Wang Hongying, Li Zhiyan, Yang Wei, Chang Le, Yan Cunling
Department of Respiratory and Critical Care Medicine, The Affiliated Nanhua Hospital, Hengyang Medical School, University of South China, No. 336, Dongfeng South Road, Zhuhui District, Hengyang City, Hunan Province, 421001, China.
Department of Clinical Laboratory, Peking University First Hospital, No. 8, Xishiku Street, Xicheng District, Beijing, 100034, China.
Anal Bioanal Chem. 2025 Sep;417(22):5001-5017. doi: 10.1007/s00216-025-06018-4. Epub 2025 Jul 30.
Conformational and colloidal stabilities are responsible for the stability of hemoglobin. However, most hemoglobin (HbA) control materials (e.g., reference materials, calibrators, and quality control materials) are unstable and noncommutable. This may be closely related to the breakdown of the balance between the conformational and colloidal stabilities of hemoglobin. Therefore, we developed a new combined formulation buffer to address the causes of conformational and colloidal instabilities and to maintain hemoglobin or HbA stability. For the commutability of HbA control materials, we purified hemoglobin to remove plasma proteins, phospholipids, and fats. On the basis of the above design, we prepared two medical concentrations of HbA control materials for the external quality assessment (EQA) program and then determined the certified values via the reference measurement method. Stability, homogeneity, value transfer, and commutability were evaluated. Moreover, the control material was distributed to 56 laboratories to assess proficiency testing. The HbA control materials showed good homogeneity and stability and reliable value transfer, and were commutable for routine clinical analyzers. In the EQA program, only one analyzer exceeded the acceptable bias range (± 6.0%), and the mean interlaboratory CVs of the three analyzers exceeded the acceptable range (3.0%), which can be used to assess true values to improve proficiency testing in the EQA program. Therefore, newly developed control materials can be used to standardize the determination of HbA.
构象稳定性和胶体稳定性决定了血红蛋白的稳定性。然而，大多数血红蛋白（HbA）对照物质（如参考物质、校准品和质量控制物质）不稳定且不可互换。这可能与血红蛋白构象稳定性和胶体稳定性之间平衡的破坏密切相关。因此，我们开发了一种新的复合配方缓冲液，以解决构象和胶体不稳定的原因，并维持血红蛋白或HbA的稳定性。为了实现HbA对照物质的互换性，我们对血红蛋白进行了纯化，以去除血浆蛋白、磷脂和脂肪。基于上述设计，我们制备了两种医疗浓度的HbA对照物质用于外部质量评估（EQA）计划，然后通过参考测量方法确定其认定值。对稳定性、均匀性、赋值传递和互换性进行了评估。此外，将对照物质分发给56个实验室以评估能力验证。HbA对照物质表现出良好的均匀性和稳定性以及可靠的赋值传递，并且可与常规临床分析仪互换。在EQA计划中，只有一台分析仪超出了可接受偏差范围（±6.0%），三台分析仪的实验室间平均变异系数超出了可接受范围（3.0%），可用于评估真值以改进EQA计划中的能力验证。因此，新开发的对照物质可用于标准化HbA的测定。
