中国实验诊断学
中國實驗診斷學
중국실험진단학
Chinese Journal of Laboratory Diagnosis
2015年
11期
1889-1893
,共5页
钟堃%王薇%何法霖%张妍%赵彦%李国华%王治国
鐘堃%王薇%何法霖%張妍%趙彥%李國華%王治國
종곤%왕미%하법림%장연%조언%리국화%왕치국
特殊蛋白%参考区间%检测系统
特殊蛋白%參攷區間%檢測繫統
특수단백%삼고구간%검측계통
Specific protein%Reference interval%Measurement system
目的:了解目前医疗机构中特殊蛋白检验项目参考区间的应用现状。方法通过互联网向2014年参加卫生部临床检验中心特殊蛋白室间质评计划的单位发送特殊蛋白参考区间调查表,收到反馈结果后使用 Microsoft Ex-cel 2007和 SPSS 13.0进行统计分析,包括参考区间来源、统计学分析、正态性检验、不同检测系统与总体结果的比较,以及参考区间应用前的验证情况。结果847家医疗机构中有667家汇报了结果,回报率78.7%。接近80%的实验室都采用试剂厂家说明书所给出的参考区间。其中只有不到10家单位进行了参考区间的分组。84.6%的项目中位数和 Mode 值一致。除部分项目参考区间下限外,第2.5和第97.5百分位数差异较大。检测系统应用数量从多到少排列为:Beckman、Siemens 和 Roche,而 Roche 系统中各检验项目参考区间与总体比较出现显著统计学差异的情况最少,为27.3%(6/22)。半数以上的实验室都未能在参考区间应用前进行参考区间的验证。特殊蛋白各项目参考区间下限和上限中位数分别为(血清中):IgA(g/L)0.7和4.0;IgE(KIU/L)0和100;IgG(g/L)7.0和16.0;IgM(g/L)0.4和2.3;C3(g/L)0.8和1.8;C4(g/L)0.1和0.4;CRP(mg/L)0.0和8.0;RF(KU/L)0和20;ASO(KIU/L)0和200;转铁蛋白(g/L)2.0和3.6;前白蛋白(mg/L)200.0和400.0。结论目前全国医疗机构特殊蛋白检验项目所应用的参考区间差异较大,所用仪器试剂和检测系统多样,建议建立适用于我国,并且较为规范和统一的参考区间。
目的:瞭解目前醫療機構中特殊蛋白檢驗項目參攷區間的應用現狀。方法通過互聯網嚮2014年參加衛生部臨床檢驗中心特殊蛋白室間質評計劃的單位髮送特殊蛋白參攷區間調查錶,收到反饋結果後使用 Microsoft Ex-cel 2007和 SPSS 13.0進行統計分析,包括參攷區間來源、統計學分析、正態性檢驗、不同檢測繫統與總體結果的比較,以及參攷區間應用前的驗證情況。結果847傢醫療機構中有667傢彙報瞭結果,迴報率78.7%。接近80%的實驗室都採用試劑廠傢說明書所給齣的參攷區間。其中隻有不到10傢單位進行瞭參攷區間的分組。84.6%的項目中位數和 Mode 值一緻。除部分項目參攷區間下限外,第2.5和第97.5百分位數差異較大。檢測繫統應用數量從多到少排列為:Beckman、Siemens 和 Roche,而 Roche 繫統中各檢驗項目參攷區間與總體比較齣現顯著統計學差異的情況最少,為27.3%(6/22)。半數以上的實驗室都未能在參攷區間應用前進行參攷區間的驗證。特殊蛋白各項目參攷區間下限和上限中位數分彆為(血清中):IgA(g/L)0.7和4.0;IgE(KIU/L)0和100;IgG(g/L)7.0和16.0;IgM(g/L)0.4和2.3;C3(g/L)0.8和1.8;C4(g/L)0.1和0.4;CRP(mg/L)0.0和8.0;RF(KU/L)0和20;ASO(KIU/L)0和200;轉鐵蛋白(g/L)2.0和3.6;前白蛋白(mg/L)200.0和400.0。結論目前全國醫療機構特殊蛋白檢驗項目所應用的參攷區間差異較大,所用儀器試劑和檢測繫統多樣,建議建立適用于我國,併且較為規範和統一的參攷區間。
목적:료해목전의료궤구중특수단백검험항목삼고구간적응용현상。방법통과호련망향2014년삼가위생부림상검험중심특수단백실간질평계화적단위발송특수단백삼고구간조사표,수도반궤결과후사용 Microsoft Ex-cel 2007화 SPSS 13.0진행통계분석,포괄삼고구간래원、통계학분석、정태성검험、불동검측계통여총체결과적비교,이급삼고구간응용전적험증정황。결과847가의료궤구중유667가회보료결과,회보솔78.7%。접근80%적실험실도채용시제엄가설명서소급출적삼고구간。기중지유불도10가단위진행료삼고구간적분조。84.6%적항목중위수화 Mode 치일치。제부분항목삼고구간하한외,제2.5화제97.5백분위수차이교대。검측계통응용수량종다도소배렬위:Beckman、Siemens 화 Roche,이 Roche 계통중각검험항목삼고구간여총체비교출현현저통계학차이적정황최소,위27.3%(6/22)。반수이상적실험실도미능재삼고구간응용전진행삼고구간적험증。특수단백각항목삼고구간하한화상한중위수분별위(혈청중):IgA(g/L)0.7화4.0;IgE(KIU/L)0화100;IgG(g/L)7.0화16.0;IgM(g/L)0.4화2.3;C3(g/L)0.8화1.8;C4(g/L)0.1화0.4;CRP(mg/L)0.0화8.0;RF(KU/L)0화20;ASO(KIU/L)0화200;전철단백(g/L)2.0화3.6;전백단백(mg/L)200.0화400.0。결론목전전국의료궤구특수단백검험항목소응용적삼고구간차이교대,소용의기시제화검측계통다양,건의건립괄용우아국,병차교위규범화통일적삼고구간。
Objective To know the current application status of reference interval of specific proteins in medical in-stitutions of China.Methods Every laboratory which attended 2014 specific protein external quality assessment pro-gram of national center of clinical laboratories has been received an internet questionnaire about reference interval.After eliminating outliers the trimmed data has been statistical analyzed by Microsoft Excel 2007 and SPSS 13.0.The re-sources of RIs,traditional statistical analysis,normalized analysis,comparison between overall median and lower and up-per limits of different measurement system,and verification status of RIs were included.Results 667 medical laborato-ries submitted the questionnaire,the rate is 78.7% (667/847).Approximately 80% of laboratories have been using the RIs referring to reagent manufacturers’instructions.Only less than 10 laboratories use RIs divided into different sub-groups.84.6% of medians of upper or lower limits of analytes are same as the Mode values.The 2.5th percentiles have tremendous differences compared with 97.5th percentiles,except several lower limits.The numbers of different meas-urement systems used in medical institutions in descending order are Beckman,Siemens and Roche measurement sys-tem.Compared with the overall medians of lower and upper limits,the RIs of Roche measurement system has more like-ly closer limits than others,only 27.3% (6/22)of the limits have statistical significance differences.More than half of laboratories do not verify their RIs before using them.The overall medians of lower and upper limits of specific protein analytes are (in serum):IgA (g/L)0.7 and 4.0;IgE (KIU/L)0 and 100;IgG (g/L)7.0 and 16.0;IgM (g/L)0.4 and 2.3;C3 (g/L)0.8 and 1.8;C4 (g/L)0.1 and 0.4;CRP (mg/L)0.0 and 8.0;RF (KU/L)0 and 20;ASO (KIU/L)0 and 200;transferring (g/L)2.0 and 3.6;prealbumin (mg/L)200.0 and 400.0.Conclusion The RIs of specific protein analytes used in medical institution have big difference between each other,and there are too many kinds of reagents and instruments which make different measurement systems.The consistent and standardized reference intervals should be established in a short time.