Clinical Performance Testing Using the Fully Automated Genetic Testing Device GENECUBE and Respiratory Pathogen Genetic Detection Reagents in Respiratory Specimens

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-jRCT1030260181

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 respiratory infection who have new consented specimens or residual/stored specimens such as postnasal, nasopharyngeal, pharyngeal swabs, or sputum.

Exclusion criteria

Exclusion criteria: When consent is withdrawn When a request to refuse secondary use is made for stored specimens originating from other studies When no residual specimens remain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 performance evaluation of GENECUBE versus existing methods (e.g., LAMP) for M. pneumoniae detection in nasopharyngeal swabs.	—

Secondary

Measure	Time frame
Detection of M. pneumoniae variants and drug susceptibility; evaluation of B. pertussis, C. pneumoniae, C. psittaci, Legionella, Rickettsia, Coxiella; pretreatment, composition, device settings; sensitivity, reproducibility, stability; cross-reactivity; magLEAD optimization; simultaneous detection of respiratory pathogens and resistance genes.	—

Contacts

Public ContactAsako kaizu

University of Tsukuba Hospital

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

Outcome results