Mycoplasma pneumoniae Antigen Detection Kit Evaluation Study

Mycoplasma pneumoniae Antigen Detection Kit Evaluation Study - Mycoplasma pneumoniae Antigen Detection Kit Evaluation Study

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000017787

Enrollment

200

Registered

2015-07-01

Start date

2015-11-15

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

Mycoplasma peumoniae infection

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) A patient over 15 years old with respiratory infection symptom. 2) A patient or legally authorized representative must provide written informed consent.

Exclusion criteria

Exclusion criteria: 1) Specimens are not obtained from a patient. 2) A patient who had been enrolled this study. 3) An investigator determines that a patient is unsuitable for this study.

Design outcomes

Primary

Measure	Time frame
Analysis of a positive agreement rate (sensitivity), a negative agreement rate (specificity), and an overall agreement rate between Mycoplasma pneumoniae antigen detection kit and quantitative polymerase chain reaction (q-PCR).	—

Secondary

Measure	Time frame
Analysis of a positive agreement rate (sensitivity), a negative agreement rate (specificity), and an overall agreement rate between the following conventional test and q-PCR. LAMP Serological test	—

Countries

Japan

Contacts

Public ContactKoichi Izumikawa

Nagasaki University Graduate School of Biomedical Sciences Unit of Molecular Microbiology and Immunology Department of Infectious Disease

koizumik@nagasaki-u.ac.jp095-819-7731

Outcome results