国际检验医学杂志
國際檢驗醫學雜誌
국제검험의학잡지
INTERNATIONAL JOURNAL OF LABORATORY MEDICINE
2014年
16期
2231-2232
,共2页
视黄醇结合蛋白%质控品%免疫比浊法%尿
視黃醇結閤蛋白%質控品%免疫比濁法%尿
시황순결합단백%질공품%면역비탁법%뇨
retinal-binding protein%quality control%immunoturbidimetry assay%urine
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，3500 r/min 离心5 min 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。
目的：探討膠乳增彊免疫比濁法檢測尿液視黃醇結閤蛋白（RBP）室內質控品的製作及其性能評價。方法分彆收集腎病患者和體檢健康人群的尿液標本，3500 r/min 離心5 min 去除沉澱物，分彆調節尿液 RBP 水平，體檢健康人群的尿液為低值，腎病患者尿液為高值；然後防腐、分裝、-20℃保存。使用尿液 RBP 商品試劑盒，應用膠乳增彊免疫比濁法檢測尿液 RBP，分彆進行批內和批間精密度檢測，然後連續5箇月對高值和低值的自製質控品每天各檢測1次。數據處理使用 SPSS13．0統計軟件。最後對自製的尿 RBP 質控品進行性能評價。結果兩箇水平的尿液 RBP 質控品的批內不精密度均小于5．0％，批間不精密度均小于6．0％；-20℃保存穩定期至少5箇月，5箇月間不精密度比較差異無統計學意義（P ＞0．05）。結論自製高低兩箇水平尿液 RBP 質控品能夠滿足室內質控品使用要求，對完善室內質控有重要臨床價值。
목적：탐토효유증강면역비탁법검측뇨액시황순결합단백（RBP）실내질공품적제작급기성능평개。방법분별수집신병환자화체검건강인군적뇨액표본，3500 r/min 리심5 min 거제침정물，분별조절뇨액 RBP 수평，체검건강인군적뇨액위저치，신병환자뇨액위고치；연후방부、분장、-20℃보존。사용뇨액 RBP 상품시제합，응용효유증강면역비탁법검측뇨액 RBP，분별진행비내화비간정밀도검측，연후련속5개월대고치화저치적자제질공품매천각검측1차。수거처리사용 SPSS13．0통계연건。최후대자제적뇨 RBP 질공품진행성능평개。결과량개수평적뇨액 RBP 질공품적비내불정밀도균소우5．0％，비간불정밀도균소우6．0％；-20℃보존은정기지소5개월，5개월간불정밀도비교차이무통계학의의（P ＞0．05）。결론자제고저량개수평뇨액 RBP 질공품능구만족실내질공품사용요구，대완선실내질공유중요림상개치。
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 >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.
