Department of Pathology & Laboratory Medicine, University of British Columbia, Vancouver, BC, Canada; Division of Medical Microbiology & Infection Control & Control, Vancouver Coastal Health, Vancouver, BC, Canada.
Division of Medical Microbiology & Infection Control & Control, Vancouver Coastal Health, Vancouver, BC, Canada.
Diagn Microbiol Infect Dis. 2021 Mar;99(3):115260. doi: 10.1016/j.diagmicrobio.2020.115260. Epub 2020 Nov 10.
The BioFire® COVID-19 Test and Respiratory Panel 2.1 (RP2.1) are rapid, fully automated assays for the detection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in nasopharyngeal swabs. In the case of the RP2.1, an additional 21 viral and bacterial pathogens can be detected. Both tests have received emergency use authorization from the U.S. Food & Drug Administration and Interim Order authorization from Health Canada for use in clinical laboratories. We evaluated the performance characteristics of these tests in comparison to a laboratory-developed real-time PCR assay targeting the viral RNA-dependent RNA polymerase and E genes. A total of 78 tests were performed using the BioFire COVID-19 Test, including 30 clinical specimens and 48 tests in a limit of detection study; 57 tests were performed using the RP2.1 for evaluation of SARS-CoV-2 detection, including 30 clinical specimens and 27 tests for limit of detection. Results showed 100% concordance between the BioFire assays and the laboratory-developed test for all clinical samples tested, and acceptable performance of both BioFire assays at their stated limits of detection. Conclusively, the BioFire COVID-19 Test and RP2.1 are highly sensitive assays that can be effectively used in the clinical laboratory for rapid SARS-CoV-2 testing.
BioFire® COVID-19 测试和呼吸道Panel 2.1（RP2.1）是用于检测鼻咽拭子中严重急性呼吸综合征冠状病毒 2（SARS-CoV-2）的快速、全自动检测方法。在 RP2.1 的情况下，还可以检测到另外 21 种病毒和细菌病原体。这两种检测方法均已获得美国食品药品监督管理局的紧急使用授权和加拿大卫生部的临时授权，可在临床实验室中使用。我们评估了这些测试与针对病毒 RNA 依赖性 RNA 聚合酶和 E 基因的实验室开发的实时 PCR 检测方法的性能特征。使用 BioFire COVID-19 测试共进行了 78 次测试，包括 30 个临床标本和 48 个检测下限研究中的测试；使用 RP2.1 进行了 57 次 SARS-CoV-2 检测评估测试，包括 30 个临床标本和 27 个检测下限测试。结果显示，所有测试的临床样本中，BioFire 检测方法与实验室开发的检测方法完全一致，两种 BioFire 检测方法在其规定的检测限内均具有可接受的性能。总之，BioFire COVID-19 测试和 RP2.1 是高度敏感的检测方法，可以有效地在临床实验室中用于快速 SARS-CoV-2 检测。
