Evaluation of the Enterprise Point-of-Care (EPOC) System for Blood Gas and Electrolyte Analysis

Objective: To evaluate the analytical performance of a new point-ofcare blood gas and electrolyte analyzer, the EPOC system. Materials and Methods: Evaluation of analytical precision and method comparison was conducted at the manufacturing facilities and at several locations in a 630-bed tertiary acute care hospital in New England, an intensive care unit, cardiac intensive care unit, an outpatient hematology/oncology clinic, and the Baystate Health system central laboratory (Springfield, Mass). The evaluation was conducted by nursing staff, medical laboratory technicians, medical technologists, and pathology residents. Results: Within-run precision (0.07%Y2.3% coefficient of variation [CV]) and total precision (0.14%Y3.8% CV) were estimated by analysis of aqueous and hematocrit control materials. A total of 143 samples leftover from laboratory analysis were compared with the predicate device, the i-STAT. One sample was excluded for potential benzalkonium interference with electrolytes, and another sample was excluded from the hematocrit correlation because of suspected incomplete mixing. The EPOC system was comparable to the i-STAT for all analytes with correlation coefficients of 0.880 to 0.990, linear regression slopes of 0.91 to 1.07, and SE of the estimates of 1.5% to 2.5% CV for electrolytes and pH, 3.9% for hematocrit, and 4.9% to 7.3% CV for blood gases. Conclusions: The EPOC system demonstrated excellent analytical precision and comparability of patient results to the i-STAT. The EPOC system has room temperature storage of test cards and wireless connectivity that provides an operational advantage over other pointof-care blood gas analyzers on the market.