CAJ | 학술논문

目的：对检测 C反应蛋白的艾瑞德干式免疫分析仪进行性能验证，确保其结果的准确、可靠。方法参考美国临床和实验室标准化协会（CLSI）推荐的EP5‐A2文件进行精密度验证，参考EP15‐A2文件进行正确度的验证，参考EP6‐A2文件进行线性范围的验证，参考CLSI C28‐A2文件进行参考区间的验证，参考常规检测方法进行携带污染率的验证。结果全血高、低浓度批内精密度分别为3．29％、3．68％，总精密度分别为4．91％、5．26％；参考区间为0～10 mg／L ；线性回归方程Y＝1．0702 X＋0．4484，r＝0．979；线性范围为2．5～160．0 mg／L ；携带污染率小于1％。结论艾瑞德免疫分析仪具有良好的精密度、准确度，较宽的线性范围、较快的检测速度等优点，适用于临床检测。
목적：대검측 C반응단백적애서덕간식면역분석의진행성능험증，학보기결과적준학、가고。방법삼고미국림상화실험실표준화협회（CLSI）추천적EP5‐A2문건진행정밀도험증，삼고EP15‐A2문건진행정학도적험증，삼고EP6‐A2문건진행선성범위적험증，삼고CLSI C28‐A2문건진행삼고구간적험증，삼고상규검측방법진행휴대오염솔적험증。결과전혈고、저농도비내정밀도분별위3．29％、3．68％，총정밀도분별위4．91％、5．26％；삼고구간위0～10 mg／L ；선성회귀방정Y＝1．0702 X＋0．4484，r＝0．979；선성범위위2．5～160．0 mg／L ；휴대오염솔소우1％。결론애서덕면역분석의구유량호적정밀도、준학도，교관적선성범위、교쾌적검측속도등우점，괄용우림상검측。
Objective To evaluate the performance of i‐READER immunity analyzer in C reactive protein (CRP) detection .Methods The precision ,accuracy ,linearity and reference interval of CRP were validated according to Clinical and Laboratory Standards Institute (CLSI) documents EP5‐A2 ,EPl5‐A2 ,EP6‐A2 and C28‐A2 respetive‐ly .Conventional detection method was used to measure carry pollution rate .Results The within‐run precisions of high level and low level samples of CRP were 3 .29% and 3 .68% respectively .And the total precisions were 4 .91%and 5 .26% respectively .The reference interval of CRP was between 0 and 10 mg/L .Equation of linear regression was Y=1 .070 2X+0 .448 4 (r=0 .979) and linearity range was from 2 .5 to 160 .0 mg/L .The carry pollution was less than 1% .Conclusion The i‐reader immunity analyzer might be suitable for clinical testing with good precision , accuracy ,wide linear range and faster detection speed .