Volume 3, Issue 1, June 2019, Page: 10-18
Large Academic Hospital Laboratory Investigates a Major Pre-Analytical Challenge in Africa and Developing Countries
Ernest Philani Buthelezi, Department of Health, Johannesburg, South Africa
Florence Marule, Department of Chemical Pathology, National Health Laboratory Service, Johannesburg, South Africa
Bahule Nimrod Motlonye, National Health Laboratory Service, Johannesburg, South Africa
Ntsoaki Mopane, National Health Laboratory Service, Kalafong Hospital, Pretoria, South Africa
Tshepo Rakhothule, Department of Chemical Pathology, National Health Laboratory Service, Johannesburg, South Africa
Donald Moshen Tanyanyiwa, Department of Chemical Pathology, University of the Witwatersrand and National Health Laboratory Service, Johannesburg, South Africa
Received: Dec. 20, 2018;       Accepted: Jan. 20, 2019;       Published: Feb. 7, 2019
DOI: 10.11648/j.plm.20190301.13      View  853      Downloads  105
Background: Delay in serum separation from red blood cells in samples collected from most primary healthcare facilities and transported to a laboratory for analysis is of great concern. Standard guidelines state that serum or plasma should be separated from cells within 2 hours of collection. The aim was to determine effects of delayed sample separation on measured biochemical analytes. The objective was to store blood samples in primary collection tubes at 20-25°C post venesection, then separate, and analyse samples of selected analytes. Methods: Multiple sample tubes of whole blood were collected from one of the authors volunteer, and subjected to time delays in centrifugation. The baseline serum was separated from red blood cells within 30 minutes of post venesection to allow adequate coagulation. Twenty analytes were studied using 2 analytical platforms. Percentage variation and standard error method were used to evaluate time-dependent variability in analytes. Total change limit was used to measure significant changes within-run variability for both platforms. Results: Most analytes were stable up to day 3 to 4 on both platforms. Serum CO2, CL, Ca, ALT and ALB were stable up to 8 days when they were measured on Cobas 8000®. BUN, TRIG, TB, CHOL, AST, ALT and ALB were stable up to 10 days on Dimension® CCS. K showed significant changes at 2h on both platforms at initial measurements. It was out-of-range at day 10 on Dimension® CCS. Serum creatinine levels showed substantial changes at day 2 on Dimension® analyzer and on Cobas 8000® at day 3. Conclusions: The study showed stability of wide range of serum analytes at 20-25°C for several days. The acceptable results can be achieved if samples are centrifuged the same day and analyzed later for most of biochemical analytes.
Analyte, Delayed Measurement, Primary Healthcare, Analytical Platforms, Serum
To cite this article
Ernest Philani Buthelezi, Florence Marule, Bahule Nimrod Motlonye, Ntsoaki Mopane, Tshepo Rakhothule, Donald Moshen Tanyanyiwa, Large Academic Hospital Laboratory Investigates a Major Pre-Analytical Challenge in Africa and Developing Countries, Pathology and Laboratory Medicine. Vol. 3, No. 1, 2019, pp. 10-18. doi: 10.11648/j.plm.20190301.13
Copyright © 2019 Authors retain the copyright of this article.
This article is an open access article distributed under the Creative Commons Attribution License (http://creativecommons.org/licenses/by/4.0/) which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
Tiwari, E., Pallipady, A. and Mishra, S. 2015. Preanalytical, Analytical and Postanalytical Errors in Chemical Laboratory. International Journal of Science and Research, 4 (3): p2279-2281.
Plebani, M. 2006. Errors in clinical laboratories or errors in laboratory medicine. Clinical Chemistry and Laboratory Medicine, 44: p750-9.
Green, S. F. 2013. The cost of poor blood specimen quality and errors in pre-analytical processes. Clinical Biochemistry, 46: p1175-9.
Rehak, N. N. and Chiang, B. T. 1988. Storage of whole blood: Effect on the measured concentration of analytes in serum. Clinical Chemistry, 34/10: p2111-2114.
Tanner, M., Kent, N., Smith, B., Fletcher, S. and Lewer, M. 2008. Stability of common biochemical analytes in serum gel tubes subjected to various storage temperatures and times pre-centrifugation. Annals of Clinical Biochemistry, 45: p375-379.
Kalasker, V. and Sudhhamadhuri, A. 2015. Effect of serum clot contact time as a major source of preanalytical variation in serum electrolytes. International Journal of Research in Health Sciences, 3: p2278-281.
Henriksen, L. O., Faber, N. R. and Moller, M. F. 2014. Stability of 35 biochemical and immunological routine tests after 10hours storage and transport of human whole blood at 210C. Scandinavian Journal of Clinical and Laboratory Investigation, 74: p603-10.
Quartey, P., Quartey, P., James, O-T. and Yawo, S. R. 2018. Stability of selected biochemical analytes in plasma samples stored under different time and temperature conditions. Journal of Clinical Chemistry and Laboratory Medicine, 1 (2): p1-4.
Pahwa, M. B., Menaka, K., Manish Raj, M. and Singh, V. 2015. Effect of storage time and temperature on serum clinical biochemistry analytes. Biochemistry: An Indian Journal, 9/4, p150-156.
Baruah, A., Goyal, P., Sinha, S., Sinha, S., Ramesh, K. L. and Datta, R. 2014. Delay in processing – Major source of preanalytical variation in serum analytes. Journal of Clinical and Diagnostic Research, 8(12): pCC01-CC03.
Vernekar, N. V. and Jabannavar, V. B. 2017. Effect of storage and temperature on two biochemical analytes (creatinine and urea) in pooled serum samples stored at -20°C. Indian Journal of Health Sciences and Biomedical Research, 10: p63-7.
Wu, D. W., Li, Y. M. and Wang, F. 2017. How long can we store blood samples: a systematic review and meta-analysis EBioMedicine, 24: p277-285.
Laessig, R. H., Indricksson, A. A., Hassemer, D. J., Paskey, T. A. and Schwartz, T. H. 1976. Changes in serum chemical values as a result of prolonged contact with the clot. American Journal of Clinical Pathology, 66: p598-604.
Heins, M., Heil, W. and Withold, W. 1995. Storage of serum or whole blood samples? Effect of time and temperature on 22 serum analytes. European Journal of Clinical Chemistry and Clinical Biochemistry, 33: p231-238.
Kachlawa, K., Kachlawa, P., Varma, M., Behera. R., Agrawal, D. and Kumar, S. 2017. Study of the stability of various biochemical analytes in samples stored at different predefined storage conditions at an accredited laboratory in India. Journal of Laboratory Physicians. 1: p11-15.
Lippi, G., Guidi, G. C., Mattiuzi, C. and Plebani, M. 2006. Preanalytical variability: the dark side of the moon in laboratory testing. Clinical Chemistry and Laboratory Medicine, 44: p358-65.
Clark, S., Youngman, L. D., Palmer, A., Parish, S., Peto, R. and Collins, R. 2003. Stability of plasma analytes after delayed separation of whole blood: implications for epidemiological studies. International Journal of Epidemiology, 32: p125-130.
Cuhadar, S., Atay, A., Koseoglu, M., Dirican, A. and Hur, A. 2012. Stability of common biochemical analytes in serum separator tubes with or without gel barrier subjected to various storage conditions. Biochemica Medica, 22 (2): p202-14.
Myers, G. L., Miller, W. G., Coresh, J., Fleming, J., Greenberg, N., Greene, T., Hostetter, T., Levey, A. S. Panteghini, M., Welch, M. and Eckfeldt, J.H. 2006. Recommendations for improving serum creatinine measurement: A report from the Laboratory Working Group of the National Kidney Disease Education Program. Clinical Chemistry, 52: p15-18.
Shepherd, J., Warner, M. H. and Kilpatrick, E. S. 2007. Stability of creatinine with delayed separation of whole blood and implications for eGFR. Annals of Clinical Biochemistry, 44: p384-387.
Joffe, M., Hsu, C. Y., Feldman, H. I., Weir, M., Landis, J. R. and Hamm, L. L. 2010. Variability of creatinine measurements in clinical laboratories: results from the. Chronic Renal Insufficiency Cohort (CRIC) Study Group American journal of nephrology, 31(5): p426-434.
Fraser, C. G., Petesen, P. H., Ricos, C. and Haeckel, R. 1992. Proposed quality specifications for the imprecision and inaccuracy of analytical systems for clinical chemistry. European Journal of Clinical Chemistry and Clinical Biochemistry. 30(5): p311-7.
Ricos, C., Alvarez, V., Cava, F., Garcia-Lario, J.V., Hernandez, A. and Jimenez, C.V., Minchinela, J., Perich, C. and Simon, M. 1999. Current databases on biologic variation; pros, cons and progress. Scandinavian Journal of Clinical and Laboratory Investigation, 59: p494–500.
Ricos, C., Alvarez, V., Cava, F., Garcia-Lario, J. V., Hernandez, A. and Jimenez, C. V., Minchinela, J., Perich, C. and Simon, M. 2009.Desirable quality specifications for total error, imprecision, and bias, derived from biological variation. http:/www.Westgard.com/biodatabase1.htm. Accessed 5 December 2018.
Westgard, J. O., Seehafer, J. J. and Barry, P. L. 1994. European specification for imprecision and inaccuracy compared with operating specifications that assure the quality required by US CLIA Proficiency-Testing criteria. Clinical Chemistry, 40 (7): p1228-1232.
Westgard James Quality requirements: Desirable biological variation database specifications. https://www.westgard.com/biodatabase1.htm. Accessed 5 December 2018.
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