Interferences from blood collection tube components on clinical chemistry assays

Biochemia Medica

Volumn 24, Issue 1, 2014, Pages 31-44

  Bowen, Raffick A R ^a   Remaley, Alan T ^b  

^a STANFORD UNIVERSITY SCHOOL OF MEDICINE   (United States)

^b NATIONAL INSTITUTES OF HEALTH   (United States)

Author keywords

Blood collection devices; Blood collection sample tube; Clinical assays; Clinical chemistry; Interference; Pre analytical; Surfactant

Indexed keywords

ACID CITRATE DEXTROSE; ALUMINUM; ANTICOAGULANT AGENT; BLOOD CLOTTING FACTOR 12; CALCIUM; EDETIC ACID; FIBRIN; FIBRINOGEN; GLYCEROL; HEPARIN; LUBRICATING AGENT; PLASTIC; POLITEF; POLYETHYLENE TEREPHTHALATE; POLYPROPYLENE; POLYVINYLCHLORIDE; PROTEINASE INHIBITOR; RUBBER; SILICONE OIL; SODIUM FLUORIDE; SULFUR; SURFACTANT;

ANALYTIC METHOD; BLOOD COLLECTION TUBE; BLOOD SAMPLING; CATHETER; CLINICAL CHEMISTRY; CYTOLYSIS; DRUG UPTAKE; EQUIPMENT DESIGN; GEL; HUMAN; HYDROPHILICITY; HYPODERMIC NEEDLE; LABORATORY TEST; MEASUREMENT ACCURACY; REVIEW;

BLOOD COLLECTION DEVICES; BLOOD COLLECTION SAMPLE TUBE; CLINICAL ASSAYS; CLINICAL CHEMISTRY; INTERFERENCE; PRE-ANALYTICAL; SURFACTANT;

BLOOD SPECIMEN COLLECTION; CLINICAL LABORATORY TECHNIQUES; HUMANS; SPECIMEN HANDLING; SURFACE-ACTIVE AGENTS;

EID: 84893588252     PISSN: 13300962     EISSN: None     Source Type: Journal    
DOI: 10.11613/BM.2014.006     Document Type: Review

References (100)

1. Lillenfiled AM, Bross I, Sartwell PE. Observations on an outbreak of infectious hepatitis in Baltimore during 1951. Amer J Pub Health 1953;43:1085-96.
2. Funderburk JV. "System for lubricating a syringe barrel", U.S. Patent No. 5,456,940, October 1995.
3. MacNutt MJ, Sheel AW. Performance of evacuated blood collection tubes at high altitude. High Alt Med Bio 2008;9:235-7. http://dx.doi.org/10.1089/ham.2008.1027.
4. Boeynaems JM, De Leener A, Dessars B, Villa-Lobos HR, Aubry JC, Cotton F, Thiry P. Evaluation of a new generation of plastic evacuated blood-collection tubes in clinical chemistry, therapeutic drug monitoring, hormone and trace metal analysis. Clin Chem Lab Med 2004;42:67-71. http://dx.doi.org/10.1515/CCLM.2004.013.
5. Daves M, Trevisan D, Cemin R. Different collection tubes in cardiac biomarkers detection. J Clin Lab Anal 2008;22:391-4. http://dx.doi.org/10.1002/jcla.20277. Interferences from blood collection tube components
6. Bush VJ, Leonard L, Szamosi DI. Advancements in blood collection devices. Lab Med 1998;29:616-22.
7. Bowen RAR, Chan Y, Cohen J, Rehak NN, Hortin GL, Csako G, et al. Effect of blood collection tubes on total triidothyronine and other laboratory assay. Clin Chem 2005;51:424-33. http://dx.doi.org/10.1373/clinchem.2004.043349.
8. Bowen RAR, Chan Y, Ruddel ME, Hortin GL, Csako G, Demosky SJ, et al. Immunoassay interference by a commonly used blood collection tube additive, the organosilicone surfactant silwet L-720. Clin Chem 2005;51:1874-82. http://dx.doi.org/10.1373/clinchem.2005.055400.
9. Vogler EA. "Blood collection assembly including mechanical phase separating insert", U.S. Patent No. 5,533,518, July 1996.
10. Dubrowny NE, Harrop AJ. "Collection device", U.S. Patent No. 6,686,204, February 2004.
11. Burns JA. "Blood microcollection tube assembly", U.S. Patent No. 5,288,466, February 1994.
12. Narayanan S, Lin FC. Sampling technique. In: Wong SHY, ed. Therapeutic drug monitoring and toxicology by liquid chromatography. New York: Marcel Dekker, Inc.; 1985. p. 79-88.
13. Hulon W. "Blood collection tube assembly", U.S. Patent No. 5,297,561, March 1994.
14. Gorbet M, Sefron M. Biomaterial-associated thrombosis: roles of coagulation factors, complement platelets and leukocytes. Biomaterials 2004;25:5681-703. http://dx.doi.org/10.1016/j.biomaterials.2004.01.023.
15. Ernst DJ. Plastic collection tubes decrease risk of employee injury. MLO Med Lab Obs 2001;33:44-6.
16. Vogler EA, Siedlecki CA. Contact activation of blood plasma coagulation: a contribution from the hematology at biomaterial interfaces research group the Pennsylvania State University. Biomaterials 2009;30:1857-69. http://dx.doi.org/10.1016/j.biomaterials.2008.12.041.
17. Anderson DR, Wiseman J, MacLeod J, Burton E, Zayed E. Evaluation of polyethylene terephthalate for ABO and Rh typing and alloantibody screening. Transfusion 2000;40:669-72. http://dx.doi.org/10.1046/j.1537-2995.2000.40060669.x.
18. Kratz A. A comparison of glass and plastic blood collection tubes for routine and specialized coagulation assays: A comprehensive study. Arch Pathol Lab Med 2006;130:39-44.
19. 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. http://dx.doi.org/10.1515/CCLM.2004.076.
20. Landry ML, Garner R, Ferguson D. Use of plastic Vacutainer tubes for quantification of human immunodeficiency virus type I in blood specimens. J Clin Microbiol 2001;39:354-6. http://dx.doi.org/10.1128/JCM.39.1.354-356.2001.
21. Feng CS, Wan CP. The plastic tube compared with the glass tube in blood bank tests. Pathol 1988;20:309-10. http://dx.doi.org/10.3109/00313028809059518.
22. Flanders MM, Crist R, Rodgers GM. A comparison of blood collection in glass versus plastic Vacutainers on results of esoteric coagulation assays. Lab Med 2003;34:732-5. http://dx.doi.org/10.1309/BMQHCD6B8984RLA3.
23. Anraku H, Shoji Y. "Vacuum blood collection tubes", U.S. Patent No. 8,565,334, August 1989.
24. Montgomery DB, Vogler EA. "Tube having regions of different surface chemistry and method therefore", U.S. Patent No. 5,318,806, June 1994.
25. Percarpio EP, Holderith WJ, Wyckoff. "Vacuum indicator closure for a blood collection tube", U.S. Patent No. 4,293,078, November 1979.
26. Wang H-C, Wong WK. "Cured rubber components for use with pharmaceutical devices", U.S. Patent No. 7,282,269, December 2002.
27. Shah VP, Knapp G, Skelly JP, Cabana BE. Interference with measurements of certain drugs in plasma by a plasticizer in Vacutainer tubes. Clin Chem 1982;28:2327.
28. Borga O, Piafsky KM, Nilsen OG. Plasma protein binding of basic drugs. I. Selective displacement from α1-acid glycoprotein by tris (2-butoxyethyl) phosphate. Clin Pharmacol Ther 1977;22:539-44.
29. Cotham RH, Shand D. Spuriously low plasma propranolol concentrations resulting from blood collection methods. Clin Pharmacol Ther 1975;18:535-8.
30. Janknegt R, Lohman JJ, Hooymans PM, Merkus FW. Do evacuated blood collection tubes interfere with therapeutic drug monitoring? Pharm Weekbl Sci Ed 1983;5:287-90.
31. Curry W, Conway S, Goodfield C, Miller K, Mueller RL, Polini E. Reducing the risk of contamination of Sterile Parenteral products via closure components. AAPS PharmSciTech 2010;11:1572-9. http://dx.doi.org/10.1208/s12249-010- 9531-8.
32. Van den Besselaar AMHP, Van Dam W, Sturk A, Bertina RM. rothrombin time ratio is reduced by magnesium contamination in evacuated BCTs. Thromb Haemost 2001;85:647-50.
33. Cummings J. Evacuated tubes for monitoring heparin treatment. Thromb Haemost 1981;34:939-40.
34. Cohen RR. "Evacuated sample collection tube with aqueous additive", U.S. patent No 5,860,937, January 1999.
35. Chowdry FR, Rodman H, Bleicher SJ. Glycerol-like contamination of commercial blood sampling tubes. J Lipid Res 1971;12:116.
36. Drake SK, Bowen RAR, Remaley AT, Hortin GL. Potential interferences from blood collection tubes in mass spectrometric analyses of serum polypeptides. Clin Chem 2004;50:2398-401. http://dx.doi.org/10.1373/clinchem.2004.040303.
37. Ladenson JH, Tsai LMB, Michael JM. Serum versus heparinized plasma for eighteen common chemistry tests. Am J Clin Pathol 1974;62:545-52.
38. Sevastos N, Theodossiades G, Efstathiou S, Papatheodoridis GV, Manesis E, Archimandritis AJ. Pseudohyperkalemia in serum: the phenomenon and its clinical magnitude. J Lab Clin Med 2006;147:139-44. http://dx.doi.org/10.1016/j.lab.2005.11.008.
39. Assembly and method to improve vacuum retention in evacuated specimen containers. Available at www.freshpatents. com/dt20090625ptan200901625.php. Accessed April 2013.
40. Clinical and Laboratory Standards Institute (CLSI): Procedures for the Collection of Diagnostic Blood Specimens by Venipuncture; Approved Standard - Fourth Edition. CLSI document H3-A4. Wayne, PA: Clinical and Laboratory Standards Institute; 2005.
41. Young DS, Bermes EW, Haverstick DM. Specimen collection and processing. In: Burtis CA, Ashwood ER, Bruns DE, eds. Tietz Textbook of Clinical Chemistry and Molecular Dianostics. 4th Ed. St. Louis: Elsevier Saunders; 2006.
42. Becton Dickinson website. Available at: www.bd.com. Accessed May 2013.
43. Tate J, Ward G. Interferences in immunoassay. Clin Biochem 2004;25:105-20.
44. Cuhadar S. Preanalytical variables and factors that interfere with the biochemical parameters: a review. OA Biotechnology 2013;2:19.
45. Toffaletti JR, Wildermann RF. The effects of heparin anticogulants and fill volume in blood gas syringes on ionized calcium and magnesium measurements. Clin Chem Acta 2001;304:147-51. http://dx.doi.org/10.1016/S0009-8981(00)00412-5.
46. Zaninotto M. Quality specifications for biochemical markers of myocardial injury. Clin Chim Acta 2004;346:65-72. http://dx.doi.org/10.1016/j.cccn.2004.02.035.
47. Wild D, John R, Sheehan C, eds. The Immunoassay Handbook. 4th ed. Oxford, UK: Elsevier; 2013.
48. Meng QH, Krahn J. Lithium heparinised blood-collection tubes give falsely low albumin results with an automated bromcresol green method in haemodialysis patients. Clin Chem Lab Med 2008;46:396-400. http://dx.doi. org/10.1515/CCLM.2008.079.
49. Tammen H, Schulte I, Hess R, Menzel C, Kellmann M, Mohring T, et al. Peptidomic analysis of human blood specimens: comparison between plasma specimens and serum by differential peptide display. Proteomics 2005;13:3414-22. http://dx.doi.org/10.1002/pmic.200401219.
50. Lippi G, Avanzini P, Cosmai M, Aloe R, Ernst D. Incomplete filling of lithium heparin tubes affects the activity of creatine kinase and gamma-utamyltransferase. Br J Biomed Sci 2012;69:67-70.
51. Narayanan S. The preanalytic phase: an important component of laboratory medicine. Am J Clin Pathol 2000;113:429-52. http://dx.doi.org/10.1309/C0NM-Q7R0-LL2E-B3UY.
52. Li G, Cabanero M, Wang Z, Wang H, Huang T, Alexis H, et al. Comparison of glucose determinations on blood samples collected in three types of tubes. Ann Clin Lab Sci 2013;43:278-84.
53. Peake MJ, Bruns DE, Sacks DB, Horvath AR. It's time for a better blood collection tube to improve the reliability of glucose results. Diabetes Care 2013;36:e2. http://dx.doi.org/10.2337/dc12-1312.
54. Gambino R. Sodium fluoride: an ineffective inhibitor of glycolysis. Ann Clin Biochem 2013; 50:3-5. http://dx.doi.org/10.1258/acb.2012.012135.
55. Gigliello JF, Kragle HA. "Method and apparatus for multiphase fluid collection and separation", U.S. Patent No. 3,920,549, November 1975.
56. Bush VJ, Janu MR, Bathur F, Wells A, Dasgupta A. Comparison of BD Vacutainer SST plus tubes and BD SST II plus tubes for common analytes. Clin Chem 2001;306:139-43.
57. Spiritus T, Zaman Z, Desmet W. Iodinated contrast media interfere with gel barrier formation in plasma and serum separator tubes. Clin Chem 2003;49:1187-9. http://dx.doi.org/10.1373/49.7.1187.
58. Fatas M, Franquelo P, Franquelo R. Anomalous flotation of separator gel: density or viscosity? Clin Chem 2008;54:771-2. http://dx.doi.org/10.1373/clinchem.2007.093716.
59. Faught RC, Marshall J, Bornhorst J. Solution densities and estimated total protein contents associated with inappropriate floatation of separator gel in different blood collection tubes. Arch Pathol Lab Med 2011;135:1081-4. http://dx.doi.org/10.5858/2010-0488-OAR.1.
60. Bergqvist Y, Eckerbom S, Funding L. Effect of use of gelbarrier sampling tubes on determination of some antiepileptic drugs in serum. Clin Chem 1984;30:465-6.
61. Koch TR, Platoff G. Suitability of collection tubes with separator gels for therapeutic drug monitoring. Ther Drug Monit 1990;12:277-80. http://dx.doi.org/10.1097/00007691-199005000-00011.
62. Chance J. Evaluation of the BD Vacutainer® SST ™ II blood collection tube for special chemistry analytes. Clin Chem Lab Med 2009;47:358-61. http://dx.doi.org/10.1515/CCLM.2009.072.
63. Babic N, Zibrat S, Gordon IO, Lee CC, Yeo KT. Effect of blood collection tubes on the incidence of artifactual hyperkalemia on patient samples from an outreach clinic. Clin Chim Acta 2012;413:1454-8. http://dx.doi.org/10.1016/j.cca.2012.06.001.
64. Ji SQ, Evenson MA. Effects of contaminants in blood-collection devices on measurement of therapeutic drugs. Clin Chem 1983;29:456-61.
65. Shi RZ, van Rossum HH, Bowen RA. Serum testosterone quantitation by liquid chromatography-tandem mass spectrometry: Interference from blood collection tubes. Clin Biochem 2012;45:1706-9. http://dx.doi.org/10.1016/j.clinbiochem.2012.08.008.
66. Dimeski G, Masci PP, Trabi M, Lavin MF, de Jersey J. Evaluation of the Becton-Dickinson rapid serum tube: does it provide a suitable alternative to lithium heparin plasma tubes? Clin Chem Lab Med 2010;48:651-7. http://dx.doi.org/10.1515/CCLM.2010.141.
67. Ng WY, Yeo CP. Thrombin-accelerated quick clotting serum tubes: an evaluation with 22 common biochemical analytes. Adv Hematol 2013; In press. http://dx.doi.org/10.1155/2013/769479.
68. Sampson M, Ruddel M, Albright S, Elin RJ. Positive interference in lithium determinations from clot activator in collection container. Clin Chem 1997;43:675-9.
69. Wang C, Shiraishi S, Leung A, Baravarian S, Hull L, Goh V, et al. Validation of a testosterone and dihydrotestosterone liquid chromatography tandem mass spectrometry assay: interference and comparison with established methods. Steroids 2008;73:1345-52. http://dx.doi.org/10.1016/j.steroids.2008.05.004.
70. Pilny R, Bouchal P, Borilova S, Ceskova P, Zaloudik J, Vyzula R, et al. Surface-enhanced laser desorption ionization/ time-of-flight mass spectrometry reveals significant artifacts in serum obtained from clot activator-containing collection devices. Clin Chem 2006;52:2115-6. http://dx.doi.org/10.1373/clinchem.2006.073841.
71. Mannello F. Serum or plasma samples? The "Cinderella" role of blood collection procedures preanalytical methodological issues influence the release and activity of circulating matrix metalloproteinases and their tissue inhibitors, hampering diagnostic trueness and leading to misinterpretation. Arterioscler Thromb Vasc Biol 2008;28:611-14. http://dx.doi.org/10.1161/ATVBAHA.107.159608.
72. Brady AM, Spencer BL, Falsey AR, Nahm MH. Blood collection tubes influence serum ficolin-1 and ficolin-2 levels. Clin Vaccine Immunol 2013; in press.
73. Gadow A, Fricke H, Strasburger CJ, Wood WG. Synthesis and evaluation of luminescent tracers and hapten-protein conjugates for use in luminescence immunoassays with immobilized antibodies and antigens. A critical study of macro solid phases for use in immunoassay systems, part II. J Clin Chem Clin Biochem 1984;22:337-47.
74. Wickus GG, Mordan RJ, Mathews EA. Interference in the Allegro immunoassay system when blood is collected in silicone-coated tubes [letter]. Clin Chem 1992;38:2347-8.
75. Vogler EA, Shepard TA, Graper JC. "Blood compatible, shear sensitive gels" European. Patent No.0678557, June 2000.
76. 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. http://dx.doi.org/10.1373/clinchem.2006.068361.
77. McKiel RR, Barron N, Needham CJ, Wilkins TA. Siliconized vs. nonsiliconized evacuated blood-collection tubes for free thyroxin measurements. Clin Chem 1982;28:2333.
78. Yin P, Peter A, Franken H, Zhao X, Neukamm SS, Rosenbaum L, et al. Preanalytical aspects and sample quality assessment in metabolomics studies of human blood. Clin Chem 2013;25:833-45. http://dx.doi.org/10.1373/clinchem.2012.199257.
79. Bowen RAR, Vu C, Remaley AT, Hortin GL, Csako G. Differential effect of blood collection tubes on total free fatty acids (FFA) and total triiodothyronine (TT3) concentration: a model for studying interference from tube constituents. Clin Chim Acta 2007;378:181-93. http://dx.doi.org/10.1016/j.cca.2006.11.020.
80. Calam R, Cooper M. Recommended "order of draw" for collecting blood specimens into additive-containing tubes. Clin Chem 1982;28:1399.
81. Clinical and Laboratory Standards Institute (CLSI): Procedure for the Collection of Diagnostic Blood Specimens by Venipuncture. Approved Standard - Fifth Edition. CLSI do- cument H3-A5. Wayne, PA: Clinical and Laboratory Standards Institute; 2007.
82. Salvagno G, Lima-Oliveira G, Brocco G, Danese E, Guidi GC, Lippi G. The order of draw: myth or science? Clin Chem Lab Med 2013;12:1-5.
83. Hortin GL, Sviridov D, Anderson NL. High-abundance polypeptides of the human plasma proteome comprising the top 4 logs of polypeptide abundance. Clin Chem 2008;54:1608-16. http://dx.doi.org/10.1373/clinchem.2008.108175.
84. Menssen HD, Brandt N, Leben R, Muller F, Thiel E, Melber K. Measurement of hematological, clinical chemistry, and infection parameters from hirudinized blood collected in universal blood sampling tubes. Semin Thromb Hemost 2001;27:349-56. http://dx.doi.org/10.1055/s-2001-16888.
85. Joly D, Drueke TB, Alberti C, Houillier P, Lawson-Body E, Martin KJ, et al. Variation in serum and plasma PTH levels in second-generation assays in hemodialysis patients: cross-sectional study. Am J Kidney Dis 2008;51:987-95. http://dx.doi.org/10.1053/j.ajkd.2008.01.017.
86. Evans MJ, Livesey JH, Ellis MJ, Yandle TG. Effect of anticoagulants and storage temperatures on stability of plasma and serum hormones. Clin Biochem 2001;34:107-12. http://dx.doi.org/10.1016/S0009-9120(01)00196-5.
87. Kim W, Egan JM. The role of incretins in glucose homeostasis and diabetes treatment. Pharmacol Rev 2008;60:470-512. http://dx.doi.org/10.1124/pr.108.000604.
88. Rai AJ, Gelfand CA, Haywood BC, Warunek DJ, Yi J, Schuchard MD, et al. HUPO Plasma Proteome Project specimen collection and handling: towards the standardization of parameters for plasma proteome samples. Proteomics 2005;5:3262-77. http://dx.doi.org/10.1002/pmic.200401245.
89. Nilsson TK, Boman K, Jansson JH, Thogersen AM, Berggren M, Broberg A, et al. Comparison of soluble thrombomodulin, von Willebrand factor, tPA/PAI-1 complex, and high-sensitivity CRP concentrations in serum, EDTA plasma, citrated plasma, and acidified citrated plasma (Stabilyte) stored at -70 degrees C for 8-11 years. Thromb Res 2005;116:249-54. http://dx.doi.org/10.1016/j.thromres.2004.12.005.
90. Hortin GL, Warshawsky I, Laude-Sharp M. Macromolecular chromogenic substrates for measuring proteinase activity. Clin Chem 2001;47:215-22.
91. Sapin R, Ongagna JC, Gasser F, Grucker D. Insulin measurements in haemolysed serum: influence of insulinase inhibitors. Clin Chim Acta 1998;274:111-17. http://dx.doi.org/10.1016/S0009-8981(98)00051-5.
92. Ayache S, Panelli M, Marincola FM, Stroncek DF. Effects of storage time and exogenous protease inhibitors on plasma protein levels. Am J Clin Pathol 2006;126:174-84. http://dx.doi.org/10.1309/3WM7XJ7RD8BCLNKX.
93. 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 2013; in press. http://dx.doi.org/10.1016/j.clinbiochem.2013.11.003.
94. Lima-Oliveira G, Lippi G, Salvagno GL, Montagnana M, Picheth G, Guidi GC. Preanalytical management: serum vacuum tubes validation for routine clinical chemistry. Biochem Med 2012;22:180-6. http://dx.doi.org/10.11613/BM.2012.021.
95. Clinical and Laboratory Standards Institute (CLSI): Method Comparison and Bias Estimation Using Patient Samples; Approved Guideline. CLSI document EP9-A. Wayne, PA: Clinical and Laboratory Standards Institute; 1992.
96. Nichols JH. Laboratory quality control based on risk management. Ann Saudi Med 2011;31:223-28. http://dx.doi.org/10.4103/0256-4947.81526.
97. Stankovic AK, Silvestri J, Mails M, Najork C. Total quality in laboratory diagnostics: the role of commercial companies. Biochem Med 2010; 20: 207-14. http://dx.doi.org/10.11613/BM.2010.025.
98. Parham S. Test tube interference shows 'chink in armor'. CAP Today 2005;19:68-72.
99. Bowen RAR, Hortin GL, Csako G, Otanez O, Remaley AT. Impact of blood collection devices on clinical chemistry assays. Clin Biochem 2010;43:4-25. http://dx.doi.org/10.1016/j.clinbiochem.2009.10.001.
100. Clinical and Laboratory Standards Institute (CLSI): Validation and Verification of Tubes for Venous and Capillary Blood Specimen Collection; Approved Guideline. CLSI document GP34-A. Wayne, PA: Clinical and Laboratory Standards Institute; 2010.