摘要
目的:根据ISO15189质量体系认证的需要,应用EP10-A初步评价DX I800发光分析仪多方面性能。方法:严格参照NCCLS EP10-A标准和中华人民共和国卫生行业标准《定量临床检验方法的初步评价》(W S/T228-2002),收集临床患者标本,在DX I800发光分析仪上连续5天对雌二醇(E2)的高、中、低值样本按照一定顺序进行测定,计算偏差、总不精密度,及其截距、斜率、非线性、交叉污染、漂移性,并进行统计学分析。结果:偏差:高值1.34 pmo/L、中值-7.90 pmo/L、低值9.53 pmo/L;总不精密度:高值5.15%、中值3.79%、低值7.36%;截距:19.042 pmo/L(P>0.01);线性:0.946(P>0.01),互染率:-0.627(P>0.01),非线性:0.12(P>0.01),漂移性:-2.226(P>0.01)。结论:DX I800分析仪测定血清雌二醇,其偏差、总不精密度均在允许范围内;在一定的范围内有良好的线性关系,携带污染率较低,稳定性很好,能满足临床常规检测和科研需求。
Objective：To preliminary evaluation of quantitative laboratory method of DXI800 photometric analyzer with EP10-A.Methods： According to the NCCLS Document EP10-A and Chinese public health profession standard Preliminary Assessment of Quantitation Clinic Analysis Method（WS/T228-2002）,collected blood sample of patients and detected E2 continuously for five days with a certain order in the DXI800 analyzer,then calculated deviation,total imprecision,intercept,slope rate,nonlinearity,cross-contamination,drift and carried out statistical analysis.Results： It showed that bias are 1.34 pmo/L,-7.90 pmo/L,9.53 pmo/L,total imprecision are 5.15%,3.79%,7.36% and intercept,slope rate,nonlinearity,cross-contamination,drift were 19.042 pmo/L（P〉0.01）,0.946（P〉0.01）,-0.627（P〉0.01）,0.12（P〉0.01）,-2.226（P〉0.01）respectively.Conclusion： The deviation,total imprecision,intercept,slope rate,nonlinearity,cross-contamination,drift of the DXI800 analyzer were within permission limit,so the analyzer could satisfy the clinical application and scientific research request of E2.
出处
《中国卫生检验杂志》
CAS
2010年第9期2329-2330,2369,共3页
Chinese Journal of Health Laboratory Technology
