梅毒螺旋体自制质控血清制备及稳定性评价

Preparation and Stability Evaluation of Treponema Pallidum Self-Made Quality Control Serum

制备适合TPPA和TRUST试验使用的梅毒螺旋体质控血清,对其稳定性进行评价。收集临床TPPA≥1:320且TRUST≥1:8的梅毒螺旋体抗体阳性血清,并确认滴度,用阴性血清按1:2、1:4、1:8、1:16、1:32倍比稀释,2~8℃和-20℃下放置18个月,定期观察稀释系列TPPA和TRUST滴度变化,探索配制梅毒质控血清的适当稀释浓度。将自制质控血清放不同温度保存,每3个月进行一次滴度检测,观察其稳定性;对实验室-70℃保存多年TRUST滴度为1:2和1:4的低浓度梅毒螺旋体抗体阳性样本,重新检测TPPA和TRUST滴度,观察稳定性变化。用阴性血清稀释梅毒螺旋体抗体阳性血清,以TRUST滴度为1:4且TPPA≥1:160稀释度作为配制浓度,2~8℃和-20℃下保存18个月,稳定性良好,对实验室保存9年内的TRUST滴度1:2和1:4的低浓度血清原液再次检测,其滴度无变化,可直接作为质控血清使用。自制梅毒螺旋体质控血清配制方法简单,原料易获得,稳定性良好,符合室内质控要求。

We prepare the quality control serum of treponema pallidum for TPPA and TRUST tests in order to evaluate its stability.The high-concentration treponema pallidum antibody positive serum with clinical TPPA≥1:320 and TRUST≥1:8 is collected and its titer is detected.The negative sera are diluted at the ratio of 1:2,1:4,1:8,1:16 and 1:32,and placed at 2-8℃and-20℃for 18 months.Their TPPA and TRUST titer changes in the dilution series are regularly observed to explore the appropriate dilution concentration for preparing syphilis quality control serum.The self-made quality control serum is stored at different temperatures for 18 months,and the titer is detected every 3 months to observe its stability.The TPPA and TRUST titers of lowconcentration positive samples of treponema pallidum antibody with TRUST titers of 1:2 and 1:4 stored at-70℃for years are retested to observe the changes in stability.Treponema pallidum antibody positive serum is diluted with negative serum,whose preparation concentration is TRUST titer 1:4 and TPPA dilution≥1:160.The stability is good after being stored at 2-8℃and-20℃for 18 months.The low concentration serum stock solution with trust titers of 1:2 and 1:4 stored in the laboratory for 9 years is re-tested.We find that the titer is unchanged and can be used as quality control serum directly.This self-made treponema pallidum quality control serum is simple to operate,easy to obtain the raw materials and with sound stability,which can meet the requirements of internal quality control.