title: Preanalytical management: serum vacuum tubes validation for routine clinical chemistry.
abstract: BACKGROUND
  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.
  
  
  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 <c501> 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 variation.
  
  
  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 order 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.
authors: Laboratory of Clinical Biochemistry, Department of Life and Reproduction Sciences, University of Verona, Italy. dr.g.lima.oliveira@gmail.com
authors: Gabriel
authors: G
authors: Lima-Oliveira
authors: Giuseppe
authors: G
authors: Lippi
authors: Gian Luca
authors: GL
authors: Salvagno
authors: Martina
authors: M
authors: Montagnana
authors: Geraldo
authors: G
authors: Picheth
authors: Gian Cesare
authors: GC
authors: Guidi
mesh_terms: D001800:Blood Specimen Collection / Q000295:instrumentation* / Q000379:methods*; D002624:Chemistry, Clinical / Q000295:instrumentation* / Q000379:methods*; D019963:Clinical Chemistry Tests; D004867:Equipment Design; D004864:Equipment and Supplies / Q000592:standards; D005782:Gels; D006801:Humans; D015233:Models, Statistical; D018962:Phlebotomy / Q000379:methods; D015203:Reproducibility of Results; D044967:Serum
chemical_list: D005782:Gels