臨床研究等提出・公開システム

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)

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

52

The participants of this clinical research are the persons 16 years of age or older who are included in any of the following (1) to (4). In addition, the participant or the participant's representative must have received and fully understood the explanation by means of informed consent form and must have given his/her free and voluntary written consent to participate in this research. (1) Persons with suspected inflammation or infection (2) Persons with suspected acute myocardial infarction or cardiogenic shock (3) Persons with suspected thrombosis (4) Normal persons

1. Obtaining of informed consent Blood samples were collected from 61 participants including 52 patients and 9 normal persons after obtaining their informed consent in this research. 2. Measurement of blood samples Using serum, plasma, and whole blood samples collected from the 52 participants containing 43 patients and 9 normal persons, the concentrations of CRP, high-sensitive (hs)-CRP, CK-MB, and D-dimer in blood samples were measured using UMA's immunochromatography test-kits and certified reagents from other manufacturers. Blood samples from nine of the 61 patients who provided informed consent were not used because they exceeded the guideline that whole blood samples for the UMA test kit must be used within 3 hours of collection. 3. Performance evaluation of UMA test kit For each test item, we evaluated the measurement accuracy of UMA test kits by examining the correlation between the concentrations obtained using UMA test kits and those obtained using certified reagents from other manufacturers.

No applicable cases in this research

To determine whether the performance of UMA test kits complies with the approval criteria set by Pharmaceuticals and Medical Devices Agency (PMDA), we carried out the correlation tests between the UMA test kits and certified reagents from other manufacturers for CRP, hs-CRP, CK-MB, and D-dimer as follows: 1. Using more than 50 blood samples, the regression line and the correlation coefficient between the UMA test kits and other manufacturers' reagents were calculated by setting the measured values obtained using UMA test kit on the Y-axis and those obtained using other manufacturers' reagents on the X-axis. 2. To comply with the approval criteria, the correlation coefficient must be 0.9 or higher, the slope of the regression line must be within 0.9 to 1.1, and the Y-intercept of the regression line must not be far from 0.

The UMA CRP and hs-CRP test kits showed strong correlations with a certified reagent from one other manufacturer and the obtained data fully complied with the approval criteria. On the other hand, the CK-MB and D-dimer test kits demonstrated good correlations with two certified reagents from other manufacturers. However, both kits exhibited weak correlations for samples with concentrations lower than the cutoff values, indicating that the kits need to be improved before submission of approval to PMDA.

July. 01, 2025

No

https://jrct.mhlw.go.jp/latest-detail/jRCT1031240595

Matsushita Kazuyuki

Chiba University Hospital

1-8-1 Inohana, Chuo-ku, Chiba City

kmatsu@faculty.chiba-u.jp

Matsushita Kazuyuki

Chiba University Hospital

1-8-1 Inohana, Chuo-ku, Chiba City

+81-43-222-7171

kmatsu@faculty.chiba-u.jp

Complete

Jan. 07, 2025

Interventional

single arm study

open(masking not used)

uncontrolled control

single assignment

screening

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.

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

Both

Inflammatory diseases, myocardial infarction, thrombosis

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

D015212, D009203, D013927

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.

+81-43-222-7171

Dec. 16, 2024

none