Effect of Processing Delay and Storage Conditions on Urine Albumin-to-Creatinine Ratio

被引:26
作者
Herrington, William [1 ,2 ,3 ]
Illingworth, Nicola [1 ,2 ,4 ]
Staplin, Natalie [1 ,2 ]
Kumar, Aishwarya [1 ,2 ,4 ]
Storey, Ben [1 ,2 ,3 ,4 ]
Hrusecka, Renata [1 ,2 ,4 ]
Judge, Parminder [1 ,2 ,3 ,4 ]
Mahmood, Maria [3 ]
Parish, Sarah [1 ,2 ,4 ]
Landray, Martin [1 ,2 ]
Haynes, Richard [1 ,2 ,3 ,4 ]
Baigent, Colin [1 ,2 ,4 ]
Hill, Michael [1 ,2 ,4 ]
Clark, Sarah [1 ,2 ,4 ]
机构
[1] Nuffield Dept Populat Hlth, Clin Trial Serv Unit, Richard Doll Bldg,Old Rd Campus,Roosevelt Dr, Oxford OX3 7LF, England
[2] Nuffield Dept Populat Hlth, Epidemiol Studies Unit, Richard Doll Bldg,Old Rd Campus,Roosevelt Dr, Oxford OX3 7LF, England
[3] Oxford Univ Hosp NHS Fdn Trust, Oxford Kidney Unit, Oxford, England
[4] Nuffield Dept Populat Hlth, MRC, Populat Hlth Res Unit, Oxford, England
来源
CLINICAL JOURNAL OF THE AMERICAN SOCIETY OF NEPHROLOGY | 2016年 / 11卷 / 10期
基金
英国医学研究理事会;
关键词
FROZEN STORAGE; KIDNEY-DISEASE; RENAL-DISEASE; SAMPLES; MICROALBUMINURIA; PROGRESSION; MORTALITY; EXCRETION; TIME; PH;
D O I
10.2215/CJN.13341215
中图分类号
R5 [内科学]; R69 [泌尿科学(泌尿生殖系疾病)];
学科分类号
1002 ; 100201 ;
摘要
Background and objectives Because there is substantial biologic intraindividual variation in albumin excretion, randomized trials of albuminuria-reducing therapies may need multiple urine samples to estimate daily urinary albumin excretion. Mailing spot urine samples could offer a convenient and cost-effective method to collect multiple samples, but urine albumin-to-creatinine ratio stability in samples stored at ambient temperatures for several days is unknown. Design, setting, participants, & measurements Patients with kidney disease provided fresh urine samples in two tubes (with and without boric acid preservative). Reference aliquots from each participant were analyzed immediately, whereas remaining aliquots were subject to different handling/storage conditions before analysis, including delayed processing for up to 7 days at three different storage temperatures (4 degrees C, 18 degrees C, and 30 degrees C), multiple freeze-thawcycles, and long-termfrozen storage at -80 degrees C, -40 degrees C, and -20 degrees C. We calculated the mean percentage change in urine albumin-to-creatinine ratio for each condition, and we considered samples stable if the 95% confidence interval was within a 65% threshold. Results Ninety-three patients provided samples with detectable albuminuria in the reference aliquot. Median (interquartile range) urine albumin-to-creatinine ratio was 87 (20-499) mg/g. The inclusion of preservative had minimal effect on fresh urine albumin-to-creatinine ratio measurements but reduced the changes in albumin and creatinine in samples subject to processing delay and storage conditions. The urine albumin-to-creatinine ratio was stable for 7 days in samples containing preservative at 4 degrees C and 18 degrees C and 2 days when stored at 30 degrees C. It was also stable in samples with preservative after three freeze-thaw cycles and in frozen storage for 6 months at -80 degrees C or -40 degrees C but not at -20 degrees C. Conclusions Mailed urine samples collected with preservative and received within 7 days if ambient temperature is <= 18 degrees C, or within 2 days if the temperature is higher but does not exceed 30 degrees C, are suitable for the measurement of urine albumin-to-creatinine ratio in randomized trials. Preserved samples frozen to -40 degrees C or -80 degrees C for 6 months before analysis also seem suitable.
引用
收藏
页码:1794 / 1801
页数:8
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