Point-of-Care Glucose Analysis in Neonates Using Modified Quinoprotein Glucose Dehydrogenase

Abstract

Background: Asymptomatic hypoglycemia in neonates may contribute to neurologic deficits during development. Wholeblood glucose sensors are often imprecise and inaccurate at the low glucose concentrations found in neonates. Subjects and 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 Ò 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; S yx = 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.

Performance of strip-based glucose meters and cassette-based blood gas analyzer for monitoring glucose levels in a surgical intensive care setting

“…Overall our results confirm previous reports [16][17][18][19][20][21]. Using the 10% criterion recently set forward by the FDA [12], only for the BGA all results fell within these boundaries.…”

“…Previous studies tested meters in populations not limited to critically ill patients [16][17][18][19][20][21] or in neonatal populations focusing on detection of hypoglycemia [17,18,20], and weighted results not [16,19,20] or per less stringent CLSI or ISO 15197 criteria [17,18,21], or used the glucose oxidase method [18,20,21] instead of the more definitive [22] coupled hexokinase -glucose-6-phosphate dehydrogenase (HK/G6PD) method [16,17,19]. In the present study we compared three hospital-type handheld strip-based systems on whole blood samples of our surgical intensive care unit (ICU), with our blood gas analyzer (BGA) and with the central laboratory HK/G6PD method.…”

Swedish national guideline for prevention and treatment of neonatal hypoglycaemia in newborn infants with gestational age ≥35 weeks

“…Large haematocrit variations in newborn entail most POC metres to overestimate p‐glucose at low haematocrit values and underestimate p‐glucose at high haematocrit levels. Although POC instruments have built‐in correction algorithms, they rarely improve the certainty in this respect among newborns or premature infants …”

“…Although POC instruments have built-in correction algorithms, they rarely improve the certainty in this respect among newborns or premature infants. [77][78][79] In special cases, it may be of value to use subcutaneous continuous glucose monitoring systems (CGMS) that displays glucose readings every five minutes. CGMS has been validated in newborn and premature infants.…”

Surface-enhanced Raman spectroscopy competitive binding biosensor development utilizing surface modification of silver nanocubes and a citrulline aptamer

“…[1][2][3][4][5] The most common and commercially available PoC device has been the glucose monitor but, as technology improves, many other applications, such as testing for HIV, for example, have been explored in recent years. [6][7][8][9] For sensitively monitoring blood biomarkers, one PoC technique being investigated is the incorporation of surface-enhanced Raman spectroscopic (SERS) labels for more sensitive analyte detection. [10][11][12] SERS is a method that uses a metallic surface or nanoparticle metal colloids to enhance the inelastic Raman scattering of photons.…”