1.Clinical significance of detection of five kinds of serum pancreas islet auto-antibodies in patients with diabetes mellitus
Yingzhong HE ; Niwei HAN ; Yan ZOU ; Can HE
International Journal of Laboratory Medicine 2015;(6):768-769,771
Objective To observe the positive rates of five kinds of serum pancreas islet auto‐antibodies IA‐2A ,GADA ,ICA‐64KD ,ICA‐40KD ,IAA in type 1 diabetes mellitus(T1DM ) ,type 2 diabetes mellitus(T2DM ) and the normal population and their clinical significance .Methods The above 5 kinds of serum auto‐antibodies were detected in 22 cases of T1DM ,160 cases of T2DM and 20 healthy people by using the immunoblotting test .Then the detection results were analyzed .Results The positive rates of IA‐2A ,GADA ,ICA‐64KD ,ICA‐40KD and IAA were 45 .5% ,72 .7% ,45 .5% ,9 .1% and 9 .1% respectively in the T1DM group , 23 .8% ,28 .8% ,8 .8% ,3 .8% and 3 .8% respectively in the group T2DM ,and 0% in the normal control group .The IA‐2A positive rate in the T1DM group was higher than that in the healthy control group(P < 0 .05) .The positive rate of GADA in the T1DM group and T2DM group was higher than that in the healthy control group(P< 0 .01 ,P= 0 .005) ,the T1DM group was higher than the T2DM group(P< 0 .01) ,the positive rate of ICA‐64KD in the T1DM group was higher than that in the healthy control group and the T2DM group(P = 0 .002 ,P < 0 .01) ,the differences in the comparison among other groups had no statistical significance (P> 0 .017) .Conclusion GADA and IA‐2A have the diagnostic value to T1DM ,GADA also has the diagnostic significance to T2DM ,GADA and ICA‐64KD have the differentiating diagnostic significance to T1DM and T2DM .
2.Precision and uncertainty evaluation and comparison analysis of 6 items blood lipids index on different Beckman AU biochemical testing systems
Jialin XIANG ; Xiaoli YANG ; Yan YANG ; Xuhong OUYANG ; Niwei HAN ; Ling YIN
International Journal of Laboratory Medicine 2015;(14):2007-2008
Objective To evaluate the precision and uncertainty and comparison analysis of 6 items blood lipids index among 5 different Beckman AU biochemical testing systems ,such as triglyceride(TG) ,total cholesterol(TCHO) ,high density lipoprotein cholesterol(HDL‐C) ,low density lipoprotein cholesterol(LDL‐C) ,apolipoproteins A1(APOA1) ,apolipoproteins B(APOB) .Meth‐ods According to the document the EP15‐A2 of national Committee for Clinical Laboratory Standards ,6 items blood lipids index were respectively detected by 5 different Beckman AU biochemical testing systems to obtain precision and comparison .The intra‐and inter‐precision and results of comparability among different system were low than 1/4 or 1/3 or 1/2 CLIA′88 as evaluation standard ,respectively .The measurement uncertainty of these items were evaluated by the calibrator uncertainty and internal quality control and external quality control .Results The intra‐and inter‐or day‐to‐day precision and relative bias were accepted by clinical requirements .The expanded measurement uncertainty for TG was 0 .079 mmol/L and 0 .035mmol/L .The expanded measurement uncertainty for TCHO was 0 .248 mmol/L and 0 .157 mmol/L .The expanded measurement uncertainty for HDL‐C was 0 .144 mmol/L and 0 .018 mmol/L .The expanded measurement uncertainty for LDL‐C was 0 .140 mmol/L and 0 .186 mmol/L .The ex‐panded measurement uncertainty for APOA1 was 0 .148 mmol/L and 0 .090 mmol/L .The expanded measurement uncertainty for APOB was 0 .104 mmol/L and 0 .058 mmol/L .Conclusion The results of 6 items blood lipids index respectively show well preci‐sion and significantly correlation among 5 different Beckman AU biochemical testing systems and the results were comparable ,and the influence factor of detection results were expression directly by evaluating the measurement uncertainty of 6 items blood lipids index .This way of assessment is simple .