T淋巴细胞亚群CD4+比例标准物质的研制

CD4⁺ T细胞的减少常见于恶性肿瘤、遗传性免疫缺陷症、艾滋病等。检测实验室常需要对CD4⁺ T细胞检测能力进行质控，急需有准确CD4⁺比例量值的T淋巴细胞标准物质。将人工制备的T淋巴细胞进行纯化后，使用流式细胞术进行标准物质候选物的均匀性检验、稳定性检验。联合8家检测实验室采用流式细胞微球计数法对标准物质候选物进行协同定值。实验数据统计表明，该标准物质候选物的均匀性好，并且在-20 ℃储存条件下可稳定12个月以上，其标准量值CD4⁺比例为74.0%±6.7%（k=2）。该标准物质适用于流式细胞仪中CD4⁺细胞占总淋巴细胞的百分比项目的计量校准，以及流式细胞术检测过程的方法验证和检测结果的质量控制。

Development of Subsets CD4+ Proportion of T Lymphocyte Standard Reference Materials

The reduction of CD4 positive （CD4⁺）^{T cells is commonly happened along with malignant tumors， hereditary immunodeficiency， AIDS， etc. To verify the detection capability of CD4+ T cells， it becomes an urgent need to develop a reference material （RM） of CD4+ T lymphocyte subset， which has definite CD4+ proportion value. We prepared the candidate reference materials and performed the uniformity test and stability monitoring. The proportion of CD4+ cells was quantified by 8 laboratories. The good test results showed that the homogeneity of the reference material is stable for more than 12 months storage under -20 ℃. The CD4+ standard rate was 74.0%±6.7%（k=2）. The candidate reference material is adaptable for the metrological calibration of flow cytometry， the method validation of flow cytometry detection process and the quality control of detection results.}