Feature
- Rapid test for identification of M.tuberculosis complex
Detecting MPB 64 protein, specifically produced by M.tuberculosis complex - Extremely high specificity to M.tuberculosis complex
Equivalent accuracy to the nucleic-acid probe - Fast test results with one-step operation
Reading time is 15 min. No special equipment required - <Need Culture> Both liquid mediums and solid mediums can be used as samples
For solid mediums, Capilia TB-Neo Extraction Buffer (sold separately) is required
Setting: The ability to rapidly distinguish between Mycobacterium tuberculosis complex (MTC) and non-tuberculous mycobacteria (NTM) is critical in clinical practice.
Objective: To evaluate the usefulness of an immunochromatographic (IC) to distinguish between MTC and NTM.
Design: We analyzed a panel of 145 cultures from 128 patients. The routine molecular identification approaches, such as the AccuProbe Mycobacterium tuberculosis complex culture identification test and GenoType Mycobacterium s, were used as reference methods.
Results: Of the 101 positive cultures, 98 were correctly identified using the Capilia TB-Neo. Of the three discordant isolates, one was identified as M. bovis bacille Calmette-Guérin (BCG) and two as M. tuberculosis. Although we have not performed the sequencing of these strains, some false-negative results have been described due to mutations in the mpb64 gene or with some M. Bovis BCG strains. We did not observe false-positive results or any cross-reaction with 22 NTM strains, 12 non-mycobacterial micro-organisms, and 10 negative cultures.
Conclusion: We report good overall performance (sensitivity 97%, specificity 100%, positive predictive value 100%, and negative predictive value 96%) of this rapid that is easy to perform and interpret and does not require sample preparation, trained technicians, or expensive equipment.