The Science Journal of the American Association for Respiratory Care

1997 OPEN FORUM Abstracts

COMPARISON OF A PORTABLE POINT-OF-CARE BLOOD GAS AND ELECTROLYTE ANALYZER (SENDX-100^{TM}) WITH CONVENTIONAL ANALYSIS IN BOTH LABORATORY AND CLINICAL SETTINGS

AUTHORS: WT Peruzzi, MD; BA Shapiro, MD; R Templin, BA, CCPT; A Natke, RN, MS; BL Smith, BA, RRT AFFILIATION: Department of Anesthesiology, Northwestern University Medical School, Chicago, Illinois, 60611

Introduction: Point-of-care (POC) testing is a rapidly developing aspect of clinical medicine. The purpose of this study was to determine the accuracy and reliability of a specific POC blood gas/electrolyte analyzer (SenDx Medical Inc, Carlsbad, CA). compared with conventional laboratory (Lab)-based analysis when the POC device is used by both laboratory technicians and clinical personnel. Methods: Approval of the Institutional Review Board was obtained. The study compared results obtained from conventional blood gas/electrolyte analyzers and those obtained from POC devices. Clinically indicated blood specimens were analyzed via a split sample technique. The study was carried out with two POC devices placed in the laboratory and two placed in the clinical environment. After 100 data points, the position (i.e., laboratory vs. clinical) of the devices was switched. In the laboratory, the specimens were split by laboratory personnel between conventional blood gas/electrolyte analyzers and the POC devices. In the clinical environment, clinically indicated blood samples were split at the point-of-care. One portion of the sample was analyzed at the bedside by respiratory therapists using the POC device and the remaining portion of the sample was sent immediately to the laboratory for conventional analysis. The results of both analysis techniques in both environments (laboratory and clinical) were compared via the method of Bland and Altman. Results: A total of 200 data points (50 for each POC device) were obtained. Data obtained from each analyzer were pooled and are presented in the table. There were no P_{a}O_{2} values >200 obtained with the POC device in the clinical setting. All parameters tested, in both the laboratory and clinical settings, demonstrated results which are consistent with guidelines for laboratory performance. Conclusions: The SenDx-100 POC blood gas/electrolyte analyzer performed with precision and accuracy equivalent to conventional laboratory methods for all parameters in the hands of both laboratory and clinical personnel in a critical care setting.

pH Pa Pa Pa Pa Na+ K+ Ca++ Hct

CO_{2} O_{2} O_{2} O_{2}

< 100 100-200 >200

1 Lab Bias 0.0 -0.1 -1.5 2.0 -1% 0.3 0.03 0.05 0.3

Precision ±0.01 ±1.6 ±2.6 ±5.6 ±1% ±1.7 ±0.08 ±0.03 ±2.6

ICU Bias 0.0 -0.2 0.4 -0.3 1.5 0.04 0.05 0.5

Precision ±0.02 ±0.7 ±2.2 ±6.9 ±1.9 ±0.08 ±0.04 ±5.6

2 Lab Bias 0.0 0.4 -2.8 -3.6 -4% -0.5 0.02 0.06 0.7

Precision ±0.01 ±1.5 ±3.6 ±7.8 ±1% ±2.2 ±0.08 ±0.03 ±1.9

ICU Bias 0.01 -0.8 0.3 -1.9 0.9 0.0 0.06 0.8

Precision ±0.01 ±0.7 ±3.1 ±3.3 ±3.1 ±0.1 ±0.07 ±2.5

3 Lab Bias 0.01 -0.3 -3.1 -4.3 -2% 0.13 0.01 0.06 0.1

Precision ±0.02 ±2.3 ±2.3 ±4.8 ±2% ±1.5 ±0.09 ±0.03 ±2.4

ICU Bias 0.01 -0.5 -1.2 -1.4 0.9 0.05 0.0 0.6

Precision ±0.01 ±1.1 ±2.8 ±3.7 ±2.2 ±0.08 ±0.06 ±2.7

4 Lab Bias 0.01 -0.8 -4.3 -0.8 -8% -0.7 0.02 0.05 0.6

Precision ±0.01 ±1.3 ±2.8 ±4.9 ±3% ±2 ±0.1 ±0.03 ±2.4

ICU Bias 0.01 -0.8 -4.0 -9.2 1.0 0.06 0.03 -0.8

Precision ±0.01 ±1.5 ±5.4 ±2.9 ±1.8 ±0.13 ±0.04 ±2.1

Guidelines for ±0.04 ±4 ±4 ±8 ±10% ±4 ±0.4 ±0.06 ±6%

Variance

OF-97-098

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