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

Abstract

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.