Valutazione delle caratteristiche analitiche di un nuovo strumento per l’elettroforesi capillare delle proteine sieriche

AUTORI

ABSTRACT

Evaluation of the analytical performance of a new capillary electrophoresis system for serum protein analysis

Electrophoresis techniques are used in clinical laboratories to detect, type and quantify monoclonal components (MC), and are therefore of pivotal importance in the management of patients with monoclonal gammopathies. Capillary electrophoresis (CE) is an attractive alternative to agarose gel electrophoresis (AGE) because it offers a higher degree of automation without requiring the use of toxic reagents. Aim of this study was to evaluate analytical characteristics of a recently marketed instrument for CE, comparing it with both a well established CE and with AGE. The new system (V8, Helena Biosciences) was compared for MC detection with Capillarys (Sebia) and for typing with both the AGE Hydrasys system (Sebia) and the immunosubtraction technique on Capillarys. All the evaluated analytical characteristics were related to MC investigations, i.e. detection, typing and quantification. The interference effect of some substances and the carryover were also investigated. For MC detection, an agreement of 98.5% has been demonstrated between the two CE systems; the discordant samples show a MC <1 gl. the limit of detection for a mc was 0.5 totalagreement in typing>5 g/L between the two CE systems was observed. V8 was able to correctly characterize 18 MC with concentration <5 g/L out of 20 samples typed by AGE immunofixation. V8 can quantify MC with elevated precision (CV 3,5% and 1,2% for b- and g-zone MC, respectively) and the measurement is linear till <1 g/L. Fibrinogen and contrast media appear in the CE patterns as homogeneous bands MC like. From these results, we conclude that the V8 analytical characteristics are fully adequate for the system use in clinical laboratories for managing patients with monoclonal gammopathies.

BIBLIOGRAFIA