Resumo

BARAKIAN, Benjamín Federico  e  LETICIA BIBIANA, Madalena. Procedimiento alternativo de evaluación externa de calidad para el proteinograma sérico por electroforesis capilar. Acta bioquím. clín. latinoam. [online]. 2023, vol.57, n.1, pp.61-73. ISSN 0325-2957.

The objective of this work was to implement an alternative procedure for external quality evaluation of the serum proteinogram by capillary electrophoresis, as well as to evaluate its development and usefulness. A shared sample between laboratories procedure was designed and conducted during the 10/2017-08/2019 period with nine deliveries of two samples per event, reaching a maximum of eight participating laboratories. Serum samples with a variety of protein profiles were stored at -70 °C until the day of transport and processing. The parameters evaluated were total proteins and albumin by chemical method, fractions of the electrophoretic proteinogram by capillary electrophoresis in absolute/relative concentration and the interpretive comment (observations and suggestions). The results were analysed taking the data from the organising laboratory as comparator values using the calculation of the allowed difference, dependent on the inter- and intra-laboratory reference variability, recommended by the GP29-A2 guideline. The observed differences of all the parameters were less than the allowed difference in 96% of the cases and average interlaboratory variation coefficients between 1.8 and 5.8% were obtained for all determinations and fractions, so it can be concluded that it is a high reproducibility technique between laboratories using the same platform. The qualitative analysis showed concordances and discrepancies regarding the profiles described, the forms of expression, and suggestions for complementary analysis: 55% without discre ancies (same profile), 34% with partial differences, and 11% with major differences. Due to the lack of consensus, the challenge continues to be the interpretation and reporting of results.

Palavras-chave : Serum electrophoretic proteinogram; Capillary electrophoresis; External quality control; Interlaboratory control; Reproducibility; Harmonization.

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