CAJ | 학술논문

目的：评定不精密度需室内质量控制（ IQC）数据最少月数的分析并验证其合理性，比较分析项目、浓度、年份对不合格率的影响。方法回顾性研究。收集2009年至2011年上海地区32家医院含20个项目（白蛋白ALB、肌酸激酶CK、总胆红素TB、丙氨酸转氨酶ALT、天冬氨酸转氨酶AST、乳酸脱氢酶LDH、γ-谷氨酰基转移酶GGT、碱性磷酸酶ALP、钙Ca、氯Cl、肌酐Cr、葡萄糖Glu、钾K、钠Na、磷P、三酯甘油TG、总胆固醇TCh、总蛋白TP、尿酸UA、尿素Urea）涉及6个测量系统（罗氏、雅培、日立、西门子德灵、贝克曼、奥林帕斯）共3534个分析组的IQC数据。对每个分析组的累积月数与总体（12个月）进行t检验，可知每个分析组达到稳定所需最少月数，得到月份对达到稳定的分析组的变化趋势，采用u检验分别分析等级医院、分析物水平、项目间的相关系数r，得到P＞0.05的分析组数百分比。比较所有分析组6个月、10个月的变异系数（ CV）与全年总CV的相对偏移。以大于我国行标不精密度的分析组作为不合格者，分析不同项目、浓度和年份对不合格率的影响。结果不同等级医院、分析物水平、项目间不精密度（用CV表示）达到稳定时间分别为94.2％、100％和100％，差异无统计学意义。在10个月内不精密度达到稳定的分析组为88％。6个月和10个月CV的相对偏移≤5％的分析组分别占25％和88％。不合格的分析组达到了20％，项目中最不易合格的为Ca，同一项目低浓度比高浓度的不合格率高，随着年份增长，不合格率呈下降趋势。结论10个月以上的IQC数据更适用于医学实验室评定不精密度，不同项目、浓度以及年份的不合格率均有所不同，不精密度行标的建立可考虑这些因素。
목적：평정불정밀도수실내질량공제（ IQC）수거최소월수적분석병험증기합이성，비교분석항목、농도、년빈대불합격솔적영향。방법회고성연구。수집2009년지2011년상해지구32가의원함20개항목（백단백ALB、기산격매CK、총담홍소TB、병안산전안매ALT、천동안산전안매AST、유산탈경매LDH、γ-곡안선기전이매GGT、감성린산매ALP、개Ca、록Cl、기항Cr、포도당Glu、갑K、납Na、린P、삼지감유TG、총담고순TCh、총단백TP、뇨산UA、뇨소Urea）섭급6개측량계통（라씨、아배、일립、서문자덕령、패극만、오림파사）공3534개분석조적IQC수거。대매개분석조적루적월수여총체（12개월）진행t검험，가지매개분석조체도은정소수최소월수，득도월빈대체도은정적분석조적변화추세，채용u검험분별분석등급의원、분석물수평、항목간적상관계수r，득도P＞0.05적분석조수백분비。비교소유분석조6개월、10개월적변이계수（ CV）여전년총CV적상대편이。이대우아국행표불정밀도적분석조작위불합격자，분석불동항목、농도화년빈대불합격솔적영향。결과불동등급의원、분석물수평、항목간불정밀도（용CV표시）체도은정시간분별위94.2％、100％화100％，차이무통계학의의。재10개월내불정밀도체도은정적분석조위88％。6개월화10개월CV적상대편이≤5％적분석조분별점25％화88％。불합격적분석조체도료20％，항목중최불역합격적위Ca，동일항목저농도비고농도적불합격솔고，수착년빈증장，불합격솔정하강추세。결론10개월이상적IQC수거경괄용우의학실험실평정불정밀도，불동항목、농도이급년빈적불합격솔균유소불동，불정밀도행표적건립가고필저사인소。
Objective To discover and certify the minimum required months of IQC ( Internal Quality Control ) data which were used to quantify the imprecision To identify the impact of test items , different concentrantions and years on the defective rate .Methods IQC data involving 20 analysis items ( including Albumin, Creatine kinase, Total bilirubin, Alanine aminotransferase, Aspartate aminotransferase, Lactate dehydrogenase,γ-Glutamyl transferase, Alkaline phosphatase, Calcium, Chlorine, Creatinine, Glucose, Potassium, Sodium, Phosphorus, Triglyceride, Total cholesterol, Total protein, Uric acid, Urea) and six measurement systems (including Roche, Architect, Hitachi, Dade/Behring, Beckman, Olympus) were collected from hospitals in Shanghaibetween 2009 and 2011.A total of 3 534 groups, referred to one year laboratory′s IQC data of one concentration range , were analysed to find the minimum required months in each group when the cumulative months were compared with the population by using T test.The correlation coefficient of hospital′grades, measurement levels and test items were evaluated by u test, and the percentage of groups of P>0.05 were collected.The cumulative IQC data′coefficient variation ( CV) of six months and eleven months were compared with the total CV, respectively .Imprecision higher than the professional specification was regarded as unqualified .Difference of unqualified rate among test items, concentrations and years were expolored .Results Rates of hospital′grades, measurement levels , items are 94.2%,100%, 100%respectively , 88%of groups′imprecision became stable in ten months .25%groups reach the criteria that the relative bias is ≤5% when calculated the cumulative IQC data′CV of six months, while 88%groups do when calculated the cumulative IQC data′CV of ten months.The unqualified rate is 20%and the most unqualified item is Ca , the unqualified groups of low level are larger .With increase of year , the unqualified rate showed a downtrend .Conclusions Ten months′IQC data is more reliable to quantify imprecision .Unqualified rates are different according to test items , measure levels and years , the establishment of professional specification should consider them.