Detection of Mycobacterial Pathogens in Clinical Specimens Using GENECUBE and Dedicated Detection Reagents

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-jRCT1030260178

Enrollment

500

Registered

2026-06-02

Start date

2026-06-02

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infectious diseases Infectious diseases

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients aged 18 years or older presenting with suspected acid-fast bacilli infections who have residual sputum specimens obtained during routine clinical care.

Exclusion criteria

Exclusion criteria: When the quantity of residual specimen is insufficient

Design outcomes

Primary

Measure	Time frame
Clinical performance evaluation of GENECUBE mycobacterial assays (M. tuberculosis, M. avium, M. intracellulare) and sputum pretreatment with Sputase versus existing methods.	—

Secondary

Measure	Time frame
Evaluation of basic performance and inter-strain variability including improved methods, compatibility with commercially available processing methods, comparison with conventional processing methods, and evaluation of reagents for M. abscessus, M. kansasii, resistance genes, NTM, M. tuberculosis, and BCG	—

Contacts

Public Contactaoi kimiyama

University of Tsukuba Hospital

tsukuba-idcenter@gwe.md.tsukuba.ac.jp+81-29-853-3682

Outcome results