自制尿液视黄醇结合蛋白质控品及其性能评价  

Self-prepared quality control product for urinary retinal-binding protein and its performance evaluation

作　　者：张培育 邓演超 李全双[2,3,4] 

机构地区：[1]江苏省新沂市人民医院检验科,江苏新沂221400 [2]徐州市医学科学研究所 [3]徐州市中心医院 [4]徐州市糖尿病研究所,江苏徐州221006

出　　处：《国际检验医学杂志》2014年第16期2231-2232,共2页International Journal of Laboratory Medicine

摘　　要：目的探讨胶乳增强免疫比浊法检测尿液视黄醇结合蛋白(RBP)室内质控品的制作及其性能评价。方法分别收集肾病患者和体检健康人群的尿液标本,3 500r/min离心5min去除沉淀物,分别调节尿液RBP水平,体检健康人群的尿液为低值,肾病患者尿液为高值;然后防腐、分装、-20℃保存。使用尿液RBP商品试剂盒,应用胶乳增强免疫比浊法检测尿液RBP,分别进行批内和批间精密度检测,然后连续5个月对高值和低值的自制质控品每天各检测1次。数据处理使用SPSS13.0统计软件。最后对自制的尿RBP质控品进行性能评价。结果两个水平的尿液RBP质控品的批内不精密度均小于5.0%,批间不精密度均小于6.0%;-20℃保存稳定期至少5个月,5个月间不精密度比较差异无统计学意义(P>0.05)。结论自制高低两个水平尿液RBP质控品能够满足室内质控品使用要求,对完善室内质控有重要临床价值。Objective To investigate the preparation of the internal quality controls for urinary retinal binding protein（RBP）de-tected by the latex enhanced immunoturbidimetry assay and its performance evaluation.Methods The urine specimens from the pa-tients with nephropathy and healthy people with physical examination were collected,centrifuged by 3 500 r/min for removing sedi-ment,urinary RBP levels were adjusted to the low value for healthy population and the high value for the patients with nephropa-thy;then conducted the anticorrosion,packed and stored at -20 ℃.By using the urinary RBP commodity kits,the latex enhanced immunoturbidimetry was adopted to detect urinary RBP,the intra-batch and inter-batch precisions were detected respectively.Then the high and low values of self-prepared controls were detected once per day for consecutive 5 months.The data were processed by using the SPSS13.0 software.Then the performance of self-prepared urinary RBP quality control was evaluated.Results The intra-batch imprecision of 2 levels of urinary RBP controls was less than 5% and the inter-batch imprecision was less than 6%;the stable period by storage at -20 ℃ was at least 5 months,the imprecision had no statistical difference within 5 months（P ＆gt;0.05）.Conclu-sion The high and low levels of self-prepared urinary RBP quality controls can meet the operating requirements of internal quality controls.

关 键 词：视黄醇结合蛋白 质控品 免疫比浊法 尿 

分 类 号：R446.12[医药卫生—诊断学]