CAJ | 학술논문

目的：验证验证 Primus Trinity Ultra2分析仪测定 HbA1c 的精密度、准确度、分析测量范围和抗干扰能力的可接受性。方法参照美国临床与实验室标准化协会（CLSI）EP 文件及相关文献对 Primus Trinity Ultra2分析仪测定 HbA1c 的精密度、准确度、分析测量范围和抗干扰能力进行验证。结果 Trinity Ultra2分析仪检测 HbA1c 精密度的批内不精密度和总不精神度均小于厂商声明的不精密度值；Trinity Ultra2分析仪测定定值参考物的结果均在各自的验证区间；Trinity Ultra2分析仪在线性验证中，通过测定按一定比例稀释后的标本，得到了理论值与实测值间的回归方程，r2＞0．95，a 值在0．97～1．03的范围内；Trinity Ultra2分析仪有良好的抗黄疸、溶血、脂血、乳糜等干扰物质的能力。结论 Primus Trinity U1tra2分析仪亲和层析法的主要分析性能均达到厂商声明的性能和有关质量的要求，可满足临床需求。
목적：험증험증 Primus Trinity Ultra2분석의측정 HbA1c 적정밀도、준학도、분석측량범위화항간우능력적가접수성。방법삼조미국림상여실험실표준화협회（CLSI）EP 문건급상관문헌대 Primus Trinity Ultra2분석의측정 HbA1c 적정밀도、준학도、분석측량범위화항간우능력진행험증。결과 Trinity Ultra2분석의검측 HbA1c 정밀도적비내불정밀도화총불정신도균소우엄상성명적불정밀도치；Trinity Ultra2분석의측정정치삼고물적결과균재각자적험증구간；Trinity Ultra2분석의재선성험증중，통과측정안일정비례희석후적표본，득도료이론치여실측치간적회귀방정，r2＞0．95，a 치재0．97～1．03적범위내；Trinity Ultra2분석의유량호적항황달、용혈、지혈、유미등간우물질적능력。결론 Primus Trinity U1tra2분석의친화층석법적주요분석성능균체도엄상성명적성능화유관질량적요구，가만족림상수구。
Objective To evaluate the precision,accuracy,linear range and anti-interference performance of HbA1c assay by u-sing Primus Trinity Ultra2 automated analyzer.Methods According to Document EP published in 2004 by American Clinical and Laboratory Standards Institution(CLSI)and relative literatures,the precision,accuracy,linear range and anti-interference perform-ance were evaluated.Results The within-run and between-run CVs of HbA1c determination were both less than that announced by manufacture.In the tests of samples with certain concentrations,all the results were within the verification range respectively.In the linear verification,regression equation between the theoretical and measured values demonstrated that r2 >0.95,and a value was within the range of 0.97-1.03.For Primus Trinity Ultra2 the limit of interference effect didn′t exceed the allowable error at the medical decision concentrations.Conclusion The precision,accuracy,linear range and anti-interference was evaluated of the Primus Trinity Ultra2 automating HbA1c all could meet the manufacture′s declaim and the clinical needs.