TALANTA
·
2013
·
IF 3.498
Si Li,Chen-Gang Guo,Lu Chen,Xiao-Yang Yin,Yi-Xin Wu,Liu-Yin Fan,Hui-Zhi Fan,Cheng-Xi Cao
Hemoglobin A 1c (HbA 1c ) has been proven to be a key biomarker for diabetes screening, and glutathiolation of HbA 1c (viz., GSS-HbA 1c ) has been identified. However, the impact of GSS-HbA 1c on the measurement of HbA 1c for diabetes screening has not been quantitatively assessed yet. To address the issue, the micropreparative capillary isoelectric focusing (cIEF) developed in our previous work was used for the high resolution separation and purification of hemoglobin (Hb) species. The main fractions of HbA 0 , HbA 3 and HbA 1c extracted from the developed cIEF were identified by validated Mono S method. The proposed GSS-HbA 1c fractions in the cIEF were pooled and identified by electrospray ionization mass spectrometry (ESI-MS). The HbA 1c enzyme-linked immunosorbent assay (ELISA) kit was employed for further quantitative analysis of GSS-HbA 1c . A total of 34 blood samples with HbA 1c levels from 4.2% to 13.4% were assessed via the above comprehensive strategy of IEF-HPLC-MS-ELISA. It was demonstrated that the HbA 1c levels detected by cation exchange LC were considerably influenced by the glutathiolation of Hb and the range of detected GSS-HbA 1c values was between 0.23% and 0.74%. The results and developed cIEF methods have considerable significances for investigation of diabetes and clinical diagnosis.
研究领域:
医学诊断
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生物化学
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DOI
PubMed
高影响因子
SENSORS AND ACTUATORS B-CHEMICAL
·
2018
·
IF 5.667
Chen Guang Zhang,Shwu Jen Chang,Kalpana Settu,Ching Jung Chen,Jen Tsai Liu
Diabetes mellitus is one of the most common noncommunicable diseases in the world. Fasting blood glucose level is one of the diabetes diagnostic criteria, but it is readily affected by stress, exercise and many other factors. Glycated hemoglobin (HbA1c) is an important clinical index for diabetes and related diseases. In this study, a cheaper, rapid-prototyping, high-sensitivity angle-scanning surface plasmon resonance (SPR) was developed by fused deposition modeling (FDM) 3D printing technology for HbA1c detection. The sensor chip is based on an aptamer that has high affinity and high specificity to HbA1c. The results showed that this HbA1c-specific aptamer had high specificity for HbA1c, and the calculated K D was 6.13 × 10 −8 M. The linear detection response of HbA1c appeared in the range of 18–147 nM, with a detection limit of 1 nM. This SPR HbA1c detection system could be a promising platform for developing clinical point-of-care diagnostic applications.
研究领域:
生物医学工程
·
糖尿病研究
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DOI
高影响因子
MICROCHEMICAL JOURNAL
·
2025
·
IF 5.1
Haohan Zhang,Mingyang Wang,Yuxuan Jiang,Zhonghuang Yang,Xin Liu,Mingjun Liu,Wanjian Liu,Aihua Liu
Diabetes mellitus is a global non-communicable disease. Glycated hemoglobin (HbA1c) is the gold standard for assessing long-term blood sugar levels, which is consistent with the average blood sugar concentration and can reflect the patient’s blood sugar control for 2–3 months. The detection of HbA1c is essential for the diagnosis of diabetes and the risk assessment of complications. Traditional HbA1c detection methods have limitations such as significant performance differences, complex technology and high cost. Herein we screened HbA1c-specific peptide by 3 rounds of negative biopanning against hemoglobin and four rounds of conventional panning against HbA1c, by which a specific peptide probe W10 (amino acid sequence: DLRKAGKKRTTS) with high affinity for HbA1c was explored. Then we constructed a label-free electrochemical impedance spectroscopy immunosensor using the W10-displayed phage as biorecognition probe. Under the optimized conditions, the sensor had a linear range of 1–1000 pg/mL and a detection limit of 0.32 pg/mL HbA1c (S/N = 3). The as-proposed sensor demonstrated selectivity against Hb and other blood components and good long-term stability. Clinical validation with 20 human blood samples showed < 7.1 % deviation from HPLC results, enabling direct HbA1c quantification without enzymatic pretreatment. Thus this work establishes a novel, cost-effective platform for diabetes monitoring, which have potential applications in resource-limited settings. This study shows that sensors based on peptide-displaying phages are expected to have potential applications in bioassay for diagnosis and therapy.
研究领域:
医学诊断
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生物技术
·
分析化学
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DOI
高影响因子
BIOMEDICAL CHROMATOGRAPHY
·
2026
·Vol. 40
·期 3
·e70382
·
IF 1.7
Linghao Zhao,Wei Yang,Shengjin Cui,Jingang Luo,Yaxin Cao,Nan Yan,Hongying Wang
Interference is a significant source of laboratory errors that can cause erroneous measurement results. In clinical practice, all the measured results should exclude the influence of interference. In this study, the ion exchange high-performance liquid chromatography of hemoglobin A1c (HbA1c) was evaluated via three brands of HbA1c analyzers, and 12 endogenous and 24 exogenous substances were added to hemoglobin solutions with different HbA1c levels to simulate the corresponding clinical samples. After the potential interfering substances were screened via interference screening testing, the interference concentration thresholds of each potential interfering substance were determined on the basis of dose–response experiment. When these substances exceed the interference concentration thresholds, elevated HbA1c values are caused by endogenous cholic acid and low pH, whereas exogenous ethanol increases HbA1c measurements in samples with low values. However, HbA1c measurements decreased in samples with high values. Although there are some differences in the thresholds of interferent concentrations between different brands of analyzers, the differences are not significant. On the basis of the detailed interference concentration thresholds and interference substances, this evidence can be provided to clinical laboratory experts and help them interpret and determine the testing results of clinical laboratories.
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PubMed
高影响因子
BIOMEDICAL CHROMATOGRAPHY
·
2025
·Vol. 39
·期 10
·e70136
·
IF 1.7
Yiyao Zhang,Guangyun Zhang,Fen Yang,Zhikang Zou
Hemoglobin A 1c (HbA 1c ) plays a role in the diagnosis and assessment of glycemic control in patients with diabetes. However, few studies have focused on the preparation methods and analytical performance evaluation of different formulations of mobile-phase buffers for HbA 1c assays. In this study, mobile-phase buffers of new formulations were prepared for the measurement of HbA 1c . Following the Clinical and Laboratory Standards Institute (CLSI) guidelines, the analytical performance of newly developed mobile-phase buffers was evaluated. The CVs of the intra- and inter-assay precision were less than 0.94%, the RDs of accuracy were less than ± 3.00%, and the carryover was 0.00%. The measured HbA 1c values were linear from 4.50% to 16.80% (26.00–160.00 mmol/mol). A comparison of newly developed and commercial mobile-phase buffers revealed that the Pearson regression equation was Y = 0.9862 x + 0.0888 ( R 2 = 0.9990), and the Bland–Altman mean difference between the two mobile-phase buffers was −0.02833% (95% CI: −0.1853% to 0.1278%). The chromatography column had a lifetime of over 7000 tests. The reference interval was 4.30%–6.30% (23.00–45.00 mmol/mol). Stability was acceptable within 24 months. The newly developed mobile-phase buffers demonstrated good analytical performance (i.e., precision, linearity, accuracy, carryover, reference interval, the number of chromatography column runs, and stability).
研究领域:
临床化学
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糖尿病诊断
·
分析方法验证
·
色谱分析
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DOI
PubMed
高影响因子
ANALYTICAL SCIENCES
·
2018
·
IF 1.355
Chaoman Ang,Doudou Lou,Linling Hu,Wei Chen,Yefei Zhu,Zhirui Guo,Ning Gu,Yu Zhang
In this research, we developed a rapid and easy-to-operate point-of-care testing (POCT) strip based on fluorescent affinity immunochromatography to quantitatively determine HbA1c concentrations in whole blood. This assay, based on a sandwich method performed on test strips, effectively utilized the principle of an affinity chromatography column, which was commonly used in the detection of HbA1c, and the technology of traditional fluorescence immunochromatographic test strips (FICTS) were combined. In our test strips, the test line of traditional FICTS was transformed into the region of affinity chromatography, while improving the linearity and reducing the interference of the precursor of HbA1c and hemoglobin variants. The test strips could quantitatively detect HbA1c over a wide range (3–13.8%) with excellent linearity ( R 2 > 0.99), and the assay accuracy was demonstrated by comparing with high-performance liquid chromatography (HPLC) ( R 2 > 0.95). The simple, rapid, effective and quantitative strips will provide a novel method for the detection of HbA1c in clinical diagnosis.
研究领域:
医学诊断
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分析化学
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生物技术
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DOI
PubMed
高影响因子
MICROCHIMICA ACTA
·
2026
·Vol. 193
·期 3
·144
·
IF 5.4
Su Yang,Cao Huiting,Xia Chengen,Gan Wei,Zhang He,Zhang Guoqi,Li Dapeng
A multi-aptamer, machine-learning–assisted sensor array is presented that integrates polyadenine (poly-A)–oriented aptamer functionalization with salt-stable, gold nanoparticles (AuNPs) colorimetry. Poly-A anchoring enables controlled aptamer orientation and improved colloidal stability under high ionic strength, allowing sensitive aggregation-based detection. Despite the inability of individual aptamers to discriminate glycated hemoglobin (HbA1c) from total hemoglobin (tHb), their combined multichannel responses provide distinct optical patterns that machine learning resolves into non-overlapping clusters. The platform successfully differentiated between clinical samples from diabetic and healthy individuals. This work establishes a generalizable strategy, interface engineering coupled with supervised pattern recognition, for resolving highly similar proteins and developing practical, low-cost point-of-care (POC) diagnostic tools.
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PubMed
高影响因子
SENSORS AND ACTUATORS B-CHEMICAL
·
2020
·
IF 7.1
Pei Zhang,Yao Zhang,Xin Xiong,Yao Lu,Nengqin Jia
A sensitive electrochemiluminescence (ECL) immunosensor was successfully fabricated utilizing Ru(bpy) 3 2+ -doped mesoporous polydopamine (MPDA) for subtle exploration of the diabetes biomarker glycosylated hemoglobin (HbA1c). In this protocol, with the advantages of relatively large specific surface area and good biocompatibility, MPDA nanoparticles are capable of loading more Ru(bpy) 3 2+ to greatly amplify the ECL efficiency during the existence of trinpropylamine (TPA) as common coreactant. The acquired Ru(bpy) 3 2+ @MPDA nanoparticles are used as a beneficial substrate for immobilizing aptamer, thereby specifically recognizing the targeting substance HbA1c as much as possible with high selectivity. It could be noted from the experimental results that the ECL intensity was evidently reduced as the proposed Ru(bpy) 3 2+ @MPDA ECL immunosensor captured HbA1c, which showed the principle of the ECL quenching determination. Under optimal experimental conditions, the prepared Ru(bpy) 3 2+ @MPDA ECL immunosensor exhibited wide linear range from 0.1% to 18.5% with the low detection limit (LOD) of 0.015% (S/N = 3) and the correlation coefficient (R 2 ) of 0.994. Moreover, the Ru(bpy) 3 2+ @MPDA immunosensor displayed high sensitivity and selectivity for detecting HbA1c. Therefore, the as-obtained Ru(bpy) 3 2+ @MPDA ECL immunosensor will open up a new promising platform for highly sensitive bioassay of HbA1c.
研究领域:
生物医学工程
·
分析化学
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DOI
高影响因子
ANALYTICAL AND BIOANALYTICAL CHEMISTRY
·
2025
·
IF 3.8
Wang Hongying,Li Zhiyan,Yang Wei,Chang Le,Yan Cunling
Conformational and colloidal stabilities are responsible for the stability of hemoglobin. However, most hemoglobin A1c (HbA 1c ) control materials (e.g., reference materials, calibrators, and quality control materials) are unstable and noncommutable. This may be closely related to the breakdown of the balance between the conformational and colloidal stabilities of hemoglobin. Therefore, we developed a new combined formulation buffer to address the causes of conformational and colloidal instabilities and to maintain hemoglobin or HbA 1c stability. For the commutability of HbA 1c control materials, we purified hemoglobin to remove plasma proteins, phospholipids, and fats. On the basis of the above design, we prepared two medical concentrations of HbA 1c control materials for the external quality assessment (EQA) program and then determined the certified values via the reference measurement method. Stability, homogeneity, value transfer, and commutability were evaluated. Moreover, the control material was distributed to 56 laboratories to assess proficiency testing. The HbA 1c control materials showed good homogeneity and stability and reliable value transfer, and were commutable for routine clinical analyzers. In the EQA program, only one analyzer exceeded the acceptable bias range (± 6.0%), and the mean interlaboratory CV s of the three analyzers exceeded the acceptable range (3.0%), which can be used to assess true values to improve proficiency testing in the EQA program. Therefore, newly developed control materials can be used to standardize the determination of HbA 1c . Graphical
研究领域:
临床化学
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诊断检测
·
实验室医学
·
生物化学
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DOI
PubMed
高影响因子
Scientific Reports
·
2017
·Vol. 7
·期 1
·1-11
·
IF 4.259
Ma Jie,Li Huan,Hu Xiangnan,Yang Lu,Chen Qi,Hu Congli,Chen Zhihao,Tian Xiaoyan,Yang Yang,Luo Ying,Gan Run,Yang Junqing
Dipeptidyl peptidase IV (DPP-IV) inhibitor has been expected to be a new class of anti-diabetic agent. The present study was designed to characterize the pharmacological profiles of CMD-05, a novel DPP-IV inhibitor discovered in our laboratory, in vitro and in vivo . The IC 50 of CMD-05 on DPP-IV inhibitory activity was approximately 12 nM while vildagliptin was 3.5 nM in vitro . In diabetes rat model established by high fat diet/low dose streptozotocin, CMD-05 inhibited DPP-IV activity, significantly improved glucose tolerance, increased GLP-1 and insulin levels in plasma. Long-term administration of CMD-05 decreased HbA1c and TG levels and improved the islet function without significantly effect on body weight. Furthermore, CMD-05 reduced INS-1 cell apoptosis and increased GLP-1 secretion in NCI-H716. After oral administration, CMD-05 reached peak concentration at 30 min with half-life of 288 minutes and the inhibitory rate of DPP-IV greater than 50% lasted for 15 h. In fasted normal rats, CMD-05 didn’t cause significant hypoglycemia. CMD-05 had a lower cytotoxicity than vildagliptin in vitro and its maximum tolerance dose in mice is beyond 2000 mg/kg. These results indicated that CMD-05 has similar activity with vildagliptin in vivo and has a much longer half-life and lower cytotoxicity than vildagliptin.
研究领域:
药理学
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内分泌学
·
糖尿病研究
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DOI
PubMed
高影响因子
TALANTA
·
2019
·
IF 4.916
Xiao Wang,Jing Su,Dongdong Zeng,Gang Liu,Lizhuang Liu,Yi Xu,Chenguang Wang,Xinxin Liu,Lu Wang,Xianqiang Mi
Glycated hemoglobin (HbA1c) represents the average glucose level over the past three months and has been considered as the most important biomarker for the diagnosis of Type Ⅱ diabetes (T2D). Herein, a label-free and quantitative electrochemical biosensor based on 4-mercaptophenylboronic acid (4-MPBA) modified gold nano-flowers (Au NFs) substrate was developed for the determination of HbA1c. Under optimal conditions, the linear dynamic ranges of HbA1c (5 μg/mL - 1000 μg/mL) and HbA1c% (2%–20%) by cyclic voltammetry were achieved. The electrochemical biosensor showed great detection specificity towards HbA1c and relatively stability after storage at 4 °C. This method could also be applied in human serum system which holds great potential to be applied to monitor real blood samples of diabetes patients. In human serum system, the recovery rate could reach 103.8% and 99.0%. It could achieve fast detection, the total analysis time was less than 65 min, and the detection time was less than 10 s. Moreover, in terms of fabrication process, operation procedure, detection time and cost, this technique was superior to the current HbA1c detection methods suggesting great promise for the practical clinical use in the future.
研究领域:
电化学
·
生物传感器
·
糖尿病诊断
·
纳米技术
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DOI
PubMed
高影响因子
危险品化学品经营许可证（带存储）