Analytical evaluation of the epoc® point-of-care blood analysis system in cardiopulmonary bypass patients

• The analytical performance of epoc® point-of-care blood analysis system in cardiopulmonary bypass patients was investigated.
• The epoc® blood analysis systems demonstrated clinically acceptable precision for all analytes.
• Comparison studies yielded a correlation with GEM4000, iSTAT, Nova CCX, and Roche Inform II and Performa meters.
• Average biases for all analytes including hemoglobin were within the total allowable error limits.

ObjectivesThe aim of this study was to evaluate the analytical performance of the new epoc® point-of-care blood analysis system in cardiopulmonary bypass patients.Design and methodsThe precision study was conducted on 3 epoc® blood analysis systems using 5 levels of quality control materials twice per day for 5 days. The blood specimen was collected in blood gas syringes from 40 cardiac perfusion patients for the comparison study on epoc® (all 3 meters), Instrumentation Laboratory GEM4000, Abbott iSTAT, Nova CCX, and Roche Accu-Chek Inform II and Performa glucose meters.ResultsThe epoc® blood analysis systems demonstrated clinically acceptable precision for all analytes (from 0.07%, 0.07%, and 0.13% for pH 7.6, 7.4, and 7.0 levels; to 3.87%, 3.74%, and 7.56% for pO2 197, 103, and 56 mm Hg levels). Comparison studies yielded a correlation coefficient R from 0.9201 (sodium) to 0.9969 (pO2) with the GEM4000; from 0.9071 (sodium) to 0.9965 (potassium) with the iSTAT; from 0.8793 (sodium) to 0.9957 (pO2) with the CCX, and 0.9850 and 0.9904 with Roche Inform II and Performa meters respectively. Average biases for all analytes were within the total allowable error limits.ConclusionThe epoc® blood analysis system is acceptable for point-of-care testing in the cardiovascular surgery setting.