About this Journal Submit a Manuscript Table of Contents
ISRN Hematology
Volume 2012 (2012), Article ID 875357, 5 pages
http://dx.doi.org/10.5402/2012/875357
Research Article

K3EDTA Vacuum Tubes Validation for Routine Hematological Testing

1Laboratory of Clinical Biochemistry, Department of Life and Reproduction Sciences, University of Verona, 37129 Verona, Italy
2Post-Graduate Program of Pharmaceutical Sciences, Department of Medical Pathology Federal University of Parana, 80210-170 Curitiba, PR, Brazil
3MERCOSUL: Sector Committee of Clinical Analyses and In Vitro Diagnostics–CSM 20, 20270-902 Rio de Janeiro, RJ, Brazil
4Brazilian Society of Clinical Analyses on Sao Paulo State, 02965-140 Sao Paulo, SP, Brazil
5Laboratory of Clinical Chemistry and Hematology, Department of Pathology and Laboratory Medicine, Academic Hospital of Parma, 43126 Parma, Italy

Received 16 April 2012; Accepted 10 June 2012

Academic Editors: D. Lavelle, W. Lösche, and C. Martinez

Copyright © 2012 Gabriel Lima-Oliveira et al. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

Abstract

Background and Objective. Some in vitro diagnostic devices (e.g, blood collection vacuum tubes and syringes for blood analyses) are not validated before the quality laboratory managers decide to start using or to change the brand. Frequently, the laboratory or hospital managers select the vacuum tubes for blood collection based on cost considerations or on relevance of a brand. The aim of this study was to validate two dry K3EDTA vacuum tubes of different brands for routine hematological testing. Methods. Blood specimens from 100 volunteers in two different K3EDTA vacuum tubes were collected by a single, expert phlebotomist. The routine hematological testing was done on Advia 2120i hematology system. The significance of the differences between samples was assessed by paired Student’s t-test after checking for normality. The level of statistical significance was set at 𝑃 < 0 . 0 5 . Results and Conclusions. Different brand’s tubes evaluated can represent a clinically relevant source of variations only on mean platelet volume (MPV) and platelet distribution width (PDW). Basically, our validation will permit the laboratory or hospital managers to select the brand’s vacuum tubes validated according to him/her technical or economical reasons for routine hematological tests.