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

• Conditions: Mycobacterium Pulmonary Infection
• Interventions: Diagnostic Test: Detection method

• Registration Number: NCT04345939
• Lead Sponsor: Shanghai Pulmonary Hospital, Shanghai, China

Brief Summary

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

Detailed 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 Timeline

• Study First Submitted: 2020-04-10
• Study First Submitted QC: 2020-04-13
• Study First Posted: 2020-04-15
• Study Start: 2021-06-28
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-29
• Last Update Posted: 2021-10-06
• Primary Completion: 2024-08-30
• Study Completion: 2024-08-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

• Suspected cases of mycobacterial lung infection

Exclusion Criteria

• No sputum
• Refused or unable to tolerate bronchoscopy

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
PCR reverse hybridization	Detection method	Sputum and lavage fluids are tested for pathogens using PCR reverse hybridization
GenSeizer	Detection method	Sputum and lavage fluids are tested for pathogens using GenSeizer
Target sequencing after incubation	Detection method	Sputum and lavage fluids are tested for pathogens using Target sequencing after incubation

Primary Outcome Measures

Name	Time	Method
Detection accuracy	through study completion, an average of 3 years

Trial Locations

Locations (1)

Haiqing Chu; 🇨🇳 Shanghai, China