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
目的探讨Lys-C胰蛋白酶在国际临床化学组织(International Federation of Clinical Chemistry and Laboratory Medicine,IFCC)推荐的质谱法测定糖化血红蛋白的参考方法中的应用价值。方法分别用两种特异性蛋白水解酶(GLU-C胞内蛋白酶和Lys-C胰蛋白酶)酶解血红蛋白后,进行SDS-PAGE电泳,衡量蛋白酶解的效率,再将消化后的血红蛋白进行质谱分析,测定标本中糖化血红蛋白的浓度。结果在相同的电泳条件下,Lys-C胰蛋白酶酶解血红蛋白的效率优于GLU-C;酶解后的血红蛋白标本经质谱方法分析可知,两种蛋白酶用于检测糖化血红蛋白浓度时,可以得到基本一致的结果,由两种方法绘制的标准曲线r2分别为0.929和0.998。结论在IFCC推荐的糖化血红的蛋白参考测量方法中,一直使用GLU-C胞内蛋白酶酶解血红蛋白,该研究尝试通过Lys-C胰蛋白酶的使用,降低整个实验成本。经结果分析,证实应用这两种特异性的蛋白酶检测糖化血红蛋白时,可以得到基本一致的结果,推荐使用文中所列方法将Lys-C胰蛋白酶作为酶解糖化血红蛋白的特异性蛋白酶。
