The local technical validation of new plasma tube with a mechanical separator

Abstract

Background: Unsuitable samples are common problem for laboratories. The blood collection tubes need to be validated or verified prior to their being used in the routine laboratory for reducing this situation. Objective: We aim to compare the technical qualifications of routinely used BD Vacutainer® Serum Separator Tubes™II Advance Plus with BD Vacutainer® Barricor™LH Plasma Tubes for local technical validation. Materials and methods: Apparently healthy 150 voluntary subjects were enrolled in the study. Samples were collected in two separated tubes by a single phlebotomist. Twelve quality indicators were used to compare these two different types of tubes for local technical validation. Differences (%) between them were calculated with the formula proposed by EFLM. In case of any difference of less than 1% for each indicator, the evaluated tube was considered as non-inferior. Results: Indicators, such as tubes with physical defects, that fail to create vacuum, not properly fitting into the blood collection device, under filling (10%), cracked tubes, tubes exterior surface contaminated with blood, hemolysed specimens, including fibrin strand/mass in the sample, red blood cell adhesion, poor/incomplete barrier formation were found non-inferior in Barricor™tubes. White particulate matter (WPM) was observed in 24.6% of Barricor™. Therefore, the last indicator (tubes including gel/foreign material/WPM in sample after centrifugation) was found inferior for Barricor™. Conclusion: Technical local validation studies should be encouraged in terms of quality management. It was thought that WPM would not cause any interference in a properly filled tube. In addition to, Barricor™was also found to be technically acceptable when evaluated through using all other indicators.