Genome Analysis Center, Yamanashi Central Hospital, 1-1-1 Fujimi, Kofu, Yamanashi, Japan.
Division of Clinical Biochemistry and Immunology, Yamanashi Central Hospital, 1-1-1 Fujimi, Kofu, Yamanashi, Japan.
Int J Infect Dis. 2021 Jul;108:263-269. doi: 10.1016/j.ijid.2021.05.067. Epub 2021 Jun 1.
Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) continues to spread worldwide. Here, we evaluated the performance of two quantitative antigen (Ag) tests, the Roche and Lumipulse Ag tests, using automated platforms.
We collected 637 nasopharyngeal swab samples from 274 individuals. Samples were subjected to quantitative reverse transcription PCR (RT-qPCR), the Roche Ag test and Lumipulse Ag test.
When RT-qPCR was used as a reference, the overall concordance rate of the Roche Ag test was 77.1% (491/637) with 70.0% (341/487) sensitivity and 100% specificity (150/150). When inconclusive results of the Lumipulse Ag test were excluded, the overall concordance rate of the Lumipulse Ag test was 88.3% (467/529) with 84.8% (330/389) sensitivity and 97.9% (137/140) specificity. The overall concordance rate between the Roche and Lumipulse Ag tests was 97.9% (518/529) with 96.7% (322/333) sensitivity and 100% (196/196) specificity. Quantitative Ag levels determined using the Roche and Lumipulse Ag tests were highly correlated (R = 0.922). The Roche and Lumipulse Ag tests showed high concordance up to nine days after symptom onset, with progressively lower concordance after that.
The Roche and Lumipulse Ag tests showed equivalent assay performance and represent promising approaches for diagnosing coronavirus disease 2019.
严重急性呼吸综合征冠状病毒 2（SARS-CoV-2）继续在全球范围内传播。在此，我们评估了两种定量抗原（Ag）检测罗氏和 Lumipulse Ag 检测的性能，这些检测使用自动化平台进行。
我们收集了 274 名个体的 637 份鼻咽拭子样本。对样本进行定量逆转录 PCR（RT-qPCR）、罗氏 Ag 检测和 Lumipulse Ag 检测。
当 RT-qPCR 作为参考时，罗氏 Ag 检测的总符合率为 77.1%（491/637），敏感性为 70.0%（341/487），特异性为 100%（150/150）。当排除 Lumipulse Ag 检测的不确定结果时，Lumipulse Ag 检测的总符合率为 88.3%（467/529），敏感性为 84.8%（330/389），特异性为 97.9%（137/140）。罗氏和 Lumipulse Ag 检测之间的总符合率为 97.9%（518/529），敏感性为 96.7%（322/333），特异性为 100%（196/196）。罗氏和 Lumipulse Ag 检测确定的定量 Ag 水平高度相关（R = 0.922）。罗氏和 Lumipulse Ag 检测在症状出现后 9 天内具有高度一致性，此后一致性逐渐降低。
罗氏和 Lumipulse Ag 检测具有等效的检测性能，是诊断 2019 年冠状病毒病的有前途的方法。
