Objectives: Free light chain (FLC) is used for the diagnosis and prediction with regard to the progression risk of plasma cell disorders and Freelite reagent using the SPAplus analyzer (The Binding Site) has been one of the widely used option. However, N Latex FLC reagent with the Atellica CH 930 analyzer (Siemens Healthineers) has shown the advantages of automation and high throughput. We aimed to evaluated clinical implication by differential analytical performances of two assays.
Methods: A total of 322 serum samples were collected from 193 patients requested for FLC analysis including 131 multiple myeloma patients. The precision, linearity, dilution recovery of N Latex FLC assay was evaluated. We compared the two assays and analyzed the monomer-dimer pattern for discrepant results.
Results: The precision, linearity, and dilution recovery performance was appropriate for the routine use in clinical laboratories. Despite the good correlation within normal range, proportional bias up-to 170% was observed in samples with high concentrations especially for lambda. The higher value samples with N Latex FLC assay contained more monomer forms than controls. All opposite changes of FLC burden by the N Latex FLC assay proved to present concordant dynamic changes when assessed by serum protein electrophoresis.
Conclusions: Clinical laboratories should be aware of the inter-assay variability of FLC quantitative measurements using different platforms, especially for high concentrations of both kappa and lambda measurements, possibly due to monomer/dimer ratio diversity. Clinical interpretations for multiple myeloma disease status might not be dramatically affected only when the same assay is utilized during follow-up periods.
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http://dx.doi.org/10.1515/cclm-2023-0050 | DOI Listing |
Indian J Hematol Blood Transfus
October 2024
Dept. of Hematology, SGPGIMS, Lucknow, India.
With the introduction of newer platforms for sFLC estimation, more comparative attempts are required to establish an assay-specific reference range, that can be used in the day-to-day clinical management of the patients, as the revised criteria for the diagnosis of myeloma recommend the use of involved Free light chain (FLC)/uninvolved FLC ratio as myeloma defining event, solely relying on Freelite assay. This was an observational study that included 101 patients, 55 (54.5%) with M-protein (myeloma), and 46 (45.
View Article and Find Full Text PDFMultiple myeloma (MM) is a disease, that at times poses diagnostic and monitoring challenges. Over the last decades laboratory methods have been expanded with serum free light chain (FLC) analysis. Alerted by two index cases with clinical impact due to failure of the FLC analysis to indicate a disease progression, we aimed to identify any clinical consequences due to known differences between FLC analysis methods.
View Article and Find Full Text PDFLab Med
July 2024
Clinical Laboratory Department, First Affiliated Hospital of Anhui Medical University, Hefei, China.
Background: A substantial number of patients with multiple myeloma (MM) who have bone destruction are initially admitted into the orthopedic service at the hospital. However, routine laboratory testing usually fails to identify these patients, thus delaying optimal therapy. Therefore, there is a clear medical need for early diagnosis of MM in these patients.
View Article and Find Full Text PDFClin Chem Lab Med
June 2023
Department of Laboratory Medicine, Yonsei University College of Medicine, Seoul, Korea.
Ther Apher Dial
April 2023
Division of Nephrology, University Hospital Würzburg, Würzburg, Germany.
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