自制尿HCG定性临界值质控物的应用评价  

Evaluation of Self-made Quality Control Material of Qualitative Urine HCG Critical Value

作　　者：何维娜[1] 华建江[1] 丁华[1] 许瑞娜[1] 吕冬月[1] 梁鸿[1] 钟瑜[1] 

机构地区：[1]广州医科大学附属深圳沙井医院,广东深圳518104

出　　处：《标记免疫分析与临床》2015年第1期63-65,55,共4页Labeled Immunoassays and Clinical Medicine

摘　　要：目的自制尿HCG定性临界值质控物,并建立相应室内质控程序以评价其实际应用效果。方法用生理盐水将已知HCG浓度的尿液稀释至25.00IU/L,加入稳定剂和防腐剂后用一次性塑料离心管分装,分别置于室温、4℃、-20℃保存,每天各监测一次,连续监测一年,并在南方惠桥检验信息系统上建立自制尿HCG室内质控程序及绘制半定量质控图。结果自制尿HCG定性临界值质控物在室温、4℃、-20℃的温度下,分别可稳定121天、300天、365天以上。在检验信息系统建立的HCG半定量质控图,监测到由HCG试剂灵敏度下降引起的3次失控。结论自制尿HCG定性临界值质控物保存在-20℃稳定性最佳,并通过建立室内质控程序能有效监测试剂的灵敏度,可作为尿HCG定性的室内质控物使用。Objective To prepare self-made quality control material of qualitative urine HCG critical value, and establish the corresponding internal control procedures to evaluate its effect in practical application. Methods The known HCG concentration of urine was diluted to 25IU/L with the physiological saline, and then the stabilizer and preservatives were added. The solution was divided into plastic centrifuge tube and then stored at room temperature, 4℃ and -20℃. The samples were daily monitoring and continuous for one year to evaluate its stability. The urinary HCG internal quality control procedures were established in the South Huiqiao laboratory information system to evaluate the detection performance and application effect. Results The self- made quality control samples of qualitative urine HCG critical value showed good stability at room temperature, 4℃, -20℃, which could be stabilized for 121 days, 300 days, 365 days or more. Conclusion The self-made quality control material of qualitative urine HCG critical value combined with the internal quality control procedures could be used as the internal quality control of urine HCG.

关 键 词：尿HCG定性 临界值质控物 自制 

分 类 号：R446.6[医药卫生—诊断学]