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Diagn Microbiol Infect Dis ; 109(4): 116373, 2024 Aug.
Article in English | MEDLINE | ID: mdl-38815365

ABSTRACT

A real time-polymerase chain reaction-based test in lyophilized form, was developed to simultaneously identify Mycobacterium tuberculosis complex (MTC) by targeting IS6110, rrs as dual markers, as well as mutations causing rifampicin and isoniazid resistance. The test was evaluated for pulmonary and non-pulmonary specimens from sample isolation to PCR analysis. The test demonstrated limit of detection of 25 CFU/mL for MTB, 200 CFU/mL for rpoB and inhA/katG targets with >95 % CI. The specificity for MTC was supported by a comprehensive clinical validation (n = 100). This load-and-go molecular platform, with features of high throughput, long shelf-life, room temperature storage provides simultaneous detection of MTC and its drug-resistant mutations in minimal time. The test named "PathoDetect TM MTB-RIF and INH resistance detection kit" has been approved by Central Drugs Standard Control Organisation, Indian Council of Medical Research and would have implications for tuberculosis elimination programs.


Subject(s)
Antitubercular Agents , High-Throughput Screening Assays , Mycobacterium tuberculosis , Tuberculosis, Multidrug-Resistant , Humans , Mycobacterium tuberculosis/genetics , Mycobacterium tuberculosis/drug effects , Mycobacterium tuberculosis/isolation & purification , Tuberculosis, Multidrug-Resistant/diagnosis , Tuberculosis, Multidrug-Resistant/microbiology , High-Throughput Screening Assays/methods , Antitubercular Agents/pharmacology , Sensitivity and Specificity , Bacterial Proteins/genetics , Real-Time Polymerase Chain Reaction/methods , Isoniazid/pharmacology , Rifampin/pharmacology , Molecular Diagnostic Techniques/methods , Microbial Sensitivity Tests
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