抗核抗体检测质控血清的研制与评价

Preparation and evaluation of quality control serum for antinuclear antibody testing

目的为了进一步提高临床实验室抗核抗体检测结果的重复性和可比性，探索可靠的制备方法，并且研制满足抗核抗体常规检测需要的质控血清。方法按照入选要求选择本室检测抗核抗体之后的患者血清制备质控血清；通过无菌实验、防腐实验、冻存、复温、浓度水平的设置等的研究，初步确定制备质控血清的方法和条件；通过对制备血清的外观、无菌性、批内及批间均匀性、稳定性等指标的评价，进一步优化制备方法和条件，确认制备的质控血清的性能。结果制备的质控血清在-20℃可以稳定保存270d，室温复温后稳定8h以上。冻存复温后批内及批问均匀性、稳定性与商品化质控性能无明显区别，与冻存前检测结果一致。结论探索出了抗核抗体检测质控物制备的合适方法和实验条件；制备的各个批号质控物具有良好的均匀性、稳定性；制备出的质控血清满足抗核抗体检测需求和质控要求。

Objective In order to further enhance the repeatability and comparability for antinuclear antibody testing results in clinical laboratory, explore the reliable preparation method, and develop the quality control serum that is capable of meeting the needs of routine antinuclear antibody testing. Methods According to selection requirements, the serum from patient which is used to test antinuclear antibody was selected, and then we prepared the quality control serum, through evaluation of index in appearance of serum, aseptic level, uniformity and stability in intra-assay and inter-assay etc, the study optimized the method and condition for preparation, also confirmed the performance of prepared quality control serum. Results Prepared quality control serums are able to preserved stable at -20 ℃ 270 d, it can be keep stable more than 8 h after rewarming at room temperature. There are no significant differences between the commercialization of quality control performance and the freez-thawed uniformity and stability in intra-assay and inter-assay, it are keep consistent to result that before freezing testing. Conclusions Suitable methods and experimental conditions are explored for preparation of antinuclear antibody testing quality control substance. Each batch of prepared quality control substance has good uniformity and stability. The prepared quality control serum are able to meet needs of antinuclear antibody testing, and meet quality control requirements.