Background. In emergency hospital settings, rapid diagnosis and isolation of SARS-CoV-2 patients are required. The aim of the study was to evaluate the performance of an antigen chemiluminescence enzymatic immunoassay (CLEIA) and compare it with that of Real-time Reverse transcription-Polymerase Chain Reaction (RT-qPCR), the gold standard assay, to assess its suitability as a rapid diagnostic method for managing patients in the emergency department (ED). Methods. Consecutive patients with no previous history of SARS-CoV-2 infection attending the ED of the Policlinico Hospital of Bari between 23rd October and 4th November 2020 were enrolled. Clinical and demographic data were collected for all patients. Nasopharyngeal swabs collected on admission were subjected both to molecular (RT-qPCR) and antigen (CLEIA) tests for SARS-CoV-2. The performance of the CLEIA antigen test was analyzed using R Studio software and Microsoft Excel. Receiver operating characteristics were also performed. Results. A total of 911 patients were enrolled, of whom 469 (51.5%) were male. Of the whole cohort, 23.7% tested positive for SARS-CoV-2 by RT-qPCR and 24.5% by CLEIA. The overall concordance rate was 96.8%. The sensitivity, specificity, positive predictive value, and negative predictive value of the antigen test were 94.9% (95% CI, 91.9–97.0), 97.4% (95% CI, 96.5–98.1), 91.9% (95% CI, 89.0–94.0), and 98.4% (95% CI, 97.4–99.1), respectively. The area under the curve (AUC) was 0.99. The kappa coefficient was 0.91. The overall positive and negative likelihood ratios were 37 (95% CI 23-58) and 0.05 (95% CI, 0.03–0.09), respectively. Conclusions. Data analysis demonstrated that the antigen test showed very good accuracy for discriminating SARS-CoV-2-infected patients from negative participants. The CLEIA is suitable for rapid clinical diagnosis of patients in hospital settings, particularly in EDs with a high prevalence of symptomatic patients and where a rapid turnaround time is critical. Timely and accurate testing for SARS-CoV-2 plays a crucial role in limiting the spread of the virus.

中文翻译：

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在急诊科使用抗原检测作为 SARS-CoV-2 感染筛查工具的挑战：意大利南部一家三级医院的经验

背景。在急诊医院环境中，需要对 SARS-CoV-2 患者进行快速诊断和隔离。该研究的目的是评估抗原化学发光酶免疫测定法 (CLEIA) 的性能，并将其与实时逆转录聚合酶链反应 (RT-qPCR) 的金标准测定法进行比较，以评估其适用性一种用于管理急诊科 (ED) 患者的快速诊断方法。方法. 入选了 2020 年 10 月 23 日至 11 月 4 日期间在巴里 Policlinico 医院急诊就诊且既往没有 SARS-CoV-2 感染史的连续患者。收集所有患者的临床和人口统计数据。对入院时收集的鼻咽拭子进行 SARS-CoV-2 分子 (RT-qPCR) 和抗原 (CLEIA) 检测。使用 R Studio 软件和 Microsoft Excel 分析了 CLEIA 抗原测试的性能。还执行了接收器操作特性。结果. 共纳入 911 名患者，其中 469 名（51.5%）为男性。在整个队列中，23.7% 的 SARS-CoV-2 经 RT-qPCR 检测呈阳性，24.5% 经 CLEIA 检测呈阳性。总体符合率为96.8%。抗原检测的敏感性、特异性、阳性预测值和阴性预测值分别为94.9%（95% CI，91.9-97.0）、97.4%（95% CI，96.5-98.1）、91.9%（95% CI，89.0） –94.0) 和 98.4% (95% CI, 97.4–99.1)。曲线下面积 (AUC) 为 0.99。kappa系数为0.91。总体阳性和阴性似然比分别为 37 (95% CI 23-58) 和 0.05 (95% CI, 0.03-0.09)。结论. 数据分析表明，抗原检测在区分 SARS-CoV-2 感染患者和阴性参与者方面表现出非常好的准确性。CLEIA 适用于对医院环境中的患者进行快速临床诊断，特别是在有症状患者高流行且快速周转时间至关重要的 ED 中。及时准确地检测 SARS-CoV-2 在限制病毒传播方面发挥着至关重要的作用。