摘要
目的基于ISO15189实验室认可要求,对实验室2套ALT检测系统进行性能验证,并做系统间比对分析。方法根据ISO15189和中华人民共和国卫生行业标准(WS/T)相关文件,对实验室2套ALT检测系统进行精密度、正确度、可报告范围、生物参考区间的验证,并做系统间比对试验。结果 2套系统检测中、高值两个浓度质控血清的批内、批间不精密度(CV)均<5%;正确度验证通过检测定值校准品及卫生部室间质评标本,结果与靶值的相对偏倚均<10%;验证可报告范围的回归方程Y^=bx+a,相关系数r2均>0.95,b均在1±0.03范围内,a≠0,假设t检验分析截距a与0的差异,均为P>0.05,截距a与0差异无统计学意义,两套检测系统在试剂说明书声明的可报告范围内的结果准确可靠;引用的生物参考区间符合本实验室服务的正常献血人群;在医学决定水平处(50 U/L),比对试验的相对系统误差SE=2.63,<1/2 TEa。结论实验室2套ALT检测系统的性能指标能够达到试剂说明书及ISO15189相关行业文件要求,系统间检测结果具有一致性。
Objective The performance of two sets of ALT detection systems in the laboratory was verified and compared based on the requirements of ISO15189 laboratory accreditation. Methods According to ISO15189 and relevant documents of the health industry standard of the People′s Republic of China(WS/T), two sets of ALT detection systems in the laboratory were verified in terms of precision, accuracy, reportable range and biological reference range, and then compared. Results By detecting medium and high values of QC serum, the degree of intra-batch and inter-batch precision were all < 5%.The relative bias of calibration and EQA was <10% compared with their target values. The regression equation of the reportable range was Y^= bx+a, the correlation coefficient r^2 was > 0.95, b was in the range of 1±0.03, and a≠0.The difference between a and 0 were analyzed by t test,and was not statistically significant(P>0.05). The results of both systems were accurate within the reportable range stated in the reagent specification. The biological reference interval was consistent with the normal blood donation population served by the laboratory. At medical decision level(50 U/L), the relative system error of the comparative test was SE = 2.63, < 1/2 TEa. Conclusion The performance indexes of two sets of ALT detection systems meets the requirements of reagent specification and ISO15189, and the test results between systems are consistent.
作者
金建怀
蒋瑞馨
许友山
宋晓菲
JIN Jianhuai;JIANG Ruixing;XU Youshan;SONG Xiaofei(Wuxi Red Cross Center Blood Bank,Wuxi 214000,China)
出处
《中国输血杂志》
CAS
2020年第11期1193-1196,共4页
Chinese Journal of Blood Transfusion
