Performance testing aimed at obtaining pharmaceutical approval for rapid diagnostic reagents for home medical care

Performance testing aimed at obtaining pharmaceutical approval for rapid diagnostic reagents for home medical care - Performance testing aimed at obtaining pharmaceutical approval by PMDA for rapid diagnostic reagents for home medical care

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT1031240595

Enrollment

Registered

2025-01-07

Start date

2025-01-07

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

Inflammatory diseases, myocardial infarction, thrombosis

Interventions

A small amount of blood is drawn from patients and healthy individuals.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: For the four test items of CRP, high-sensitivity CRP (inflammation), CKMB (myocardial infarction), and D-dimer (thrombosis), concentrations will be measured using a rapid test drug currently being developed by UMA using residual samples that have already been tested in the testing department, and the data will be compared with existing reagents.

Exclusion criteria

Exclusion criteria: Those who indicated their refusal to participate in the study through a disclosure document.

Design outcomes

Primary

Measure	Time frame
The remaining samples will be used to examine the correlation between the measurements taken during clinical testing and those taken using the test drug being developed by UMA, and to evaluate the performance of the test drug.	—

Contacts

Public ContactKazuyuki Matsushita

Chiba University Hospital

kmatsu@faculty.chiba-u.jp+81-43-222-7171

Outcome results

None listed

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