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评价使用回顾性和前瞻性收集的标本的 BioFire 多重 PCR 面板检测关节感染的性能。

Evaluation of a BioFire multiplex PCR panel for detection of joint infections using retrospective and prospectively collected specimens.

机构信息

Department of Pathology and Laboratory Medicine, Endeavor Health, Evanston, Illinois, USA.

Department of Pathology, University of Chicago, Pritzker School of Medicine, Chicago, Illinois, USA.

出版信息

J Clin Microbiol. 2024 Aug 14;62(8):e0018224. doi: 10.1128/jcm.00182-24. Epub 2024 Jul 17.

Abstract

The BioFire Joint Infection Panel (JI panel) is a newly FDA-approved multiplex PCR assay for detection of common bone and joint pathogens with 39 targets which include select Gram-positive and Gram-negative bacteria, yeast, and antimicrobial resistance genes. We evaluated the performance of the JI panel in detecting joint infections in our patient population. Sixty-three frozen, residual joint fluid specimens were retrospectively tested using the JI panel. An additional 104 residual joint fluid specimens were de-identified and prospectively tested within 1 week of collection. Results from routine bacterial cultures were used as the reference standard, which included inoculation to agar plates and blood culture bottles. For the frozen specimens, the JI panel showed a positive percent agreement (PPA) of 92.8% and a negative percent agreement (NPA) of 97.1%. PPA was 71.4% and NPA was 94.8% for fresh specimens. A total of 12 discrepancies were observed among the 167 specimens tested. The JI panel demonstrated good overall agreement with routine culture for the detection of joint infections and may improve timely diagnosis when used in conjunction with bacterial culture. However, potential false-positive and false-negative results were observed in both retrospective and prospective testing of specimens.IMPORTANCEThe BioFire JI panel is a new commercially available multiplex PCR assay for detecting common pathogens causing bone and joint infections. The test is performed directly on joint fluids with a fast turnaround time of 1 hour. Our study shows that while the JI panel overall shows good agreement with routine culture, discrepancies were observed in 7% of cases and results should be interpreted with appropriate clinical context.

摘要

BioFire 联合感染面板(JI 面板)是一种新的美国 FDA 批准的多重 PCR 检测方法,用于检测常见的骨骼和关节病原体,有 39 个靶点,包括选择的革兰氏阳性和革兰氏阴性细菌、酵母和抗菌药物耐药基因。我们评估了 JI 面板在我们患者人群中检测关节感染的性能。63 份冷冻的、剩余的关节液标本用 JI 面板进行了回顾性检测。另外 104 份剩余的关节液标本在采集后 1 周内进行了匿名和前瞻性检测。常规细菌培养的结果被用作参考标准,包括接种到琼脂平板和血培养瓶。对于冷冻标本,JI 面板的阳性百分比一致率(PPA)为 92.8%,阴性百分比一致率(NPA)为 97.1%。新鲜标本的 PPA 为 71.4%,NPA 为 94.8%。在 167 个测试标本中观察到 12 个差异。JI 面板与常规培养在检测关节感染方面具有良好的总体一致性,并且当与细菌培养结合使用时,可能会提高及时诊断的能力。然而,在对标本进行回顾性和前瞻性检测时,都观察到了潜在的假阳性和假阴性结果。

重要性

BioFire JI 面板是一种新的商业上可获得的用于检测引起骨骼和关节感染的常见病原体的多重 PCR 检测方法。该测试直接在关节液上进行,周转时间为 1 小时。我们的研究表明,虽然 JI 面板总体上与常规培养具有良好的一致性,但在 7%的情况下观察到差异,结果应结合适当的临床背景进行解释。

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Clinical performance evaluation of the BioFire Joint Infection Panel.BioFire 联合感染检测试剂盒的临床性能评估。
J Clin Microbiol. 2024 Nov 13;62(11):e0102224. doi: 10.1128/jcm.01022-24. Epub 2024 Oct 9.

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