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

## TL;DR

This study verifies the performance of the Nova Stat Profile Prime Plus blood gas analyzer against manufacturer claims and compares it to another analyzer.

## Contribution

The study provides empirical validation of the Nova analyzer's precision, bias, and linearity in a clinical context.

## Key findings

- The Nova analyzer met manufacturer precision claims for most parameters, with minor exceptions.
- Linearity was confirmed for most analytes except sodium.
- A strong correlation was found between the Nova and GEM analyzers for most parameters.

## Abstract

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.

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.

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.

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.