Error factors for point-of-care testing (POCT) instruments in measuring postmortem blood HbA1c levels

2022 Fiscal Year Final Research Report

• Project/Area Number: 20K07853
• Research Category: Grant-in-Aid for Scientific Research (C)
• Allocation Type: Multi-year Fund
• Section: 一般
• Review Section: Basic Section 52010:General internal medicine-related
• Research Institution: Fukushima Medical University
• Principal Investigator: Naho Kato 福島県立医科大学, 医学部, 助教 (20457766)
• Project Period (FY): 2020-04-01 – 2023-03-31
• Keywords: 死体血HbA1c値 / 臨床現場即時検査機器 / ボロン酸アフィニティ法 / 高速液体クロマトグラフィ法 / ラテックス凝集法 / 誤差要因

Outline of Final Research Achievements

In order to investigate error factors, trends, and the possibility of using a POCT (Point-of-Care Testing) device for HbA1c measurement with different measurement principles for the auxiliary diagnosis of diabetes in forensic autopsy cases, we compared the measured values of blood samples from forensic autopsy cases and various treated blood samples from various treated volunteers with those of an outsourced latex coagulation (LC) method.
The boronate affinity (BA) assay showed higher values in anemia and carbon monoxide (CO) intoxication samples, suggesting the influence of light wavelength. LC assay showed measurement errors in anemia and concentrated blood samples. The error values of BA and LC instrument measurement were eliminated by washing the samples. The cation-exchange high-performance liquid chromatography instrument showed a slightly high value regardless of blood condition and a high value in severe CO intoxication.

Free Research Field

法医学

Academic Significance and Societal Importance of the Research Achievements

HbA1cは死後変化が少なく長期保存後も比較的安定とされ，法医剖検例の糖尿病補助診断に利用されることも多い．糖尿病性昏睡は糖尿病合併症の中でも死因たりうる病態であり，生前診断されていない，または診断されていても血糖コントロールが不良であった可能性を知る手段として，POCT（臨床現場即時検査）機器の利用には意義がある．一方で，生体試料での検査目的に開発されたPOCT機器を法医取扱事例に利用する場合，検査結果の解釈には生体試料との差異を考慮する必要がある．本研究では測定原理の異なるPOCT機器による測定値の特徴や誤差要因を比較検討したことで，法医検体に適した機器や使用法を提案できた．