificity, and the kappa index of agreement for the RAgT were 71.0%, 99.9%, and 0.813, respectively. The kappa index and the RAgT sensitivity were significantly higher in the group aged 13-17 years (0.89 and 82.4%, respectively) compared to the groups aged 0-5 and 6-12 years. This may be due to the lower viral load observed in patients younger than 12 years.
Although RAgTs shorten the time to result and improve the isolation strategy for COVID-19 patients, their sensitivity in children younger than 12 years or asymptomatic children is not within the recommended ranges, especially during periods of low disease prevalence.
SARS-CoV-2 的快速抗原检测（RAgT）被认为可在护理点进行充分诊断。我们的目的是确定 RAgT 在儿科人群中与逆转录-定量聚合酶链反应（RT-qPCR）的一致性。
2021 年 11 月 6 日至 3 月 10 日期间，在一家儿童医院的急诊发热科就诊的所有 1 个月至 17 岁零 11 个月的患者均被纳入研究。Panbio COVID-19 Ag® 检测（雅培诊断）与参考方法 RT-qPCR（根据美国疾病控制与预防中心的方案）进行比较。
共纳入 6491 例患者。COVID-19 的患病率为 2.8%。92.1%的患者有症状。RAgT 的敏感性、特异性和一致性kappa 指数分别为 71.0%、99.9%和 0.813。与 0-5 岁和 6-12 岁组相比，13-17 岁组的 kappa 指数和 RAgT 敏感性更高（分别为 0.89 和 82.4%）。这可能是由于 12 岁以下患者的病毒载量较低所致。
尽管 RAgT 缩短了获得结果的时间并改善了 COVID-19 患者的隔离策略，但在 12 岁以下儿童或无症状儿童中，其敏感性不在推荐范围内，尤其是在疾病低流行期间。
