检验医学
檢驗醫學
검험의학
LABORATORY MEDICINE
2015年
4期
381-385
,共5页
李国华%王薇%何法霖%钟堃%张妍%赵彦%王治国
李國華%王薇%何法霖%鐘堃%張妍%趙彥%王治國
리국화%왕미%하법림%종곤%장연%조언%왕치국
不精密度%室内质控%干化学%变异系数%生物学变异%行业标准
不精密度%室內質控%榦化學%變異繫數%生物學變異%行業標準
불정밀도%실내질공%간화학%변이계수%생물학변이%행업표준
Imprecision%Internal quality control%Dry chemistry%Coefficient of variation%Biological variation%Industry standard
目的：通过调查2014年全国374家实验室上报的干化学检测项目室内质控数据，以生物学变异导出的质量规范和我国卫生行业标准WS／T 403-2012来分析我国各实验室不精密度水平。方法采用基于Web的室间质量评价软件系统，收集参加全国干化学室间质评项目的374家实验室2014年2月2个浓度（浓度1和浓度2）室内质控数据，包括钾、钠、氯、钙、磷、血糖、尿素、尿酸、肌酐、白蛋白、总蛋白、总胆固醇、甘油三酯、丙氨酸氨基转移酶、天门冬氨酸氨基转移酶、总胆红素、碱性磷酸酶、淀粉酶、肌酸激酶、乳酸脱氢酶、镁、γ-谷氨酰基转移酶22个检测项目的室内质控变异系数（ CV）。应用（ CLinetlab IQC） V3．0计算室内质控CV通过率来反映各实验室检测系统的不精密度水平能否满足规定的质量要求。结果结合浓度1和浓度2水平，对基于生物学变异导出的允许不精密度来说，尿素、尿酸、甘油三酯、总胆红素、丙氨酸氨基转移酶、肌酸激酶、γ-谷氨酰基转移酶7个项目比较满意，满足生物学变异“适当标准”的实验室比例均在92％以上，95％以上的实验室均能满足“最低标准”，满足“最佳标准”的实验室也能大约占到60％以上。血糖、总胆固醇、钾、磷、天门冬氨酸氨基转移酶、淀粉酶、乳酸脱氢酶7个项目基本满意，满足生物学变异“适当标准”的实验室基本在60％～90％之间，满足生物学变异“最低标准”的实验室均能在87％以上，而满足“最佳标准”的实验室数相对较低，在5．70％～69．74％之间。然而，钠、氯、钙、总蛋白、白蛋白、镁6个检测项目满足“适当标准”的实验室就极少。以我国卫生行业标准WS／T 403-2012质量规范为标准，各实验室精密度水平较好，基本在47％～70％之间。结论从统计的室内质控数据看，不同的检测项目满足允许不精密度质量规范的实验室百分数不同。实验室应设置适当的质量要求，针对各自的不足加强室内质量控制，提高其检测质量水平，从而改善我国干化学精密度水平的现状。
目的：通過調查2014年全國374傢實驗室上報的榦化學檢測項目室內質控數據，以生物學變異導齣的質量規範和我國衛生行業標準WS／T 403-2012來分析我國各實驗室不精密度水平。方法採用基于Web的室間質量評價軟件繫統，收集參加全國榦化學室間質評項目的374傢實驗室2014年2月2箇濃度（濃度1和濃度2）室內質控數據，包括鉀、鈉、氯、鈣、燐、血糖、尿素、尿痠、肌酐、白蛋白、總蛋白、總膽固醇、甘油三酯、丙氨痠氨基轉移酶、天門鼕氨痠氨基轉移酶、總膽紅素、堿性燐痠酶、澱粉酶、肌痠激酶、乳痠脫氫酶、鎂、γ-穀氨酰基轉移酶22箇檢測項目的室內質控變異繫數（ CV）。應用（ CLinetlab IQC） V3．0計算室內質控CV通過率來反映各實驗室檢測繫統的不精密度水平能否滿足規定的質量要求。結果結閤濃度1和濃度2水平，對基于生物學變異導齣的允許不精密度來說，尿素、尿痠、甘油三酯、總膽紅素、丙氨痠氨基轉移酶、肌痠激酶、γ-穀氨酰基轉移酶7箇項目比較滿意，滿足生物學變異“適噹標準”的實驗室比例均在92％以上，95％以上的實驗室均能滿足“最低標準”，滿足“最佳標準”的實驗室也能大約佔到60％以上。血糖、總膽固醇、鉀、燐、天門鼕氨痠氨基轉移酶、澱粉酶、乳痠脫氫酶7箇項目基本滿意，滿足生物學變異“適噹標準”的實驗室基本在60％～90％之間，滿足生物學變異“最低標準”的實驗室均能在87％以上，而滿足“最佳標準”的實驗室數相對較低，在5．70％～69．74％之間。然而，鈉、氯、鈣、總蛋白、白蛋白、鎂6箇檢測項目滿足“適噹標準”的實驗室就極少。以我國衛生行業標準WS／T 403-2012質量規範為標準，各實驗室精密度水平較好，基本在47％～70％之間。結論從統計的室內質控數據看，不同的檢測項目滿足允許不精密度質量規範的實驗室百分數不同。實驗室應設置適噹的質量要求，針對各自的不足加彊室內質量控製，提高其檢測質量水平，從而改善我國榦化學精密度水平的現狀。
목적：통과조사2014년전국374가실험실상보적간화학검측항목실내질공수거，이생물학변이도출적질량규범화아국위생행업표준WS／T 403-2012래분석아국각실험실불정밀도수평。방법채용기우Web적실간질량평개연건계통，수집삼가전국간화학실간질평항목적374가실험실2014년2월2개농도（농도1화농도2）실내질공수거，포괄갑、납、록、개、린、혈당、뇨소、뇨산、기항、백단백、총단백、총담고순、감유삼지、병안산안기전이매、천문동안산안기전이매、총담홍소、감성린산매、정분매、기산격매、유산탈경매、미、γ-곡안선기전이매22개검측항목적실내질공변이계수（ CV）。응용（ CLinetlab IQC） V3．0계산실내질공CV통과솔래반영각실험실검측계통적불정밀도수평능부만족규정적질량요구。결과결합농도1화농도2수평，대기우생물학변이도출적윤허불정밀도래설，뇨소、뇨산、감유삼지、총담홍소、병안산안기전이매、기산격매、γ-곡안선기전이매7개항목비교만의，만족생물학변이“괄당표준”적실험실비례균재92％이상，95％이상적실험실균능만족“최저표준”，만족“최가표준”적실험실야능대약점도60％이상。혈당、총담고순、갑、린、천문동안산안기전이매、정분매、유산탈경매7개항목기본만의，만족생물학변이“괄당표준”적실험실기본재60％～90％지간，만족생물학변이“최저표준”적실험실균능재87％이상，이만족“최가표준”적실험실수상대교저，재5．70％～69．74％지간。연이，납、록、개、총단백、백단백、미6개검측항목만족“괄당표준”적실험실취겁소。이아국위생행업표준WS／T 403-2012질량규범위표준，각실험실정밀도수평교호，기본재47％～70％지간。결론종통계적실내질공수거간，불동적검측항목만족윤허불정밀도질량규범적실험실백분수불동。실험실응설치괄당적질량요구，침대각자적불족가강실내질량공제，제고기검측질량수평，종이개선아국간화학정밀도수평적현상。
Objective To investigate the imprecision level of dry chemistry tests in China through analyzing the internal quality control data of dry chemistry tests reported by 374 laboratories in 2014 according to the specifications based on biological variation and the health industry standard WS /T 403-2012 of China.Methods Web-based external quality assessment system was used to collect internal quality control data of 2 concentrations ( concentration 1 and concentration 2) of dry chemistry tests from 374 laboratories in February 2014, including the internal quality control coefficients of variation (CV) of 22 items, potassium, sodium, chloride, calcium, phosphorus, blood glucose, urea, uric acid, creatinine, total protein, albumin, total cholesterol, triglyceride, alanine aminotransferase , aspartate aminotransferase, total bilirubin, alkaline phosphatase, amylase, creatine kinase, lactate dehydrogenase, magnesium and gamma-glutamyltransferase.CLinetlab IQC V3.0 were applied for data processing .The percentages of laboratories meeting the quality requirements were calculated to reflect whether the imprecision of different test systems can meet the quality requirements.Results Combined with the concentrations of 1 and 2, for the results according to the specifications based on biological variation , seven projects such as urea, uric acid, triglyceride, total bilirubin, alanine aminotransferase , creatine kinase and gamma-glutamyltransferase were quite satisfied . Laboratories meeting the specifications based on biological variation including the desirable , minimal and optimal allowable imprecisions were above 92%, 95% and 60%, respectively. Blood glucose, total cholesterol, potassium, phosphorus, aspartate aminotransferase , amylase and lactate dehydrogenase were basically satisfied , laboratories who met the desirable allowable imprecision accounted for 60%to 90%, more than 87% laboratories met the minimal specification , but the percentages who met the optimal specification was relatively low which was between 5.70%and 69.74%.However, for items like sodium, chloride, calcium, total protein, albumin and magnesium, laboratories who met the desirable specification was nothing much .For the results based on health industry standard WS/T403-2012, the imprecision level of each laboratory is really satisfied , and the percentages of laboratories meeting the requirement was basically between 47%and 70%.Conclusions Based on the data above , the percentage of laboratories meeting the requirement varies between different items .Laboratories shall set proper quality requirements , strengthen their deficiency and improve the testing quality , so as to improve the present situation of dry chemistry tests in our country .
