Consistency and correlation of a domestic Kehua serum free light chain assay with two imported analytical systems
- 1State Key Laboratory of Experimental Hematology, National Clinical Research Center for Blood Diseases, Haihe Laboratory of Cell Ecosystem, Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College
- 2Shanghai Kehua Bio-Engineering Co., Ltd, Reagent R and D Center
Abstract
Background: Serum free light chain (sFLC) testing is central to the diagnosis and monitoring of plasma cell disorders, but assay availability and implementation can vary by laboratory setting. We evaluated a domestic latex-enhanced immunoturbidimetric Kehua serum sFLC assay against Freelite and N Latex systems.
Methods: Residual serum samples from 133 adults with suspected or established monoclonal gammopathies were measured in parallel by Kehua and Freelite; 122 were also tested by N Latex. Precision was assessed with low- and high-level serum controls. Method agreement was evaluated using correlation, Passing-Bablok regression, Bland-Altman analysis, qualitative concordance and comparator-defined ROC analysis.
Results: Kehua within-run CVs were <5% for κ and λ controls. Agreement with Freelite was excellent for FLC-κ, FLC-λ and κ/λ ratio (Pearson r = 0.988-1.000; CCC = 0.983-0.999), with Passing-Bablok slopes close to unity. Agreement with N Latex was also strong (r = 0.991-0.998), although κ/λ ratio showed proportional bias. Total qualitative concordance was 89.47-93.23% versus Freelite and 83.61-91.80% versus N Latex, with Cohen’s κ of 0.67-0.85. Comparator-defined ROC AUCs were 0.994-0.999 for elevated FLC-κ or FLC-λ and 0.796-0.869 for κ/λ ratio abnormality.
Conclusion: The Kehua serum assay demonstrated acceptable precision and good clinical agreement with two imported methods. It may serve as a domestic option for routine serum sFLC quantification, provided method-specific intervals are maintained and the same platform is used for serial monitoring.
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BibTeX
@article{ren2026consistency,
title = {{Consistency and correlation of a domestic Kehua serum free light chain assay with two imported analytical systems}},
author = {Yansong Ren and Shoulei Wang and Limin Han and Yansheng Wang and Qian Ren and Mengxin Wang and Yonghui Xia and Guoqing Zhu},
journal = {Frontiers in Oncology},
year = {2026},
month = oct,
doi = {10.3389/fonc.2026.1900671},
url = {https://www.frontiersin.org/articles/10.3389/fonc.2026.1900671/full},
note = {CC BY 4.0},
}
RIS
TY - JOUR
TI - Consistency and correlation of a domestic Kehua serum free light chain assay with two imported analytical systems
AU - Yansong Ren
AU - Shoulei Wang
AU - Limin Han
AU - Yansheng Wang
AU - Qian Ren
AU - Mengxin Wang
AU - Yonghui Xia
AU - Guoqing Zhu
PY - 2026
DA - 2026/10/15
JO - Frontiers in Oncology
DO - 10.3389/fonc.2026.1900671
UR - https://www.frontiersin.org/articles/10.3389/fonc.2026.1900671/full
AB - Background: Serum free light chain (sFLC) testing is central to the diagnosis and monitoring of plasma cell disorders, but assay availability and implementation can vary by laboratory setting. We evaluated a domestic latex-enhanced immunoturbidimetric Kehua serum sFLC assay against Freelite and N Latex systems. Methods: Residual serum samples from 133 adults with suspected or established monoclonal gammopathies were measured in parallel by Kehua and Freelite; 122 were also tested by N Latex. Precision was assessed with low- and high-level serum controls. Method agreement was evaluated using correlation, Passing-Bablok regression, Bland-Altman analysis, qualitative concordance and comparator-defined ROC analysis. Results: Kehua within-run CVs were <5% for κ and λ controls. Agreement with Freelite was excellent for FLC-κ, FLC-λ and κ/λ ratio (Pearson r = 0.988-1.000; CCC = 0.983-0.999), with Passing-Bablok slopes close to unity. Agreement with N Latex was also strong (r = 0.991-0.998), although κ/λ ratio showed proportional bias. Total qualitative concordance was 89.47-93.23% versus Freelite and 83.61-91.80% versus N Latex, with Cohen’s κ of 0.67-0.85. Comparator-defined ROC AUCs were 0.994-0.999 for elevated FLC-κ or FLC-λ and 0.796-0.869 for κ/λ ratio abnormality. Conclusion: The Kehua serum assay demonstrated acceptable precision and good clinical agreement with two imported methods. It may serve as a domestic option for routine serum sFLC quantification, provided method-specific intervals are maintained and the same platform is used for serial monitoring.
SN - 2234-943X
ER -