[1]靳 洁,康晓军,李 燕,等.胶乳凝集目视检测尿液游离轻链的方法建立及诊断效能评价[J].现代检验医学杂志,2026,41(03):172-176.[doi:10.3969/j.issn.1671-7414.2026.03.031]
　JIN Jie,KANG Xiaojun,LI Yan,et al.Development and Validation of a Latex Agglutination Visual Assay for Detecting Urinary Free Light Chains[J].Journal of Modern Laboratory Medicine,2026,41(03):172-176.[doi:10.3969/j.issn.1671-7414.2026.03.031]
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胶乳凝集目视检测尿液游离轻链的方法建立及诊断效能评价()

《现代检验医学杂志》[ISSN:/CN:]

卷:
第41卷
期数:
2026年03期
页码:
172-176
栏目:
论著
出版日期:
2026-05-13

文章信息/Info

Title:
Development and Validation of a Latex Agglutination Visual Assay for Detecting Urinary Free Light Chains
文章编号:
1671-7414（2026）03-172-05
作者:
靳 洁a，康晓军b，李 燕b，张小娟b，庞高阳b
巩义市人民医院 a.血液科；b.检验科，郑州 451200
Author(s):
JIN Jie a，KANG Xiaojun b，LI Yan b，ZHANG Xiaojuan b，PANG Gaoyang b
a. Department of Hematology; b. Depart-ment of Laboratory Medicine, Gongyi City People’s Hospital, Zhengzhou 451200, China
关键词:
胶乳凝集试验; 游离轻链; 目视筛查; 单克隆免疫球蛋白增殖性疾病
分类号:
R733.73；R446.12
DOI:
10.3969/j.issn.1671-7414.2026.03.031
文献标志码:
A
摘要:
目的建立通过目视检测尿液中游离轻链（FLC）的胶乳凝集方法，为单克隆免疫球蛋白增殖性疾病提供经济简便的筛查方法。方法采用乳胶凝集试验(LAT)，分别使用抗游离κ/λ轻链抗体包被胶乳微球，制备胶乳试剂，通过目视观察胶乳试剂和尿液的凝集反应进行定性检测。对胶乳微球致敏的抗体浓度进行优化；对稳定性、重复性、线性、检测范围等性能指标进行评价；采用双盲法分析37例尿液样本，评估敏感度与特异度。结果成功建立一种通过目视检测尿液中游离轻链的LAT方法。该方法最优的致敏抗体浓度为0.429mg/ml。胶乳试剂在4℃保存21天，6例样本定性结果的阴性/阳性符合率为100%，2例阳性样本终点滴度的一致性为95.71%（均P＜0.05）。4例梯度稀释样本的终点滴度与游离轻链浓度表现出良好的线性关系（r2=0.9984～0.9995）。κ/λ游离轻链的检测范围为300～5000mg/L。研究组（n=22）和对照组（n=15）的双盲胶乳凝集结果与金标准100%符合。结论该研究建立的LAT可通过目视定性检测尿液中游离轻链，试剂稳定，具有较高的敏感度与特异度，在单克隆免疫球蛋白增殖性疾病的筛查中具有应用价值。
Abstract:
Objective To establish a latex agglutination test (LAT) for visual detection of urinary free light chains (FLCs), provid-ing a simple and cost-effective screening approach for monoclonal immunoglobulin proliferative disorders. Methods LAT micro-spheres were coated with anti-free κ/λ light chain antibodies to prepare latex reagents. Qualitative analysis was performed by visually observing the agglutination reactions between the latex reagents and urine samples. The antibody concentration for sensi-tizing the latex microspheres was optimized. Performance characteristics including stability, reproducibility, linearity, and detec-tion range were systematically evaluated. A double-blind analysis involving 37 urine samples was conducted to assess sensitivity and specificity. Results A LAT for visual detection of urinary FLCs was successfully developed. The optimal antibody coating concentration was 0.43 mg/ml. The latex reagents maintained 100% concordance in negative/positive results for 6 samples stored at 4 ℃ for 21 days, with 95.71% consistency in endpoint titers for 2 positive samples (all P < 0.05). The endpoint titers of 4 gra-dient-diluted samples showed good linear correlation with FLC concentrations (r2=0.998 4～0.999 5). The detection range for κ/λ free light chains was 300～5 000 mg/L. Double-blind LAT results in both the study group (n=22) and the control group (n=15) demonstrated 100% agreement with the gold standard. Conclusions The established LAT enables visual qualitative detection of urinary FLCs with high stability, sensitivity, and specificity, showing practical value for screening monoclonal immunoglobulin proliferative disorders.

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备注/Memo

备注/Memo:
基金项目：河南省医学科技攻关计划（LHGJ20240529）。
作者简介：靳洁（1985-)，女，学士，副主任医师，研究方向：血液病诊断与治疗，E-mail：516580589@qq.com。
通迅作者：庞高阳（1989-），男，硕士，检验师，研究方向：蛋白电泳与血液病诊断，E-mail：623522656@qq.com。
更新日期/Last Update: 2026-05-15