Original scientific paper

Preanalytical management: serum vacuum tubes validation for routine clinical chemistry

Gabriel Lima-Oliveira orcid.org/0000-0002-5937-9137 ; 1Laboratory of Clinical Biochemistry, Department of Life and Reproduction Sciences, University of Verona, Italy 2Post-Graduate Program of Pharmaceutical Sciences, Department of Medical Pathology Federal University of Parana, Curitiba, Parana, Brazil 3MERC
Giuseppe Lippi ; U.O. Diagnostica Ematochimica, Azienda Ospedaliero-Universitaria di Parma, Italy
Gian Luca Salvagno ; Laboratory of Clinical Biochemistry, Department of Life and Reproduction Sciences, University of Verona, Italy
Martina Montagnana ; Laboratory of Clinical Biochemistry, Department of Life and Reproduction Sciences, University of Verona, Italy
Geraldo Picheth ; Post-Graduate Program of Pharmaceutical Sciences, Department of Medical Pathology Federal University of Parana, Curitiba, Parana, Brazil
Gian Cesare Guidi ; 1Laboratory of Clinical Biochemistry, Department of Life and Reproduction Sciences, University of Verona, Italy 2Post-Graduate Program of Pharmaceutical Sciences, Department of Medical Pathology Federal University of Parana, Curitiba, Parana, Brazil

Abstract

Introduction: The validation process is essential in accredited clinical laboratories. Aim of this study was to validate five kinds of serum vacuum tubes for routine clinical chemistry laboratory testing.
Materials and methods: Blood specimens from 100 volunteers in five different serum vacuum tubes (Tube I: VACUETTE®, Tube II: LABOR IMPORT®, Tube III: S-Monovette®, Tube IV: SST® and Tube V: SST II®) were collected by a single, expert phlebotomist. The routine clinical chemistry tests were analyzed on cobas® 6000 module. 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 < 0.005. Finally, the biases from Tube I, Tube II, Tube III, Tube IV and Tube V were compared with the current desirable quality specifications for bias (B), derived from biological varia-tion.
Results and conclusions: Basically, our validation will permit the laboratory or hospital managers to select the brand’s vacuum tubes validated according him/her technical or economical reasons, in or-der to perform the following laboratory tests: glucose, total cholesterol, high density lipoprotein-cholesterol, triglycerides, total protein, albumin, blood urea nitrogen, uric acid, alkaline phosphatise, aspartate aminotransferase, gamma-glutamyltransferase, lactate dehydrogenase, creatine kinase, total bilirubin, direct bilirubin, calcium, iron, sodium and potassium. On the contrary special attention will be required if the laboratory already performs creatinine, amylase, phosphate and magnesium determinations and the quality laboratory manager intend to change the serum tubes. We suggest that laboratory management should both standardize the procedures and frequently evaluate the quality of in vitro diagnostic devices.

Keywords

preanalytical variability; blood collection; serum samples; vacuum tubes; validation process

Hrčak ID:

83223

URI

https://hrcak.srce.hr/83223

Publication date:

15.6.2012.

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