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The Verification Process of a POC Blood Gas Analyser—The Nova Stat Profile Primer Plus Analyser
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The Verification Process of a POC Blood Gas Analyser—The Nova Stat Profile Primer Plus Analyser
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Journal Article
The Verification Process of a POC Blood Gas Analyser—The Nova Stat Profile Primer Plus Analyser
2025
Overview
ABSTRACT
Background
Point‐of‐care testing of blood gases plays a critical role in patient management. The aim of this study was to verify the manufacturer's specifications of the Nova Stat Profile Prime Plus Analyser, along with a comparison study with the GEM Premier 4000 Blood Gas Analyser.
Methods
Parameters analysed were pH, pCO2, pO2, Na+, Cl−, K+, iCa, lactate, and glucose. Data for the precision and bias study were generated using control samples in a 5 × 5 study design. Linearity was checked using a five‐level Linearity Control Set, while comparison was done between the Nova and GEM analysers using whole blood samples (N = 103). Acceptance was based on the CLIA TEa for all analytes except for lactate, for which the TEa defined by CAP and AAB was used.
Results
The within‐run and between‐run CVR% precision were all lower than the claimed CVs%, except for pCO2 control level 2 within run (CV% 1.5 [claim CV% 1.1]) and iCa control level 5 between run (CV% 1.42 [claim 1.12]). The observed bias for all parameters was within the calculated lower and upper bias limits. Linearity was verified for all analytes except for Na+. Upon comparison of the Nova and GEM analysers, a correlation coefficient above 0.95 was observed for most parameters.
Conclusion
The Nova Stat Profile Prime Plus analyser meets the manufacturer's precision and bias claims. Linearity was confirmed for most analytes. There was a good correlation between the Nova and GEM Blood Gas analyser at concentrations within the reference range intervals for all investigated parameters.
Point‐of‐care (POC) testing of blood gases plays a critical role in the management of patients both in the emergency department and in a critical care setting. Findings from this study confirm that the Nova Stat Profile Prime Plus analyser meets the manufacturer's precision and bias claims. Linearity was confirmed for pCO2, pO2, K+, Cl‐ and iCa. A good correlation was found between the Nova Stat Profile Prime Plus and GEM Premier Blood Gas analysers at concentrations within the reference range intervals for all the investigated parameters.
Publisher
John Wiley & Sons, Inc,John Wiley and Sons Inc
