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Oak Ridge Poster Sessions |
1
Div. of Lab. Med., Dept. of Pathol., Box 8118, 660 S. Euclid Ave., Washington Univ. School of Med., St. Louis, MO, 63110;
2
Dept. of Labs., Barnes-Jewish Hosp., St. Louis, MO;
a author for correspondence: fax 314-362-1461, e-mail mscott{at}pathology.wustl.edu
The use of point-of-care meters for bedside blood glucose monitoring has become common in hospitalized patients. The management of patients in critical care units, those receiving aggressive supportive therapy, and those with type 1 or 2 diabetes may require frequent testing of their blood glucose concentrations (1)(2)(3). Bedside monitoring is often done with capillary whole blood from a fingerstick, and these whole-blood glucose meters produce values 810% lower than those in plasma (4). However, most clinical laboratory instruments measure glucose concentrations in plasma or serum, not whole blood. A whole-blood glucose meter that reports a plasma-equivalent result might be useful to reduce possible confusion when comparing glucose meter and laboratory glucose values.
Here, we evaluated the SureStep®-Pro Hospital System, a reflectance meter that uses glucose oxidase chemistry to report plasma-equivalent glucose concentrations from capillary, venous, and arterial whole blood. We compared whole-blood and plasma glucose concentrations measured by the SureStep-Pro Hospital System (LifeScan) with values from the One Touch® II Hospital System (LifeScan), the Yellow Springs Instrument Model 2700 Select Biochemistry Analyzer (YSI), and the Vitros 750 Analyzer (Johnson & Johnson). Plasma equivalent results on the SureStep-Pro Hospital System are achieved by calibrating the meter to plasma glucose concentrations obtained from donor blood samples supplemented with glucose and measured on the YSI analyzer.
Capillary, venous, and arterial whole-blood samples were obtained from patients at Barnes-Jewish Hospital for whom routine glucose values by the central laboratory or glucose meter had been requested. This study had the approval of the Washington University School of Medicine Human Studies Committee. Patients for the study were selected such that glucose values covered a wide range of values. Whole-blood samples were analyzed with the SureStep-Pro Hospital System, the One Touch II Hospital System, and the YSI. Plasma glucose concentrations were obtained with the YSI and the Vitros 750. The effect of hematocrit (Hct) and PO2 was examined by using the Stat-Crit (Wampole Labs.) instrument and the Radiometer ABL 505 blood gas analyzer (Radiometer Corp.), respectively. Low, normal, and high quality-control samples provided by LifeScan were used for precision studies on the SureStep-Pro Hospital System.
Day-to-day precision (CV) was 4.4% at a glucose concentration of 430 ± 19 mg/L (n = 20), 4.1% at a glucose concentration of 1008 ± 41 mg/L (n = 20), and 43% at a glucose concentration of 3175 ± 136 mg/L (n = 20) for the low, normal, and high controls, respectively.
Over the range of glucose concentrations tested (7304530 mg/L) in capillary blood, the SureStep-Pro Hospital System (mean SureStep = 1710 mg/L) correlated well with whole-blood values measured by the One Touch II Hospital System and by the YSI (SureStep = 1.13YSI + 0.66, n = 52, r2 = 0.987, Sy|x = 90 mg/L; mean blood YSI = 1500 mg/L). The SureStep-Pro Hospital System values averaged 10% and 14% higher, respectively, than the values from the One-Touch and YSI whole-blood analyzers. In contrast, the SureStep-Pro Hospital System both correlated with and closely matched values determined in plasma by the YSI (SureStep = 1.04YSI - 0.17, n = 52, r2 = 0.981, Sy|x = 111 mg/L; mean plasma YSI = 1640 mg/L), averaging only 4% higher.
For glucose concentrations (5704100 mg/L) measured in venous blood, the SureStep-Pro Hospital System (mean SureStep = 1540 mg/L) correlated well with whole-blood values measured by the YSI (SureStep = 1.18YSI - 5.08, n = 53, r2 = 0.980, Sy|x = 111 mg/L; mean blood YSI = 1350 mg/L), with SureStep-Pro values being 14% higher. In contrast, the SureStep-Pro Hospital System values not only correlated well but again closely matched plasma values determined by the Vitros 750 Analyzer (SureStep = 1.02Vitros - 2.81, n = 53, r2 = 0.971, Sy|x = 135 mg/L; mean Vitros = 1540 mg/L) and by the YSI (SureStep = 1.05YSI - 1.58, n = 53, r2 = 0.973, Sy|x = 130 mg/L; mean plasma YSI = 1480 mg/L).
Likewise, the SureStep-Pro Hospital System (mean SureStep = 1640 mg/L) correlated well with arterial whole-blood glucose values (5803300 mg/L) measured by the YSI (SureStep = 1.08YSI + 3.38, n = 49, r2 = 0.983, Sy|x = 89 mg/L; mean blood YSI = 1480 mg/L), with SureStep-Pro values averaging 11% higher. For arterial plasma samples, the SureStep-Pro Hospital System values not only correlated well but closely matched those determined by the YSI (SureStep = 0.99YSI + 3.38, n = 49, r2 = 0.983, Sy|x = 88 mg/L; mean plasma YSI = 1620 mg/L).
In the capillary, venous, and arterial whole-blood samples with Hct
determinations, we found no correlation between Hct and the difference
between the SureStep-Pro Hospital System and YSI values. Fig. 1
A shows the comparison of Hct and the difference between the
SureStep-Pro Hospital System and Vitros values from venous samples.
Similar findings were observed for capillary and arterial whole blood.
Likewise, there was no correlation between the
PO2 and the difference between the
SureStep-Pro Hospital System and YSI values in arterial whole blood
(Fig. 1B
).
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The SureStep-Pro Hospital System has excellent day-to-day precision and is capable of measuring glucose concentrations in capillary, venous, and arterial whole blood. The SureStep-Pro Hospital System provides glucose values essentially equivalent to those obtained from plasma, with Hct and PO2 having no effect on the results. Taken together, these studies demonstrate that the SureStep-Pro Hospital System provides highly accurate plasma-equivalent results on whole-blood samples. This approach should help eliminate possible confusion when comparing bedside meter results with those from the clinical laboratory.
References
The following articles in journals at HighWire Press have cited this article:
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K. Dungan, J. Chapman, S. S. Braithwaite, and J. Buse Glucose Measurement: Confounding Issues in Setting Targets for Inpatient Management Diabetes Care, February 1, 2007; 30(2): 403 - 409. [Full Text] [PDF] |
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N. Fogh-Andersen and P. D'Orazio Proposal for standardizing direct-reading biosensors for blood glucose Clin. Chem., March 1, 1998; 44(3): 655 - 659. [Abstract] [Full Text] [PDF] |
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