Genome Analysis Center, Yamanashi Central Hospital, 1-1-1 Fujimi, Kofu, Yamanashi, Japan.
Division of Microbiology in Clinical Laboratory, Yamanashi Central Hospital, 1-1-1 Fujimi, Kofu, Yamanashi, Japan.
J Infect Chemother. 2021 Feb;27(2):406-409. doi: 10.1016/j.jiac.2020.10.026. Epub 2020 Oct 29.
Various diagnostic tests utilizing different principles are currently under development for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). However, these tests can occasionally produce discrepant results, causing confusion in their interpretation. Here, we evaluated the performance and features of three diagnostic assays: quantitative reverse transcription polymerase chain reaction (RT-qPCR), FilmArray Respiratory Panel (RP) v2.1, and the LUMIPULSE antigen test. Twenty-seven serial nasopharyngeal swabs were collected from a prolonged viral shedding patient who had been hospitalized for 51 days. We examined the SARS-CoV-2 detection rates of the three tests. The overall agreement rate was 81% between RT-qPCR and FilmArray RP v2.1, 63% between the antigen test and FilmArray RP v2.1, and 59% between the antigen test and RT-qPCR. We obtained concordant results in samples with high viral loads (low threshold cycle values) by all three tests. RT-qPCR and FilmArray RP v2.1 accurately detected SARS-CoV-2 at the early to intermediate phases of infection, but the results varied at the late phase. The antigen test also produced a positive result at the early phase but varied at the intermediate phase and consistently produced negative results at late phase of infection. These results demonstrated FilmArray RP v2.1 could detect SARS-CoV-2 with accuracy comparable to RT-qPCR. Further, there were discrepant results using different types of diagnostic tests during the clinical course of prolonged viral shedding patient. We provided insights into how to utilize different types of kits to assess and manage SARS-CoV-2 infections.
目前,针对严重急性呼吸综合征冠状病毒 2 (SARS-CoV-2),已经开发了多种利用不同原理的诊断检测方法。然而,这些检测方法偶尔会产生不一致的结果,导致其解释出现混淆。在这里,我们评估了三种诊断检测方法的性能和特点:实时荧光定量逆转录聚合酶链反应 (RT-qPCR)、FilmArray Respiratory Panel (RP) v2.1 和 LUMIPULSE 抗原检测。我们从一名住院 51 天的病毒持续排出患者中采集了 27 份连续的鼻咽拭子。我们检查了三种检测方法对 SARS-CoV-2 的检测率。RT-qPCR 和 FilmArray RP v2.1 的总体符合率为 81%,抗原检测和 FilmArray RP v2.1 的符合率为 63%,抗原检测和 RT-qPCR 的符合率为 59%。我们在所有三种检测方法中都获得了高病毒载量(低阈值循环值)样本的一致结果。RT-qPCR 和 FilmArray RP v2.1 能够准确检测 SARS-CoV-2 在感染的早期到中期阶段,但在晚期阶段结果有所不同。抗原检测在早期阶段也会产生阳性结果,但在中期阶段会有所变化,并且在感染的晚期阶段始终产生阴性结果。这些结果表明,FilmArray RP v2.1 可以像 RT-qPCR 一样准确地检测 SARS-CoV-2。此外,在病毒持续排出患者的临床病程中,使用不同类型的诊断检测方法会出现不一致的结果。我们提供了如何利用不同类型的试剂盒来评估和管理 SARS-CoV-2 感染的见解。