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Clinical Trial Summary

Comparison of rapid detection methods of mycobacterial pathogens, GenSeizer v.s. PCR reverse hybridization.


Clinical Trial Description

The investigators developed a new platform called GenSeizer, which combines bioinformatics analysis of a large dataset with multiplex PCR-based targeted gene sequencing, to identify eleven major Mycobacterium species implicated in human disease. Simultaneous detection of certain antibiotic resistance genotypes, i.e., erm(41) and rrl in M. abscessus, is also feasible. This platform detected both reference strains and clinical isolates with a high degree of specificity and sensitivity. In this study, the investigators plan to verify the detection efficiency of GenSeizer in clinical samples (sputum, alveolar lavage fluid) and compare it with existing methods on the market (PCR reverse hybridization) and gold standard method (target sequencing after incubation) ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04345939
Study type Observational
Source Shanghai Pulmonary Hospital, Shanghai, China
Contact
Status Recruiting
Phase
Start date June 28, 2021
Completion date August 30, 2024