细菌性阴道炎临界值室内质控物的研制及评价

Development and Evaluation of Indoor Quality Control Substance for Critical Value of Bacterial Vaginitis

目的:研制细菌性阴道炎(BV)临界值室内质控物并建立相应的质控程序。方法:用生理盐水将唾液酸酶原液稀释至浓度为7 U/mL,加入复合酶稳定剂和叠氮钠防腐剂,分装于用1%小牛血清白蛋白封闭过的离心管,制备出BV临界值室内质控物;在南方惠侨检验信息系统上建立BV的室内质控程序及半定量质控图,以评价其检测效能和应用效果。结果:BV临界值室内质控物浓度处于试验方法的临界值水平,其稳定性较好,在室温、4℃、-20℃的保存条件下,分别可稳定220、310、365 d;建立的BV室内质控程序及半定量质控图可直观、有效地监测、检验试剂的灵敏度和可靠性。结论:BV临界值室内质控物与建立相应的质控程序,可作为BV质控物商品化之前的一个补充,具有一定的临床应用价值。

Objective To develop a piece of indoor quality control substance for the critical value of bacterial vaginitis （BV） and the corresponding quality control procedure. Methods The sialidase stock solution was diluted until the concentration came to 7 U/mL, the compound enzyme stabilizer and sodimn azide preservative were added into the solution, the solution was put into the centrifuge tube sealed with calf serum albumin, then the indoor quality control substance for the critical value of BC came into being. The indoor quality control procedure and semi-quantitative quality control diagram were established based on NFHB-Lab Information System in order to evaluate the efficacy. Results The indoor quality control substance for the critical value of BV was stable, and had a service life of 220, 310 or 365 d respectively when the ambient temperature was room temperature, 4℃ or -20 ℃. The quality control procedure and semi-quantitative quality control diagram could be used for monitoring the sensitivity and reliability of the agent. Conclusion The indoor quality control substance for the critical value of BV and the corresponding quality control procedure are of significance for clinical application.