Diagnostic Accuracy of the GeneXpert MTB/RIF Ultra for Tuberculous Meningitis: A Systematic Review and Meta-Analysis

Abstract

Tuberculous meningitis (TBM) is the most severe form of extrapulmonary tuberculosis and remains difficult to diagnose because conventional methods are either insensitive or time-consuming. This study aimed to evaluate the diagnostic accuracy of GeneXpert MTB/RIF Ultra for TBM through a systematic review and meta-analysis. A literature search was conducted in PubMed, Scopus, ScienceDirect, and ProQuest, and eligible studies were assessed using the QUADAS-2 tool. Pooled estimates of sensitivity, specificity, diagnostic odds ratio (DOR), and summary receiver operating characteristic (SROC) curves were generated using Meta-DiSc 2.0. Thirteen studies met the inclusion criteria. Using culture as the reference standard, GeneXpert MTB/RIF Ultra demonstrated high pooled sensitivity (91.01%), specificity (78.66%), and an area under the curve (AUC) of 0.88. When evaluated against the Composite Reference Standard (CRS), pooled sensitivity decreased to 58.88%, whereas specificity remained excellent at 98.52%, with an AUC of 0.90. Publication bias analysis showed no significant evidence of bias for the culture-based studies. Overall, GeneXpert MTB/RIF Ultra demonstrated strong diagnostic performance and represents a rapid, highly specific diagnostic tool for TBM, supporting its clinical use, particularly in high TB-burden and resource-limited settings.