Institute of Laboratory Medicine, Kantonsspital Aarau AG, Aarau, Switzerland.
Department of Infectious Diseases and Hospital Hygiene, Kantonsspital Aarau AG, Aarau, Switzerland.
Clin Chem Lab Med. 2023 Mar 22;61(9):1661-1669. doi: 10.1515/cclm-2023-0087. Print 2023 Aug 28.
Laboratory testing for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has played an important role in the effort to prevent and contain local outbreaks. The aim of this study was to assess the diagnostic accuracy of a new fully automated SARS-CoV-2 laboratory-based antigen assay (CoV2Ag) and to explore the efficiency of a diagnostic algorithm combining antigen and conventional high-throughput molecular assays to address potential future challenges of the SARS-CoV-2 pandemic.
One thousand two hundred and twenty four consecutive nasopharyngeal swabs were tested using RT-PCR and CoV2Ag assay.
The overall sensitivity and specificity of CoV2Ag were 79.1 and 97.8%, respectively. When the analysis was restricted to cases with Ct values ≤30, the sensitivity of the assay improved to 98.1%. Acceptable sensitivity was found when the analysis was limited to patients presenting within one or two to four days of symptom onset (80.5 and 84.8%, respectively). A retrospective analysis of the use of a two-step diagnostic approach combining the CoV2Ag assay and RT-PCR during an acute pandemic phase of 97 days showed a potential reduction in the number of RT-PCR tests by 36.1%, corresponding to savings in reagent costs and technician workload of approximately €8,000 and 10.5 h per day, respectively.
Our data show that the proposed algorithm represents a valid alternative diagnostic approach to increase testing efficiency during future pandemic phases with high positivity rates (>20%) and elevated numbers of RT-PCR test requests.
严重急性呼吸综合征冠状病毒 2（SARS-CoV-2）的实验室检测在预防和控制本地疫情方面发挥了重要作用。本研究旨在评估一种新的全自动 SARS-CoV-2 基于实验室的抗原检测（CoV2Ag）的诊断准确性，并探索结合抗原和常规高通量分子检测的诊断算法的效率，以应对 SARS-CoV-2 大流行未来的潜在挑战。
对 1224 例连续鼻咽拭子进行 RT-PCR 和 CoV2Ag 检测。
CoV2Ag 的总体敏感性和特异性分别为 79.1%和 97.8%。当分析仅限于 Ct 值≤30 的病例时，该检测的敏感性提高至 98.1%。当分析仅限于发病后 1 天或 2-4 天内就诊的患者时，可获得可接受的敏感性（分别为 80.5%和 84.8%）。在 97 天的急性大流行阶段，对联合使用 CoV2Ag 检测和 RT-PCR 的两步诊断方法的回顾性分析显示，RT-PCR 检测的数量可能减少 36.1%，这相当于试剂成本和技术人员工作量分别节省约 8000 欧元和每天 10.5 小时。
我们的数据表明，所提出的算法代表了一种有效的替代诊断方法，可以在未来高阳性率（>20%）和大量 RT-PCR 检测请求的大流行阶段提高检测效率。
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