Evaluation of clinical trial for the rapid detection kit of Respiratory Syncytial Virus
Not Applicable
Completed
- Conditions
- RSV infections
- Registration Number
- JPRN-UMIN000020312
- Lead Sponsor
- Eiken Chemical Co.,Ltd.
- Brief Summary
For the nasal swab specimens, positive, negative and total concordance rates of RT-PCR with the rapid detection kit ware 89.9%(71/79), 100.0%(131/131), 96.2%(202/210), respectively. For the nasopharyngeal aspirates, positive, negative and total concordance rates of RT-PCR with the rapid detection kit ware 93.9%(46/49), 97.6%(83/85), 96.3%(129/134), respectively.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 400
Inclusion Criteria
Not provided
Exclusion Criteria
1) Patients who have difficulty to collect Specimens 2) An investigator determines that a patient is unsuitable for this study
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Positive, negative and total concordance rate in comparison with the RT-PCR method
- Secondary Outcome Measures
Name Time Method