Department of Pathology and Critical Care Medicine, University of Pittsburgh, Pittsburgh, PAUS.
Department of Pathology, University of Pittsburgh, Pittsburgh, PAUS.
Lab Med. 2023 Mar 7;54(2):e54-e57. doi: 10.1093/labmed/lmac107.
Independent assessment of SARS-CoV-2 antigen (COV2Ag) tests remains important as varying performance between assays is common. We assessed the performance of a new high-throughput COV2Ag test compared to SARS-CoV-2 nucleic acid amplification tests (NAAT).
A total of 347 nasopharyngeal samples collected from January to October 2021 were assessed by NAAT as part of standard-of-care testing (CDC LDT or GeneXpert System, Cepheid) and COV2Ag using the ADVIA Centaur CoV2Ag assay (Siemens Healthineers).
Among NAAT positive specimens we found 82.4% agreement and in NAAT negative specimens we found 97.3% agreement (overall agreement 85.6%). In symptomatic persons, COV2Ag agreed with NAAT 90.0% (n = 291), and in asymptomatic persons, 62.5% (n = 56). Agreement between positive NAAT and COV2Ag increased at lower cycle threshold (Ct) values.
The COV2Ag assay exceeded the World Health Organization minimum performance requirements of ≥ 80% sensitivity and ≥ 97% specificity. The COV2Ag assay is helpful for large scale screening efforts due to high-throughput and reduced wait times.
由于不同检测方法之间的性能差异很常见，因此对 SARS-CoV-2 抗原（COV2Ag）检测进行独立评估仍然很重要。我们评估了一种新的高通量 COV2Ag 检测与 SARS-CoV-2 核酸扩增检测（NAAT）的性能。
共评估了 2021 年 1 月至 10 月采集的 347 份鼻咽样本，这些样本是作为标准护理检测（CDC 的 LDT 或 Cepheid 的 GeneXpert 系统）的一部分通过 NAAT 进行评估，并用 ADVIA Centaur CoV2Ag 检测（西门子医疗）进行 COV2Ag 检测。
在 NAAT 阳性标本中，我们发现 82.4%的一致性，在 NAAT 阴性标本中，我们发现 97.3%的一致性（总体一致性为 85.6%）。在有症状的人群中，COV2Ag 与 NAAT 的一致性为 90.0%（n=291），在无症状人群中，一致性为 62.5%（n=56）。阳性 NAAT 和 COV2Ag 之间的一致性随着循环阈值（Ct）值的降低而增加。
COV2Ag 检测符合世界卫生组织的最低性能要求，灵敏度≥80%，特异性≥97%。COV2Ag 检测由于高通量和缩短等待时间，有助于大规模筛查工作。
