Unique ID issued by UMIN | UMIN000049900 |
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Receipt number | R000056834 |
Scientific Title | Prospective observational study on GeneSoC test accuracy and dedicated reagents for sexually transmitted infections |
Date of disclosure of the study information | 2022/12/26 |
Last modified on | 2023/06/27 12:42:48 |
Prospective observational study on GeneSoC test accuracy and dedicated reagents for sexually transmitted infections
Observational study on GeneSoC for sexually transmitted infections
Prospective observational study on GeneSoC test accuracy and dedicated reagents for sexually transmitted infections
Observational study on GeneSoC for sexually transmitted infections
Japan |
urethritis and cervicitis
Infectious disease |
Others
NO
Clinical specimens and DNA-preserved samples collected from patients with suspected chlamydia or gonorrhoea infection will be measured with GeneSoC and test reagents, and their performance will be evaluated by comparing the results with those determined by existing test methods.
Efficacy
Evaluate the percentage of agreement between the results of each method.
Observational
20 | years-old | <= |
Not applicable |
Male and Female
Patients with suspected chlamydial or gonococcal infection
Patients who can provide a specimen of primary urine, urethral discharge, cervical abruption, pharyngeal abruption, or gargle
Patients who can provide written consent to participate in this study
Patients who did not give consent to participate in this study
40
1st name | Satoshi |
Middle name | |
Last name | Takahashi |
Sapporo Medical University School of Medicine
Department of Infection Control & Laboratory Medicine
060-8543
S1 W16,Chuo-ku,Sapporo, Hokkaido
011-611-2111
stakahas@sapmed.ac.jp
1st name | Mitsuru |
Middle name | |
Last name | Yasuda |
Sapporo Medical University School of Medicine
Department of Infection Control & Laboratory Medicine
060-8543
S1 W16,Chuo-ku,Sapporo, Hokkaido
011-611-2111
yasuda7jpe@sapmed.ac.jp
Sapporo Medical University School of Medicine
KYORIN Pharmaceutical Co., Ltd
Other
Sapporo Medical University School of Medicine
S1 W17,Chuo-ku,Sapporo, Hokkaido
011-611-2111
ji-rskk@sapmed.ac.jp
NO
2022 | Year | 12 | Month | 26 | Day |
Unpublished
40
Completed
2021 | Year | 09 | Month | 24 | Day |
2021 | Year | 11 | Month | 11 | Day |
2021 | Year | 11 | Month | 11 | Day |
2023 | Year | 03 | Month | 31 | Day |
2023 | Year | 03 | Month | 31 | Day |
A 2 x 2 contingency table is created from the results of the GeneSoC and test reagent measurements and the respective control test results, and the overall agreement, positive agreement, negative agreement, positive predictive value, and negative predictive value are calculated.
2022 | Year | 12 | Month | 26 | Day |
2023 | Year | 06 | Month | 27 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000056834
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