Background： Hemoglobin A 1 c （HbA1 c） measurement is of great value for the diagnosis and monitoring of diabetes. Many manufacturers have developed various experiments to determine the HbAlc concentration. However,...Background： Hemoglobin A 1 c （HbA1 c） measurement is of great value for the diagnosis and monitoring of diabetes. Many manufacturers have developed various experiments to determine the HbAlc concentration. However, the longitudinal use of these tests requires strict quality management. This study aimed to analyze the quality of HbAlc measurement systems in China using six sigma techniques to help improve their performances. Methods： A total of 135 laboratories were involved in this investigation in 2015. Bias values and coefficients of variation were collected from an HbA 1 c 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. Results： The 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 ＂TO SOH＂ and ＂ARKRAY＂ groups, respectively, were scored as ＂world class＂, whereas none of the laboratories in ＂BIO-RAD＂ group were scored as ＂world class＂. Conclusions： This study indicated that, although participating laboratories were laboratories with better performance in China, the performances were still unsatisfactory. Actions should be taken to improve HbAlc measurement performance before we can include HbAlc assays in diabetes diagnosis in China.展开更多
Objective To investigate the relationship between glycosylated hemoglobin A1 c （HbA1 c） and blood glucose levels of eight different points throughout the day in well-glycemic-controlled medical nutrition therapy （...Objective To investigate the relationship between glycosylated hemoglobin A1 c （HbA1 c） and blood glucose levels of eight different points throughout the day in well-glycemic-controlled medical nutrition therapy （MNT） alone type 2 diabetic pafients. Methods Data were collected as＂ capillary blood glucose value of eight different sample points among sixteen observing days in thirty MNT alone type 2 diabetic patients. The correlation between HbAI c and capillary blood glucose value was evaluated by Pearson＇s correlation method. Results The r-values between HbA1c and capillary blood glucose of 3：00, 6：00, and bedtime （22：00-23：00） were 0. 81,0. 79, and 0. 78, respectively（P 〈0. 001 ）. The best correlation was found between the mean value of 8- point blood glucose value throughout the day and HbA1c （ r=0. 84, P 〈0. 001 ）. Conclustion Fasting blood glucose and postabsorptive blood glucose have better correlations with HbAlc compared with other points in this group of well-glycemic-controlled MNT alone type 2 diabetic patients.展开更多
文摘Background： Hemoglobin A 1 c （HbA1 c） measurement is of great value for the diagnosis and monitoring of diabetes. Many manufacturers have developed various experiments to determine the HbAlc concentration. However, the longitudinal use of these tests requires strict quality management. This study aimed to analyze the quality of HbAlc measurement systems in China using six sigma techniques to help improve their performances. Methods： A total of 135 laboratories were involved in this investigation in 2015. Bias values and coefficients of variation were collected from an HbA 1 c 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. Results： The 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 ＂TO SOH＂ and ＂ARKRAY＂ groups, respectively, were scored as ＂world class＂, whereas none of the laboratories in ＂BIO-RAD＂ group were scored as ＂world class＂. Conclusions： This study indicated that, although participating laboratories were laboratories with better performance in China, the performances were still unsatisfactory. Actions should be taken to improve HbAlc measurement performance before we can include HbAlc assays in diabetes diagnosis in China.
文摘Objective To investigate the relationship between glycosylated hemoglobin A1 c （HbA1 c） and blood glucose levels of eight different points throughout the day in well-glycemic-controlled medical nutrition therapy （MNT） alone type 2 diabetic pafients. Methods Data were collected as＂ capillary blood glucose value of eight different sample points among sixteen observing days in thirty MNT alone type 2 diabetic patients. The correlation between HbAI c and capillary blood glucose value was evaluated by Pearson＇s correlation method. Results The r-values between HbA1c and capillary blood glucose of 3：00, 6：00, and bedtime （22：00-23：00） were 0. 81,0. 79, and 0. 78, respectively（P 〈0. 001 ）. The best correlation was found between the mean value of 8- point blood glucose value throughout the day and HbA1c （ r=0. 84, P 〈0. 001 ）. Conclustion Fasting blood glucose and postabsorptive blood glucose have better correlations with HbAlc compared with other points in this group of well-glycemic-controlled MNT alone type 2 diabetic patients.
