XE-2100全自动血细胞分析仪质控物的性能验证

Performance verification of control materials for XE-2100 automated hematology analyzer

目的对Sysmex公司生产的血液质控物e-CHECK的性能进行验证。方法依据《中华人民共和国医药行业标准YY/T0702-2008》对血细胞分析仪用质控物(品)的要求,使用XE-2100全自动血液分析仪、电化学发光分析仪等对质控物eCHECK(包括水平1,水平2,水平3)的外观、瓶内均匀性、瓶间均匀性、定值、长期稳定性、开瓶有效期稳定性(短期稳定性)、生物安全性等性能进行验证。结果瓶内均匀性性能验证试验显示:低水平质控物PLT和PCT参数的变异系数分别为4.42%、8.93%,略微高于XE-2100分析仪的重复性要求(CVplt≤4.0%,CVpct≤5.0%),其他各项性能指标包括外观与装量、瓶间均匀性、质控物定值、生物安全性、长期稳定性及开瓶有效期稳定性(短期稳定性)等均符合中华人民共和国医药行业标准对全血质控物的要求。结论 Sysmex公司生产的血液质控物e-CHECK均匀稳定、可靠,有条件的实验室应使用配套的血液质控物对血液分析仪进行质量控制。

Objective To verify the performance of hematology control materials e‐CHECK ？ produced by the Sysmex corpora‐tion .Methods According to the requirements for the control material used in the hematology analyzer in the Pharmaceutical Indus‐try Standards of the People′s Republic of China YY/T0702‐2008 ,the XE‐2100 automated hematology analyzer and the electrochem‐iluminescence analyzer were adopted to verify the performance of control material e‐CHECK ？ （level 1 ,level 2 ,level 3） ,including ap‐pearance ,within‐bottle homogeneity ,between‐bottle homogeneity ,stated value ,long‐term stability ,corkage valid period stability （short‐term stability） and biological safety ,etc .Results The test of performance verification for within‐bottle homogeneity showed that the coefficient of variation of PLT and PCT from the level 1 control materials was 4 .42% and 8 .93% respectively ,which was slightly higher than reproducibility requirements of XE‐2100 hematology analyzer（CVplt ≤ 4 .0% ,CVpct ≤ 5 .0% ） ,all other perform‐ance indicators completely met the requirements of the Pharmaceutical Industry Standards of the People′s Republic of China for the whole blood quality control materials ,such as appearance and packing volumes ,between‐bottle homogeneity ,stated value of control materials ,biological safety ,long‐term stability ,and corkage valid period stability（short‐term stability） ,etc .Conclusion The hema‐tology control materials e‐CHECK produced by the Sysmex corporation are homogeneous ,stable and reliable .The conditional la‐boratory should use the matched hematology control materials to conduct the quality control on the hematology analyzers .