Bilateral SERS‐Microneedle Patch for Co‐Diagnosis of Diabetes Mellitus and Tuberculosis Comorbidity

ABSTRACT The prevalence of diabetes mellitus (DM) and tuberculosis (TB) comorbidity is constantly rising worldwide, thus there is an urgent need for a co‐diagnostic method of TB‐DM in the clinic. Here, we introduced a bilateral surface‐enhanced Raman scattering (SERS)‐microneedle (MN) patch that incorporated Au hybrid mesoporous polydopamine‐coated urchin Au/Ag (U@mP@Au) for analyzing glucose in interstitial fluid (ISF) and TB biomarker (ESAT‐6/CFP‐10) in sputum toward the co‐detection of TB‐DM comorbidity. The feasibility of the bilateral SERS‐MN patch was demonstrated in ex vivo artificial skin, in vivo mouse models, and trials of recruiting patients. In the clinical assessment, DM patients ( N = 18 ) and healthy subjects ( N = 3 ) were classified with satisfactory sensitivity (88.9%) and specificity (100%), among which one DM positive sample (P11) with TB infection was successfully identified. Results revealed the sensitivity (87.5%) and specificity (90.9%) of SERS‐MN array for TB diagnosis (N = 33 ), which were comparable to traditional clinical methods (smear, TST, and Xpert). More importantly, three TB‐positive patients (P9, P15, and P20) showed abnormally elevated glucose levels, which is highly suggestive of TB‐DM complication. This integrated dual‐analyte detecting platform represented a significant step toward the cooperative diagnosis of TB‐DM comorbidity, facilitating the early detection of complications by clinicians.