Volume 4, Issue 2, December 2020, Page: 27-36
Point of Care Blood Gas Analyser Verification at the Largest Academic Hospital in Southern Hemisphere Revived by Coronavirus Calls for Tests to Be Verified
Ernest Philani Buthelezi, Department of Health, Laboratory and Blood Services, Johannesburg, South Africa
Edwin Rampota, Department of Chemical Pathology National Health Laboratory Service, Johannesburg, South Africa
Matumi Mphogo, Department of Chemical Pathology National Health Laboratory Service, Johannesburg, South Africa
Florence Marule, Department of Chemical Pathology National Health Laboratory Service, Johannesburg, South Africa
Donald Moshen Tanyanyiwa, Department of Chemical Pathology, University of the Witwatersrand, Johannesburg, South Africa; Department of Chemical Pathology, Sefako Magkatho Health Sciences University, Pretoria, South Africa
Received: Apr. 19, 2020;       Accepted: May 9, 2020;       Published: Jun. 15, 2020
DOI: 10.11648/j.plm.20200402.11      View  26      Downloads  17
Abstract
Introduction: At no point in the history of medicine has the importance of point-of-care testing (POCT) devices, tests and methods verification and utilisation been recognised and accepted than during the coronavirus pandemic. Blood gas analysers offer the best form of POCT and this has been demonstrated in the management of coronavirus patients admitted to hospital intensive care units with respiratory challenges. The new analysers were evaluated in compliance with the Clinical Laboratory Improvement Amendments (CLIA) regulation. The new method must be evaluated by comparison to the central laboratory or the outgoing analyser. The study was undertaken to verify if the new instrument, OMNI S b221 matches the well-established analysers currently in use at the hospital. Objectives: To evaluate method performance of pH, the partial pressure of carbon dioxide (pCO2), the partial pressure of oxygen (pO2), glucose, lactate, and electrolytes on OMNI S b221 blood gas analyser. Materials and Methods: To analyse the method performance of the pH, pO2, pCO2, glucose, lactate and electrolytes (Na+, K+ Ca++) on OMNI S b221 blood gas analyser 40 samples run on OMNI S b221 blood gas analyser were compared with the results obtained from ABL700, GEM PREMIER for all the parameters and the Roche Hitachi 917 analyser to compare two electrolytes (Na+ and K+). The correlation coefficient was calculated for the results obtained from each paired set of instruments (ABL 700 vs GEM PREMIER and ABL 700 vs OMNI S b221). Comparability between analyser methods performance was determined using linear regression analysis. Results: The correlation coefficient between the paired analytical platforms were all between 0.81 and 0.99, demonstrating a strong linear relationship. The coefficient of variation for all the parameters were less than 2 also demonstrating good precision. Conclusion: OMNI S b221 blood gas analyser correlated well with the outgoing ABL 700, GEM PREMIER blood gas analyser and the central laboratory analyser, Roche Hitachi 917 and therefore, verified as a good platform to run arterial blood gas samples.
Keywords
Point of Care Testing, Central Laboratory, Electrolytes, Arterial Blood, Regression Analysis, Coefficient of Variation
To cite this article
Ernest Philani Buthelezi, Edwin Rampota, Matumi Mphogo, Florence Marule, Donald Moshen Tanyanyiwa, Point of Care Blood Gas Analyser Verification at the Largest Academic Hospital in Southern Hemisphere Revived by Coronavirus Calls for Tests to Be Verified, Pathology and Laboratory Medicine. Vol. 4, No. 2, 2020, pp. 27-36. doi: 10.11648/j.plm.20200402.11
Copyright
Copyright © 2020 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.
Reference
[1]
Ross J. Molinaro; https://www.aacc.org/-/media/Files/Meetings-and-Events/Resources-from-Past-Events/Conferences/2013/Professional-Practice/April-28/MV_Method_Validation. Accessed 10092013.
[2]
Khatami, Z., Hill, R., Sturgeon, C., Kearney, E., Breadon, P. and Kallner. A. 2005. Measurement verification in the clinical laboratory: A guide to assessing analytical performance during the acceptance testing of methods (quantitative examination procedures) and/or analysers http://www.acb.org.uk/docs/default-source/committees/scientific/guidelines/measurement verification/Measurement_verification_final_090608.pdf. Accessed 10092008.
[3]
Severinghaus, J. W., Astrup, P. and Murray. J. F. 1998. Blood gas analysis and critical care medicine. American Journal of Respiratory and Critical Care Medicine 157 (4 Pt 2): S114-22.
[4]
Schneider, F., Maurer, C. and Friedberg. C. R. 2017. International Organization for Standardization (ISO) 15189. Annals of Laboratory Medicine. 37 (5): p 365–370.
[5]
South African Health Products Regulatory Authority. (SAHPRA). 2018. https://www.hpasa.co.za/wp-content/uploads/2018/06/SAHPRA-Strategic-Plan-2018-19-to-2022-23.pdf. Accessed 02112018.
[6]
Kratz, A and Lewandrowski, K. B. 2003. Principles and Practice of Point-of-Care Testing. Archives of Pathology and Laboratory Medicine. 127 (4): p 511–511.
[7]
D’Orazio, P., Ehrmeyer, S. S., Jacobs, E., Toffaletti, J. G. and Wandrup, J. H. 2009. Blood Gas and pH Analysis and Related Measurements, Approved Guideline, Second edition, CLSI Document C46-A2, Wayne, PA, 21 (14). http://www.gauteng.gov.za/government/departments/health/services/hospitals/Pages/Chris-Hani-Baragwanath-Academic-Hospital.aspx. (accessed 16/05/2019.
[8]
John Hopkins Arterial Blood Gas POCTTeam at Bayview. http://apps.pathology.jhu.edu/blogs/pathology/arterial-blood-gas-bayview-team Accessed 12052010.
[9]
Zelmat, M. S. 2015. Direct and indirect ion-selective electrodes methods: the differences specified through a case of Waldenström's macroglobulinemia. Annales De Biologie Clinique Journal (Paris). 73 (3): p 345-52.
[10]
Data Innovations® Delivering Tomorrows Lab Today. https://datainnovations.com/ep-evaluator. Accessed 05062019.
[11]
Miniwebtool–Online Tools and Calculators. https://miniwebtool.com/coefficient-of-variation/calculator. Accessed 07082019.
[12]
Das, B. 2011. Verification Protocol: First Step of a Lean-Total Quality Management Principle in a New Laboratory Set-up in a Tertiary Care Hospital in India. Indian Journal of Clinical Biochemistry. 26 (3): p 235–43.
[13]
Astrup, P., Gotzche, H. and Neukirch, F. 1954. Laboratory investigations during treatment of patients with poliomyelitis and respiratory paralysis. British Medical Journal, 4865: p 780–786.
[14]
http://www.nata.com.au/phocadownload/publications/Technical_publications/Technotes Info papers/technical_note_17.pdf, Accessed 10062019.
[15]
Nanda, S. K., Ray, L. and Dinakaran, A. 2014. Verification of Method Performance of pH, PCO2, PO2, Na+, K+ of Cobas b121 ABG Analyser. Journal of Clinical and Diagnostic Research. 8 (6): CC05-CC0.
[16]
Ebner, P. A. R., Romano, P., Sant’Anna, A., Mendes., M. E., Oliveira, M. and Sumita, N. M. 2015. Verification protocol for multiple blood gas analysers in accordance with laboratory accreditation programs. Brazilian Journal of Pathology and Laboratory Medicine. 51 (5): p 296-302.
[17]
Oris, C., Clavel, Y., Jabaudon, M., Pialat, A., Mohamed, H. A., Lioret, F., Sapin, V. and Bouvier, D. 2018. Method verification of a set of 12 GEM® Premier™ 4000 blood gas analysers for point-of-care testing in a university teaching hospital. Practical Laboratory Medicine 10: p 21–33.
Browse journals by subject