Evaluation of Xpert MTB/RIF Ultra, BD MAX MDR-TB and Anyplex MTB/NTM vs. MGIT/MALDI-TOF in mycobacterial diagnosis - 26/08/26

Abstract |
Purpose |
Early tuberculosis (TB) diagnosis is critical for overall health, enabling prompt treatment initiation and decreased mortality. This study is aimed at evaluating the respective performances of Xpert MTB/RIF Ultra, BD MAX MDR-TB and Anyplex MTB/NTM compared to microbiological methods of diagnosing mycobacteria.
Methods |
Respiratory specimens taken from a third-level hospital in Monterrey, Mexico between January 2025 and January 2026 were included. Samples were processed for mycobacteria identification by microbiological (Lowenstein-Jensen, MGIT culture, and MALDI-TOF mass spectrometry) and molecular methods (Xpert MTB/RIF Ultra, BD MAX MDR-TB, and Anyplex MTB/NTM). The diagnostic performance of each methodology was evaluated in terms of sensitivity and specificity, as well as degree of agreement between results.
Results |
During the study period, 131 samples were tested for microbiological culture and concomitantly processed by Anyplex ( n = 121, 92.4%), BD Max ( n = 82, 62.6%), and Xpert ( n = 41, 31.3%). The sensitivity, specificity, and concordance of each molecular method with regard to microbiological culture was 100%, 70.4%, and κ = 0.619 for Xpert; 97.1%, 83.7%, and κ = 0.728 for Anyplex; and 88.9%, 85.0% and κ = 0.730 for BD MAX. Comparison of Xpert, Anyplex, and BD MAX, including paired samples ( n = 41), showed high sensitivity (100%, 100%, and 92.9%), moderate specificity (70.4%, 81.5%, and 77.5%), and good concordance (κ =0.619, 0.750, and 0.650) with microbiological culture.
Conclusion |
All three molecular methods showed good concordance with the reference method for MTC detection. While Xpert had lower specificity than Anyplex and BD MAX, the three methodologies all showed good concordance with microbiological culture.
Le texte complet de cet article est disponible en PDF.Highlights |
• | The diagnostic performances of Xpert MTB/RIF Ultra, BD MAX MDR-TB, and Anyplex MTB/NTM were compared to those achieved by means of microbiological culture. |
• | The molecular platforms showed satisfactory concordance in detecting the M. tuberculosis complex. |
• | Anyplex MTB/NTM exhibited optimal clinical balance, offering high sensitivity (97.1%) and superior specificity (83.7%). |
• | Xpert Ultra showed optimal sensitivity (100%) but lower specificity (70.4%). |
• | No significant correlation was observed between the semi-quantitative bacterial loads reported by means of Xpert and Anyplex. |
Keywords : Tuberculosis, Molecular diagnostic, Sensitivity, Specificity, Concordance
Plan
Vol 56 - N° 6
Article 105335- août 2026 Retour au numéroBienvenue sur EM-consulte, la référence des professionnels de santé.
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