Division of Clinical Tropical Medicine, Heidelberg University Hospital, Heidelberg, Germany.
Virology, Heidelberg University Hospital, Heidelberg, Germany.
PLoS One. 2021 May 27;16(5):e0247918. doi: 10.1371/journal.pone.0247918. eCollection 2021.
Diagnostics are essential for controlling the pandemic. Identifying a reliable and fast diagnostic device is needed for effective testing. We assessed performance and ease-of-use of the Abbott PanBio antigen-detecting rapid diagnostic test (Ag-RDT).
This prospective, multi-centre diagnostic accuracy study enrolled at two sites in Germany. Following routine testing with reverse-transcriptase polymerase chain reaction (RT-PCR), a second study-exclusive swab was performed for Ag-RDT testing. Routine swabs were nasopharyngeal (NP) or combined NP/oropharyngeal (OP) whereas the study-exclusive swabs were NP. To evaluate performance, sensitivity and specificity were assessed overall and in predefined sub-analyses accordingly to cycle-threshold values, days after symptom onset, disease severity and study site. Additionally, an ease-of-use assessment (EoU) and System Usability Scale (SUS) were performed.
1108 participants were enrolled between Sept 28 and Oct 30, 2020. Of these, 106 (9.6%) were PCR-positive. The Abbott PanBio detected 92/106 PCR-positive participants with a sensitivity of 86.8% (95% CI: 79.0% - 92.0%) and a specificity of 99.9% (95% CI: 99.4%-100%). The sub-analyses indicated that sensitivity was 95.8% in Ct-values <25 and within the first seven days from symptom onset. The test was characterized as easy to use (SUS: 86/100) and considered suitable for point-of-care settings.
The Abbott PanBio Ag-RDT performs well for SARS-CoV-2 testing in this large manufacturer independent study, confirming its WHO recommendation for Emergency Use in settings with limited resources.
诊断对于控制大流行至关重要。需要找到一种可靠且快速的诊断设备，以进行有效的检测。我们评估了 Abbott PanBio 抗原检测快速诊断检测（Ag-RDT）的性能和易用性。
本前瞻性、多中心诊断准确性研究在德国的两个地点进行。在使用逆转录酶聚合酶链反应（RT-PCR）进行常规检测后，进行了第二项仅限研究的拭子 Ag-RDT 检测。常规拭子为鼻咽（NP）或 NP/口咽（OP）联合拭子，而仅限研究的拭子为 NP。为了评估性能，我们根据循环阈值、症状出现后天数、疾病严重程度和研究地点，对总灵敏度和特异性进行了评估，并进行了亚组分析。此外，还进行了易用性评估（EoU）和系统可用性量表（SUS）评估。
2020 年 9 月 28 日至 10 月 30 日期间，共纳入 1108 名参与者。其中，106 名（9.6%）PCR 阳性。Abbott PanBio 检测到 106 名 PCR 阳性者中的 92 名，其灵敏度为 86.8%（95%CI：79.0%-92.0%），特异性为 99.9%（95%CI：99.4%-100%）。亚组分析表明，在 Ct 值<25 和症状出现后 7 天内，灵敏度为 95.8%。该检测被认为易于使用（SUS：86/100），适合在资源有限的即时检测环境中使用。
在这项大型独立制造商研究中，Abbott PanBio Ag-RDT 对 SARS-CoV-2 检测表现良好，证实了其在资源有限的环境下紧急使用的世界卫生组织推荐。
