【摘要】 目的 对奥森多VITROS 5600生化免疫分析仪自动检测的血清指数进行性能验证，评价血清指数[HIL(Hemolysis, H;Icterus, I;Lipemia, L)-indices, HIL-I)之间的干扰性能。方法 在奥森多VITROS 5600生化免疫分析仪上分别对溶血指数(hemolytic index, HI)、黄疸指数(icteric index, II)和脂血指数(lipemic index, LI)的高低值质控品进行检测，计算批间变异系数以评价其精密度，在基础血清池中加入不同浓度干扰物，检测血清指数并对其线性范围和干扰性能进行评价。结果 溶血指数(HI)、黄疸指数(II)、脂血指数(LI)批间变异系数高值分别为1.47%、5.19%、4.58%;低值分别为1.68%、0.00%、7.92%,不精密度均小于10.00%。HIL-I线性偏差的95%可信区间均在线性允许偏差范围内。低水平溶血对中水平黄疸指数检测产生干扰，相对偏差大于10.00%。结论 血清指数精密度符合要求，线性范围可以达到厂商声明要求，HI、II、LI之间除了溶血对黄疸指数检测产生干扰外其他均未检测出干扰，抗干扰性能较好，血清溶血和黄疸同时存在时黄疸指数会受到干扰，导致黄疸指数测量值高于其真实水平。更多还原

【Abstract】 ObjectiveTo verify the performance of serum indices automatically detected by Ortho VITROS 5600 biochemical immune analyzer, and to evaluate the interference between serum indices.Methods The precision, linear range, and interfering performance of the measurement results for serum hemolysis index(HI), icteric index(II), and lipemic index(LI) were analyzed statistically using the Ortho VITROS 5600 biochemical immune analyzer. Additionally, different concentrations of distractors were added to the basal serum pool to detect the serum indices and evaluate its linear range and interference performance.Results The high value coefficient of variation of hemolysis index, icteric index and lipemic index were 1.47%, 5.19% and 4.58%, respectively, while the low values were 1.68%, 0% and 7.92% respectively. All three coefficients of variation were less than 10%. The 95% confidence intervals for the linear deviation of serum indices were within the allowable deviation range. There was no general interference between HI, II and LI. Low level hemolysis interferes with the detection of icteric index at medium level. And the relative deviation was greater than 10%.Conclusion The precision of serum indices performs well. The linear range can meet the requirements of the manufacturer’s declaration, and have advantages of good performance of anti-interference between HI, II and LI. The interic index will be disturbed when hemolysis and icterus exist at the same time, resulting in a higher measurement value of icteric index than its true value.更多还原