Verification of serum protein electrophoresis on the Cappilarys ۲ Flex Piercing automaton

Introduction: The verification/validation of analytical equipment and methods is both part of this reasoning and an indispensable condition for their use and is one of the priorities of the medical biologist. The aim of our study is to verify the electrophoresis of serum proteins on the Cappilarys ۲ Flex Piercing automaton. Materials and methods: The evaluation methodology concerned the scope A which is based on the recommendations of the Valtec protocol of the French Society of Clinical Biology, as well as those of the SH-GTA O۴ protocol of the COFRAC (Comité français d’accréditation). We studied the repeatability on normal and pathological serum samples, and the reproducibility on normal and pathological internal quality control samples. Results: The values of the coefficient of variation of repeatability and reproducibility obtained by our study for each serum protein fraction (Albumin, Alpha-۱, Alpha-۲, Beta-۱, Beta-۲, Gamma globulins), are overall satisfactory and are in accordance with the requirements issued by the supplier and those issued by RICOS. In addition, these results are consistent with those of other similar studies. Discussion and conclusion: This type of study will provide a solid basis for the realization of an accreditation procedure for the tests used in our laboratory. For any laboratory wishing to be accredited according to the ISO ۱۵۱۸۹ standard, the validation/verification of methods is a determining criterion. It is an essential step to be taken before the implementation of the newly acquired equipment.

Keywords:

Cappilarys ۲ Flex Piercing , Serum protein , Electrophoresis , Validation