高通量 SARS-CoV-2 抗原检测与核酸检测的性能比较。
Performance of High Throughput SARS-CoV-2 Antigen Testing Compared to Nucleic Acid Testing.
机构信息
Department of Pathology and Critical Care Medicine, University of Pittsburgh, Pittsburgh, PAUS.
Department of Pathology, University of Pittsburgh, Pittsburgh, PAUS.
出版信息
Lab Med. 2023 Mar 7;54(2):e54-e57. doi: 10.1093/labmed/lmac107.
OBJECTIVE
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).
METHODS
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).
RESULTS
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.
CONCLUSION
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.
目的
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。
方法
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。
结果
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。
结论
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。
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