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Abstract：
Central nervous system infection (CNSI) is a significant type of infection that plagues the fields of neurology and neurosurgical science. Prompt and accurate diagnosis of CNSI is a major challenge in clinical and laboratory assessments; however, developing new methods may help improve diagnostic protocols. This study evaluated the second-generation micro/nanofluidic chip platform (MNCP-II), which overcomes the difficulties of diagnosing bacterial and fungal infections in the CNS. The MNCP-II is simple to operate, and can identify 44 genus or species targets and 35 genetic resistance determinants in 50 minutes. To evaluate the diagnostic accuracy of the second-generation micro/nanofluidic chip platform for CNSI in a multicenter study. The limit of detection (LOD) using the second-generation micro/nanofluidic chip platform was first determined using six different microbial standards. A total of 180 bacterium/fungi-containing cerebrospinal fluid (CSF) cultures and 26 CSF samples collected from CNSI patients with negative microbial cultures were evaluated using the MNCP-II platform for the identification of microorganism and determinants of genetic resistance. The results were compared to those obtained with conventional identification and antimicrobial susceptibility testing methods. The LOD of the various microbes tested with the MNCP-II was found to be in the range of 250-500 copies of DNA. For the 180 CSF microbe-positive cultures, the concordance rate between the platform and the conventional identification method was 90.00%; eight species attained 100% consistency. In the detection of 9 kinds of antibiotic resistance genes, including carbapenemases, ESBLs, aminoglycoside, vancomycin-related genes, and mecA, concordance rates with the conventional antimicrobial susceptibility testing methods exceeded 80.00%. For carbapenemases and ESBLs-related genes, both the sensitivity and positive predictive values of the platform tests were high (>90.0%) and could fully meet the requirements of clinical diagnosis. MNCP-II is a very effective molecular detection platform that can assist in the diagnosis of CNSI and can significantly improve diagnostic efficiency.
摘要：
中枢神经系统感染（CNSI）是一种重要的感染类型，困扰着神经病学和神经外科科学领域。在临床和实验室评估中，及时准确地诊断CNSI是一项重大挑战；然而，开发新的方法可能有助于改进诊断方案.本研究评估了第二代微/纳米流体芯片平台（MNCP-II），它克服了诊断CNS中细菌和真菌感染的困难。MNCP-II操作简单，并且可以在50分钟内鉴定出44个属或物种靶标和35个遗传抗性决定子。评价第二代微/纳米流控芯片平台在CNSI多中心研究中的诊断准确性。首先使用六种不同的微生物标准确定使用第二代微/纳米流体芯片平台的检测限（LOD）。使用MNCP-II平台评估了从微生物培养阴性的CNSI患者收集的总共180个含细菌/真菌的脑脊液（CSF）培养物和26个CSF样品，以鉴定微生物和遗传抗性决定因素。将结果与通过常规鉴定和抗菌敏感性测试方法获得的结果进行比较。发现用MNCP-II测试的各种微生物的LOD在DNA的250-500拷贝的范围内。对于180个CSF微生物阳性培养物，平台与常规鉴定方法的符合率为90.00%；8个物种达到100%的一致性。在9种抗生素抗性基因的检测中，包括碳青霉烯酶,ESBLs,氨基糖苷类,万古霉素相关基因，还有mecA,与常规抗菌药物敏感性试验方法的符合率超过80.00%。对于碳青霉烯酶和ESBLs相关基因，平台试验的敏感性和阳性预测值均较高(>90.0%),完全可以满足临床诊断的要求.MNCP-II是一个非常有效的分子检测平台，可以辅助CNSI的诊断，可以显着提高诊断效率。
