tuberculosis
Conditions
Interventions
Gold Standard:Using the final clinical diagnosis and/or microbiological confirmation as the gold standard: a case is classified as tuberculous meningitis (TBM) if any of the following are met—(i) a fi
(ii) a positive cerebrospinal fluid (CSF) Xpert MTB/RIF Ultra result
or (iii) a positive CSF culture for Mycobacterium tuberculosis complex (or a positive CSF acid-fast bacilli [AFB] smear).
Index test:Assay/Kit: Mycobacterium tuberculosis complex (MTBC) nucleic acid test kit (fluorescent real-time PCR) using a fully enclosed, integrated microfluidic cartridge—point-of-care testing (POCT)
performs pre-processing ? extraction ? amplification ? detection
total turnaround ˜30 minutes).
Key Pre-analytical Technology: Non-contact side-wall ultrasonic lysis to enhance lysis and nucleic-acid enrichment in low-bacillary-load CSF specimens.
Sponsors
Beijing Tuberculosis and Thoracic Tumor Research Institute
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age >=18 years; underwent lumbar puncture during hospitalization with an archived, intact cerebrospinal fluid (CSF) specimen available. 2. Presence of clinical features suggestive of tuberculous meningitis (TBM), such as fever, headache, altered consciousness, neck stiffness, or cranial nerve deficits. 3. Neuroimaging (cranial CT/MRI) showing supportive changes, e.g., intracranial inflammatory lesions, meningeal enhancement, or hydrocephalus. 4. A definitive clinical diagnostic outcome is available (diagnosed TBM, suspected TBM, or non-TBM) to serve as the reference for evaluation. 5. CSF specimen adequately preserved with complete accompanying information, suitable for nucleic acid testing/analysis.
Exclusion criteria
Exclusion criteria: 1. Received a full course of anti-tuberculosis therapy for latent or active TB within the 12 months prior to admission. 2. Received antibiotics with anti-mycobacterial activity or anti-TB drugs (e.g., rifampin/rifampicin, isoniazid) within 2 weeks before CSF collection, potentially affecting test results. 3. Pregnant or breastfeeding women, excluded due to special physiological considerations. 4. Patients with confirmed disseminated tuberculosis or extrapulmonary TB involving multiple organs with HIV co-infection, given the complexity of their clinical status and markedly different prognosis/immune state that could confound evaluation. 5. Missing or incomplete CSF specimens or related clinical data, insufficient for retrospective analysis. 6. Specimens deemed unacceptable by the investigators due to poor quality, contamination, or other conditions that do not meet testing requirements.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Sensitivity;Specificity;Kappa; | — |
Countries
China
Contacts
Public ContactPang Yu
Beijing Chest Hospital, Capital Medical University
Outcome results
None listed