Rapid and Accurate Detection of Major Mycobacterium Species in Pulmonary Infection Based on GenSeizer Platform

Shanghai Pulmonary Hospital, Shanghai, China

Status: Enrolling

Conditions: Mycobacterium Pulmonary Infection

Treatments: Diagnostic Test: Detection method

Study type: Observational

Funder types: Other

Identifiers

NCT04345939

L20-203Y

Details and patient eligibility

About

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

Full 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)

Enrollment: 400 estimated patients

Sex: All

Ages: 16 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Suspected cases of mycobacterial lung infection

Exclusion criteria

• No sputum
• Refused or unable to tolerate bronchoscopy

Trial design

400 participants in 3 patient groups

GenSeizer

Description:

Sputum and lavage fluids are tested for pathogens using GenSeizer

Treatment:

Diagnostic Test: Detection method

PCR reverse hybridization

Description:

Sputum and lavage fluids are tested for pathogens using PCR reverse hybridization

Treatment:

Diagnostic Test: Detection method

Target sequencing after incubation

Description:

Sputum and lavage fluids are tested for pathogens using Target sequencing after incubation

Treatment:

Diagnostic Test: Detection method