Immunochemical measurement of urinary free light chains and Bence Jones proteinuria.

IF 3.8 2区 医学 Q1 MEDICAL LABORATORY TECHNOLOGY
Laura Michetti, Rudi Ravasio, Roberto Marozzi, Ester Antelmi, Arianna Ghirardi, Greta Bolzoni
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Abstract

Objectives: To evaluate the characteristics of an immunochemical urinary free light chains (uFLC) test in screening and quantifying Bence Jones proteinuria (BJP) and its potential application in laboratory practice as an alternative to the gold standard method, urine immunofixation (UIFE) and densitometric quantification on 24 h urine sample.

Methods: A total of 300 subjects were divided into five groups: controls, patients with BJP Kappa and Lambda present in trace amounts not densitometrically quantifiable, and patients with BJP Kappa and Lambda present in densitometrically measurable quantities. The Wilcoxon-Mann-Whitney test was applied to compare uFLC in controls and BJP trace samples. The correlation between immunochemical and densitometric measurements was assessed using Spearman's correlation coefficient, and agreement was evaluated with Bland-Altman plots. Samples were also stratified by estimated glomerular filtration rate (eGFR) and total urinary proteins (TUP).

Results: Despite significant differences between the median values of uFLC measures in controls and BJP in trace sample groups, using the uFLC upper reference ranges would have led to over 50 % false negative results. Although a strong correlation existed between the two methods, turbidimetry consistently overestimated BJP levels.

Conclusions: uFLC turbidimetric measurements cannot accurately differentiate negative samples from those containing trace BJP, lacking the sensitivity required for clinical use. UIFE has shown greater sensitivity compared to turbidimetry. In monitoring, the systematic overestimation in the quantification of BJP, aggravated in cases of reduced renal function or high TUP concentration, makes it challenging for clinicians to evaluate therapeutic efficacy since the decision thresholds outlined in clinical guidelines are based on densitometric measurements.

尿游离轻链和本·琼斯蛋白尿的免疫化学测定。
目的:评价免疫化学尿游离轻链(uFLC)试验筛选和定量Bence Jones蛋白尿(BJP)的特点及其在实验室实践中替代金标准法、尿免疫固定(UIFE)和24 h尿样密度定量的潜在应用。方法:将300名受试者分为5组:对照组、微量且无法密度测量的BJP Kappa和Lambda患者和密度可测量的BJP Kappa和Lambda患者。采用Wilcoxon-Mann-Whitney检验比较对照和BJP痕量样品中的uFLC。使用Spearman相关系数评估免疫化学和密度测量之间的相关性,并使用Bland-Altman图评估一致性。根据肾小球滤过率(eGFR)和总尿蛋白(TUP)对样本进行分层。结果:尽管痕量样品组中uFLC测量值的中位数与对照组和BJP之间存在显著差异,但使用uFLC上限参考范围将导致超过50% %的假阴性结果。尽管两种方法之间存在很强的相关性,但浊度法始终高估了BJP水平。结论:uFLC浊度法测量不能准确区分阴性样品和含有微量BJP的样品,缺乏临床使用所需的灵敏度。与浊度法相比,UIFE显示出更高的灵敏度。在监测中,由于临床指南中概述的决策阈值是基于密度测量的,因此,在肾功能下降或TUP浓度高的情况下,对BJP量化的系统性高估使临床医生评估治疗效果具有挑战性。
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来源期刊
Clinical chemistry and laboratory medicine
Clinical chemistry and laboratory medicine 医学-医学实验技术
CiteScore
11.30
自引率
16.20%
发文量
306
审稿时长
3 months
期刊介绍: Clinical Chemistry and Laboratory Medicine (CCLM) publishes articles on novel teaching and training methods applicable to laboratory medicine. CCLM welcomes contributions on the progress in fundamental and applied research and cutting-edge clinical laboratory medicine. It is one of the leading journals in the field, with an impact factor over 3. CCLM is issued monthly, and it is published in print and electronically. CCLM is the official journal of the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) and publishes regularly EFLM recommendations and news. CCLM is the official journal of the National Societies from Austria (ÖGLMKC); Belgium (RBSLM); Germany (DGKL); Hungary (MLDT); Ireland (ACBI); Italy (SIBioC); Portugal (SPML); and Slovenia (SZKK); and it is affiliated to AACB (Australia) and SFBC (France). Topics: - clinical biochemistry - clinical genomics and molecular biology - clinical haematology and coagulation - clinical immunology and autoimmunity - clinical microbiology - drug monitoring and analysis - evaluation of diagnostic biomarkers - disease-oriented topics (cardiovascular disease, cancer diagnostics, diabetes) - new reagents, instrumentation and technologies - new methodologies - reference materials and methods - reference values and decision limits - quality and safety in laboratory medicine - translational laboratory medicine - clinical metrology Follow @cclm_degruyter on Twitter!
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