Standardization of glycosylated hemoglobin testing promotes consistency in clinical diagnosis and treatment of diabetes mellitus
As the most important chronic non communicable disease, diabetes has become
the third major disease threatening human health after tumor, cardiovascular and
cerebrovascular diseases. According to the latest data from the International
Diabetes Federation (IDF), the number of people with diabetes in the world has
reached 382 million in 2014, and the number of people with diabetes will reach
592 million in 2035. Each year, 4 million 900 thousand people die of diabetes,
or 1 deaths every 7 seconds. In China, there were 96 million 290 thousand
diabetes patients in 2014, accounting for 1/3 of the total number of people
worldwide. It is estimated that by 2035, the number of diseases will increase to
1.5 times. China has become the world's largest country in diabetes, and the
situation of prevention and control is very serious.
Diabetes is characterized by high blood glucose metabolic disease, patients need lifelong monitoring and treatment, if not good glycemic control, can cause systemic organ complications, and ultimately lead to cardiovascular disease, dyslipidemia, blindness, kidney failure and amputation and other serious complications. How to control blood glucose in the ideal range, delay the complications of diabetes, and achieve effective diagnosis and treatment of diabetes is essential. In recent years, glycosylated hemoglobin (HbA1c) has been an important indicator of clinical management of diabetes mellitus because it can effectively assist in the diagnosis, screening, treatment, monitoring and prognosis evaluation of diabetes mellitus.
The day before the meeting, the consistency of the Roche Diagnostics biochemical academic exchanges and HbA1c held in Shanghai, the experts discussed the important value of HbA1c in diabetes management, as well as the HbA1c detection standard and consistent development plan for the important guiding significance to promote the clinical diagnosis and treatment of diabetes.
Glycosylated hemoglobin: the gold standard for diagnosis and treatment of diabetes mellitus
A1 (Hb) usually accounts for 5%-8% of total hemoglobin and consists of HbA1a, HbA1b and HbA1c. As an important sub component, HbA1c refers to the amount of glucose (referred to as glycosylated hemoglobin) that is carried by circulating and neutralizing hemoglobin, which accounts for HbA1 of 70%-90%.
In the early years 19681969, studies have confirmed that diabetes is related to increased HbA1c; in 1976, scholars have found that the main cause of elevated blood glucose in patients with diabetes is HbA1c; the same year, the researchers confirmed that the level of HbA1c and fasting blood glucose concentration; the 1983 study found the level of HbA1c dynamic changes in the life cycle of red blood cells, followed by a large number of the research confirmed. Because the detection is more objective and does not depend on other conditions of patients (such as blood, fasting time, whether the use of insulin and so on), 1980s, because HbA1c can reflect the average blood glucose level in patients with diabetes for 2-3 months, become a good indicator to determine the long-term control of blood sugar conditions, has been widely used in clinical.
Two diabetes clinical study of the most authoritative: the United States mass type 1 diabetes control and complications trial (DCCT) study and the British type 2 diabetes mellitus (UKPDS), were put forward HbA1c as an important evaluation index of diabetes control, and fully confirmed the glycemic control and development of the relationship between the risk of chronic complications of diabetes between. Good glycemic control will greatly reduce the occurrence and development of diabetic complications (retinopathy, kidney damage, vasculopathy, etc.). According to the UKPDS survey, the average level of HbA1c patients decreased 1%, which caused by peripheral vascular disease can be reduced by 43%, 37% reduction in microvascular complications, incidence of myocardial infarction can be reduced by 14%, all kinds of causes of diabetes related mortality decreased by 21%, the risk of chronic complications of diabetes can be reduced by 45%.
Since 2009, by the American Diabetes Association (ADA), the European Diabetes Association (EASD) since the group of experts and members of the IDF consensus statement in support of HbA1c for the diagnosis of diabetes, in recent years, the HbA1c was used to study the diagnosis index for screening diabetes increased gradually. The research shows that because the patients were detected before HbA1c reflects the average blood glucose level of 2 to 3 months, and is not affected by short-term fluctuations in blood glucose concentration, the detection of convenience, stability and repeatability are better than the commonly used blood glucose testing, such as fasting blood glucose (FPG) test and oral glucose tolerance (OGTT), is an ideal screening index for diagnosis of diabetes.
In 2010, ADA will HbA1c more than 6.5% formally incorporated into the first diabetes diagnosis index, HbA1c not only become the treatment monitoring and prognosis assessment of the "gold standard", but also as a diagnostic screening index, throughout the entire process of the diagnosis and treatment of diabetes. In 2011, the WHO (WHO) also recommended the use of HbA1c as a diabetes aid diagnostic tool in areas where conditions were ripe and suggested that HbA1c>6.5% be used as a diagnostic point.
Global standardization and consistency of HbA1c testing
The HbA1c detection method commonly used in clinical laboratory can be divided into two categories, one is based on the non glycosylated hemoglobin and glycosylated hemoglobin with different charge, including electrophoresis and ion exchange chromatography, the other is based on the structure of hemoglobin A1c group, divided into affinity layer analysis and immunoassay.
In 1995, the American Pathologists Association (CAP) found that 54% of the laboratories tested the HbA1c value by affinity layer analysis. In 2007, most of the 2498 laboratories involved in PT began using immunoassay and ion exchange chromatography (65% and 32% respectively). Changes in laboratory methods show that these two methods are more in line with the needs of routine clinical laboratories. In recent years, with the sample concentration detection demand continues to increase, compared with ion exchange chromatography, immunity can help clinical laboratory in reporting the results consistent with the premise of a turbidimetric method, further improve the detection efficiency. Therefore, to 2011, free of charge
Diabetes is characterized by high blood glucose metabolic disease, patients need lifelong monitoring and treatment, if not good glycemic control, can cause systemic organ complications, and ultimately lead to cardiovascular disease, dyslipidemia, blindness, kidney failure and amputation and other serious complications. How to control blood glucose in the ideal range, delay the complications of diabetes, and achieve effective diagnosis and treatment of diabetes is essential. In recent years, glycosylated hemoglobin (HbA1c) has been an important indicator of clinical management of diabetes mellitus because it can effectively assist in the diagnosis, screening, treatment, monitoring and prognosis evaluation of diabetes mellitus.
The day before the meeting, the consistency of the Roche Diagnostics biochemical academic exchanges and HbA1c held in Shanghai, the experts discussed the important value of HbA1c in diabetes management, as well as the HbA1c detection standard and consistent development plan for the important guiding significance to promote the clinical diagnosis and treatment of diabetes.
Glycosylated hemoglobin: the gold standard for diagnosis and treatment of diabetes mellitus
A1 (Hb) usually accounts for 5%-8% of total hemoglobin and consists of HbA1a, HbA1b and HbA1c. As an important sub component, HbA1c refers to the amount of glucose (referred to as glycosylated hemoglobin) that is carried by circulating and neutralizing hemoglobin, which accounts for HbA1 of 70%-90%.
In the early years 19681969, studies have confirmed that diabetes is related to increased HbA1c; in 1976, scholars have found that the main cause of elevated blood glucose in patients with diabetes is HbA1c; the same year, the researchers confirmed that the level of HbA1c and fasting blood glucose concentration; the 1983 study found the level of HbA1c dynamic changes in the life cycle of red blood cells, followed by a large number of the research confirmed. Because the detection is more objective and does not depend on other conditions of patients (such as blood, fasting time, whether the use of insulin and so on), 1980s, because HbA1c can reflect the average blood glucose level in patients with diabetes for 2-3 months, become a good indicator to determine the long-term control of blood sugar conditions, has been widely used in clinical.
Two diabetes clinical study of the most authoritative: the United States mass type 1 diabetes control and complications trial (DCCT) study and the British type 2 diabetes mellitus (UKPDS), were put forward HbA1c as an important evaluation index of diabetes control, and fully confirmed the glycemic control and development of the relationship between the risk of chronic complications of diabetes between. Good glycemic control will greatly reduce the occurrence and development of diabetic complications (retinopathy, kidney damage, vasculopathy, etc.). According to the UKPDS survey, the average level of HbA1c patients decreased 1%, which caused by peripheral vascular disease can be reduced by 43%, 37% reduction in microvascular complications, incidence of myocardial infarction can be reduced by 14%, all kinds of causes of diabetes related mortality decreased by 21%, the risk of chronic complications of diabetes can be reduced by 45%.
Since 2009, by the American Diabetes Association (ADA), the European Diabetes Association (EASD) since the group of experts and members of the IDF consensus statement in support of HbA1c for the diagnosis of diabetes, in recent years, the HbA1c was used to study the diagnosis index for screening diabetes increased gradually. The research shows that because the patients were detected before HbA1c reflects the average blood glucose level of 2 to 3 months, and is not affected by short-term fluctuations in blood glucose concentration, the detection of convenience, stability and repeatability are better than the commonly used blood glucose testing, such as fasting blood glucose (FPG) test and oral glucose tolerance (OGTT), is an ideal screening index for diagnosis of diabetes.
In 2010, ADA will HbA1c more than 6.5% formally incorporated into the first diabetes diagnosis index, HbA1c not only become the treatment monitoring and prognosis assessment of the "gold standard", but also as a diagnostic screening index, throughout the entire process of the diagnosis and treatment of diabetes. In 2011, the WHO (WHO) also recommended the use of HbA1c as a diabetes aid diagnostic tool in areas where conditions were ripe and suggested that HbA1c>6.5% be used as a diagnostic point.
Global standardization and consistency of HbA1c testing
The HbA1c detection method commonly used in clinical laboratory can be divided into two categories, one is based on the non glycosylated hemoglobin and glycosylated hemoglobin with different charge, including electrophoresis and ion exchange chromatography, the other is based on the structure of hemoglobin A1c group, divided into affinity layer analysis and immunoassay.
In 1995, the American Pathologists Association (CAP) found that 54% of the laboratories tested the HbA1c value by affinity layer analysis. In 2007, most of the 2498 laboratories involved in PT began using immunoassay and ion exchange chromatography (65% and 32% respectively). Changes in laboratory methods show that these two methods are more in line with the needs of routine clinical laboratories. In recent years, with the sample concentration detection demand continues to increase, compared with ion exchange chromatography, immunity can help clinical laboratory in reporting the results consistent with the premise of a turbidimetric method, further improve the detection efficiency. Therefore, to 2011, free of charge
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