The Verification Process of a POC Blood Gas Analyser-The Nova Stat Profile Primer Plus Analyser.

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 TE_a for all analytes except for lactate, for which the TE_a defined by CAP and AAB was used.

Results: The within-run and between-run CV_R% 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.