Preparation and evaluation of quality control serum for antinuclear antibody testing / 中华检验医学杂志

ABSTRACT

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.