Doern Christopher D, Lacey Damon, Huang Rong, Haag Crissie
Departments of Pediatrics.
J Clin Microbiol. 2013 Dec;51(12):4036-9. doi: 10.1128/JCM.02546-13. Epub 2013 Sep 25.
The BioFire FilmArray respiratory panel is a multiplex PCR technology capable of detecting a number of bacteria and viruses that cause respiratory tract infection. The assay is technically simple to perform and provides rapid results, making it an appealing option for physicians and laboratorians. The initial product released by BioFire (version 1.6) was reported to have poor sensitivity for adenovirus detection and was therefore of concern when testing immunocompromised patients. This study evaluates the redesigned FilmArray assay (version 1.7) for detection of adenovirus. In this evaluation, we performed both retrospective and prospective verification studies, as well as a detailed serotype analysis. We found that version 1.7 demonstrated improved adenovirus sensitivity. In retrospective studies, sensitivity improved from 66.6% to 90.5%, and in prospective studies, it improved from 42.7% to 83.3%. In addition, when 39 clinically relevant serotypes were tested, 8 were not detected by version 1.6 and only 1 was not detected by version 1.7. The limit of detection remained the same when tested against serotype 4 but improved by 2 log units for serotype 7. Lastly, turnaround time analyses showed that the FilmArray assay was completed 3 h and 9 min after collection, which was more than a 37-h improvement over the previous multiplex PCR assay performed in our laboratory.
BioFire FilmArray呼吸道检测板是一种多重PCR技术，能够检测多种引起呼吸道感染的细菌和病毒。该检测方法在技术上操作简单，并能快速得出结果，这使其成为医生和实验室工作人员的一个有吸引力的选择。据报道，BioFire最初发布的产品（1.6版本）对腺病毒检测的灵敏度较差，因此在检测免疫功能低下的患者时令人担忧。本研究评估了重新设计的FilmArray检测方法（1.7版本）对腺病毒的检测能力。在本次评估中，我们进行了回顾性和前瞻性验证研究以及详细的血清型分析。我们发现1.7版本的腺病毒检测灵敏度有所提高。在回顾性研究中，灵敏度从66.6%提高到了90.5%，在前瞻性研究中，从42.7%提高到了83.3%。此外，在对39种临床相关血清型进行检测时，1.6版本未检测出8种，而1.7版本仅未检测出1种。针对血清型4进行检测时，检测限保持不变，但针对血清型7时检测限提高了2个对数单位。最后，周转时间分析表明，FilmArray检测在样本采集后3小时9分钟完成，比我们实验室之前进行的多重PCR检测缩短了超过37小时。
