Setting: Patients infected with non-tuberculous mycobacteria usually fail treatment due to erroneous diagnoses. Early detection of mycobacterial species is essential for adequate case management.
Objective: To conduct a multicentre, prospective evaluation of the recently developed biochip test and to determine its sensitivity and specificity in three clinical hospitals in China.
Results: A total of 1565 clinical isolates obtained from three hospitals were identified as 19 mycobacterial species by 16S sequencing. The same 53 reference strains were detected in all three hospitals as quality control and to evaluate the reproducibility of the assay. The overall accuracy of the species identification assay among all strains was 99.9% (1722/1724). The two unidentified samples, belonging to Mycobacterium parascrofulaceum and M. monacense, were not included among the 17 mycobacterial species. The reference strains demonstrated that the reproducibility of the assay was 100%.
Conclusion: The biochip test provided cost-effective and highly sensitive identification of mycobacterial species in less than 6 h. This will help clinical staff carry out more efficient and personalized clinical treatment without delay.