CAJ | 학술논문

目的：应用CLSI EP10-A2文件初步评价DXI800化学发光仪的分析性能。方法严格按照 EP10-A2文件要求，连续5 d按特定顺序测定高、中、低浓度质控血清中的人生长激素（hG H ）浓度，采用 Excel软件计算hG H测定的偏差、总不精密度及每天的多元回归分析参数（即截距、斜率、非线性、携带污染率及漂移度）。结果当质控血清hGH浓度为2．15、5．47、10．80 mmol/L时，hGH测定值与靶值间线性良好（Y ＝0．992X＋0．083，r2＝0．978）；偏差分别为0．066、0．265、0．055 mmol/L ；总不精密度分别为6．57％、8．53％、4．56％；采用单样本 t检验，每个多元回归分析参数5 d的值与其预测值相比，差异均无统计学意义（ P＞0．05）。结论 DXI800化学发光仪测定hG H ，其偏差及总不精密度均在允许范围内，线性关系良好，携带污染率较低，稳定性良好，能满足临床及科研需求。
목적：응용CLSI EP10-A2문건초보평개DXI800화학발광의적분석성능。방법엄격안조 EP10-A2문건요구，련속5 d안특정순서측정고、중、저농도질공혈청중적인생장격소（hG H ）농도，채용 Excel연건계산hG H측정적편차、총불정밀도급매천적다원회귀분석삼수（즉절거、사솔、비선성、휴대오염솔급표이도）。결과당질공혈청hGH농도위2．15、5．47、10．80 mmol/L시，hGH측정치여파치간선성량호（Y ＝0．992X＋0．083，r2＝0．978）；편차분별위0．066、0．265、0．055 mmol/L ；총불정밀도분별위6．57％、8．53％、4．56％；채용단양본 t검험，매개다원회귀분석삼수5 d적치여기예측치상비，차이균무통계학의의（ P＞0．05）。결론 DXI800화학발광의측정hG H ，기편차급총불정밀도균재윤허범위내，선성관계량호，휴대오염솔교저，은정성량호，능만족림상급과연수구。
Objective To evaluate the detection performance of DXI800 chemiluminescence analyzer (DXI800 analyzer) according to EP10-A2 document of Clinic and Laboraroty Standard Institute (CLSI) .Methods According to EP10-A2 document ,human growth hormone (hGH) in quality control serum were continuously detected for five days with a certain order ,then the deviation ,total imprecision ,intercept ,slope rate ,non-linearity ,cross-contami-nation and drift were analyzed by using Microsoft Excellsoftware .Results The linearity between measured value and target value was relatively well (Y=0 .992X+0 .083 ,r2 =0 .978) when the concentrations of hGH were 2 .15 ,5 .47 and 10 .80 mmol/L ,with bias of 0 .066 ,0 .265 and 0 .055 mmol/L ,and total imprecision of 6 .57% ,8 .53% and 4 .56% ,respectively .Simple sample t test indicated that the difference of intercept ,slope rate ,non-linearity ,cross-contamination and drift was no statistically significant (P>0 .05) .Conclusion The deviation ,total imprecision ,in-tercept ,slope rate ,non-linearity ,cross-contamination and drift of DXI800 analyzer might be within permission lim-it ,and could satisfy the request of clinical application and scientific research of hGH .