In spite of the development of diagnostic tests for Mycobacterium tuberculosis (M. tuberculosis), the etiological agent of tuberculosis, there has remained a gap
between the established methods and an easily accessible diagnostic
test, particularly in developing and resource-poor areas. By combining
isothermal amplification of IS6110 as the target gene and recognition
by DNA-functionalized Au nanoparticles (DNA-AuNPs), we develop a colorimetric
LAMP assay for convenient in vitro diagnostics of tuberculosis with
a quick (≤50 min) “yes” or “no”
readout. The DNA-AuNPs not only tolerate the interference in the complex
LAMP system but also afford in situ identification of the amplicon,
allowing for colloidal dispersion via steric effect depending on DNA
grafting density. The target-induced stabilization and red appearance
of the DNA-AuNPs contrast with the occurrence of gray aggregates in
a negative sample. Furthermore, the DNA-AuNPs demonstrate excellent
performance after long-term (≥7 months) storage while preserving
the unsacrificed sensitivity. The high specificity of the DNA-AuNPs
is further demonstrated in the naked-eye LAMP assay of M. tuberculosis in patients’ sputum samples.
Given the rapidity, cost-effectiveness, and instrument-free characteristics,
the naked-eye LAMP assay is particularly beneficial for tuberculosis
diagnosis in urgent situations and resource-limited settings and can
potentially expedite patient care and treatment initiation.