中华检验医学杂志
中華檢驗醫學雜誌
중화검험의학잡지
Chinese Journal of Laboratory Medicine
2015年
10期
691-695
,共5页
索明环%温冬梅%张秀明%吴剑杨%陈亚琼%徐全中%李曼%胡婷%萧金丽%张德才%徐胜男
索明環%溫鼕梅%張秀明%吳劍楊%陳亞瓊%徐全中%李曼%鬍婷%蕭金麗%張德纔%徐勝男
색명배%온동매%장수명%오검양%진아경%서전중%리만%호정%소금려%장덕재%서성남
β地中海贫血%血红蛋白A,糖基化
β地中海貧血%血紅蛋白A,糖基化
β지중해빈혈%혈홍단백A,당기화
beta-Thalassemia%Hemoglobin A,glycosylated
目的：探讨轻型β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β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－Rad VariantⅡ系统为参比系统，美国Bio－Rad Variant ⅡTurbo、美国Primus Ultra2、瑞士Roche Modular PPI 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HbA1c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－Rad VariantⅡTurbo、Bio－Rad VariantⅡ、Roche Modular PPI与Primus Ultra2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－Rad Variant Ⅱ Turbo、Primus Ultra2、Modular PPI 与Bio－Rad Variant Ⅱ的相对偏差在－6％～＋6％之间，3个系统与Bio－Rad Variant Ⅱ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－Rad Variant Ⅱ Turbo、Bio－Rad Variant Ⅱ、Roche Modular PPI系统与Primus Ultra2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－Rad Variant Ⅱ Turbo、Bio－Rad Variant Ⅱ、Roche Modular PPI 系统与Primus Ultra2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－Rad Variant Ⅱ、Bio－Rad Variant ⅡTurbo、Primus Ultra2及Roche Modular PPI 4个系统检测HbA1c无明显影响。（中华检验医学杂志，2015，38：691－695）
目的：探討輕型β地中海貧血對4箇糖化血紅蛋白A1c檢測繫統的影響。方法方法學比對研究。收集2014年3月至8月來自中山大學附屬中山醫院的65例全血樣本，分為正常對照組（40份）、非糖尿病組（20份）和糖尿病組（5份），其中非糖尿病組和糖尿病組同時閤併輕型β地中海貧血。以通過美國國傢糖化血紅蛋白標準化計劃（ NGSP）Ⅰ級實驗室認證的美國Bio－Rad VariantⅡ繫統為參比繫統，美國Bio－Rad Variant ⅡTurbo、美國Primus Ultra2、瑞士Roche Modular PPI 為比較繫統，通過新鮮全血賦值傳遞方法達到比較繫統與參比繫統結果可比。分彆用4種檢測繫統檢測65份全血樣本的HbA1c的濃度，採用獨立樣本t檢驗比較各箇繫統正常對照組和非糖尿病組HbA1c結果的差異。按照NGSP判斷標準，比較Bio－Rad VariantⅡTurbo、Bio－Rad VariantⅡ、Roche Modular PPI與Primus Ultra2繫統結果的差異，採用配對設計定量資料的t檢驗進行統計學分析。結果通過新鮮全血賦值傳遞後，Bio－Rad Variant Ⅱ Turbo、Primus Ultra2、Modular PPI 與Bio－Rad Variant Ⅱ的相對偏差在－6％～＋6％之間，3箇繫統與Bio－Rad Variant Ⅱ繫統結果可比。4箇檢測繫統正常對照組和非糖尿病組HbA1c測定結果之間差異均無統計學意義（ P ＞0．05）。 Bio－Rad Variant Ⅱ Turbo、Bio－Rad Variant Ⅱ、Roche Modular PPI繫統與Primus Ultra2繫統檢測結果的相關繫數r分彆是：0．995、0．999及0．995，P值均小于0．01。且Bio－Rad Variant Ⅱ Turbo、Bio－Rad Variant Ⅱ、Roche Modular PPI 繫統與Primus Ultra2繫統檢測結果的相對偏差在－6％～＋6％之間。結論輕型β地中海貧血對Bio－Rad Variant Ⅱ、Bio－Rad Variant ⅡTurbo、Primus Ultra2及Roche Modular PPI 4箇繫統檢測HbA1c無明顯影響。（中華檢驗醫學雜誌，2015，38：691－695）
목적：탐토경형β지중해빈혈대4개당화혈홍단백A1c검측계통적영향。방법방법학비대연구。수집2014년3월지8월래자중산대학부속중산의원적65례전혈양본，분위정상대조조（40빈）、비당뇨병조（20빈）화당뇨병조（5빈），기중비당뇨병조화당뇨병조동시합병경형β지중해빈혈。이통과미국국가당화혈홍단백표준화계화（ NGSP）Ⅰ급실험실인증적미국Bio－Rad VariantⅡ계통위삼비계통，미국Bio－Rad Variant ⅡTurbo、미국Primus Ultra2、서사Roche Modular PPI 위비교계통，통과신선전혈부치전체방법체도비교계통여삼비계통결과가비。분별용4충검측계통검측65빈전혈양본적HbA1c적농도，채용독립양본t검험비교각개계통정상대조조화비당뇨병조HbA1c결과적차이。안조NGSP판단표준，비교Bio－Rad VariantⅡTurbo、Bio－Rad VariantⅡ、Roche Modular PPI여Primus Ultra2계통결과적차이，채용배대설계정량자료적t검험진행통계학분석。결과통과신선전혈부치전체후，Bio－Rad Variant Ⅱ Turbo、Primus Ultra2、Modular PPI 여Bio－Rad Variant Ⅱ적상대편차재－6％～＋6％지간，3개계통여Bio－Rad Variant Ⅱ계통결과가비。4개검측계통정상대조조화비당뇨병조HbA1c측정결과지간차이균무통계학의의（ P ＞0．05）。 Bio－Rad Variant Ⅱ Turbo、Bio－Rad Variant Ⅱ、Roche Modular PPI계통여Primus Ultra2계통검측결과적상관계수r분별시：0．995、0．999급0．995，P치균소우0．01。차Bio－Rad Variant Ⅱ Turbo、Bio－Rad Variant Ⅱ、Roche Modular PPI 계통여Primus Ultra2계통검측결과적상대편차재－6％～＋6％지간。결론경형β지중해빈혈대Bio－Rad Variant Ⅱ、Bio－Rad Variant ⅡTurbo、Primus Ultra2급Roche Modular PPI 4개계통검측HbA1c무명현영향。（중화검험의학잡지，2015，38：691－695）
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 ⅡTurbo, Primus Ultra2 ,Roche Modular PPI to Bio-Rad Variant Ⅱwhich was NGSP Ⅰlaboratory certificated.The whole-blood concentration of HbA 1c 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 Ultra 2 as comparable system and others as experimental system ,the HbA1c results from no diabetic group and diabetic group were compared by the standardization NGSP Ⅰlaboratory 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 HbA1c 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 of Primus Ultra2 with Variant Ⅱ, Modular PPI, VariantⅡTurbo were 0.995, 0.999 and 0.995, 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 ⅡTurbo,Primus Ultra2,Roche Modular PPI detection systems.
