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| 胱抑素C冰冻人血清国家标准品的建立及溯源性研究 |
| Establishment of Cystatin C frozen human serum national standard and Traceability Research |
| 投稿时间：2023-04-27 修订日期：2023-12-27 |
| DOI： |
| 中文关键词: 胱抑素C、量值溯源、国际标准物质、免疫比浊法 |
| 英文关键词: Cystatin C, quantity traceability, international standard material, immune turbidimetry |
| 基金项目: |
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| 摘要点击次数: 120 |
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| 中文摘要: |
| 目的：对胱抑素C进行量值溯源性研究，研制胱抑素C冰冻人血清国家标准品，建立用于胱抑素C检测试剂盒准确度评价的质量评价标准，提升检验检测水平。
方法：以人血清样本为原料进行无菌分装、制备胱抑素C国家标准品，采用多实验室联合赋值的方法对胱抑素C进行赋值、标定，建立可溯源至国际标准物质ERM-DA471的溯源链，并采用免疫比浊的方法对国家标准品的均匀性、稳定性进行了验证。
结果：建立了胱抑素C冰冻人血清国家标准品，水平1：（0.94 ±0.03）mg/L（k=2）；水平2：（3.52±0.09）mg/L（k=2）。该国家标准品均匀性和稳定性良好。30天短期稳定性研究结果显示，室温条件下，水平1和水平2均可稳定5天；2~8℃条件下，水平1可稳定10天、水平2可稳定20天；-20℃条件下，水平1和水平2均至少可稳定30天。溯源准确性采用血清参考盘和临床血清样本进行验证，研究结果显示，该国家标准品和国际标准品ERM-DA471具有良好的溯源性。
结论：通过对胱抑素C进行量值溯源性研究，研制出冰冻人血清国家标准品（360046-202001），该标准品已获得批准项社会提供。建立可以用于人血清中胱抑素C检测试剂盒的正确度评价及临床实验室检测系统量值准确性评价的质量标准。 |
| 英文摘要: |
| Objective: Carry out quantitative traceability research on Cystatin C, to develop the national standard of frozen human serum cystatin C, which can be use for evaluation of the accuracy of cystatin C test kit, and help to establish the quality evaluation standard. Improving the ability of human serum cystatin C detection.
Methods: Human serum samples were used as raw materials for aseptic sub-packaging and preparation of the national standard of cystatin C. The value of cystatin C of national standard was assigned and calibrated by the method of multi-laboratory joint assignment, which was traceable to the international standard ERM-DA471, and the accuracy of the traceability chain has been verified. The homogeneity and stability of the national standard was verified by the method of immune turbidimetry.
Results: The national standard of cystatin C frozen human serum was established, level 1: (0.94 ± 0.03) mg/L (k=2); Level 2: (3.52 ± 0.09) mg/L (k=2); The national standard has good homogeneity and stability. The results of the 30-day short-term stability study showed that both level 1 and level 2 were stable for 5 days at room temperature; At 2~8 ℃, level 1 can be stable for 10 days and level 2 can be stable for 20 days- At 20 ℃, both level 1 and level 2 can be stable for at least 30 days. The accuracy of the traceability was verified by using the serum reference panel and clinical serum samples, study results show that the national standard and international standard ERM-DA471 have good traceability.
Conclusion: The national standard of cystatin C frozen human serum (360046-202001) has been approved and provided to the society with the quantitative traceability study. And stablished the evaluation method of accuracy of the cystatin C test kit in human serum and the accuracy of the clinical laboratory test system. |
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