摘要
目的以2011年的数据为基线数据,分析上海地区2012~2014年度各级医疗机构糖化血红蛋白(Hb A1c)项目能力验证计划(PT)/正确度验证计划(TPT)结果,为提高Hb A1c检测质量、推进Hb A1c标准化提供依据。方法收集2011~2014年参加上海市临床检验中心(SCCL)组织的Hb A1cPT/TPT医院4次调查结果。分析上海地区各医院检测Hb A1c4年的基础数据演变,包括医院分布、检测方法分布;分别采用国际临床化学与检验医学联合会(IFCC)Hb A1c一级参考方法赋值和参加医院的公议值(组中位数)方法作为调查品的指定值(或称靶值),采用美国病理家协会(CAP)和上海地区Hb A1c质评标准分别对各级医院和各检测方法的合格率进行比较分析;分析每个调查品的总体检测性能(精密度和正确度)和各方法组的达标率,并与CAP全球质评结果进行比较。结果参加SCCL组织的PT/TPT的医院数从2011年的245家增加到2014年的308家。国产品牌MQ2000PT和进口品牌Bio-Rad、Tosoh、Arkray高效液相色谱法(HPLC)检测系统用户数增加较快,增减率为38.1%~360.0%;3个即时检验(POCT)产品中Axis-Shield增减率为-78.9%,Boditech 2013年起未见医院使用,Quo-Test从2012年起有医院开始使用,增减率为27.8%;2个低压液相色谱(LPLC)产品Drew DS5、MQ 2000的增减率分别为-80.0%和-25.0%。上海地区各级医院总体合格率呈逐年提高趋势,从2011年的83.7%(CAP标准为69.8%)提高至2014年的95.8%(CAP标准为90.3%)。2014年二级甲等以上医院合格率均达到了98.8%,达到了同年CAP全球质评水平(88.8%~96.2%)。一级医院和二级医院不合格数高于其他级别。各方法组中以组中位数为靶值得出的总体合格率高于参考方法赋值得出的合格率,采用上海地区标准得出的总体合格率高于CAP标准。采用CAP年度标准评价HPLC的合格率,除2013年的Tosoh组外,其余组仍能达81.0%~100.0%;2个LPLC、3个POCT和Immuno组(除2014年外)的合格率为0%~75.
Objective To analyze the results of proficiency testing （PT） /trueness-based proficiency testing （TPT） for hemoglobin A1c（HbA1c） in Shanghai from 2012 to 2014 by the use of 2011 data as baseline, in order to provide the reference for HbA1c determination quality improvement and standardization promotion. Methods The results of HbA1c PT/TPT organized by Shanghai Center for Clinical Laboratory （SCCL） from 2011 to 2014 were collected, and the 4-year datum change trend was analyzed about hospital and determination method distributions. The pass rates of each hospital and each method were analyzed by means of comparing the assigned values （target values ） by the International Federation of Clinical Chemistry and Laboratory Medicine （IFCC） HbAlo primary reference method and the group median values. Both College of American Pathologists （CAP） criteria and Shanghai local criteria of quality assessment for HbA1c were also used. The performance （precision and accuracy） of each survey material and each group＇s pass rate were analyzed and compared with CAP global quality assessment results. Results The number of participants increased from 245 in 2011 to 308 in 2014. The usage of domestic brand, MQ 200OPT, and imported brands, Bio-Rad, Tosoh and Arkray [ high performance liquid chromatography （HPLC） ] , increased rapidly, and the rate was 38. 1%-360. 0%. A total of 3 point-of-care testing （POCT） devices were as follows： Axis-Shield （ -78.9% ）, Boditech （no usage since 2013） and Quo-Test （usage since 2012, 27.8% ）. The usage rates of 2 low pressure liquid chromatography （LPLC） devices, Drew DS5 and MQ 2000, were - 80. 0% and - 25. 0%, respectively. The whole pass rate increased annually from 83.7% in 2011 （CAP 69.8% ） to 95.8% in 2014 （CAP 90.3% ）. In 2014, the hospitals above Grade 2A had the pass rate 98.8% , while the CAP global quality assessment data were 88.8% -96.2% in the same year. The Grade 1 and Grade 2 hospitals had low pass rate than other grades.
出处
《检验医学》
CAS
2015年第11期1059-1069,共11页
Laboratory Medicine
基金
上海市卫生和计划生育委员会资助项目(2013ZYJB0010)
上海市科学技术委员会科研计划项目(14441903503)
关键词
糖化血红蛋白
正确度验证计划
糖尿病
Hemoglobin A1c
Trueness-based proficiency testing
Diabetes mellitus
