Department of Clinical Chemistry, Ghent University Hospital, Gent, Belgium.
Department of Clinical Chemistry, Ghent University Hospital, Gent, Belgium.
Clin Chim Acta. 2017 Aug;471:107-112. doi: 10.1016/j.cca.2017.05.032. Epub 2017 May 26.
Populations at increased risk for chronic kidney disease should be screened for albuminuria. Possibilities of advanced urine strip readers based on complementary metal oxide semiconductor (CMOS) sensor technology were investigated for obtaining quantitative albuminuria results.
Reflectance data of test strips (Sysmex UFC 3500 reader+CMOS) were compared with albuminuria (BNII) and with proteinuria (Cobas 8000). Urinary creatinine was assayed using a Jaffe-based creatinine assay (Cobas 8000).
Calibration curve was made between 11.5 and 121.5mg/L with detection limit of 5.5mg/L. Within-run CV values of reflectance data were 0.21% (UC-Control L; 10mg/L) and 0.37% (UC-Control H; >150mg/L) for albumin, and 0.71%/3.97% for creatinine. Between-run CV values were 0.24%/0.42% for albumin and 0.93%/5.13% for creatinine. A strong correlation (r=0.92) was obtained between albuminuria (BNII) and protein strip reflectance data. Creatinine reflectance data correlated well with Jaffe-based urinary creatinine data (r=0.90). Albumin:creatinine ratio obtained by test strip and by wet chemistry showed a good correlation (r=0.59). Carbamylated, glycated and partially hydrolyzed isoforms of albumin could be detected by test strip.
Dye-binding based albumin test strip assay in combination with a CMOS based reader would potentially allow quantitative analysis of albuminuria and determination of albumin:creatinine ratio.
患有慢性肾病风险增加的人群应进行白蛋白尿筛查。本研究探索了基于互补金属氧化物半导体（CMOS）传感器技术的高级尿液条带阅读器的可能性，以获得定量白蛋白尿结果。
比较了测试条（Sysmex UFC 3500 阅读器+CMOS）的反射率数据与白蛋白尿（BNII）和蛋白尿（Cobas 8000）。使用基于 Jaffe 的肌酐测定法（Cobas 8000）测定尿肌酐。
在 11.5 至 121.5mg/L 之间制作校准曲线，检测限为 5.5mg/L。白蛋白的反射率数据的批内 CV 值分别为 0.21%（UC-Control L；10mg/L）和 0.37%（UC-Control H；>150mg/L），肌酐为 0.71%/3.97%。批间 CV 值分别为 0.24%/0.42%的白蛋白和 0.93%/5.13%的肌酐。白蛋白尿（BNII）和蛋白条带反射率数据之间存在很强的相关性（r=0.92）。肌酐反射率数据与基于 Jaffe 的尿肌酐数据相关性良好（r=0.90）。测试条和湿化学法获得的白蛋白：肌酐比值相关性良好（r=0.59）。测试条可检测到白蛋白的氨甲酰化、糖化和部分水解形式。
基于染料结合的白蛋白测试条分析与基于 CMOS 的阅读器相结合，可能允许定量分析白蛋白尿和测定白蛋白：肌酐比值。
