Infectious Disease Diagnostics, Northwell Health Laboratories, Lake Success, New York, USA.
Department of Pathology and Laboratory Medicine, The Donald and Barbara Zucker School of Medicine at Hofstra/Northwell, Hempstead, New York, USA.
J Clin Microbiol. 2022 May 18;60(5):e0006622. doi: 10.1128/jcm.00066-22. Epub 2022 Apr 7.
As the incidence of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) begins to overlap with the traditional respiratory season in the Northern Hemisphere, simultaneous testing for SARS-CoV-2 and the other common causes of respiratory infections is imperative. This has led to the development of multiplex respiratory assays that include SARS-CoV-2 as a target. One such assay is the BioFire respiratory panel 2.1 (RP2.1), which is an expansion of the original BioFire FilmArray respiratory panel 2 (RP2) to include SARS-CoV-2. In this multicenter evaluation, we assessed the performance characteristics of the BioFire RP2.1 for the detection of SARS-CoV-2. One or more targets on the panel were detected in 19.3% (101/524) of specimens tested, with SARS-CoV-2 detected in 12.6% (66/524) of specimens. Human rhinovirus/enterovirus was also detected in 32.7% (33/101) and adenovirus in 3.0% (3/101) of positive specimens, with one dual positive for both SARS-CoV-2 and adenovirus being detected. A further breakdown of pathogens by age revealed a 4-fold predominance of human rhinovirus/enterovirus in subjects 0 to 18 years of age, whereas in all other age groups, SARS-CoV-2 was clearly the predominant pathogen. Overall, SARS-CoV-2 results obtained from the BioFire RP2.1 were highly concordant with the composite result, exhibiting 98.4% (61/62) positive percent agreement (95% confidence interval [CI], 91.4 to 99.7%) and 98.9% (457/462) negative percent agreement (95% CI, 97.5 to 99.5%) with further analysis of discordant results suggesting that the concentration of SARS-CoV-2 in the specimens was near the limit of detection (LoD) for both the BioFire RP2.1 and the comparator assays. Overall, the BioFire RP2.1 exhibited excellent performance in the detection of SARS-CoV-2.
随着严重急性呼吸综合征冠状病毒 2（SARS-CoV-2）的发病率开始与北半球的传统呼吸道季节重叠，同时检测 SARS-CoV-2 和其他常见呼吸道感染原因是必要的。这导致了多重呼吸道检测方法的发展，其中包括 SARS-CoV-2 作为检测目标。其中一种检测方法是 BioFire 呼吸道检测面板 2.1（RP2.1），它是原始 BioFire FilmArray 呼吸道检测面板 2（RP2）的扩展，其中包括 SARS-CoV-2。在这项多中心评估中，我们评估了 BioFire RP2.1 检测 SARS-CoV-2 的性能特征。在检测的 524 份标本中，有 19.3%（101/524）的标本在一个或多个面板上检测到目标，其中 12.6%（66/524）的标本检测到 SARS-CoV-2。在阳性标本中，还检测到人类鼻病毒/肠道病毒 32.7%（33/101）和腺病毒 3.0%（3/101），其中有 1 份标本同时检测到 SARS-CoV-2 和腺病毒阳性。按年龄进一步细分病原体发现，0 至 18 岁的人群中人类鼻病毒/肠道病毒的比例明显较高，而在所有其他年龄组中，SARS-CoV-2 显然是主要病原体。总体而言，BioFire RP2.1 检测到的 SARS-CoV-2 结果与综合结果高度一致，阳性符合率为 98.4%（61/62）（95%置信区间[CI]，91.4 至 99.7%），阴性符合率为 98.9%（457/462）（95%CI，97.5 至 99.5%），对不一致结果的进一步分析表明，SARS-CoV-2 在标本中的浓度接近 BioFire RP2.1 和比较检测方法的检测限（LoD）。总体而言，BioFire RP2.1 在 SARS-CoV-2 的检测中表现出优异的性能。
