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GLOBAL STUDY ON THE CLINICAL DETECTION PERFORMANCE AND USEFULNESS OF NOVEL CORONAVIRUS RAPID DIAGNOSIS KIT

GLOBAL STUDY ON THE CLINICAL DETECTION PERFORMANCE AND USEFULNESS OF NOVEL CORONAVIRUS RAPID DIAGNOSIS KIT - GLOBAL STUDY ON THE CLINICAL DETECTION PERFORMANCE AND USEFULNESS OF NOVEL CORONAVIRUS RAPID DIAGNOSIS KIT

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
JPRN
Registry ID
JPRN-UMIN000049018
Enrollment
600
Registered
2022-09-27
Start date
2021-01-31
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

SARS-CoV-2

Interventions

None listed

Sponsors

National Center for Global Health and Medicine
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: (1) For compliance on the ethical aspects of the study, only individuals who willingly and voluntarily participate are selected. In addition, the wide range of age population is sufficient to address the objectives of the study. (2) Based on the presumption that seven years old is the minimum age that can comprehend any explanation about the study (3) The Rapid Antigen Test in this study is designed to detect SARS-CoV-2 virus which can be useful in the diagnosis of the infection

Exclusion criteria

Exclusion criteria: (1) Swab specimens is difficult to collect from individuals who use illegal drugs due to a possible nasal mucosal injury. (2) Detection of virus may be difficult to collect if symptoms have elapsed 5 days from the onset (3) Any incompatible factors may affect the study

Design outcomes

Primary

MeasureTime frame
Primary endpoint: The agreement rate between the test results of RT-PCR test and the Rapid Antigen Test.

Secondary

MeasureTime frame
Secondary endpoint: The agreement rate between the Rapid Antigen Test and RT-PCR test in specimens collected at different times after onset and the agreement rate of test results in two different types of specimen.

Countries

Asia(except Japan)

Contacts

Public ContactMaria Ruriko Umano

National Center for Global Health and Medicine Department of International Trials

mumano@hosp.ncgm.go.jp03-6228-0445

Outcome results

None listed

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