Analytical and Clinical Evaluation of a Point-of-Care Rapid Molecular Detection System for the Influenza Virus
Not Applicable
Recruiting
- Conditions
- Respiratory Tract Infection/Influenza
- Registration Number
- JPRN-UMIN000035281
- Lead Sponsor
- Tsukuba Medical Center Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 300
Inclusion Criteria
Not provided
Exclusion Criteria
Patients are excluded if they are unable to communicate effectively in Japanese.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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