High performance liquid chromatography (HPLC) is currently the mainstream technology for detecting hemoglobin. Glycated hemoglobin (HbA1c) is a gold indicator for diagnosing diabetes, however, the accuracy of HbA1c test is affected by thalassemia factor hemoglobin F (HbF)/hemoglobin A2 (HbA2) and variant hemoglobin during HPLC analysis. In this study, a new anti-interference hemoglobin analysis system of HPLC is proposed. In this system, the high-pressure three-gradient elution method was improved, and the particle size and sieve plate aperture in the high-pressure chromatography column and the structure of the double-plunger reciprocating series high-pressure pump were optimized. The system could diagnose both HbA1c and thalassemia factor HbF/HbA2 and variant hemoglobin, and the performance of the system was anti-interference and stable. It is expected to achieve industrialization. In this study, the HbA1c and thalassemia factor HbF/HbA2 detection performance was compared between this system and the world's first-line brand products such as Tosoh G8, Bio-Rad Ⅶ and D10 glycosylated hemoglobin analysis system. The results showed that the linear correlation between this system and the world-class system was good. The system is the first domestic hemoglobin analysis system by HPLC for screening of HbA1c and thalassemia factor HbF/HbA2 rapidly and accurately.
Chromatography, High Pressure Liquid ; Fetal Hemoglobin/analysis* ; Glycated Hemoglobin A/analysis* ; Hemoglobin A2/analysis* ; Hemoglobins

China ; Diabetes Mellitus ; diagnosis ; metabolism ; Glycated Hemoglobin A ; metabolism ; Humans

Objective: To compare the effects of different hemolytic diseases on the level of glycosylated hemoglobin (HbA(1c)) to further explore the relationship between HbA(1c) and laboratory indexes to disclose implications of HbA(1c) in hemolytic diseases. Methods: The distribution of 192 decreased HbA(1c) cases in 4 categories of hemolytic diseases was analyzed. Laboratory indexes related to hemolysis were tested and analyzed in each kind of disease, and relationship between laboratory indexes and HbA(1)c was statistically explored. Results: Diagnoses of decreased HbA(1c) cases mainly included erythrocyte membranopathies (88 cases), immunohemolytic anemia (72 cases), hemoglobinopathy (4 cases) and erythrocyte enzymopathy (5 cases). The distribution of HbA(2) and normal HbF subjects in immunohemolytic anemia and hemoglobinopathy was significantly different from those of HbA(2) and / or abnormal HbF subjects (41.7% vs 22.0%, χ(2)=5.574, P=0.018; 0.7% vs 7.3%, P=0.031). Compared with non-hemolytic disease patients, those who suffered from 4 categories of hemolytic diseases showed lower HbA(1c) level and higher reticulocyte percentage (Ret), indirect bilirubin (IBIL) and free hemoglobin (F-Hb). Different levels of Ret, reticulocyte hemoglobin content (Ret-He), mean corpuscular volume (MCV), IBIL and F-Hb among the 4 kinds of diseases were observed, but the causes of the differences were not the same. HbA(1c) was negatively correlated with other laboratory indexes in erythrocyte membranopathies and immunohemolytic anemia. Conclusions: Hemolytic disease resulted in false lower HbA(1c), but impact of difference on HbA1c between different diseases was not significant. HbA(1c) was closely connected to laboratory indexes related to hemolysis, which might have potential implications for hemolytic diseases such as erythrocyte membranopathies and immunohemolytic anemia.
Data Analysis ; Erythrocytes ; Glycated Hemoglobin ; Hemoglobinopathies ; Hemolysis ; Humans

To determine the types and proportion of common hemoglobin variants in Tianjin and surrounding areas, to analyze the recognition ability and the effects of hemoglobin variants on experimental results in two commonly used glycated hemoglobin systems, so as to provide data support for the consistency of HbA1c detection in Tianjin City. A case-control study was used for retrospective analysis,156 specimens with abnormal electrophoretic peaks in the detection of glycated hemoglobin were collected from more than 50 000 specimens of patients in Chu Hsien-I Memorial Hospital of Tianjin Medical University between June 2020 and December 2020. Determined their hemoglobin mutation sites by DNA sequencing, and compared the values of hemoglobin variants on glycated hemoglobin detection values by high performance liquid chromatography and capillary electrophoresis. SPSS 23 was used to calculate the blood routine results of the variant specimens, and compared with the normal reference interval. The results showed that DNA sequencing identified 21 hemoglobin variants, of which 11 were α strand variants and 10 were β strand variants. In addition, an unreported hemoglobin variant was identified, Hb Headington (HBB: c.217A>C). The HbA_1c of 11 variants including Hb G-Honolulu, Hb Queens, Hb Q-Thailand, Hb J-Broussais, Hb O-Indonesia, Hb G-Coushatta, Hb G-Taipei, Hb E, Hb Headington, Hb New York and Hb D-Los Angeles were shifted by more than 7% when measured by high-performance liquid chromatography. Patients with the Hb Q-Thailand and Hb E cause reduced MCV and MCH. In conclusion, an unreported hemoglobin variant was found from Tianjin and neighboring areas. Patients with the Hb Q-Thailand and Hb E cause reduced MCV and MCH. 11 of these hemoglobin variants interfered with the detection of glycated hemoglobin using high-performance liquid chromatography, resulting in inaccurate results.
Humans ; Glycated Hemoglobin ; Case-Control Studies ; Retrospective Studies ; Hospitals

To determine the types and proportion of common hemoglobin variants in Tianjin and surrounding areas, to analyze the recognition ability and the effects of hemoglobin variants on experimental results in two commonly used glycated hemoglobin systems, so as to provide data support for the consistency of HbA1c detection in Tianjin City. A case-control study was used for retrospective analysis,156 specimens with abnormal electrophoretic peaks in the detection of glycated hemoglobin were collected from more than 50 000 specimens of patients in Chu Hsien-I Memorial Hospital of Tianjin Medical University between June 2020 and December 2020. Determined their hemoglobin mutation sites by DNA sequencing, and compared the values of hemoglobin variants on glycated hemoglobin detection values by high performance liquid chromatography and capillary electrophoresis. SPSS 23 was used to calculate the blood routine results of the variant specimens, and compared with the normal reference interval. The results showed that DNA sequencing identified 21 hemoglobin variants, of which 11 were α strand variants and 10 were β strand variants. In addition, an unreported hemoglobin variant was identified, Hb Headington (HBB: c.217A>C). The HbA_1c of 11 variants including Hb G-Honolulu, Hb Queens, Hb Q-Thailand, Hb J-Broussais, Hb O-Indonesia, Hb G-Coushatta, Hb G-Taipei, Hb E, Hb Headington, Hb New York and Hb D-Los Angeles were shifted by more than 7% when measured by high-performance liquid chromatography. Patients with the Hb Q-Thailand and Hb E cause reduced MCV and MCH. In conclusion, an unreported hemoglobin variant was found from Tianjin and neighboring areas. Patients with the Hb Q-Thailand and Hb E cause reduced MCV and MCH. 11 of these hemoglobin variants interfered with the detection of glycated hemoglobin using high-performance liquid chromatography, resulting in inaccurate results.
Humans ; Glycated Hemoglobin ; Case-Control Studies ; Retrospective Studies ; Hospitals

China ; epidemiology ; Diabetes Mellitus ; diagnosis ; epidemiology ; metabolism ; Glycated Hemoglobin A ; metabolism ; Humans ; Prevalence

BACKGROUNDHemoglobin A1c (HbA1c) measurement is of great value for the diagnosis and monitoring of diabetes. Many manufacturers have developed various experiments to determine the HbA1c concentration. However, the longitudinal use of these tests requires strict quality management. This study aimed to analyze the quality of HbA1c measurement systems in China using six sigma techniques to help improve their performances.

METHODSA total of 135 laboratories were involved in this investigation in 2015. Bias values and coefficients of variation were collected from an HbA1c trueness verification external quality assessment program and an internal quality control program organized by the National Center of Clinical Laboratories in China. The sigma (σ) values and the quality goal index (QGI) were used to evaluate the performances of different groups, which were divided according to principles and instruments.

RESULTSThe majority of participants (88, 65.2%) were scored as "improvement needed (σ < 3)", suggesting that the laboratories needed to improve their measurement performance. Only 8.2% (11/135) of the laboratories were scored as "world class (σ ≥ 6)". Among all the 88 laboratories whose σ values were below 3, 52 (59.1%) and 23 (26.1%) laboratories needed to improve measurement precision (QGI <8.0) and trueness (QGI >1.2), respectively; the remaining laboratories (13, 14.8%) needed to improve both measurement precision and trueness. In addition, 16.1% (5/31) and 15.0% (3/20) of the laboratories in "TOSOH" and "ARKRAY" groups, respectively, were scored as "world class", whereas none of the laboratories in "BIO-RAD" group were scored as "world class".

CONCLUSIONSThis study indicated that, although participating laboratories were laboratories with better performance in China, the performances were still unsatisfactory. Actions should be taken to improve HbA1c measurement performance before we can include HbA1c assays in diabetes diagnosis in China.

China ; Diabetes Mellitus ; blood ; metabolism ; Glycated Hemoglobin A ; metabolism ; Humans ; Quality Assurance, Health Care ; methods

OBJECTIVETo investigate the status of glycosylated hemoglobin A1c (GHbA(1c)) control in type 2 diabetic patients and its relation to diabetic complications.

METHODSA total of 676 patients with type 2 diabetes were investigated for GHbA(1c) level and the diabetic complications. The patients were divided into two groups with GHbA(1c) >7% and GHbA(1c)< or =7%, and the relation of GHbA(1c) with the complications was analyzed.

RESULTSThe rate of good GHbA(1c) control (GHbA(1c)< or =7%) was 35.1% (237/676) in these patients, and 64.9% (439/676) of the patients showed poor GHbA(1c) control (GHbA(1c)>7%). The rates of hypertension and cerebralovascular complications were significantly higher in patients with GHbA(1c)>7% than in those with GHbA(1c)< or =7% (69.9% vs 55.7%, and 21.8% vs 8.9%, respectively, P<0.001), but the rate of coronary heart disease was comparable between the two groups (18.7% vs 17.3%, P>0.05). The patients with poor GHbA(1c) control had significantly higher incidences of diabetic peripheral neuropathy and fatty liver than those with good GHbA(1c) control (46.0% vs 35.0%, and 36.9% vs 25.3%, respectively, P<0.01), but no significant differences were found in the incidences of diabetic nephropathy (18.7% vs 16.5%), diabetic retinopathy (30.8% vs 27.4%) or diabetic feet (5.0% vs 3.8%) between the two groups (P>0.05).

CONCLUSIONType 2 diabetic patients have generally low rate of successful GHbA(1c) control, which can be associated with the occurrence of diabetic complications, suggesting the necessity of more rigorous diabetic health education and GHbA(1c) monitoring in these patients.

Adult ; Aged ; Diabetes Mellitus, Type 2 ; blood ; complications ; Female ; Glycated Hemoglobin A ; metabolism ; Humans ; Male ; Middle Aged

OBJECTIVETo evaluate the effects of periodontal treatment on the clinical response, systemic inflammatory parameters, and metabolic control of type 2 diabetes patients with moderate to severe periodontitis.

METHODSA total of 56 patients with mean clinical attachment level (CAL)>3 mm were included in the subgroup analysis. A repeated-measures ANOVA (group factor: treatment group and control group; time factor: initial visit, 1.5, 3, and 6 months) was used to analyze the probing depth (PD), CAL, bleeding on probing (BOP), high-sensitivity C-reactive protein (hsCRP), glycated hemoglobin (HbA1c), and fasting plasma glucose.

RESULTSSignificantly lower PD (F=62.898, P-0.000), CAL (F=51.263, P-0.000), BOP (F=75.164, P=0.000), hsCRP (F=6.391, P=0.010), HbA1c(F=4.536, P=0.011), and fasting plasma glucose level (F= 3.073, P=0.031) were observed after therapeutic periodontal improvement. The inter-group differences for PD (t=-2.050, P=0.045), BOP (t=-4.538, P=0.000), and hsCRP (t=-2.261, P=0.028) were statistically significant after therapy.

CONCLUSIONNon-surgical periodontal treatment can effectively improve periodontal status, circulating inflammatory status, and metabolic control of diabetic patients with moderate to severe periodontitis.

C-Reactive Protein ; Chronic Periodontitis ; Diabetes Mellitus, Type 2 ; Glycated Hemoglobin A ; Humans ; Periodontitis

Glycated haemoglobins are haemoglobins with an attached sugar moiety. They constitute the HbA1 fraction of the adult haemoglobin HbA. HbA1c is the predominant fraction of HbA1 and gives an estimate of the blood sugar levels of an individual over the last three months. It has been observed that an HbA1c value of less than seven percent reduces the microvascular complications in diabetic patients. However, HbA1c is not affected by blood sugar levels alone. Apart from blood sugar, there are other factors that affect HbA1c. This article reviews in detail the structure, formation, methods of measurement, factors affecting HbA1c levels and their clinical significance.
Blood Glucose ; metabolism ; Diabetes Mellitus ; metabolism ; physiopathology ; Glycated Hemoglobin A ; analysis ; metabolism ; Humans