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基于多重 PCR 的联合感染检测的临床评估:49 例患者的前瞻性诊断准确性研究。

Clinical evaluation of a multiplex PCR-based test for joint infection: a prospective diagnostic accuracy study of forty-nine patients.

机构信息

Department of Orthopedic Surgery and Traumatology, Copenhagen University Hospital, Bispebjerg and Frederiksberg, Copenhagen, Denmark.

Department of Clinical Biochemistry, Copenhagen University Hospital, Bispebjerg and Frederiksberg, Copenhagen, Denmark.

出版信息

Eur J Orthop Surg Traumatol. 2024 Dec;34(8):4105-4111. doi: 10.1007/s00590-024-04114-2. Epub 2024 Oct 2.

Abstract

PURPOSE

The purpose of this study was to evaluate the diagnostic accuracy (sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV)) of the PCR-based BioFire® Joint Infection Panel (BJI Panel) against microbiological culture growth for patients suspected of having a native or prosthetic joint infection.

METHODS

Synovial fluid and tissue biopsies were prospectively collected from patients from June 2022 to June 2023. The results of the BJI Panel were compared with those of culture growth.

RESULTS

51 samples were included. Including all pathogens, the sensitivity was 69%, the specificity 89%, the PPV 73% and the NPV 86%. Including only pathogens in the BJI Panel, the sensitivity was 100%, the specificity 90%, the PPV 73% and the NPV 100%.

CONCLUSION

The BJI Panel has a high accuracy for detecting the pathogens in its panel, but the absence of important common pathogens from the panel reduces its sensitivity and NPV. With a short turnaround time and precise pathogen detection, the BJI Panel has the potential to add value as a complementary diagnostic method.

摘要

目的

本研究旨在评估基于 PCR 的 BioFire®关节感染检测 panel(BJI Panel)对疑似患有原发性或人工关节感染的患者的微生物培养生长的诊断准确性(敏感性、特异性、阳性预测值(PPV)和阴性预测值(NPV))。

方法

从 2022 年 6 月至 2023 年 6 月,前瞻性地收集了来自患者的滑液和组织活检样本。将 BJI Panel 的结果与培养生长的结果进行比较。

结果

共纳入 51 例样本。包括所有病原体在内,敏感性为 69%,特异性为 89%,PPV 为 73%,NPV 为 86%。仅包括 BJI Panel 中的病原体时,敏感性为 100%,特异性为 90%,PPV 为 73%,NPV 为 100%。

结论

BJI Panel 对其检测 panel 中的病原体具有较高的准确性,但 panel 中缺乏重要的常见病原体降低了其敏感性和 NPV。BJI Panel 具有较短的周转时间和精确的病原体检测,有可能作为一种补充诊断方法增加价值。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/aaf9/11519097/3a65c6e8b142/590_2024_4114_Fig1_HTML.jpg

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