Department of Laboratory Medicine, University of Washington, Seattle.
Harborview Medical Center Clinical Microbiology Laboratory, Seattle.
Clin Infect Dis. 2018 Nov 13;67(11):1688-1696. doi: 10.1093/cid/ciy357.
Molecular syndromic diagnostic panels can enhance pathogen identification in the approximately 2-4 billion episodes of acute gastroenteritis that occur annually worldwide. However, the clinical utility of these panels has not been established.
We conducted a prospective, multi-center study to investigate the impact of the BioFire FilmArray Gastrointestinal polymerase chain reaction panel on clinical diagnosis and decision-making, and compared the clinical acuity of patients with positive results obtained exclusively with the FilmArray with those detected by conventional stool culture. A total of 1887 consecutive fecal specimens were tested in parallel by FilmArray and stool culture. Laboratory and medical records were reviewed to determine rates of detection, turnaround times, clinical features, and the nature and timing of clinical decisions.
FilmArray detected pathogens in 35.3% of specimens, compared to 6.0% for culture. Median time from collection to result was 18 hours for FilmArray and 47 hours for culture. Median time from collection to initiation of antimicrobial therapy was 22 hours for FilmArray and 72 hours for culture. Patients diagnosed by FilmArray were more likely to receive targeted rather than empirical therapy, compared to those diagnosed by culture (P = .0148). Positive Shiga-like toxin-producing E. coli results were reported 47 hours faster with FilmArray and facilitated discontinuation of empirical antimicrobials. Patients diagnosed exclusively by FilmArray had clinical characteristics similar to those identified by culture.
FilmArray markedly improved clinical sensitivity in patients with acute diarrhea, identified cases with clinical acuity comparable to those identified by culture, and enabled clinicians to make more timely and targeted therapeutic decisions.
分子综合征诊断小组可以提高全球每年约 20 亿至 40 亿例急性肠胃炎病例的病原体识别能力。然而，这些小组的临床应用尚未确定。
我们进行了一项前瞻性、多中心研究，以调查 BioFire FilmArray 胃肠道聚合酶链反应小组对临床诊断和决策的影响，并比较了仅用 FilmArray 获得阳性结果和用传统粪便培养检测到的患者的临床严重程度。总共对 1887 个连续粪便标本进行了 FilmArray 和粪便培养的平行检测。实验室和病历记录用于确定检测率、周转时间、临床特征以及临床决策的性质和时间。
与培养相比，FilmArray 在 35.3%的标本中检测到病原体，而培养的比例为 6.0%。从采集到结果的中位数时间为 FilmArray 18 小时，培养为 47 小时。从采集到开始抗菌治疗的中位数时间为 FilmArray 22 小时，培养为 72 小时。与培养诊断的患者相比，经 FilmArray 诊断的患者更有可能接受靶向治疗而不是经验性治疗（P =.0148）。FilmArray 更快地报告了产志贺样毒素的大肠杆菌阳性结果，这有助于停止经验性抗菌药物的使用。仅经 FilmArray 诊断的患者具有与培养鉴定相似的临床特征。
FilmArray 明显提高了急性腹泻患者的临床灵敏度，鉴定出了与培养鉴定相似的临床严重程度的病例，并使临床医生能够更及时、更有针对性地做出治疗决策。
