Comparison of Improvacuter™ tubes with BD Vacutainer™ tubes for various hormones in the aspects of stability and influence of gel separators
Abstract
Background: Validation of blood collection tubes are important to determine the role of different collection tubes which influence the assurance of laboratory results. We compared two different tubes (Improvacuter™ and Becton Dickinson [BD] Vacutainer™) and investigated the effect of gel and storage time in comparison with each other.
Methods: We compared the results of nine immunoassays performed on UniCel® DxI 800 using blood samples collected in BD Vacutainer SST II Advance tubes, Improvacuter Gel and Clot Activator tubes, BD Vacutainer Clot Activator tubes and Improvacuter tubes. Analytes were measured in all tubes on 3 consecutive days to study the effect of long-term storage. Evaluation of clinical significance was performed based on total allowable error.
Results: Estradiol and testosterone concentrations obtained from Improvacuter Gel and Clot Activator tubes and BD Vacutainer SST II Advance tubes remained below the lower limits of analytical range for the same analytes while they were within the limits in BD Vacutainer Clot Activator tubes and Improvacuter tubes. Statistical significance of stability was not clinically significant for the hormone parameters we tested in all four tubes.
Conclusions: Gel containing tubes (both BD and Improve) gave comparable results with the tubes which do not contain gel except for estradiol and testosterone. The use of gel containing tubes for estradiol and testosterone are not recommended on UniCel® DxI 800 according to our results. The change in the analyte concentrations over 48 h remained within the TEA limits for the studied analytes. Improve tubes gave similar results to BD tubes.
References
1. Clinical and Laboratory Standarts Institute (CLSI). Procedures for the handling and processing of blood specimens for common laboratory tests: approved guideline, 4th ed. Document H18-A4. 2010:30(10).Search in Google Scholar
2. Landt M, Smith CH, Hortin GL. Evaluation of evacuated blood-collection tubes: effects of three types of polymeric separators on therapeutic drug-monitoring specimens. Clin Chem 1993;39:1712–7.10.1093/clinchem/39.8.1712Search in Google Scholar
3. Koch TR, Platoff G. Suitability of collection tubes with separator gels for therapeutic drug monitoring. Ther Drug Monit 1990;12:277–80.10.1097/00007691-199005000-00011Search in Google Scholar PubMed
4. Dasgupta A, Blackwell W, Bard D. Stability of therapeutic drug measurement in specimens collected in VACUTAINER plastic blood-collection tubes. Ther Drug Monit 1996;18:306–9.10.1097/00007691-199606000-00016Search in Google Scholar PubMed
5. Bowen RA, Chan Y, Cohen J, Rehak NN, Hortin GL, Csako G, et al. Effect of blood collection tubes on total triiodothyronine and other laboratory assays. Clin Chem 2005;51:424–33.10.1373/clinchem.2004.043349Search in Google Scholar PubMed
6. Morovat A, James TS, Cox SD, Norris SG, Rees MC, Gales MA, et al. Comparison of Bayer Advia Centaur immunoassay results obtained on samples collected in four different Becton Dickinson Vacutainer tubes. Ann Clin Biochem 2006;43:481–7.10.1258/000456306778904713Search in Google Scholar PubMed
7. Daves M, Trevisan D, Cemin R. Different collection tubes in cardiac biomarkers detection. J Clin Lab Anal 2008;22:391–4.10.1002/jcla.20277Search in Google Scholar PubMed PubMed Central
8. U.S. Food and Drug Administration. 510 (k) substantial equivalence determination decision summary of Improvacuter tube. Available from: www.accessdata.fda.gov/cdrh_docs/pdf9/k093910.pdf. Accessed 23 June, 2014.Search in Google Scholar
9. Westgard QC. Optimal biological variation database specifications. Available from: https://www.westgard.com/optimal-biodatabase1htm.htm. Accessed 27 June, 2014.Search in Google Scholar
10. Westgard QC. Quality requirements of the Royal College of Pathologists of Australasia. Available from: https://www.westgard.com/rcpa-australasian-quality-requirements.htm. Accessed 27 June, 2014.Search in Google Scholar
11. Dasgupta A, Yared MA, Wells A. Time-dependent absorption of therapeutic drugs by the gel of the Greiner Vacuette blood collection tube. Ther Drug Monit 2000;22:427–31.10.1097/00007691-200008000-00011Search in Google Scholar PubMed
12. Dasgupta A, Dean R, Saldana S, Kinnaman G, McLawhon RW. Absorption of therapeutic drugs by barrier gels in serum separator blood collection tubes. Volume- and time-dependent reduction in total and free drug concentrations. Am J Clin Pathol 1994;101:456–61.10.1093/ajcp/101.4.456Search in Google Scholar PubMed
13. Vesper HW, Botelho JC, Shacklady C, Smith A, Myers GL. CDC project on standardizing steroid hormone measurements. Steroids 2008;73:1286–92.10.1016/j.steroids.2008.09.008Search in Google Scholar PubMed
14. Smets EM, Dijkstra-Lagemaat JE, Blankenstein MA. Influence of blood collection in plastic vs. glass evacuated serum-separator tubes on hormone and tumour marker levels. Clin Chem Lab Med 2004;42:435–9.10.1515/CCLM.2004.076Search in Google Scholar PubMed
15. Bush VJ, Janu MR, Bathur F, Wells A, Dasgupta A. Comparison of BD Vacutainer SST Plus Tubes with BD SST II Plus Tubes for common analytes. Clin Chim Acta 2001;306:139–43.10.1016/S0009-8981(01)00396-5Search in Google Scholar
16. Ferry JD, Collins S, Sykes E. Effect of serum volume and time of exposure to gel barrier tubes on results for progesterone by Roche Diagnostics Elecsys 2010. Clin Chem 1999;45: 1574–5.10.1093/clinchem/45.9.1574Search in Google Scholar
17. Reinartz JJ, Ramey ML, Fowler MC, Killeen AA. Plastic vs glass SST evacuated serum-separator blood-drawing tubes for endocrinologic analytes. Clin Chem 1993;39:2535–6.10.1093/clinchem/39.12.2535Search in Google Scholar
18. Bowen RA, Sattayapiwat A, Gounden V, Remaley AT. Blood collection tube-related alterations in analyte concentrations in quality control material and serum specimens. Clin Biochem 2014;47:150–7.10.1016/j.clinbiochem.2013.11.003Search in Google Scholar PubMed PubMed Central
19. Banfi G, Parma P, Pontillo M. Stability of tumor markers CA 19.9, CA 125, and CA 15.3 in serum obtained from plain tubes and tubes containing thixotropic gel separator. Clin Chem 1997;43:2430–1.10.1093/clinchem/43.12.2430Search in Google Scholar
20. Wang S, Ho V, Roquemore-Goins A, Smith FA. Effects of blood collection tubes, including pediatric devices, on 16 common immunoassays. Clin Chem 2006;52:892–3.10.1373/clinchem.2006.068361Search in Google Scholar PubMed
21. Schouwers S, Brandt I, Willemse J, Van Regenmortel N, Uyttenbroeck W, Wauters A, et al. Influence of separator gel in Sarstedt S-Monovette(R) serum tubes on various therapeutic drugs, hormones, and proteins. Clin Chim Acta 2012;413:100–4.10.1016/j.cca.2011.08.037Search in Google Scholar PubMed
22. Kilinc AS, Duzoylum A, Uncugil CF, Yucel D. Falsely increased free triiodothyronine in sera stored in serum separator tubes. Clin Chem 2002;48:2296–7.10.1093/clinchem/48.12.2296Search in Google Scholar
©2015 by De Gruyter
Articles in the same Issue
- Frontmatter
- Editorials
- The new and the old of heparin-induced thrombocytopenia
- Biological variation – reliable data is essential
- Biological variation: back to basics
- Review
- Influence of educational, audit and feedback, system based, and incentive and penalty interventions to reduce laboratory test utilization: a systematic review
- Opinion Papers
- Recent guidelines and recommendations for laboratory assessment of the direct oral anticoagulants (DOACs): is there consensus?
- Meeting report: present state of molecular genetics in clinical laboratories. Report on the VII European Symposium on Clinical Laboratory and In Vitro Diagnostic Industry in Barcelona
- Genetics and Molecular Diagnostics
- Non-invasive prenatal diagnosis of monogenic disorders: an optimized protocol using MEMO qPCR with miniSTR as internal control
- A novel biosensor-based microarray assay for the visualized detection of CYP2C19 ∗2, ∗3, ∗4 and ∗5 polymorphisms
- General Clinical Chemistry and Laboratory Medicine
- Preanalytical errors: a preliminary approach to the point of view of primary health care givers
- Comparison of Improvacuter™ tubes with BD Vacutainer™ tubes for various hormones in the aspects of stability and influence of gel separators
- Use of quality indicators to compare point-of-care testing errors in a neonatal unit and errors in a STAT central laboratory
- Serological features of antibodies to protamine inducing thrombocytopenia and thrombosis
- Comparison of three different immunoassays in the diagnosis of heparin-induced thrombocytopenia
- How the direct oral anticoagulant apixaban affects hemostatic parameters. Results of a multicenter multiplatform study
- Auto-validation of complete blood counts in an outpatient’s regional laboratory
- Performance evaluation of the digital cell imaging analyzer DI-60 integrated into the fully automated Sysmex XN hematology analyzer system
- Circulating keratan sulfate as a marker of metabolic changes of cartilage proteoglycan in juvenile idiopathic arthritis; influence of growth factors as well as proteolytic and prooxidative agents on aggrecan alterations
- Reference Values and Biological Variations
- Biological variation database: structure and criteria used for generation and update
- Cardiovascular Diseases
- The tumor necrosis factor-α –238G/A and IL-6 –572G/C gene polymorphisms and the risk of idiopathic dilated cardiomyopathy: a meta-analysis of 25 studies including 9493 cases and 13,971 controls
- Diabetes
- Multicentre evaluation of the Premier Hb9210 HbA1c analyser
- Infectious Diseases
- Determination of quality control limits for serological infectious disease testing using historical data
- Corrigendum
- Enrichment and enumeration of circulating tumor cells by efficient depletion of leukocyte fractions
- Letters to the Editors
- Influence of age and gender on red blood cell distribution width
- Effect of exhaustive running exercise on red blood cell distribution width
- Clinically useful samples and reference change value
- Loss of retinol stability in patient samples
- Evaluation of a new thyroglobulin sensitive assay in patients with differentiated thyroid cancer
- Caution in a case of highly discrepant carbohydrate antigen 19-9 values in an apparently healthy patient taking spirulina: a case report
- Influence of vitamin K antagonist treatment on activated partial thromboplastin time
- Evaluation of the diagnostic characteristics of urinary kidney injury molecule 1 (uKIM-1) and uKIM-1/creatinine ratio in the assessment of incipient diabetic kidney disease
Articles in the same Issue
- Frontmatter
- Editorials
- The new and the old of heparin-induced thrombocytopenia
- Biological variation – reliable data is essential
- Biological variation: back to basics
- Review
- Influence of educational, audit and feedback, system based, and incentive and penalty interventions to reduce laboratory test utilization: a systematic review
- Opinion Papers
- Recent guidelines and recommendations for laboratory assessment of the direct oral anticoagulants (DOACs): is there consensus?
- Meeting report: present state of molecular genetics in clinical laboratories. Report on the VII European Symposium on Clinical Laboratory and In Vitro Diagnostic Industry in Barcelona
- Genetics and Molecular Diagnostics
- Non-invasive prenatal diagnosis of monogenic disorders: an optimized protocol using MEMO qPCR with miniSTR as internal control
- A novel biosensor-based microarray assay for the visualized detection of CYP2C19 ∗2, ∗3, ∗4 and ∗5 polymorphisms
- General Clinical Chemistry and Laboratory Medicine
- Preanalytical errors: a preliminary approach to the point of view of primary health care givers
- Comparison of Improvacuter™ tubes with BD Vacutainer™ tubes for various hormones in the aspects of stability and influence of gel separators
- Use of quality indicators to compare point-of-care testing errors in a neonatal unit and errors in a STAT central laboratory
- Serological features of antibodies to protamine inducing thrombocytopenia and thrombosis
- Comparison of three different immunoassays in the diagnosis of heparin-induced thrombocytopenia
- How the direct oral anticoagulant apixaban affects hemostatic parameters. Results of a multicenter multiplatform study
- Auto-validation of complete blood counts in an outpatient’s regional laboratory
- Performance evaluation of the digital cell imaging analyzer DI-60 integrated into the fully automated Sysmex XN hematology analyzer system
- Circulating keratan sulfate as a marker of metabolic changes of cartilage proteoglycan in juvenile idiopathic arthritis; influence of growth factors as well as proteolytic and prooxidative agents on aggrecan alterations
- Reference Values and Biological Variations
- Biological variation database: structure and criteria used for generation and update
- Cardiovascular Diseases
- The tumor necrosis factor-α –238G/A and IL-6 –572G/C gene polymorphisms and the risk of idiopathic dilated cardiomyopathy: a meta-analysis of 25 studies including 9493 cases and 13,971 controls
- Diabetes
- Multicentre evaluation of the Premier Hb9210 HbA1c analyser
- Infectious Diseases
- Determination of quality control limits for serological infectious disease testing using historical data
- Corrigendum
- Enrichment and enumeration of circulating tumor cells by efficient depletion of leukocyte fractions
- Letters to the Editors
- Influence of age and gender on red blood cell distribution width
- Effect of exhaustive running exercise on red blood cell distribution width
- Clinically useful samples and reference change value
- Loss of retinol stability in patient samples
- Evaluation of a new thyroglobulin sensitive assay in patients with differentiated thyroid cancer
- Caution in a case of highly discrepant carbohydrate antigen 19-9 values in an apparently healthy patient taking spirulina: a case report
- Influence of vitamin K antagonist treatment on activated partial thromboplastin time
- Evaluation of the diagnostic characteristics of urinary kidney injury molecule 1 (uKIM-1) and uKIM-1/creatinine ratio in the assessment of incipient diabetic kidney disease