CAJ | 학술논문

目的：了解湖北省临床化学常规检验项目满足允许不精密度质量规范的水平。方法收集2013年参加湖北省临床化学室内质控数据实验室间比对计划中值浓度水平的室内质控数据，分析钾、钠、氯、总钙、磷、葡萄糖、尿素、尿酸、肌肝、总蛋白、清蛋白、总胆固醇、三酰甘油、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、乳酸脱氢酶和γ-谷氨酰基转移酶等21个临床化学常规检验项目的室内质控变异系数，采用1／3TEa，1／4TEa，WS／T403-2012和基于生物学变异导出的允许不精密度作为质量规范，分析实验室满足各质量规范标准所占的比例。结果50％以上实验室能满足1／3 Tea，1／4 Tea，WS／T403-2012和基于生物学变异导出的最适、最低允许不精密度质量规范要求的项目有三酰甘油、丙氨酸氨基转移酶、肌酸激酶、总胆红素；50％以上实验室不能满足以上所有质量规范的项目有氯和肌酐；所有实验室不能满足基于生物学变异导出的最佳允许不精密度的项目有钠和总钙。以80％的实验室变异系数小于质量规范作为合格评价标准，21个项目中满足生物学变异最低质量规范的项目数最多，占66.7％，满足 WS／T403-2012和生物学变异最佳质量规范的项目数最少，占14.3％。结论参加湖北省室内质控数据实验室间比对的实验室21个项目的室内质控变异系数总体上是达到要求的，但部分项目的检测结果离散度大，实验室应根据该室的检测能力和质量规范标准设定合适的不精密度水平，并通过实验室的持续改进不断提高检验质量。
목적：료해호북성림상화학상규검험항목만족윤허불정밀도질량규범적수평。방법수집2013년삼가호북성림상화학실내질공수거실험실간비대계화중치농도수평적실내질공수거，분석갑、납、록、총개、린、포도당、뇨소、뇨산、기간、총단백、청단백、총담고순、삼선감유、병안산안기전이매、천문동안산안기전이매、총담홍소、감성린산매、정분매、기산격매、유산탈경매화γ-곡안선기전이매등21개림상화학상규검험항목적실내질공변이계수，채용1／3TEa，1／4TEa，WS／T403-2012화기우생물학변이도출적윤허불정밀도작위질량규범，분석실험실만족각질량규범표준소점적비례。결과50％이상실험실능만족1／3 Tea，1／4 Tea，WS／T403-2012화기우생물학변이도출적최괄、최저윤허불정밀도질량규범요구적항목유삼선감유、병안산안기전이매、기산격매、총담홍소；50％이상실험실불능만족이상소유질량규범적항목유록화기항；소유실험실불능만족기우생물학변이도출적최가윤허불정밀도적항목유납화총개。이80％적실험실변이계수소우질량규범작위합격평개표준，21개항목중만족생물학변이최저질량규범적항목수최다，점66.7％，만족 WS／T403-2012화생물학변이최가질량규범적항목수최소，점14.3％。결론삼가호북성실내질공수거실험실간비대적실험실21개항목적실내질공변이계수총체상시체도요구적，단부분항목적검측결과리산도대，실험실응근거해실적검측능력화질량규범표준설정합괄적불정밀도수평，병통과실험실적지속개진불단제고검험질량。
Objective To learn how well these items of Hubei Province meet the quality standards of allowed imprecision. Methods Collected the indoor quality control data of median concentration levels from the laboratories which participated the project of interlaboratory comparisons of clinical chemistry indoor quality control data in Hubei Province.This paper was to analyze the variation coefficient of indoor quality control for 21 routine clinical chemistry examination items which were K,Na,Cl,TCa,P,GLu,Urea,UA,Cr,TP,Alb,TC,TG,ALT,AST,TBil,ALP,AMS,CK,LDH andγ-GT.The other objec-tive was to learn how well these items of Hubei Province meet the quality standards of allowed imprecision.Then took the 1/3 TEa,1/4 TEa,WS/T-403-2012 and minimum imprecision derived from biological variation as quality specification.And an-alyzed the percentage of laboratories in meeting the quality standards.Results The TG,ALT,CK and TBil in more than 50% of the participated laboratories could meet the quality standards of the 1/3 TEa,1/4 TEa,WS/T-403-2012 and the low-est appropriate imprecision derived from biological variation.The Cl and Cr in more than 50% of laboratories couldn’t meet the all above quality standards.The Na and TCa in all laboratories couldn’t meet the quality standards of best imprecision derived from biological variation.The evaluation criterion for qualified items setted was that the variation coefficient in more than 80% laboratories was less than the quality standard.Thus,the percentage of the items which meet the lowest quality standard of biological variation and the all 21 items was the most (66.7%).While the percentage of the items which met the quality standards of the WS/T403-2012 and the best biological variation was the least (14.3%).Conclusion In short,the values of indoor variation coefficient of the 21 items in laboratories which participated the project of interlaboratory compari-sons of clinical chemistry indoor quality control data generally met the requirements.But some items had a little higher de-gree of dispersion.The laboratories should set the appropriate imprecision levels based on the detection capability and quality standards and improve the quality of examination through continuous efforts.