Division of Infectious Diseases and Geographic Medicine, Department of Medicine, Stanford University School of Medicine, Stanford, CA, USA.
Department of Pathology, Stanford University School of Medicine, Stanford, CA, USA; Clinical Microbiology Laboratory, Stanford Health Care, Stanford, CA, USA.
Diagn Microbiol Infect Dis. 2019 Sep;95(1):10-14. doi: 10.1016/j.diagmicrobio.2019.03.013. Epub 2019 Mar 29.
Though the FilmArray GI Panel has a reported aggregate specificity and reproducibility of >97% and > 99%, respectively, the reproducibility is less understood in clinical practice. We measured the reproducibility of positive results for low-prevalence pathogens. Samples with positive results for selected targets were repeated using a different FilmArray module. Overall, 331 of 373 (89%) results were reproducible. Giardia lamblia (57/57, 100%), Cryptosporidium spp. (61/63, 97%), Cyclospora cayetanensis (34/35, 97%), Plesiomonas shigelloides (17/18, 94%), and Rotavirus A (76/77, 99%) were highly reproducible, while Adenovirus F40/41 (38/54, 70%), Vibrio spp. (8/10, 80%), V. cholerae (3/8, 37.5%), and Yersinia enterocolitica (36/50, 72%) were poorly reproducible. Review of 38 patients with nonreproducible results showed that 19 (50%) had evidence of gastroenteritis and only 6 (16%) had possible infection with the organism that showed a nonreproducible result. Higher false-positive rates with certain targets on FAGP emphasize the need for diagnostic stewardship.
虽然 FilmArray GI Panel 的综合特异性和重现性分别报告为>97%和>99%，但其在临床实践中的重现性了解较少。我们测量了低流行病原体阳性结果的重现性。使用不同的 FilmArray 模块对选定靶标阳性结果的样本进行重复检测。总体而言，373 个样本中有 331 个（89%）结果是可重现的。蓝氏贾第鞭毛虫（57/57，100%）、隐孢子虫属（61/63，97%）、环孢子虫属（34/35，97%）、类志贺邻单胞菌（17/18，94%）和轮状病毒 A（76/77，99%）的重现性很高，而腺病毒 F40/41（38/54，70%）、弧菌属（8/10，80%）、霍乱弧菌（3/8，37.5%）和小肠结肠炎耶尔森菌（36/50，72%）的重现性较差。对 38 例非重现性结果患者的回顾性研究表明，19 例（50%）有肠胃炎证据，只有 6 例（16%）可能感染了表现出非重现性结果的病原体。某些 FAGP 靶标出现较高的假阳性率，强调了诊断管理的必要性。
