Graduate Program in Bioclinical Sciences, Chulabhorn International College of Medicine, Thammasat University, Pathum Thani, Thailand.
Department of Medicine, Faculty of Medicine, Thammasat University, Pathum Thani, Thailand.
PLoS One. 2023 Jun 29;18(6):e0276949. doi: 10.1371/journal.pone.0276949. eCollection 2023.
Monitoring the level of glycated hemoglobin (HbA1c) has become the gold standard measure for diabetes mellitus (DM) diagnosis and control, used in conjunction with fasting blood glucose (FBG) and oral glucose tolerance test. This study aimed to investigate the applicability of a newly developed nanoparticle-based electrochemical sensor-multiwalled nanotubes incorporated with gold nanoparticles (POCT-HbA1cMWCNTs/AuNPs)-used as a routine point-of-care test (POCT) for detection of HbA1c for the diagnosis of DM. Finger-prick and venous blood samples were collected from 108 DM and 98 non-DM subjects to determine HbA1c and total hemoglobin by POCT-HbA1cMWCNTs/AuNPs compared with the standard HPLC method. The performance of the POCT-HbA1cMWCNTs/AuNPs was evaluated using the standard cut-off HbA1c level of >6.5%. The test's sensitivity, specificity, positive predictive value, and negative predictive value were 100.00%, 90.32%, 87.23%, and 100.00%, respectively. The probability of DM diagnosis in a subject with HbA1c >6.5% (positive predictive value) was 87.23% (82/94). The accuracy of the POCT-HbA1cMWCNTs/AuNPs was 94.18%, with a %DMV (deviation from the mean value) of 0.25%. The results indicate satisfactory assay performance and applicability of the POCT-HbA1cMWCNTs/AuNPs for diagnosis of DM using the cut-off criteria of HbA1c >6.5.
监测糖化血红蛋白（HbA1c）水平已成为糖尿病（DM）诊断和控制的金标准，与空腹血糖（FBG）和口服葡萄糖耐量试验一起使用。本研究旨在探讨一种新开发的基于纳米粒子的电化学传感器-多壁碳纳米管与金纳米粒子（POCT-HbA1cMWCNTs/AuNPs）的适用性，作为一种常规的即时检测（POCT）用于检测 HbA1c 以诊断 DM。从 108 例 DM 和 98 例非 DM 受试者中采集指尖和静脉血样，通过 POCT-HbA1cMWCNTs/AuNPs 与标准 HPLC 方法测定 HbA1c 和总血红蛋白。使用标准的 HbA1c 切点 >6.5%评估 POCT-HbA1cMWCNTs/AuNPs 的性能。该测试的灵敏度、特异性、阳性预测值和阴性预测值分别为 100.00%、90.32%、87.23%和 100.00%。HbA1c >6.5%（阳性预测值）受试者 DM 诊断的可能性为 87.23%（82/94）。POCT-HbA1cMWCNTs/AuNPs 的准确率为 94.18%，%DMV（均值偏差）为 0.25%。结果表明，该 POCT-HbA1cMWCNTs/AuNPs 具有令人满意的分析性能和适用性，可用于根据 HbA1c >6.5%的切点标准诊断 DM。
