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国产尿微量白蛋白快速定量检测仪的临床评价

2012-02-03365必发娱乐:未知 阅读: 【字号:
导读: 摘要:【目的】对国产金标斑点法定量读数仪(Uppergold U2)快速定量微量白蛋白检测进行临床评价,旨在为尿微量白蛋白测定选择体积小、便于携带,能快捷提供准确和特异性检测结果的国产设备。证明国产尿液微量白蛋白快速定量检测技术符合临床检测的要求。【方

陈健1 吴文清1 孙立山2 吴京3王洁1

(1复旦大学附属华山医院检验医学科上海,2上海东方医院,3上海胸科医院)

摘要:【目的】对国产金标斑点法定量读数仪(Uppergold U2)快速定量微量白蛋白检测进行临床评价,旨在为尿微量白蛋白测定选择体积小、便于携带,能快捷提供准确和特异性检测结果的国产设备。证明国产尿液微量白蛋白快速定量检测技术符合临床检测的要求。【方法】通过采用健康体检者以及门诊和住院病人各类特征样本,与对照组芬兰进口的同类产品QuikRead U-ALB的比对试验,对尿液微量白蛋白进行考核。考核指标为精密度、准确度、检测范围(线性范围)、可报告范围、干扰试验、稳定性、参考区间等来评估尿液微量白蛋白快速定量试剂盒的临床有效性。【结果】Uppergold U2 ALB-DOT医学决定水平的平均值:32.08mg/L,总标准差:4.45、CV13.88%。与QuikRead U-ALB相关性较好(Y=1.1049X-9.5675)R=0.963,P  >0.05,两种方法学的测试结果无显著性差异。回收率在84.8%。检测限可以达到12mg/L,线性12-160mg/L,可报告范围12-320mg/L。测定时不受样本中颗粒、血红蛋白的影响,参考区间为>30mg/L,经验证,符合95百分位,可以引用。【结论】国产Uppergold U2及ALB-DOT配套试剂盒与进口同类产品QuikRead U-ALB检测仪及配套试剂比较具有较好的精密度和成本优势。该方法快捷、方便、可携带,非常适合各基层医院用于糖尿病早期肾病病人筛查及监测。

关键词:金标斑点定量检测;增强速率免疫法;尿微量白蛋白

Clinical evaluation of domestic Micro-albumin quantitative reader

Uppergold U2

Chen Jian;Wu wen Qin;WANG jie . Department of Laboratory Medicine, HuashanHospital, FudanUniversity, Shanghai 200040, China

Corresponding author: Wang Jie, Email: jie_218@126.com

Abstract: 【Objective】To evaluate the clinical performance of domestic Dot-immuno-gold filtration assay quantitative Reader (Uppergold U2) on the quantitative determination of Micro-albumin, aim to provide a small、portable domestic reader that show precise and specific results. It proved that domestic technology on the quantitative measurement of Micro-albumin can meet the standards of clinical test.【Methods】Compares precision 、accuracy、AMR、CCR、intereference、stability、reference range with QuikRead U-ALB made in by Finland to evaluate the clinical validity of urine Micro-albumin quantitative Kits.【Result】Medical decide level of Uppergold U2 ALB-DOT was 32.08mg/L, total SD is 4.45mg/L, total precision was 13.88%;results from Uppergold U2 and QuickRead U-ALB correlated well(Y=1.1049X-9.5675)R=0.963, and there were no significant difference between the two methods(P>0.05); recovery  rate was 84.8%. The sensitivity of the test was 12mg/L, linear range was 12-160mg/L, reportable range was 12-320mg/L, reference interval was >30mg/L, conform to 95th percentiles in real test.【Conclusion】Compared with QuickRead U-ALB and affiliated kits, the domestic Uppergold U2 and affiliated kits showed better results and cost advantage. It's an ideal instrument in medium or small laboratories and it can also be used as a backup analyzer in large laboratories.

Key waords: Dot-immuno-gold filtration assay, Latex-enhanced  immunoturbidimetric assay Micro-albumin.

尿“微量白蛋白”是指尿中白蛋白排泄明显高于正常,但常规生化检查方法难以测出的一种病理现象,是临床蛋白尿前的一种亚临床症状。国内外已有大量文献报道,尿微量白蛋白的检测不仅对糖尿病肾病的早期诊断和改善预后具有重要意义,而且对高血压、肾病都具

有重要的诊断价值。目前其检测方法有放射免疫分析法(RIA),酶联免疫分析法(EIA)及散射浊度法(nephelometry)等,这些方法灵敏、准确,但需要昂贵的设备及业人员操作,费用高、耗时无法普及。而国产创新产品便携式微量白蛋白检测仪弥补了这种缺憾。以下对该仪器及配套试剂进行方法学评价。

仪器与试剂

1.仪器

1.1被评估组是由上海奥普生物医药有限公司自主生产的金标斑点法定量读数仪(Uppergold U2).

1.2对照组是芬兰进口定量检测仪QuikRead

 2.试剂

2.1 奥普金标斑点法定量读数仪的配套试剂主要成份①ALB反应板②ALB封闭液③ALB洗涤液④ALB金标冻干品复溶液⑤ALB样品复溶液⑥ALB样品稀释液。

2.2 QuikRead U-ALB配套试剂主要成份①尿微量白蛋白试剂帽(内含与干化学微粒子结合的白蛋白抗体试剂)②缓冲液③测量杯④磁卡

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