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

IF 2.9 4区医学 Q2 MEDICAL LABORATORY TECHNOLOGY Journal of Clinical Laboratory Analysis Pub Date : 2025-03-25 DOI:10.1002/jcla.70006

Joseph Costa, Ritienne Attard, the GGH Medical Laboratory Services team

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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.

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POC血气分析仪的验证过程- Nova Stat Profile Primer Plus分析仪。

背景：即时血气检测在患者管理中起着至关重要的作用。本研究的目的是验证Nova Stat Profile Prime Plus分析仪的制造商规格，以及与GEM Premier 4000血气分析仪的比较研究。方法：分析pH、pCO2、pO2、Na+、Cl-、K+、iCa、乳酸、葡萄糖等参数。精确度和偏倚研究的数据采用5 × 5研究设计的对照样本。使用五级线性控制集检查线性，同时使用全血样本（N = 103）在Nova和GEM分析仪之间进行比较。除乳酸盐外，所有分析物均采用CLIA TEa进行验收，乳酸盐使用CAP和AAB定义的TEa。结果：除运行内pCO2控制等级2 （CV% 1.5[权利要求CV% 1.1]）和运行间iCa控制等级5 （CV% 1.42[权利要求1.12]）外，运行内和运行间CVR%精密度均低于权利要求的CV%。观察到的所有参数偏差都在计算的偏差下限和上限内。除Na+外，所有分析物均证实为线性。在Nova和GEM分析仪的比较中，大多数参数的相关系数大于0.95。结论：Nova Stat Profile Prime Plus分析仪符合制造商的精度和偏差要求。大多数分析物均为线性。Nova和GEM血气分析仪在所有研究参数的参考范围内的浓度具有良好的相关性。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Journal of Clinical Laboratory Analysis 医学-医学实验技术

CiteScore

5.60

自引率

7.40%

发文量

584

审稿时长

6-12 weeks

期刊介绍： Journal of Clinical Laboratory Analysis publishes original articles on newly developing modes of technology and laboratory assays, with emphasis on their application in current and future clinical laboratory testing. This includes reports from the following fields: immunochemistry and toxicology, hematology and hematopathology, immunopathology, molecular diagnostics, microbiology, genetic testing, immunohematology, and clinical chemistry.