AI Article Synopsis
- Free light chain (FLC) measurements are crucial for diagnosing monoclonal gammopathies, but different testing methods may lead to inconsistent results, impacting patient assessments.
- The study compared two main FLC testing methods over several years and found significant deviations, particularly in the lambda (λ) FLC measurements, with varying levels of precision between different instruments and reagents.
- Imprecision in λFLC results affects the κFLC/λFLC ratio, which is important for accurately diagnosing and differentiating between conditions in affected patients.
Article Abstract
Background: Free light chain (FLC) measurements are important in diagnosing monoclonal gammopathies. As FLC are heterogeneous, different reagents and instruments for measuring FLC concentrations may give diverging results that affect assessment of patients with monoclonal gammopathies. Here we investigated agreement between different FLC methods using data from the Swedish external quality assurance (EQA) programme.
Methods: The two main FLC assays, N Latex FLC (Siemens) and Serum Freelite (The Binding Site), using four nephelometric or turbidimetric instrument platforms, were compared. Results from 27 EQA rounds distributed to 11-16 Swedish hospital laboratories during 2015-2020 were investigated.
Results: The kappa (κ) FLC measurements deviated significantly over time, but when only nephelometry was used, deviation from the mean was lower (median ranges: -5% to 13 %). The CV was significantly higher for the Freelite assay (mean CV = 8.7) than for the N latex assay (mean CV = 5.7) (p < 0.0001). The coefficient of determination between all combinations of reagents and instrument platforms used was generally good (r = 0.76-0.87), and the correlation slope acceptable (0.81-1.2). For lambda (λ) FLC measurements, no concordance between combinations of instruments and reagents is apparent, deviating between -40 % to + 48 % from the mean. The CV was significantly higher for the combination with nephelometry and the Freelite assay (CV mean = 13.9 %) than nephelometry and the N latex assay (CV mean = 9.9 %) (p <0.001). The coefficient of determination varied between combinations of reagents and instrument platforms (r = 0.59-0.89) and the slope ranged between 0.48 and 1.5. Significant differences between the two reagents used were sometimes noted.
Conclusions: Imprecision in λFLC affects the κFLC/λFLC ratio. This may be important in clinical assessment of patients, especially differentiating between monoclonal and polyclonal gammopathies.
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| http://dx.doi.org/10.1016/j.clinbiochem.2022.10.003 | DOI Listing |
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