Validation study of a novel, rapid, open platform real-time LAMP assay for early diagnosis of pulmonary tuberculosis.

ABSTRACT: Current nucleic acid amplification techniques for the diagnosis of pulmonary tuberculosis (TB) lack the simplicity and affordability of achieving the goals envisioned in the WHO END-TB strategy, particularly for low- and middle-income countries (LMICs). Here we report a cost-effective real-time LAMP (rt-LAMP) assay with high sensitivity for the early diagnosis of pulmonary TB. A sample size of 350 was calculated using Buderer's formula. The assay was validated in the laboratory using mpt64 cloned gene targets and clinical patient samples. The lower limit of detection for the rt-LAMP assay was observed as 10 copies/µl. Out of 350 suspected TB patient samples, 47 were positive for MGIT culture (microbiological reference standard, MRS), 42 were positive for Xpert MTB/RIF and 41 were positive

SUBMITTER: Nair SS 

PROVIDER: S-EPMC11933381 | biostudies-literature | 2025 Mar

REPOSITORIES: biostudies-literature