【摘要】 目的：评估免疫印迹法检测抗可提取性核抗原抗体（抗ENA抗体）时室内质控品制备方法及性能。方法：收集强阳性（+++）抗RO-52抗体和抗SSA抗体的血清样本，将其与血清样本稀释媒介PBST（含1%吐温的PBS）按不同比例配比稀释制备成弱阳性（+）的室内质控品，收集阴性血清制备阴性质控品。通过免疫印迹法检测，对自制的弱阳性质控品均一性和稳定性进行验证。结果：自制的弱阳性抗Ro-52抗体及抗SSA抗体和阴性室内质控品均有良好的均一性和稳定性，自制的弱阳性质控品验证仪器也具有良好的重复性和一致性。结论：使用免疫印迹法可实现抗Ro-52抗体及抗SSA抗体室内质控品定性及半定量检测，且科室自制的抗Ro-52抗体及抗SSA抗体室内质控品具备良好的均一性及稳定性，可满足临床检验需求，并为其他实验室制备及验证自制质控品提供参考依据。更多还原

【Abstract】 Objective: To prepare and validate in-house quality controls(QCs) for anti-ENA antibody immunoblotting. Methods: Weak positive(1% PBST-diluted) and negative QCs were prepared. Homogeneity, stability, and repeatability were assessed. Results: QCs demonstrated good homogeneity, stability(≤3 CV%), and inter-instrument consistency. Conclusion: In-house QCs meet clinical needs and provide reference for other laboratories.更多还原