Method verification of blood gas tests on the RAPIDPOINT 500E blood gas analyzer
Main Article Content
Abstract
Blood gas analysis is the important test in clinical practice, analyzing pO2, pCO2, and acid-base balance conditions (pH). All clinical laboratory analyzer, including point-of-care testing (POCT), need to be validated before being officially in service. This study aims to verify the accuracy and precision of the pH, pO2, and pCO2 testing methods on the RAPIDPOINT 500E arterial blood gas analyzer (SIEMENS) in the Emergency Department of Ninh Binh General Hospital, according to CLSI's EP15A3 guidelines. The precision and accuracy of the pH, pO2, and pCO2 test in blood gas at three QC levels were lower than the CLIA 2024 criteria, which verify the precision and accuracy of these methods.
Article Details
Keywords
Method verification, arterial blood gas (ABG) analysis, point-of-care testing (POCT)
References
2. Castro D, Patil S, Zubair M, et al. Arterial Blood Gas. StatPearls. Published online January 8, 2024. Accessed November 13, 2024. https://www.statpearls.com/point-of-care/17837
3. Shaw JLV. Identifying and Reducing Errors in Point-of-Care Testing. EJIFCC. 2021;32(3):298.
4. Rodríguez-Villar S, Paloma Poza-Hernández, Sascha Freigang, et al. Automatic real-time analysis and interpretation of arterial blood gas sample for Point-of-care testing: Clinical validation. PLoS One. 2021;16(3):e0248264. doi:10.1371/journal.pone.0248264
5. James O Westgard. Basic Method Validation. 4th Edition. Westgard QC; 2020.
6. EP15A3 User Verification of Precision & Bias Estimation. Clinical & Laboratory Standards Institute. Accessed January 21, 2024. https://clsi.org/standards/products/method-evaluation/documents/ep15/
7. Westgard. 2024 CLIA Proposed Acceptance Limits for Proficiency Testing. 2024. Accessed May 22, 2024. https://www.westgard.com/clia-a-quality/quality-requirements/1002-2024-clia-requirements.html
8. Luppa P, Müller C, Schlichtiger A, et al. Point-of-care testing (POCT): Current techniques and future perspectives. Trends Anal Chem. 2011;30(6):887. doi:10.1016/j.trac.2011.01.019
9. Indrasari ND, Wonohutomo JP, Sukartini N. Comparison of point-of-care and central laboratory analyzers for blood gas and lactate measurements. J Clin Lab Anal. 2019;33:e22885. doi:10.1002/jcla.22885
10. Charlotte Oris, Yoan Clavel, Matthieu Jabaudon, et al. Method validation of a set of 12 GEM® PremierTM 4000 blood gas analyzers for point-of-care testing in a university teaching hospital. Pr Lab Med. 2017;10:21-33.