Conducting research aimed at validating the rapid development of standardized quality control regents for utilization in pathogen nucleic acid testing

2023 Fiscal Year Final Research Report

• Project/Area Number: 21K08497
• Research Category: Grant-in-Aid for Scientific Research (C)
• Allocation Type: Multi-year Fund
• Section: 一般
• Review Section: Basic Section 54030:Infectious disease medicine-related
• Research Institution: Toho University
• Principal Investigator: Ishii Yoshikazu 東邦大学, 医学部, 教授 (90246695)
• Co-Investigator(Kenkyū-buntansha): 舘田 一博 東邦大学, 医学部, 教授 (20236558)
• Project Period (FY): 2021-04-01 – 2024-03-31
• Keywords: 病原体核酸検査 / 精度管理 / レンチウイルス / SARS -CoV-2 / RT-qPCR

Outline of Final Research Achievements

This study established a rapid and inexpensive method for producing full-process control reagents for standardization and accuracy management of emerging infectious disease testing, using the novel coronavirus nucleic acid test as a model. Recombinant lentivirus samples with assigned international units, based on reference materials purchased from NIBSC, were produced. These samples remained stable at 4°C for 7 days even after freeze-thawing, and no issues were encountered during refrigerated transport in external proficiency testing. Full-process controls with assigned international units based on reference materials are expected to be utilized as secondary reference materials for international standardization, accuracy management, and validation during equipment implementation.

Free Research Field

臨床微生物学

Academic Significance and Societal Importance of the Research Achievements

新型コロナウイルス感染症のような新興感染症にかかる核酸検査は、標的塩基配列が明らかになっていれば、プライマーおよびプローブを迅速に作成して検査系を迅速に構築することが可能である。しかし、その検査の国際標準化や精度管理、検査機器や試薬の妥当性確認において、国際単位を付した安定で安全な試料を容易に入手する必要があり、タイムリーな対応をすることが困難であった。本研究で確立した手法を用いれば、将来の新興感染症の核酸検査の国際標準化と精度管理、および妥当性確認に対して迅速な対応が可能になると考えられる。