Performance evaluation of a point of care cartridge of the new GEM Premier ChemSTAT analyzer

García-Fernández, Alba Estela; Barquin, R.; Martínez, Mariano; Ferrer-Costa, Roser; Casis, Ernesto; Xu, Clarke

doi:10.1016/j.plabm.2022.e00297

Cited by 3 publications

(1 citation statement)

References 5 publications

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“…The following supporting information can be downloaded at: https:// www.mdpi.com/article/10.3390/diagnostics13020297/s1: Table S1: Review of the existing literature on the analytical performances of various Point-of-Care (POC) analyzers [2,4,7,12,21,22,[27][28][29][30][31][32][33][34][35][36][37][38].…”

Section: Supplementary Materialsmentioning

confidence: 99%

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

et al. 2023

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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, Pco2, Po2, 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 (R2 = 90–95%) or very strongly (R2 > 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 (R2 = 86.0% and 89.7%), and biases in the Po2 (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 Po2, creatinine and PT results with caution.

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Section: Supplementary Materialsmentioning

confidence: 99%

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

et al. 2023

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Comparison of Creatinine, Urea, Ionized Calcium, and Bicarbonate Methods by 2 POC Systems and a Mainframe Chemistry Analyzer

Toffaletti

Handel

Riese³

et al. 2023

The Journal of Applied Laboratory Medicine

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Background The i-STAT (iST) and GEM Premier ChemSTAT (ChmST) are point-of-care systems that measure electrolytes, metabolites, acid-base parameters, and hematocrit on blood. We compared results for creatinine, urea (blood urea nitrogen [BUN]), total carbon dioxide (tCo2), and ionized calcium (ion Ca) on blood by the ChmST and iST to Beckman DxC600 (DxC600) results for creatinine and urea on plasma and GEM Premier 5000 (GEM5K) results for ion Ca and tCo2 on blood. Methods 107 heparinized blood specimens were analyzed on the ChmST and iST systems, with plasma tested by DxC600 for creatinine and BUN and blood tested by GEM5K for ion Ca and tCo2. We evaluated the methods primarily by the mean and SD of the biases at clinically relevant concentrations. Results The correlations of ChmST and iST results on blood for creatinine, BUN, ion Ca, and tCo2 correlated to plasma by the DxC600 and to blood by the GEM5K were r ≥ 0.98 for all analytes except for ion Ca on the iST (r = 0.93). The mean and SD of biases were within clinically and analytically acceptable limits for all methods except for tCo2 on the ChmST, which measures bicarbonate with a bicarbonate-sensing electrode. Also, creatinine and BUN by the ChmST were less affected by icterus or hemolysis than were the DxC600 (icterus) and the iST (hemolysis). Conclusions The ChmST and iST results on blood demonstrated strong correlations with each other and with the DxC600 results on plasma. We conclude the ChmST provides reliable results for whole blood creatinine, urea, ion Ca, and tCo2.

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An Evaluation of a Point-of-Care GEM Premier ChemSTAT Analyzer in an Emergency Department: Prevention of Contrast-Induced Nephropathy and Optimization of Patient Flow

Brailova,

Audin,

Raconnat

et al. 2024

JCM

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Background: Having a laboratory renal profile for medical imaging examinations requiring contrast media (CM) administration is strongly advised. Creatinine helps identify patients at risk of contrast-induced nephropathy (CIN). The GEM® Premier™ ChemSTAT (Werfen) is a point-of-care (POC) analyzer with 12 emergency parameters, including a creatinine assay. This study aims to compare ChemSTAT with the central analytical solution of the University Hospital of Clermont-Ferrand and to evaluate the interest in using POC creatinine in the emergency department (ED) to optimize the flow of patients, especially when CM administration is necessary. Methods: More than 200 whole blood (WB) samples from the ED were evaluated on the ChemSTAT analyzer. As comparative methods, the plasma aliquots from the same samples were assayed on an Atellica® CH (Siemens Healthineers). The clinical concordance was assessed according to the decision cut-offs of the French Society of Radiology for the risk of CIN. The availability times of biological results between ChemSTAT and the central laboratory were studied. Results: WB results from the ChemSTAT analyzer correlated well with those from the Atellica® CH, except for tCO2 (the known bias between the Siemens and Cobas Roche methods for predicting ChemSTAT values). The results of the creatinine assay allow for identical medical decisions in comparison to the renal-risk cut-offs. The availability of the biological results was reduced by 50 min on average with ChemSTAT vs the central laboratory. Computed tomography (CT) was performed for 44.7% of patients, including the injection of the CM in 68% of cases. For these patients, the availability of creatinine results relative to imaging time is faster with the ChemSTAT by an average of 45.2 min. Conclusions: Great analytical and clinical correlations for creatinine assays allow for the safe identification of patients at risk of CIN, and improve patient flow in ED, especially for those requiring computed tomography with CM.

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Performance evaluation of a point of care cartridge of the new GEM Premier ChemSTAT analyzer

Cited by 3 publications

References 5 publications

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

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

Comparison of Creatinine, Urea, Ionized Calcium, and Bicarbonate Methods by 2 POC Systems and a Mainframe Chemistry Analyzer

An Evaluation of a Point-of-Care GEM Premier ChemSTAT Analyzer in an Emergency Department: Prevention of Contrast-Induced Nephropathy and Optimization of Patient Flow

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