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33 位健康受试者尿液标本中分析物及分析物/肌酐比值的个体内生物学变异估计值。

Biological variation estimates for spot urine analytes and analyte/creatinine ratios in 33 healthy subjects.

机构信息

Department of Medical Biochemistry, University of Health Sciences Ankara Training and Research Hospital, Ankara, Türkiye.

出版信息

Clin Chem Lab Med. 2023 Feb 17;61(8):1481-1489. doi: 10.1515/cclm-2022-1290. Print 2023 Jul 26.

DOI:10.1515/cclm-2022-1290
PMID:36794468
Abstract

OBJECTIVES

Urine samples are frequently used in the clinical practice. In our study, we aimed to calculate the biological variations (BV) of analytes and analyte/creatinine ratios measured in spot urine.

METHODS

Second-morning spot urine samples were collected from 33 (16 female, 17 male) healthy volunteers once weekly for 10 weeks and analyzed in the Roche Cobas 6,000 instrument. Statistical analyzes were performed using BioVar, an online BV calculation software. The data were evaluated in terms of normality, outliers, steady state, homogeneity of the data, and BV values were obtained by analysis of variance (ANOVA). A strict protocol was established for within-subject (CV) and between-subject (CV) estimates for both genders.

RESULTS

There was a significant difference between female/male CV estimates of all analytes except potassium, calcium and magnesium. No difference was found in CV estimates. When the analytes that had a significant difference in CV estimates in spot urine analytes were compared to creatinine, it was observed that the significant difference between the genders disappeared. There was no significant difference between female/male CV and CV estimates in all spot urine analyte/creatinine ratios.

CONCLUSIONS

Since the CV estimates of analyte/creatinine ratios are lower, it would be more reasonable to use them in result reporting. Reference ranges should be used with caution, since II values of almost all parameters are between 0.6 and 1.4. The CV detection power of our study is 1, which is the highest value.

摘要

目的

尿液样本在临床实践中经常被使用。在我们的研究中,我们旨在计算单次随机尿样中分析物和分析物/肌酐比值的生物学变异(BV)。

方法

33 名(16 名女性,17 名男性)健康志愿者每周采集一次晨尿,共采集 10 周,在罗氏 Cobas 6,000 仪器上进行分析。使用在线 BV 计算软件 BioVar 进行统计分析。数据评估基于正态性、离群值、稳态、数据同质性,通过方差分析(ANOVA)获得 BV 值。为男性和女性建立了严格的个体内(CV)和个体间(CV)估计的方案。

结果

除钾、钙和镁外,所有分析物的女性/男性 CV 估计值之间存在显著差异。CV 估计值之间没有差异。当将 CV 估计值有显著差异的随机尿分析物与肌酐进行比较时,发现性别之间的显著差异消失了。所有随机尿分析物/肌酐比值的女性/男性 CV 和 CV 估计值之间没有显著差异。

结论

由于分析物/肌酐比值的 CV 估计值较低,因此在报告结果时使用它们更为合理。参考范围应谨慎使用,因为几乎所有参数的 II 值都在 0.6 到 1.4 之间。我们研究的 CV 检测能力为 1,这是最高值。

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