Zhang Yunjiao, Guo Qingxin, Chen Jinmei, Shen Hao, Fang Yuan, Zhang Yi, Han Pei, Chen Xiaohua
Department of Respiratory and Critical Care Medicine, Shanghai Sixth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai, 200233, People's Republic of China.
Department of Infectious Diseases, Shanghai Sixth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai, 200233, People's Republic of China.
Infect Drug Resist. 2025 Sep 11;18:4817-4826. doi: 10.2147/IDR.S523306. eCollection 2025.
While conventional culture-based diagnosis of bone and joint infections (BJI) requires prolonged incubation periods and metagenomic next-generation sequencing (mNGS) remains cost-prohibitive for routine clinical use, there is an urgent need for diagnostic strategies that balance timeliness with economic feasibility. This study investigates the clinical utility of a high-throughput (HT) gene chip array as a novel solution, offering significantly shorter turnaround time while maintaining cost-effectiveness than mNGS expenses.
Thirty-six patients of the BJI group (28 positives and 8 negatives diagnosed by clinician) and 20 patients of respiratory tract infection (RTI) group (14 positives and 6 negatives diagnosed by clinician) were included in this study. Synovial fluid and ultrasound fluid samples of BJI group and alveolar lavage fluid samples of RTI group were collected and subjected to microbiological analysis performed by HT gene chip array, metagenomic next-generation sequencing (mNGS) and conventional culture. Sensitivity, specificity, accuracy, positive predictive value (PPV) and negative predictive value (NPV) were calculated. Positive and negative percent agreement and Cohen`s kappa coefficient were calculated.
The sensitivity and accuracy of HT gene chip assay for BJI detection was 71.43% and 77.78%, respectively ( value <0.05). HT gene chip assay exhibited the 100% of specificity and PPV, which is significantly higher than those of mNGS (62.5%, 89.29%) and conventional culture (78.57% and 88.89%). Our results position HT gene chip assay as a clinically actionable solution for accurate and timely bone and joint infection management.
HT gene chip assay demonstrates superior diagnostic specificity and cost-effectiveness with rapid turnaround, significantly reducing unnecessary invasive procedures while maintaining high concordance with mNGS, and exhibited higher clinical value of BJI diagnosis compared with mNGS and conventional culture.
虽然基于传统培养的骨与关节感染（BJI）诊断需要较长的培养时间，且宏基因组下一代测序（mNGS）在常规临床应用中成本过高，但迫切需要一种能兼顾及时性和经济可行性的诊断策略。本研究调查了一种高通量（HT）基因芯片阵列作为一种新解决方案的临床实用性，它能提供比mNGS费用显著更短的周转时间，同时保持成本效益。
本研究纳入了36例BJI组患者（临床诊断28例阳性和8例阴性）和20例呼吸道感染（RTI）组患者（临床诊断14例阳性和6例阴性）。收集BJI组的滑液和超声引导穿刺液样本以及RTI组的肺泡灌洗液样本，通过HT基因芯片阵列、宏基因组下一代测序（mNGS）和传统培养进行微生物分析。计算敏感性、特异性、准确性、阳性预测值（PPV）和阴性预测值（NPV）。计算阳性和阴性百分比一致性以及科恩kappa系数。
HT基因芯片检测BJI的敏感性和准确性分别为71.43%和77.78%（ 值<0.05）。HT基因芯片检测的特异性和PPV均为100%，显著高于mNGS（62.5%，89.29%）和传统培养（78.57%和88.89%）。我们的结果表明，HT基因芯片检测是一种可用于临床的准确及时管理骨与关节感染的解决方案。
HT基因芯片检测具有卓越的诊断特异性和成本效益，周转迅速，在与mNGS保持高度一致性的同时，显著减少了不必要的侵入性操作，与mNGS和传统培养相比，在BJI诊断中具有更高的临床价值。
