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.
Highlights
Central nervous system infection (CNSI) is a significant type of infection that plagues the fields of neurology and neurosurgical science
Rapid diagnosis of CNSI caused by bacteria and fungi is a crucial challenge in the fields of neurology and neurosurgery
The literature reports that the incidence of post-neurosurgical CNSI is as high as 0.3%–25%19, and the proportion of spontaneous CNSI-related meningitis is high, which can lead to serious health consequences and a significant increase in patient mortality[20]
Summary
Central nervous system infection (CNSI) is a significant type of infection that plagues the fields of neurology and neurosurgical science. There are currently several prompt and accurate diagnostic methods for CNSI in the clinical laboratory, such as multiplex PCR, high-throughput sequencing, Matrix-Assisted Laser Desorption/Ionization Time-of-Flight Mass Spectrometry (MALDI-TOF MS), microfluidic chip platform (MNCP), etc. Most of these approaches have shortcomings; multiplex PCR is limited due to high rates of false positives in the detection procedure[7], and high-throughput sequencing is expensive and may produce high rates of false positives, which limits its clinical application[8]. In contrast with conventional identification and AST methods that may take up to 48 hours to obtain results, MNCP detection of microbial identification and antibiotic resistance genes can be achieved in 50 minutes, greatly improving the diagnosis efficiency of patients with CNSI and saving patient costs. With the MNCP-II, more parameters can be obtained, which increases the extensiveness of clinical application significantly
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