A-401 Performance Evaluation of POCT Equipment for Blood Gas Measurement and Metabolic Parameters

Abstract Background According to the Clinical & Laboratory Standards Institute (CLSI) guideline, Point of Care technology (POCT) refers to devices used to provide clinical parameters at the site of a patient care or its proximity, allowing faster test results and improving medical response. However, the improvement in clinical outcomes depends on how healthcare professionals utilize this advantage and the performance of the chosen system. With a vast and growing scope, POCT devices enable the analysis of a wide range of analytes, including cardiac markers, coagulation markers, glucose, blood gases, chemical and metabolic parameters, among others. The Stat Profile Prime® analyzer, which exhibits POCT characteristics, offers benefits to patient care, especially during emergency periods and in restricted situations related to patient movement for conducting tests. In this context, the analytical verification of the device is important to clarify the process, the risks associated with the use of the equipment as well as suitability for the intended use. Moreover, performance evaluation ensures the quality and safety of the results obtained from the tests carried out. This study aimed to evaluate the performance of the POCT Stat Profile Prime equipment to measure blood gases and metabolic parameters. Methods Verification tests were conducted between October and December 2024 based on the CLSI-POCT09-A protocol. Precision study was assayed using three commercial control levels, used to monitor the performance of the Stat Profile Prime (Prime Auto QC Cartridge CCS), in quintuplicate over 5 days, for the quantitative determination of the parameters pH, PCO2, PO2, Htc, Na+, K+, Cl-, iCa, Gli (glucose), and Lac (lactate). The acceptance criteria for this analysis included the coefficient of variation (CV) or standard deviation (SD) according to the manufacturer*s specifications. For the comparative study, two sample groups were used: 42 heparinized whole blood samples and 34 serum samples for iCa. Both sample groups were tested on the Gem 3500 (Werfen) and Stat Profile Prime (Nova Biomedical) instruments. The allowable total error and correlation (r = 0.95) were considered approval criteria for the major of tested analytes and Kappa index (= 75%) for Htc. The linearity study was determined using four levels of the linearity standards (Nova Linearity Levels set), which were processed in three replicates, with the expected correlation of r = 0.99. Results The precision tests performed with 3 control levels showed a confidence interval greater than 95% and SD and CV close to the values specified by the manufacturer, indicating satisfactory performance for all evaluated parameters. In the comparative study, the tested parameters showed a correlation = 0.95, displaying 95% of the results within the total allowable error (TEa), and a Kappa index of 79.3% for Htc. According to quality specifications, the parameters from linearity study demonstrated a correlation = 0.99. Conclusion The Stat Profile Prime device demonstrated reliable performance and verification data in accordance with quality standards, ensuring safety and efficiency for clinical use. Furthermore, as a POCT, the equipment provides prompt and accurate results, which is crucial in a hospital environment, improving patient care.