验证罗氏试剂试剂盒测量尿液β-2-微球蛋白与血清测量结果的相关性。

Validating urinary measurement of beta-2-microglobulin with a Roche reagent kit designed for serum measurements.

机构信息

Department of Clinical Pathology, Sunnybrook Health Sciences Centre, Toronto, ON, M4N 3M5, Canada.

出版信息

Clin Biochem. 2012 Nov;45(16-17):1533-5. doi: 10.1016/j.clinbiochem.2012.06.029. Epub 2012 Jul 5.

DOI:10.1016/j.clinbiochem.2012.06.029

PMID:22771504

Abstract

OBJECTIVE

To validate the use of a Roche serum beta-2-microglobulin (B2MG) kit for urinary B2MG measurements, and to establish reference limits for urinary B2MG/creatinine ratio from healthy individuals.

DESIGN AND METHODS

The Roche B2MG Tina-Quant serum kit was used to measure urinary B2MG immunoturbidimetrically.

RESULTS

Using human urine as a diluent, the B2MG method was linear from 73-2156 μg/L. The imprecision on a commercially available urine QC was 4.4% at a concentration of 380 μg/L. Limit of quantification at <20% CV was 40 μg/L. Method comparison with Immulite 2000 (Siemens) yielded slope=1.180 (95% CI 1.14-1.22), intercept=11.5 (95% CI -3.6-26.6), SEE=27.6 and r=0.99 (n=26) by the Deming regression analysis. The upper reference limit of B2MG/creatinine ratio determined from 195 healthy adults was 29 μg/mmol (97.5th centile).

CONCLUSIONS

The serum B2MG Tina Quant reagent kit is acceptable to measure urinary B2MG.

摘要

目的

验证罗氏血清β-2-微球蛋白（B2MG）试剂盒用于尿液 B2MG 测量的有效性，并为健康个体建立尿液 B2MG/肌酐比值的参考范围。

设计和方法

使用罗氏 B2MG Tina-Quant 血清试剂盒免疫比浊法测量尿液 B2MG。

结果

用人尿作为稀释液，B2MG 方法的线性范围为 73-2156μg/L。在浓度为 380μg/L 的商业尿液质控品上的不精密度为 4.4%。<20%CV 的定量下限为 40μg/L。通过 Deming 回归分析，与 Immulite 2000（西门子）的方法比较，斜率为 1.180（95%置信区间 1.14-1.22），截距为 11.5（95%置信区间 -3.6-26.6），SEE 为 27.6，r=0.99（n=26）。从 195 名健康成年人中确定的 B2MG/肌酐比值的参考上限为 29μg/mmol（97.5%百分位）。