目的 探索自制抗双链DNA抗体(dsDNA)室内质控品研制方法，并完成性能验证，为临床实验室dsDNA检验质量保证提供解决方案。方法 收集高滴度(1∶100～1∶320)dsDNA单一荧光核型的临床血清样本，将其与血清样本稀释媒介PBST(含1%吐温的PBS)按不同比例倍比稀释制备成1∶10荧光滴度的弱阳性室内质控品，收集阴性血清制备阴性质控品。将自制弱阳性质控品灭活后采用间接免疫荧光法检测，双人同时进行荧光强度判读，并对自制质控品均一性和稳定性进行验证。结果 自制弱阳性和阴性dsDNA室内质控品均有良好的均一性和稳定性，以自制室内质控品验证仪器也具有良好的重复性和一致性。结论 本室自制的dsDNA室内质控品具有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自制质控品提供理论参考依据。

Objective To make the in-house quality control of anti-dsDNA antibody(dsDNA) and complete the performance verification are the prerequisites to ensure the quality of the test. Methods The serum samples of high titer(1∶100-1∶320) dsDNA with a single fluorescent karyotype were collected, and the dilution medium PBST(PBS containing 1% Tween) was prepared into a weakly positive indoor control with a 1∶10 fluorescent titer in different proportions, and also the negative serum was collected to prepare a negative control. The self-made weak positive control was inactivated and detected by indirect immunofluorescence, the fluorescence intensity was interpreted by two people at the same time, and the uniformity and stability of the self-made quality control were verified. Results The in-house controls for self-made weak positive and negative dsDNA had good uniformity and stability, meanwhile the instruments validated with self-made in-house controls are also with good reproducibility and consistency. Conclusion The self-made dsDNA in-house quality control has good uniformity and stability, which can meet the needs of clinical testing and provide a theoretical reference for other laboratory self-made quality controls.