Point-of-care glucose analysis in neonates using modified quinoprotein glucose dehydrogenase.
BACKGROUND
Asymptomatic hypoglycemia in neonates may contribute to neurologic deficits during development. Whole-blood glucose sensors are often imprecise and inaccurate at the low glucose concentrations found in neonates.


METHODS
In this study, a glucose sensor using a mutated glucose dehydrogenase that does not cross-react significantly with maltose was evaluated at three pediatric centers. Blood samples (n=575) from infants less than 30 days of age (hematocrit 23-70%) were analyzed using six reagent lots on three ACCU-CHEK(®) meters (Roche Diagnostics, Indianapolis, IN): the Inform II, Performa, and Aviva. Reference glucose level was determined in duplicate in perchloric acid extracts using a coupled hexokinase procedure.


RESULTS
Imprecision of glucose measurement using stable control materials ranged from 2.0% to 3.1% (coefficient of variation) using the glucose meters and from 0.8% to 5.3% (coefficient of variation) in perchloric acid-treated controls. The difference between meter glucose values and reference values showed a slight dependence on hematocrit from 23% to 70% (r=-0.391, P<0.001) but not in the typical range of neonatal hematocrit from 45% to 70% (r=-0.036, P=0.239). Linear regression of the aggregated results yielded the following relationship: Meter glucose=0.99×Reference Glucose+0.04; r(2)=0.976; Syx=0.249. Receiver-operator characteristic analysis of the data using 2.2 mmol/L as the reference threshold for hypoglycemia yielded an area under the curve value of 0.993. All infants with a glucose level of <2.2 mmol/L were detected (100% sensitivity) when the meter glucose value was below 2.8 mmol/L.


CONCLUSIONS
These data indicate that the modified ACCU-CHEK chemistry may be used effectively in neonatal settings to detect clinically significant hypoglycemia.
1 Department of Pediatrics, Washington University , St. Louis, Missouri.
Dennis J
DJ
Dietzen
Timothy R
TR
Wilhite
Maynard
M
Rasmussen
Mark
M
Sheffield
D001786:Blood Glucose / Q000378:metabolism*; D002140:California; D005260:Female; D005948:Glucose Dehydrogenases / Q000097:blood*; D006400:Hematocrit; D006801:Humans; D007003:Hypoglycemia / Q000097:blood* / Q000175:diagnosis*; D007231:Infant, Newborn; D008297:Male; D008320:Maltose / Q000378:metabolism; D008923:Missouri; D019095:Point-of-Care Systems / Q000592:standards; D011934:Reagent Strips; D015203:Reproducibility of Results; D014589:Utah
D001786:Blood Glucose; D011934:Reagent Strips; D008320:Maltose; D005948:Glucose Dehydrogenases; C033955:glucose dehydrogenase (pyrroloquinoline-quinone)