Abstract:The study revealed several weak points in the methodology, including the need for a uniform sample dilution procedure. Interlaboratory reproducibility was comparable with values achieved in the NEQAS programme. Because the κ/λ ratio cannot be measured with high precision, κ and λ FLC concentrations should be used where possible. Due to its impact on the clinical management of patients with gammopathy, FLC quantification needs to become a part of the regular quality control cycle in myeloma centres.
“…Parameters of interest were negative immunofixation in two consecutive samples, less than 5% of plasma cells in the bone marrow, no plasmocytoma, negative urine immunofixation , and occurrence of relapse. For all patients, the samples for FLCr evaluation were collected at time of reaching complete remission as a part of a new standard evaluation in the Czech Republic . The samples for FLCr were obtained at standard timepoints after ASCT at D+28, D+100, or whenever CR was reached.…”
Section: Methodsmentioning
confidence: 99%
“…The biochemical analysis was completed according to currently established methods . For all FLC analysis, the standard FreeLite ™ (Binding Site, Birmingham, United Kingdom) method was used.…”
“…Parameters of interest were negative immunofixation in two consecutive samples, less than 5% of plasma cells in the bone marrow, no plasmocytoma, negative urine immunofixation , and occurrence of relapse. For all patients, the samples for FLCr evaluation were collected at time of reaching complete remission as a part of a new standard evaluation in the Czech Republic . The samples for FLCr were obtained at standard timepoints after ASCT at D+28, D+100, or whenever CR was reached.…”
Section: Methodsmentioning
confidence: 99%
“…The biochemical analysis was completed according to currently established methods . For all FLC analysis, the standard FreeLite ™ (Binding Site, Birmingham, United Kingdom) method was used.…”
“…This needs to be studied. Furthermore, there is growing evidence of considerable interlaboratory and interplatform variability in measurement and EQA distributions (http://www.immqas.org.uk) which must be taken into account. Previous publications acknowledge some of these issues, but more recent data suggest that non‐linear dose–response relationships affect significant numbers of patients .…”
SummarySerum free light chain (sFLC) measurement has gained widespread acceptance and is incorporated into various diagnostic and response criteria. Nonlinearity and antigen excess are the main causes of 'variability' in the measurement of sFLC using immunoassay, but the impact of these on measurement has been unclear. We performed a retrospective evaluation using a dilutional strategy to detect these phenomena. A total of 464 samples in 2009 and 373 samples in 2010 were analysed for sFLC. Non-linearity was detected in both high and apparently normal sFLC. Major non-linearity of more than twofold is common in high kappa (20·2%) and lambda (14·1%). It is less common in samples with apparently normal levels -kappa (6·4%) and lambda (9·5%). 9·4% of kappa and 15·5% of lambda showed antigen excess at screening dilutions. 34·4% of the samples had either non-linearity or antigen excess. We conclude that significant measurement variability is common in the measurement of sFLC. There is currently no reliable technique to detect non-linearity phenomena unless a serial dilution strategy is applied to every analysis. We recommend that laboratories routinely reporting sFLC results for clinical services need appropriate strategies for addressing these issues. Clinicians should be aware of these limitations in interpretation of sFLC assay for individual patients. Future guidelines should adopt action thresholds which are grounded firmly in test performance parameters.
“…Un sérum présentant un taux élevé en chaînes légères libres lambda a présenté un effet de zone sur l'Immage ® 800, donnant une valeur faible erronée, alors que le SPAPLUS ® le détectait supérieur à la gamme de mesure et relançait spontanément une vérification avec une dilution supérieure de l'échantillon de sérum. À l'inverse, un échantillon avec un taux élevé en IgD (évalué par immunodiffusion radiale) a présenté un effet de analyseurs ont déjà été rapportées [15,16], y compris entre le SPAPLUS® et 'immunonéphélémètre BNII® [17]. Ces différences pourraient être dues aux lots de réactifs, au fait que le dosage de certaines chaînes légères libres monoclonales n'est pas linéaire quand on les dilue [18] des cuvettes) durent environ dix minutes.…”
Section: Détection De L'effet De Zone Par Excès D'antigèneunclassified
423Pour citer cet article : Thevenet I, Benat C, Chauzeix J, Blancher A, Puissant-Lubrano B. Évaluation des performances analytiques du turbidimètre SPAPLUS ® pour le dosage des immunoglobulines et de la bêta-2 microglobuline dans le sérum.
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