Serum free light chain quantitative assays: Dilemma of a biomarker

Cigliana, Giovanni; Gulli, Francesca; Napodano, Cecilia; Pocino, Krizia; Santis, Elena De; Colacicco, Luigi; Cordone, Iole; Conti, Laura; Basile, Umberto

doi:10.1002/jcla.22243

Cited by 11 publications

(11 citation statements)

References 30 publications

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“…The two assays are not entirely equivalent. Care should be taken by interpreting physicians and laboratories when considering switching assays (Cigliana et al, 2017).…”

Section: Introductionmentioning

confidence: 99%

Free light chains: Eclectic multipurpose biomarker

Basile

Gulli

Gragnani

et al. 2017

Journal of Immunological Methods

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The production of antibodies is accompanied by a slight excess of synthesis of κ and λ immunoglobulin light chains; small amounts of them are released in the peripheral blood and can also be found in various body fluids, such as synovial fluid, cerebrospinal fluid, urine and saliva. They are rapidly filtered by the glomerulus and >99% are reabsorbed from the cells of the proximal convoluted tubule, making them present in the urine in only trace amounts. The production of an excess of protein without a reason or a specific function in a biological system is rare. Free light chains, considered for years a waste product of Ig synthesis, are currently known to be very active molecules, able to bind antigens as well as whole immunoglobulin and helping to develop specific antibody affinity. The ability of free light chains to activate mast cells and then become an active part of the pathogenic mechanisms of chronic inflammatory diseases has increased interest in their clinical use, both as an attractive therapeutic target or as a biochemical marker of disease evolution or remission. This is an overview of relevant scientific interest that immunoglobulin light chains κ and λ have attracted over the years, a report on the progress in knowledge about their structure and function, with a special focus on their biological meaning and potential clinical utility in different diseases.

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“…The two assays are not entirely equivalent. Care should be taken by interpreting physicians and laboratories when considering switching assays (Cigliana et al, 2017).…”

Section: Introductionmentioning

confidence: 99%

Free light chains: Eclectic multipurpose biomarker

Basile

Gulli

Gragnani

et al. 2017

Journal of Immunological Methods

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“…Method comparison of the clinically available assays for sFLC analysis has been reported, where good overall agreements for κFLC, λFLC, and FLC-ratio were observed [15], where the agreement became poorer as the analyte concentrations increased above 100 mg/ ml. However, it is recognised that the sFLC assays used in clinical practice exhibit significant analytical limitations, including antigen excess, imprecision, lot-to-lot variations, and non-linear dose response curves [16][17][18]. In addition, the different assays report results that differ from each other and therefore the assays cannot be used interchangeably [17] and that patient follow-up should be performed using a single assay [19].…”

Section: Discussionmentioning

confidence: 99%

“…However, it is recognised that the sFLC assays used in clinical practice exhibit significant analytical limitations, including antigen excess, imprecision, lot-to-lot variations, and non-linear dose response curves [16][17][18]. In addition, the different assays report results that differ from each other and therefore the assays cannot be used interchangeably [17] and that patient follow-up should be performed using a single assay [19].…”

Section: Discussionmentioning

confidence: 99%

Accuracy of determination of free light chains (Kappa and Lambda) in plasma and serum by Swedish laboratories as monitored by external quality assessment

Rollborn

Jakobsson

Campbell³

et al. 2023

Clinical Biochemistry

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“…Although Cigliana et al . suggest that internationally available standard should help to harmonise results, this would not solve test result discrepancies in certain patients ( 25 ).…”

Section: Discussionmentioning

confidence: 99%

Verification study of free light chains assays on reagent-optimized analysers

Šegulja

Matišić

Barišić

et al. 2019

Biochem. med. (Online)

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Introduction: Our aim was to compare analytical specifications of two assays (monoclonal vs. polyclonal) for free light chains (FLCs) quantification optimized for two different analytical platforms, nephelometer ProSpec (Siemens, Erlangen, Germany) and turbidimetric analyser Optilite (The Binding Site, Birmingham, UK). Materials and methods: The evaluation included verification of the precision, repeatability and reproducibility, estimation of accuracy and method comparison study with 37 serum samples of haematological patients. Kappa and lambda FLC were measured in each sample by both methods and kappa/lambda ratio was calculated. Results: Results show satisfactory precision of both methods with coefficients of variation for ProSpec of CVwr = 2.20% and CVbr = 3.44%, and for Optilite CVwr = 2.82% and CVbr = 4.15%. Estimated bias for FLC lambda was higher on the ProSpec analyser, but bias for FLC kappa was higher on the Optilite analyser. Correlation coefficients were 0.98; P < 0.001 for FLC kappa and 0.97; P < 0.001 for FLC lambda. Considering normal/pathological FLC ratio moderate agreement within assays was detected (κ = 0.621). When the results were categorized according to criteria for progressive disease, 4/37 (0.10) cases were differently classified. Lambda FLC values by Optilite in three samples with monoclonal FLC lambda were more than twelve times higher than by ProSpec. A 25% difference in FLC ratio was detected in 16/37 (0.43) and 50% difference in 13/37 (0.35) patients. Conclusions: All manufacturers’ precision claims could not be achieved in the verification study. The comparison of results to biological variations data showed that coefficients of variations are acceptable for both assays. The assays should not be used interchangeably in haematological patients.

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Serum free light chain quantitative assays: Dilemma of a biomarker

Cited by 11 publications

References 30 publications

Free light chains: Eclectic multipurpose biomarker

Free light chains: Eclectic multipurpose biomarker

Accuracy of determination of free light chains (Kappa and Lambda) in plasma and serum by Swedish laboratories as monitored by external quality assessment

Verification study of free light chains assays on reagent-optimized analysers

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