Near-point-of-care diagnosis of tuberculosis with LyocartE MTB Assay: a multicentre diagnostic accuracy study

Abstract Background Tuberculosis (TB) continues to pose a major threat to global public health. The development of rapid near point-of-care diagnostics utilizing non-sputum specimens is critical for advancing TB control efforts. Methods In this multicentre prospective diagnostic accuracy study, 689 consecutive individuals with presumptive TB were enrolled from three sites in China. Sputum and tongue swab specimens were collected from all participants for index testing with the LyocartE assay and comparator testing with Xpert Ultra, smear microscopy, and culture. The diagnostic performance of LyocartE for active TB was evaluated against two pre-defined reference standards: Xpert Ultra results and the composite microbiological reference (MRS) standard. Results Among the 689 participants analyzed, LyocartE on sputum demonstrated a sensitivity of 95.2% and specificity of 98.6% against the MRS. For tongue swab specimens compared to sputum Xpert Ultra results, LyocartE sensitivity was 87.4% with a specificity of 99.7%. When evaluated against MRS for tongue swabs, sensitivity was 84.1% and specificity was 99.7%. The diagnostic accuracy of LyocartE remained robust across specimen types, clinical symptoms, and comorbidities. Strong correlation was observed between LyocartE and Xpert Ultra Ct values (sputum: r=0.7476, P<0.0001; tongue swab: r=0.5607, P<0.0001). Conclusion The near point-of-care LyocartE assay offers rapid and accurate TB detection from both sputum and tongue swab specimens. Its performance is comparable to Xpert Ultra on sputum and demonstrates improved sensitivity for tongue swab analysis. Further evaluation in asymptomatic and paucibacillary populations is urgently required to confirm these findings.