Tuberculosis (TB) remains a relevant infectious disease in the 21st century, and its extermination is still far from being attained. Due to the extreme infectivity of incipient TB patients, a rapid sensing system for proficient point-of-care (POC) diagnostics is required. In our study, a plastic-chip-based magnetophoretic immunoassay (pcMPI) is introduced using magnetic and gold nanoparticles (NPs) modified with Mycobacterium tuberculosis (MTB) antibodies. This pcMPI offers an ultrasensitive limit of detection (LOD) of 1.8 pg·ml(-1) for the detection of CFP-10, an MTB-secreted antigen, as a potential TB biomarker with high specificity. In addition, by combining the plastic chip with an automated spectrophotometer setup, advantages include ease of operation, rapid time to results (1 h), and cost-effectiveness. Furthermore, the pcMPI results using clinical sputum culture filtrate samples are competitively compared with and integrated with clinical data collected from conventional tools such as the acid-fast bacilli (AFB) test, mycobacteria growth indicator tube (MGIT), polymerase chain reaction (PCR), and physiological results. CFP-10 concentrations were consistently higher in patients diagnosed with MTB infection than those seen in patients infected with nontuberculosis mycobacteria (NTM) (P < 0.05), and this novel test can distinguish MTB and NTM while MGIT cannot. All these results indicate that this pcMPI has the potential to become a new commercial TB diagnostic POC platform in view of its sensitivity, portability, and affordability.
Keywords: CFP-10; Mycobacterium tuberculosis (MTB); magnetophoretic immunoassay (MPI); mycobacteria growth indicator tube (MGIT); plastic chip; tuberculosis (TB).