Performance evaluation test of rapid diagnostic kit for testing RS virus and adenovirus infectio
Not Applicable
- Conditions
- respiratory syncytial virus (RSV) infection, adenovirus infection
- Registration Number
- JPRN-UMIN000037477
- Lead Sponsor
- Sekisui Medical Co., Ltd.
- Brief Summary
1) Control method: PCR Positive predictive value (sensitivity) RSV: 90.2~97.8% Adeno: 91.2~94.1% Negative concordance (specificity) RSV: 100% Adeno: 99.5~100% 2) Control method: Approved products Positive predictive value (sensitivity) RSV: 93.3~97.2% Adeno: 98.0~100% Negative concordance (specificity) RSV: 97.0~99.1% Adeno: 99.5
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 691
Inclusion Criteria
Not provided
Exclusion Criteria
1) Patients who are difficult to obtain clinical samples from. 2) For any reason other than above, patients who were determined by doctor as being unfit to participate in this study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Sensitivity, specificity and detection limit of rapid diagnostic test for RS virus and adenovirus infection
- Secondary Outcome Measures
Name Time Method