即时检测点使用与 RT-qPCR 相比的 SARS-CoV-2 快速抗原检测的临床性能评估。

Clinical performance evaluation of SARS-CoV-2 rapid antigen testing in point of care usage in comparison to RT-qPCR.

机构信息

Institute for Hygiene and Microbiology, University of Wuerzburg, Josef-Schneider-Str. 2 / E1, Wuerzburg 97080, Germany.

Institute for Virology and Immunobiology, University of Wuerzburg, Wuerzburg, Germany.

出版信息

EBioMedicine. 2021 Jul;69:103455. doi: 10.1016/j.ebiom.2021.103455. Epub 2021 Jun 26.

BACKGROUND

Antigen rapid diagnostic tests (RDT) for SARS-CoV-2 are fast, broadly available, and inexpensive. Despite this, reliable clinical performance data from large field studies is sparse.

METHODS

In a prospective performance evaluation study, RDT from three manufacturers (NADAL®, Panbio™, MEDsan®, conducted on different samples) were compared to quantitative reverse transcription polymerase chain reaction (RT-qPCR) in 5 068 oropharyngeal swabs for detection of SARS-CoV-2 in a hospital setting. Viral load was derived from standardised RT-qPCR Cycle threshold (C) values. The data collection period ranged from November 12, 2020 to February 28, 2021.

FINDINGS

The sensitivity of RDT compared to RT-qPCR was 42·57% (95% CI 33·38%-52·31%). The specificity was 99·68% (95% CI 99·48%-99·80%). Sensitivity declined with decreasing viral load from 100% in samples with a deduced viral load of ≥10 SARS-CoV-2 RNA copies per ml to 8·82% in samples with a viral load lower than 10 SARS-CoV-2 RNA copies per ml. No significant differences in sensitivity or specificity could be observed between samples with and without spike protein variant B.1.1.7. The NPV in the study cohort was 98·84%; the PPV in persons with typical COVID-19 symptoms was 97·37%, and 28·57% in persons without or with atypical symptoms.

INTERPRETATION

RDT are a reliable method to diagnose SARS-CoV-2 infection in persons with high viral load. RDT are a valuable addition to RT-qPCR testing, as they reliably detect infectious persons with high viral loads before RT-qPCR results are available.

FUNDING

German Federal Ministry for Education and Science (BMBF), Free State of Bavaria.

背景

用于 SARS-CoV-2 的抗原快速诊断检测（RDT）快速、广泛可用且价格低廉。尽管如此，来自大型现场研究的可靠临床性能数据仍然很少。

方法

在一项前瞻性性能评估研究中，在医院环境中，对来自三个制造商（NADAL®、Panbio™、MEDsan®）的 RDT（在不同样本上进行检测）与定量逆转录聚合酶链反应（RT-qPCR）进行了比较，共检测了 5068 例咽拭子样本，以检测 SARS-CoV-2。病毒载量源自标准化 RT-qPCR 循环阈值（C）值。数据收集期为 2020 年 11 月 12 日至 2021 年 2 月 28 日。

结果

与 RT-qPCR 相比，RDT 的灵敏度为 42.57%（95%CI 33.38%-52.31%）。特异性为 99.68%（95%CI 99.48%-99.80%）。灵敏度随病毒载量的降低而下降，从推断病毒载量≥10 SARS-CoV-2 RNA 拷贝/ml 的样本中 100%下降到病毒载量低于 10 SARS-CoV-2 RNA 拷贝/ml 的样本中 8.82%。在有无尖峰蛋白变异体 B.1.1.7 的样本之间，无法观察到灵敏度或特异性的显著差异。在研究队列中，NPV 为 98.84%；在有典型 COVID-19 症状的人中，PPV 为 97.37%，而在无症状或有非典型症状的人中，PPV 为 28.57%。