Comparative Evaluation of Blood Collection Tubes for Clinical Chemistry Analysis

Author(s):  
Nadia Ayala-Lopez ◽  
Steven E. Conklin data analysis ◽  
Brandon J. Tenney ◽  
Maryann Ness ◽  
Mark A. Marzinke
Author(s):  
Giuseppe Lippi ◽  
Michael P. Cornes ◽  
Kjell Grankvist ◽  
Mads Nybo ◽  
Ana-Maria Simundic

AbstractThe selection or procurement of blood collection devices in healthcare facilities is often an underestimated issue. This is probably due to different factors including the lack of knowledge of policymakers, hospital administrators and even laboratory managers about the importance of preanalytical quality and phlebotomy process, as well as to the absence of reliable guidelines or recommendations on how to precisely assess the quality of blood collection devices around the globe. With the awareness that a gap remains between manufacturers’ and local validation of blood collection devices, the Working Group for Preanalytical Phase (WG-PRE) of the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) has drafted a consensus document aimed to provide a set of essential requisites, technical criteria (e.g. presence of physical defects, malfunctioning, safety problems) and clinical issues for supporting laboratory professionals in organization blood collection tubes tenders and validating new devices before local routine implementation. The laboratory professionals should also make sure that the tenders accurately and strictly define the responsibilities for validation experiments and the potential consequences in the case the validation outcome shows that tubes due not fulfill the expectations.


2018 ◽  
Vol 56 (10) ◽  
pp. 1660-1666 ◽  
Author(s):  
Giuseppe Lippi ◽  
Ana-Maria Simundic ◽  

Abstract The Working Group for the Preanalytical Phase (WG-PRE) was officially established by the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) in 2013, with the aim of improving harmonization in the preanalytical phase across European member societies. Since its early birth, the WG-PRE has already completed a number of projects, including harmonizing the definition of fasting status, patient and blood tubes identification, color coding of blood collection tubes, sequence of tubes during blood drawing and participation in the development of suitable preanalytical quality indicators. The WG-PRE has also provided guidance on local validation of blood collection tubes, has performed two European surveys on blood sampling procedures and has organized four European meetings to promote the importance of quality in the preanalytical phase. The future activities entail development and validation of an external quality assessment scheme focused on preanalytical variables, development and dissemination of a survey about the local management of unsuitable samples in clinical laboratories, as well as release of EFLM phlebotomy guidelines. This article summarizes all recent achievements of the WG-PRE and illustrates future projects to promote harmonization in the preanalytical phase.


1998 ◽  
Vol 44 (6) ◽  
pp. 1325-1333 ◽  
Author(s):  
Dongbo J Zhang ◽  
R K Elswick ◽  
W Greg Miller ◽  
Jimmy L Bailey

Abstract The effect of serum-clot contact time on laboratory results was studied by dividing each blood specimen into four blood collection tubes. The control sera were separated from the clot within 30 min of the collection. The other tubes were incubated at 32 °C, and the sera were separated at 3, 6, and 24 h. The sera were stored at 4 °C and analyzed at the same time. The stability of the tests was determined by comparing the results of the 3-, 6-, and 24-h samples with the values from the 30-min samples. The acceptable limits around the 30-min values were derived from the analytical and intraindividual biological variation of the tests. A total of 63 analytes were studied. Potassium, phosphorous, and glucose were the least stable, and the serum should be separated from the clot within 3 h for these analytes. Albumin, bicarbonate, chloride, C-peptide, HDL-cholesterol, iron, LDL-cholesterol, and total protein should be separated within 6 h. The other analytes were stable for 24 h of serum-clot contact.


2019 ◽  
Vol 45 (1) ◽  
pp. 26-36 ◽  
Author(s):  
Arzu Kösem ◽  
Canan Topçuoğlu ◽  
Sevilay Sezer ◽  
Şimal Köksal Cevher ◽  
Ezgi Coşkun Yenigün ◽  
...  

Abstract Objective Blood collection tubes (BCTs) related interferences in test results can adversely influence on patient outcomes. We compared test results of samples in BD (Becton-Dickinson, Franklin Lakes, NJ, USA) Vacutainer Serum Separator Tubes (SST), BD Vacutainer® Barricor™ Plasma BCTs (Barricor™) and BD Vacutainer® Rapid Serum Tube (RST). Materials and methods Thirty-two samples were obtained from patients after the hemodialysis were included in this study. Eight routine clinical chemistry parameters (AST, creatinin, urea, PTH, glucose, LDH, K, calcium) were measured on Roche Cobas Analyzer (Roche Diagnostics, North America). The results of samples obtained from RST and Barricor™ were compared with SST as reference tubes. Results Results of Glucose, K, Urea, PTH from the SST and Barricor™ were statistically significantly different (p = 0.017, p < 0.001, p = 0.011, p < 0.001, respectively). In addition, results of PTH, LDH from SST and RST were significantly different (p < 0.001, p = 0.019). However, statistical significance of test results was not clinically significant for the biochemical parameters. Conclusion Working with Barricor™ may provide not just a fast, clean, high-quality plasma samples, safety results, but also time and cost-effectivity. Therefore, these types of tubes, which are less costly than other BCTs, may be preferred to obtain plasma.


2005 ◽  
Vol 51 (2) ◽  
pp. 424-433 ◽  
Author(s):  
Raffick AR Bowen ◽  
Yung Chan ◽  
Joshua Cohen ◽  
Nadja N Rehak ◽  
Glen L Hortin ◽  
...  

Abstract Background: Increased total triiodothyronine (TT3) assay results in apparently euthyroid patients triggered an investigation of the effect of blood collection tubes on serum TT3 and other laboratory assays. Methods: We examined potential assay interference for three types of tubes: plastic Greiner Bio-One™ Vacuette™; glass Becton Dickinson (BD) Vacutainer™; and plastic BD Vacutainer SST™ tubes. Serum samples from apparently healthy volunteers (age range, 30–60 years; 15 males and 34 females) were collected in different tube types and analyzed in 17 immunoassays (n = 49), 30 clinical chemistry tests (n = 20), and 33 immunology assays (n = 15). Tube effects were also examined by adding pooled serum to different tube types. Results: TT3 values, when measured by the IMMULITE™ 2000 but not the AxSYM™ analyzer, were significantly higher (P &lt;0.0001) for SST (2.81 nmol/L) than either glass (2.15 nmol/L) or Vacuette (2.24 nmol/L) tubes. The effect was large enough to substantially shift the distribution of patient values, increasing the percentage of values above the reference interval from 11.3% to 35.8%. The degree of interference from SST tubes on TT3 differed among various tube lots and could be attributed to a tube additive shared by other plastic tubes. Results from several other tests statistically differed among tube types, but differences were not considered to be clinically significant. Conclusions: Assay interferences from blood collection tubes represent challenges to clinical laboratories because they are not detected by the usual quality-control or proficiency testing programs. Laboratories can, however, address this problem by monitoring distribution of patients’ results.


2017 ◽  
Vol 28 (1) ◽  
Author(s):  
Janne Cadamuro ◽  
Cornelia Mrazek ◽  
Alexander B. Leichtle ◽  
Ulrike Kipman ◽  
Thomas K. Felder ◽  
...  

Diagnostics ◽  
2021 ◽  
Vol 11 (6) ◽  
pp. 1019
Author(s):  
Kyungjin Hong ◽  
Gabriella Iacovetti ◽  
Ali Rahimian ◽  
Sean Hong ◽  
Jon Epperson ◽  
...  

Blood sample collection and rapid separation—critical preanalytical steps in clinical chemistry—can be challenging in decentralized collection settings. To address this gap, the Torq™ zero delay centrifuge system includes a lightweight, hand-portable centrifuge (ZDrive™) and a disc-shaped blood collection device (ZDisc™) enabling immediate sample centrifugation at the point of collection. Here, we report results from clinical validation studies comparing performance of the Torq System with a conventional plasma separation tube (PST). Blood specimens from 134 subjects were collected and processed across three independent sites to compare ZDisc and PST performance in the assessment of 14 analytes (K, Na, Cl, Ca, BUN, creatinine, AST, ALT, ALP, total bilirubin, albumin, total protein, cholesterol, and triglycerides). A 31-subject precision study was performed to evaluate reproducibility of plasma test results from ZDiscs, and plasma quality was assessed by measuring hemolysis and blood cells from 10 subject specimens. The ZDisc successfully collected and processed samples from 134 subjects. ZDisc results agreed with reference PSTs for all 14 analytes with mean % biases well below clinically significant levels. Results were reproducible across different operators and ZDisc production lots, and plasma blood cell counts and hemolysis levels fell well below clinical acceptance thresholds. ZDiscs produce plasma samples equivalent to reference PSTs. Results support the suitability of the Torq System for remotely collecting and processing blood samples in decentralized settings.


2017 ◽  
Vol 19 (5) ◽  
pp. 801-804 ◽  
Author(s):  
Christina Alidousty ◽  
Danielle Brandes ◽  
Carina Heydt ◽  
Svenja Wagener ◽  
Maike Wittersheim ◽  
...  

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