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

• Published in: Practical laboratory medicine Vol. 31; p. e00297
• Main Authors: García-Fernández, Alba E., Barquín, Raquel, Martínez, Mariano, Ferrer, Roser, Casis, Ernesto, Xu, Clarke
• Format: Journal Article
• Language: English
• Published: Netherlands Elsevier B.V 01.08.2022; Elsevier
• Subjects: Acute kidney injury; Blood urea nitrogen; Chemistry panel; Creatinine; Estimated glomerular filtration rate; Original; Point-of-care; Creatinine; Blood urea nitrogen; Point-of-care; Chemistry panel; Estimated glomerular filtration rate; Acute kidney injury
• ISSN: 2352-5517; 2352-5517
• DOI: 10.1016/j.plabm.2022.e00297

GEM Premier ChemSTAT is a new point-of-care system providing rapid creatinine, BUN and tCO2 measurements together with electrolytes, metabolites, hematocrit, pH and pCO2 from a single whole blood specimen in acute care settings such as emergency departments and intensive care units. Accurate measurements of whole blood creatinine can aid in the diagnosis and treatment of renal diseases. Heparinized whole blood samples from different clinical locations were evaluated on the GEM Premier ChemSTAT and results compared to plasma from the same samples on the Beckman AU5800 or whole blood on the GEM Premier 4000. Precision studies were conducted with whole blood and quality control material. ChemSTAT correlated well with plasma samples on the AU5800 (regression slopes (S): 0.957–1.159, correlation coefficients (r)≥0.952) and with whole blood specimens on the GEM Premier 4000 (S: 0.9646–1.124, r ≥ 0.974). The repeatability was 0.1%–3.1% and QC precision were within lab and manufacturers’ specifications. ChemSTAT demonstrated strong correlation to the comparative methods and excellent precision. Combining with its continuous quality management, ChemSTAT is suitable for acute care settings to provide rapid, reliable results, which could minimize time-to-treatment and improve patient outcome. •GEM Premier ChemSTAT evaluated against Beckman AU 5800 and GEM Premier 4000.•A multi-use cartridge-based system measures twelve analytes in whole blood sample.•Method comparison and precision meet laboratory and manufacturers' specifications.•Whole blood creatinine assays showed lab quality performance.•Plasma vs serum bias observed for creatinine and urea on lab analyzer.