Analytical and Clinical Evaluation of a Point-of-Care Rapid Molecular Detection System for the Influenza Virus

Analytical and Clinical Evaluation of a Point-of-Care Rapid Molecular Detection System for the Influenza Virus - Utility of a Point-of-Care Rapid Molecular Detection System for the Influenza Virus

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000035281

Enrollment

300

Registered

2018-12-17

Start date

2017-12-18

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

Respiratory Tract Infection/Influenza

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients are included if all the following criteria are met: 1) Patients suspected with influenza 2) Patients who physicians consider eligible for an antigen test 3) Patients who provide written informed consent

Exclusion criteria

Exclusion criteria: Patients are excluded if they are unable to communicate effectively in Japanese.

Design outcomes

Primary

Measure	Time frame
Evaluation of the diagnostic performance of the cobas Liat system and the cobas Influenza A/B & RSV assay (Roche Diagnostics) for the diagnosis of influenza.	—

Secondary

Measure	Time frame
1) Evaluation of the sensitivity and specificity of antigen testing for the diagnosis of influenza 2) To clarify factors that influence the diagnostic performance (sensitivity and specificity) of influenza antigen testing 3) To examine the agreement between the clinical assessment of disease probabilities for influenza and the results of antigen testing or the cobas Liat system 4) To investigate the validity of decisions on work restrictions among health care workers suspected of having influenza 5) To investigate the pattern of anti-influenza drug prescriptions among patients suspected of having influenza	—

Measure

Time frame

1) Evaluation of the sensitivity and specificity of antigen testing for the diagnosis of influenza 2) To clarify factors that influence the diagnostic performance (sensitivity and specificity) of influenza antigen testing 3) To examine the agreement between the clinical assessment of disease probabilities for influenza and the results of antigen testing or the cobas Liat system 4) To investigate the validity of decisions on work restrictions among health care workers suspected of having influenza 5) To investigate the pattern of anti-influenza drug prescriptions among patients suspected of having influenza

—

Countries

Japan

Contacts

Public ContactIshikawa Hiroichi

Tsukuba Medical Center Hospital Department of Respiratory Medicine

hishikawa@tmch.or.jp029-851-3511

Outcome results