Journal of clinical laboratory analysis · 2025
The Verification Process of a POC Blood Gas Analyser-The Nova Stat Profile Primer Plus Analyser.
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Costa Joseph, Attard Ritienne, GGH Medical Laboratory Services team
Аннотация
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.
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.