Validation of a hand-held lactate device in determination of blood lactate in critically injured patients

OBJECTIVES: Admission blood lactate is an accurate predictor of injury severity and mortality in trauma patients. The purpose of this study was to evaluate a portable lactate analyzer in a clinical setting by patient care staff. DESIGN: A prospective, single-operator control solution and patient sample study, using two test devices and a reference device. SETTING: An urban Level I trauma center. PATIENTS: A convenience sample of 47 trauma patients. INTERVENTIONS: Intra-assay precision was demonstrated by performance of consecutive analyses of two lactate control solutions (high and low lactate control concentrations) by medical students and physicians. Split sample, simultaneous testing of the portable lactate analyzer was then performed on 66 whole blood specimens from a convenience sample of 47 trauma patients admitted to an urban Level 1 trauma center over 4 mos. Samples were tested simultaneously tested on two portable lactate analyzers and a reference instrument. MEASUREMENTS AND MAIN RESULTS: Acceptable intra-assay precision was achieved. Regression analysis for two test instruments demonstrated a slope of 0.920, an intercept of 0.323, an r2 of .982, and an SEM of 0.496. Regression analysis for test instrument "A" vs. the reference instrument showed a slope of 0.861, an intercept of 0.209, an r2 of .977, and an SEM of 0.598. Regression analysis for test instrument "B" vs. the reference instrument demonstrated a slope of 0.929, an intercept of -0.095, an r2 of .983, and an SEM of 0.506. CONCLUSIONS: Good correlation with a low SEM was obtained over a wide range of clinically relevant lactate values. Use of point of care lactate analysis will decrease analytic time, making an important diagnostic parameter immediately available in the critical care setting.