Evaluation of the Analytical Performance of the Modified Enterprise Point-of-Care Blood Gas and Electrolyte Analyzer in a Pediatric Hospital

Abstract

Arterial blood gas testing is an essential component that directs the evaluation of a patient’s general condition, especially in the emergent setting. We evaluated the analytical performance of the modified Enterprise point-of-care (EPOC) blood gas and electrolyte analyzer system with respect to precision and accuracy and compared our results with those obtained using the point-of-care i-STAT method and the criterion standard ABL 835 Radiometer blood gas analyzer in a pediatric hospital. Evaluation studies were performed as per the Clinical Laboratory Standards Institute guidelines and included intra-assay and interassay precision and accuracy, linearity, and concordance analyses with i-STAT and ABL 835 Radiometer. Intra-assay and interassay coefficient of variation for each analyte was calculated and was less than 6% for all analytes in the ranges tested including pH, Po2, Pco2, Na+, K+, Ca2+, glucose, lactate, and hematocrit, Cl−, and creatinine. All of the analytes were linear across the reportable range. For the methods comparison of EPOC system with the i-STAT method, using 40 samples, the correlation coefficients were r > 0.94 for all analytes with the exception of Ca2+ (r = 0.61). For the methods comparison of EPOC system with the criterion standard ABL 835 Radiometer on 40 samples, the correlation coefficients were higher than 0.97 for all analytes with the exception of hematocrit and hemoglobin (r = 0.8). Thus, in our pediatric hospital setting, the EPOC system showed excellent precision and accuracy and compared favorably with the i-STAT and ABL 835 Radiometer assay results. These findings, together with the low cost, room temperature storage of test cards and availability of metabolites such as lactate, glucose, and creatinine along with the wireless connectivity of the EPOC system, provide an operational advantage over other point-of-care blood gas analyzers currently available.