Evaluation of a micro/nanofluidic chip platform for diagnosis of central nervous system infections: a multi-center prospective study

Sci Rep. 2020 Jan 31;10(1):1568. doi: 10.1038/s41598-020-58670-8.

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.

Publication types

  • Multicenter Study
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Anti-Bacterial Agents / therapeutic use
  • Antifungal Agents / therapeutic use
  • Central Nervous System Bacterial Infections / cerebrospinal fluid
  • Central Nervous System Bacterial Infections / diagnosis
  • Central Nervous System Bacterial Infections / drug therapy
  • Central Nervous System Fungal Infections / cerebrospinal fluid
  • Central Nervous System Fungal Infections / diagnosis
  • Central Nervous System Fungal Infections / drug therapy
  • Central Nervous System Infections / cerebrospinal fluid
  • Central Nervous System Infections / diagnosis*
  • Central Nervous System Infections / drug therapy
  • China
  • Drug Resistance, Bacterial / genetics
  • Drug Resistance, Fungal / genetics
  • Humans
  • Lab-On-A-Chip Devices*
  • Limit of Detection
  • Microbial Sensitivity Tests
  • Prospective Studies
  • Reproducibility of Results
  • Sensitivity and Specificity

Substances

  • Anti-Bacterial Agents
  • Antifungal Agents