CAJ | 학술논문

目的评价探讨2012年我国临床实验室检测抗核抗体(ANA)滴度报告的一致性程度中存在的问题,为进一步促进ANA检测标准化提供依据.方法实验性调查研究.卫生部临床检验中心2012年共发放5份样本(1份ANA阴性,4份ANA阳性的自身免疫病患者血清)至533家参评实验室.滴度结果报告的方式分为稀释梯度为2倍滴度系统和3.2倍滴度系统,要求临床实验室根据各自实验室日常工作所用滴度报告方式,选择不同滴度系统回报ANA滴度和起始稀释度结果.计算滴度结果的中位数,对2倍滴度系统采用中位数±2个稀释梯度作为允许滴度范围；对3.2倍滴度系统采用中位数±1个稀释梯度作为允许范围,分别计算滴度与中位数相符的实验室比例和在允许范围内的实验室比例,以分析2种方法检测滴度报告的一致性.结果 412家实验室参加滴度结果回报,其中:11.9％ (49/412)的实验室采用2倍滴度系统回报结果；88.1％ (363/412)的实验室采用3.2倍滴度系统回报结果.2倍滴度系统报告1211、1212、1213和1215号样本,中位数分别为1∶640、1∶320、＞1∶1280和1∶160,其中与中位数相符的实验室比例最低为24.5％(12/49),最高为57.1％(28/49)；在允许范围内的实验室比例最低为87.8％ (43/49).随机选取49家采用3.2倍滴度系统的实验室报告1211、1212、1213和1215号样本,中位数分别为1∶1000、1∶1000、＞1∶3200和1∶320,与中位数相符的实验室比例最低为63.3％ (31/49),最高为83.7％ (41/49).各样本滴度结果在允许范围内的实验室比例最低为98.0％ (48/49).结论全国ANA滴度回报结果不理想,要提高ANA检测滴度结果报告的实验室间可比性,有必要对试剂、荧光显微镜、实验室测定操作和结果报告解释进行标准化.
목적 평개탐토2012년아국림상실험실검측항핵항체(ANA)적도보고적일치성정도중존재적문제,위진일보촉진ANA검측표준화제공의거.방법 실험성조사연구.위생부림상검험중심2012년공발방5빈양본(1빈ANA음성,4빈ANA양성적자신면역병환자혈청)지533가삼평실험실.적도결과보고적방식분위희석제도위2배적도계통화3.2배적도계통,요구림상실험실근거각자실험실일상공작소용적도보고방식,선택불동적도계통회보ANA적도화기시희석도결과.계산적도결과적중위수,대2배적도계통채용중위수±2개희석제도작위윤허적도범위；대3.2배적도계통채용중위수±1개희석제도작위윤허범위,분별계산적도여중위수상부적실험실비례화재윤허범위내적실험실비례,이분석2충방법검측적도보고적일치성.결과 412가실험실삼가적도결과회보,기중:11.9％ (49/412)적실험실채용2배적도계통회보결과；88.1％ (363/412)적실험실채용3.2배적도계통회보결과.2배적도계통보고1211、1212、1213화1215호양본,중위수분별위1∶640、1∶320、＞1∶1280화1∶160,기중여중위수상부적실험실비례최저위24.5％(12/49),최고위57.1％(28/49)；재윤허범위내적실험실비례최저위87.8％ (43/49).수궤선취49가채용3.2배적도계통적실험실보고1211、1212、1213화1215호양본,중위수분별위1∶1000、1∶1000、＞1∶3200화1∶320,여중위수상부적실험실비례최저위63.3％ (31/49),최고위83.7％ (41/49).각양본적도결과재윤허범위내적실험실비례최저위98.0％ (48/49).결론 전국ANA적도회보결과불이상,요제고ANA검측적도결과보고적실험실간가비성,유필요대시제、형광현미경、실험실측정조작화결과보고해석진행표준화.
Objective To evaluate the agreement of antinuclear antibody (ANA) titer reported in clinical laboratories and analyze possible problems in clinical laboratories.Methods Experiment survey.The panel consisting of 5 samples was distributed to 533 laboratories.Each panel contains one negative sample and 4 positive samples,which were from individuals of autoimmune disease.ANA titer system was divided into traditional titer system with two-fold dilution and titer system with 3.2 times dilution.Clinical laboratories were required to report the ANA titers and initial screening dilution according to the standard used in routine work.Results were expressed as median titers and range for acceptable performance.As to titer system with two-fold dilution,acceptable performance on proficiency testing was defined by a result equal to median titer ± two two-fold dilutions.While as to titer system with 3.2 times dilution,acceptable performance on proficiency testing was defined by a result equal to median titer ± 3.2 times dilutions.The laboratories percentages with acceptable performance were calculated to evaluate their agreements.Results 412 laboratories reported ANA titer results,of which 11.9％ (49/412)reported results with two-fold dilution titer system,88.1％ (363/412)reported results with 3.2 times dilution titer system.The median titers of sample 1211,1212,1213 and 1215 reported with two-fold titer system were 1 ∶ 640,1∶ 320,＞ 1 ∶ 1280 and1∶ 160,respectively.The agreement within the median ANA titer reported with two-fold dilution titer system ranged from 24.5％ (12/49) to 57.1％ (28/49) and the lowest percentage of the results within the acceptable limits was 87.8％ (43/49).The median titers of sample 1211,1212,1213 and 1215 reported with 3.2 times dilution titer system were 1 ∶ 1000,1∶ 1000,＞ 1 ∶ 3200 and 1 ∶ 320,respectively.The agreement within the median ANA titer reported with 3.2 times dilution titer system ranged from 63.3％ (31/49)to 83.7％ (41/49).The lowest percentage of the results within the acceptable limits was 98.0％ (48/49).Conclusions The results of ANA titer reported are unsatisfactory.Standardization for reagent,microscopy,procedure and result interpretation is necessary to improve the agreement of ANA titer report in different laboratories.