Unique ID issued by UMIN | UMIN000020312 |
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Receipt number | R000023447 |
Scientific Title | Evaluation of clinical trial for the rapid detection kit of Respiratory Syncytial Virus |
Date of disclosure of the study information | 2015/12/22 |
Last modified on | 2015/12/24 15:35:45 |
Evaluation of clinical trial for the rapid detection kit of Respiratory Syncytial Virus
Evaluation of clinical trial for the rapid detection kit of RSV
Evaluation of clinical trial for the rapid detection kit of Respiratory Syncytial Virus
Evaluation of clinical trial for the rapid detection kit of RSV
Japan |
RSV infections
Infectious disease | Pediatrics |
Others
NO
Evaluation of the rapid detection kit based on an immunochromatographic assay for detection of RSV
Efficacy
Confirmatory
Pragmatic
Not applicable
Positive, negative and total concordance rate in comparison with the RT-PCR method
Observational
Not applicable |
Not applicable |
Male and Female
Patients who come to the institutions and are applicable to the following items
1) Patients who have lower respiratory tract inflammation with suspicion of RSV
2) Patients who have agreed with the participation to this clinical trial
1) Patients who have difficulty to collect Specimens
2) An investigator determines that a patient is unsuitable for this study
400
1st name | |
Middle name | |
Last name | Akira Kimura |
Eiken Chemical Co.,Ltd.
Biochemical Research Laboratory-I
143 Nogi, Nogi-machi, Shimotsuga-gun, Tochigi, 329-0114 Japan
0280-57-0715
Akira_Kimura@eiken.co.jp
1st name | |
Middle name | |
Last name | Atsuko Shinozaki |
Eiken Chemical Co.,Ltd.
Biochemical Research Laboratory-I
143 Nogi, Nogi-machi, Shimotsuga-gun, Tochigi, 329-0114 Japan
0280-57-0715
Atsuko_Shinozaki@eiken.co.jp
Eiken Chemical Co.,Ltd.
Eiken Chemical Co.,Ltd.
Profit organization
Wakaba Children's Clinic, Saiwai Pediatric Clinic, Yui Clinic
NO
外房こどもクリニック(千葉県),若葉こどもクリニック(埼玉県),
さいわいこどもクリニック(東京都),ゆいクリニック(神奈川県)
2015 | Year | 12 | Month | 22 | Day |
Published
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.
Completed
2013 | Year | 09 | Month | 01 | Day |
2013 | Year | 09 | Month | 01 | Day |
2013 | Year | 12 | Month | 31 | Day |
2014 | Year | 01 | Month | 31 | Day |
2014 | Year | 01 | Month | 31 | Day |
2014 | Year | 03 | Month | 31 | Day |
After informed consent was obtained, the nasal swab specimens and the nasopharyngeal aspirates were collected from patients who come to the institutions from September to December 2013 and have lower respiratory tract inflammation with suspicion of RSV.
2015 | Year | 12 | Month | 22 | Day |
2015 | Year | 12 | Month | 24 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023447
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