Study on Nucleic Acid Detection Methods for Mycobacteria

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-jRCT1030260179

Enrollment

1000

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 presenting with suspected acid-fast bacilli infection who have residual or stored specimens such as sputum.

Exclusion criteria

Exclusion criteria: When a request to refuse secondary use is made for stored specimens originating from other studies When no residual specimens remain

Design outcomes

Primary

Measure	Time frame
Comparative evaluation of GENECUBE mycobacterial assays (M. tuberculosis complex, M. avium, M. intracellulare) versus smear, conventional genetic tests, and culture.	—

Secondary

Measure	Time frame
Sensitivity, reproducibility, and inter-strain variation assessment; compatibility with commercially available processing solutions; pretreatment methods and device conditions; cross-reactivity testing; performance evaluation in culture media; evaluation of reagents for detecting non-tuberculous mycobacteria and resistant bacteria; magLEAD optimization	—

Contacts

Public ContactAsako kaizu

University of Tsukuba Hospital

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

Outcome results