Analytical Performances of the Novel i-STAT Alinity Point-of-Care Analyzer

Many Point-of-Care devices have been released over the past decade. However, data regarding their analytical performances in real-world situations remains scarce. Herein, we aimed to assess the analytical performances of the i-STAT Alinity system. We conducted an analytical performances study with t...

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Main Authors: Romaric Larcher, Maxence Lottelier, Stephanie Badiou, Anne-Marie Dupuy, Anne-Sophie Bargnoux, Jean-Paul Cristol
Format: Article
Language:English
Published: MDPI AG 2023-01-01
Series:Diagnostics
Subjects:
Online Access:https://www.mdpi.com/2075-4418/13/2/297
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author Romaric Larcher
Maxence Lottelier
Stephanie Badiou
Anne-Marie Dupuy
Anne-Sophie Bargnoux
Jean-Paul Cristol
author_facet Romaric Larcher
Maxence Lottelier
Stephanie Badiou
Anne-Marie Dupuy
Anne-Sophie Bargnoux
Jean-Paul Cristol
author_sort Romaric Larcher
collection DOAJ
description Many Point-of-Care devices have been released over the past decade. However, data regarding their analytical performances in real-world situations remains scarce. Herein, we aimed to assess the analytical performances of the i-STAT Alinity system. We conducted an analytical performances study with the i-STAT Alinity device using cartridges CG4+ (pH, Pco<sub>2</sub>, Po<sub>2</sub>, lactate, bicarbonate and base excess); CHEM8+ (Na, K, Cl, ionized Ca, urea, creatinine, glucose, hematocrit and hemoglobin) and PT/INR (prothrombin time and international normalized ratio). We assessed the imprecision and compared the results to those obtained on existing instruments in the central laboratory. We found that the within-lab coefficients of variation (CV) were very low (<2%) or low (2–5%), except for creatinine and PT (CV = 5.2% and CV = 6.3%, respectively). For almost all the parameters, the results were strongly (R<sup>2</sup> = 90–95%) or very strongly (R<sup>2</sup> > 95%) correlated with those of the existing laboratory instruments, and the biases were very low (<2%) or low (2–5%). However, correlations of the PT and INR measurements with existing instruments were lower (R<sup>2</sup> = 86.0% and 89.7%), and biases in the Po<sub>2</sub> (7.9%), creatinine (5.4%) and PT (−6.6%) measurements were higher. The i-STAT Alinity appeared as a convenient device for measurements of numerous parameters. However, clinicians should interpret Po<sub>2</sub>, creatinine and PT results with caution.
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spelling doaj.art-057ce43586c94bb0a1da0d058b7e1f372023-11-30T21:53:32ZengMDPI AGDiagnostics2075-44182023-01-0113229710.3390/diagnostics13020297Analytical Performances of the Novel i-STAT Alinity Point-of-Care AnalyzerRomaric Larcher0Maxence Lottelier1Stephanie Badiou2Anne-Marie Dupuy3Anne-Sophie Bargnoux4Jean-Paul Cristol5Biochemistry and Hormonology Department, Montpellier University Hospital, PhyMedExp (Physiology and Experimental Medicine), INSERM (French Institute of Health and Medical Research), CNRS (French National Centre for Scientific Research), University of Montpellier, 34000 Montpellier, FranceBiochemistry and Hormonology Department, Montpellier University Hospital, 34000 Montpellier, FranceBiochemistry and Hormonology Department, Montpellier University Hospital, PhyMedExp (Physiology and Experimental Medicine), INSERM (French Institute of Health and Medical Research), CNRS (French National Centre for Scientific Research), University of Montpellier, 34000 Montpellier, FranceBiochemistry and Hormonology Department, Montpellier University Hospital, 34000 Montpellier, FranceBiochemistry and Hormonology Department, Montpellier University Hospital, PhyMedExp (Physiology and Experimental Medicine), INSERM (French Institute of Health and Medical Research), CNRS (French National Centre for Scientific Research), University of Montpellier, 34000 Montpellier, FranceBiochemistry and Hormonology Department, Montpellier University Hospital, PhyMedExp (Physiology and Experimental Medicine), INSERM (French Institute of Health and Medical Research), CNRS (French National Centre for Scientific Research), University of Montpellier, 34000 Montpellier, FranceMany Point-of-Care devices have been released over the past decade. However, data regarding their analytical performances in real-world situations remains scarce. Herein, we aimed to assess the analytical performances of the i-STAT Alinity system. We conducted an analytical performances study with the i-STAT Alinity device using cartridges CG4+ (pH, Pco<sub>2</sub>, Po<sub>2</sub>, lactate, bicarbonate and base excess); CHEM8+ (Na, K, Cl, ionized Ca, urea, creatinine, glucose, hematocrit and hemoglobin) and PT/INR (prothrombin time and international normalized ratio). We assessed the imprecision and compared the results to those obtained on existing instruments in the central laboratory. We found that the within-lab coefficients of variation (CV) were very low (<2%) or low (2–5%), except for creatinine and PT (CV = 5.2% and CV = 6.3%, respectively). For almost all the parameters, the results were strongly (R<sup>2</sup> = 90–95%) or very strongly (R<sup>2</sup> > 95%) correlated with those of the existing laboratory instruments, and the biases were very low (<2%) or low (2–5%). However, correlations of the PT and INR measurements with existing instruments were lower (R<sup>2</sup> = 86.0% and 89.7%), and biases in the Po<sub>2</sub> (7.9%), creatinine (5.4%) and PT (−6.6%) measurements were higher. The i-STAT Alinity appeared as a convenient device for measurements of numerous parameters. However, clinicians should interpret Po<sub>2</sub>, creatinine and PT results with caution.https://www.mdpi.com/2075-4418/13/2/297analytical performancePoint-of-Care Analyzeri-STAT Alinityblood gaslactatechemistry
spellingShingle Romaric Larcher
Maxence Lottelier
Stephanie Badiou
Anne-Marie Dupuy
Anne-Sophie Bargnoux
Jean-Paul Cristol
Analytical Performances of the Novel i-STAT Alinity Point-of-Care Analyzer
Diagnostics
analytical performance
Point-of-Care Analyzer
i-STAT Alinity
blood gas
lactate
chemistry
title Analytical Performances of the Novel i-STAT Alinity Point-of-Care Analyzer
title_full Analytical Performances of the Novel i-STAT Alinity Point-of-Care Analyzer
title_fullStr Analytical Performances of the Novel i-STAT Alinity Point-of-Care Analyzer
title_full_unstemmed Analytical Performances of the Novel i-STAT Alinity Point-of-Care Analyzer
title_short Analytical Performances of the Novel i-STAT Alinity Point-of-Care Analyzer
title_sort analytical performances of the novel i stat alinity point of care analyzer
topic analytical performance
Point-of-Care Analyzer
i-STAT Alinity
blood gas
lactate
chemistry
url https://www.mdpi.com/2075-4418/13/2/297
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