摘要
目的探讨轻型13地中海贫血对4个糖化血红蛋白A1c检测系统的影响。方法方法学比对研究。收集2014年3月至8月来自中山大学附属中山医院的65例全血样本，分为正常对照组（40份）、非糖尿病组（20份）和糖尿病组（5份），其中非糖尿病组和糖尿病组同时合并轻型B地中海贫血。以通过美国国家糖化血红蛋白标准化计划（NGSP）I级实验室认证的美国Bio—RadVariantⅡ系统为参比系统，美国Bio—RadVariant1ITurbo、美国PrimusUltra、瑞士RocheModularPPI为比较系统，通过新鲜全血赋值传递方法达到比较系统与参比系统结果可比。分别用4种检测系统检测65份全血样本的HbA。的浓度，采用独立样本t检验比较各个系统正常对照组和非糖尿病组HbA1c结果的差异。按照NGSP判断标准，比较Bio—RadVariantIITurbo、Bio—RadVariantlI、RocheModularPPI与PrimusUltra。系统结果的差异，采用配对设计定量资料的t检验进行统计学分析。结果通过新鲜全血赋值传递后，Bio．RadVariantIITurbo、PrimusUltra、ModularPPI与Bio-RadVariantⅡ的相对偏差在-6％-＋6％之间，3个系统与Bio-RadVariantⅡ系统结果可比。4个检测系统正常对照组和非糖尿病组HbA1c，测定结果之间差异均无统计学意义（P〉0．05）。Bio—RadVariantⅡTurbo、Bio—RadVariantⅡ、RocheModularPPI系统与PrimusUltra。系统检测结果的相关系数r分别是：0．995、0．999及0．995，P值均小于0．01。且Bio—RadVariant11Turbo、Bio—RadVariantII、RocheModularPPI系统与PrimusUltra。系统检测结果的相对偏差在-6％～＋6％之间。结论轻型β地中海贫血对Bio—RadVariantII、Bio．RadVariantIITurbo、PrimusUltra。及RocheModularPPI4个系统检测HbAk无明显影响。
Objective To investigate the Influence of beta-thalassemia minor on four different HbA1c detection systems. Methods All 65 blood samples from March 2014 to August 2014 were collected from Zhongshan Hospital of Sun Yat-sen University, and divided to normal control group （40 cases ） , no diabetic group（ 20 cases ） and diabetic group （ 5 cases ） combining with beta-thalassemia minor. The fresh mixed whole-blood samples were used for transferring value-assignment in order to improve the comparability of Bio-Rad variant Ⅱ Turbo, Primus Ultra2, Roche Modular PPI to Bio-Rad Variant Ⅱ which was NGSP Ⅰ laboratory certificated. The whole-blood concentration of HbAto were measured by four detection systems. Differences between normal control group and no diabetic group were compared using the Independent Samples T Test. Then Taking the Primus Ultra2 as comparable system and others as experimental system, the HbA1c results from no diabetic group and diabetic group were compared by the standardization NGSP Ⅰ laboratory and statistical techniques of consistency test. Results Compared with Variant Ⅱ detection system, after transferring value-assignment, deviations of Variant Ⅱ, Modular PPI and Variant Ⅱ Turbo were -6% to ＋ 6%. The HbAlc testing results from normal control group and no diabetic group had no statistical significance （ P 〉 0.05 ）. Linear regression analysis demonstrated that the correlation coefficient ofPrimus Ultra2 with Variant Ⅱ , Modular PPI, Variant II Turbo were 0. 995, 0. 999 and O. 995, respectively （P 〈0. 01）. The percentage deviation of the reference system and experimental system was - 6. 0% to ＋ 6.0%. Conclusion There was no obviously significant influence of beta-thalassemia minor on Bio-Rad Variant Ⅱ , Bio-Rad variant Ⅱ Turbo, Primus Ultra2 , Roche Modular PPI detection systems.
出处
《中华检验医学杂志》
CAS
CSCD
北大核心
2015年第10期691-695,共5页
Chinese Journal of Laboratory Medicine
基金
基金项目：广东省科技计划项目（20138021800112）
中山市卫生局资助课题（2014J040）
