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Post-marketing Clinical Study for SARS-CoV-2 Antigen Test Kit and SARS-CoV-2/Flu Nucleic Acid Test Kit

Post-marketing Clinical Study for SARS-CoV-2 Antigen Test Kit and SARS-CoV-2/Flu Nucleic Acid Test Kit - Post-marketing clinical study for SARS-CoV-2 detection kits

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
JPRN
Registry ID
JPRN-UMIN000049197
Enrollment
150
Registered
2022-10-24
Start date
2022-10-24
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COVID-19 and Influenza

Interventions

None listed

Sponsors

Hakujikai Healthcare Foundation, Hakujikai Memorial Hospital
Lead Sponsor
Ichikawa children&#39
Collaborator
s clinic
Collaborator

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Patients who fall under any of the following selection criteria 1 to 4, fulfill the following selection criterion 4 and do not fall under all of the exclusion criteria will be selected as study subjects 1 Patients who fulfill "Table 3-1: Prerequisites for Suspected Patients" in the MHLW Manual for Covid-19 Diagnosis and Treatment, ver. 8 2 Patient to whom a definite diagnosis of Covid-19 was made 3 Patient who is suspected of a respiratory infection caused by such other viruses including influenza virus than novel coronavirus. 4 Patient who is able to understand the explanation about this study and gives informed consent regarding the explanatory documents at his/her own will or at the will of his/her legal representative.

Exclusion criteria

Exclusion criteria: * Patients whose participation in this study is considered inappropriate by the physician involved * Patients who reject to participate in this study by themselves or through their legal representatives

Design outcomes

Primary

MeasureTime frame
Percent agreement between the study products and the control method

Secondary

MeasureTime frame
Percent agreement based on SARS-CoV-2 RNA copies per test

Countries

Japan

Contacts

Public ContactShusaku Tozaka

Nippon Becton Dickinson Co., Ltd. Medical affairs

shusaku_tozaka@bd.com08023377144

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026