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These studies suggest that the EML 105 glucose analyzer is accurate but tends to overestimate plasma glucose levels.
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Accuracy and Reliability of Glucose Analyzers
Blood glucose monitoring is crucial in neonatal intensive care, but the reliability of current analyzers is often questioned. A study compared the EML 105, a glucose electrode-based analyzer, with the Advantage, a non-wipe reflectance photometry method, against the Hexokinase laboratory reference method. The results showed that both EML 105 and Hexokinase methods were highly accurate in vitro, with small proportional biases of 2% and 5%, respectively. However, in vivo, both analyzers tended to overestimate neonatal plasma glucose levels, with EML 105 venous samples showing the least overestimation at 0.45 mmol/l.
Effect of Sample Route and Haematocrit
The study also investigated the impact of sample route (capillary vs. venous) and haematocrit on glucose readings. It was found that venous samples analyzed by EML 105 provided more accurate plasma glucose estimates compared to capillary samples. The relationship between haematocrit and glucose differences was non-linear, indicating no significant difference in the performance of EML 105 versus Advantage analyzers regardless of the sample route.
Precision and Comparison with Other Methods
Another evaluation of the EML 105 system highlighted its precision, with both analyzers reporting a coefficient of variation (CV) of 1.0% at a glucose concentration of 13.4 mmol/l. However, patient glucose results from EML 105 were lower compared to those obtained with the Hitachi 911 analyzer, and there was no significant haematocrit dependency affecting the results.
Impact on Diurnal Profiles of Plasma Glucose
Gestational diabetes mellitus (GDM) significantly affects intermediary metabolism during late pregnancy. A study monitored glucose levels in women with GDM, distinguishing between those with fasting plasma glucose below 105 mg/dl (GDM < 105) and those with levels of 105 mg/dl or greater (GDM ≥ 105). It was found that plasma glucose levels were consistently higher in the GDM ≥ 105 group compared to the GDM < 105 group and normal pregnant women. This indicates that higher fasting glucose levels in GDM are associated with more pronounced metabolic abnormalities.
Universal Criteria for Gestational Diabetes
A large-scale study involving 3,505 pregnant women aimed to establish universal criteria for gestational diabetes using a 75-gram glucose tolerance test. The study found that fasting plasma glucose levels of 105 mg/dl or higher were associated with increased birth weights and macrosomia. However, no clear glucose threshold values were identified that could predict clinical outcomes, suggesting that criteria for gestational diabetes may need to be established by consensus rather than strict numerical thresholds.
Recent research underscores the importance of accurate blood glucose monitoring in both neonates and pregnant women with gestational diabetes. The EML 105 analyzer shows promise in terms of precision and accuracy, particularly with venous samples. In the context of gestational diabetes, fasting glucose levels of 105 mg/dl or higher are indicative of more severe metabolic disturbances, although establishing universal diagnostic criteria remains complex. These insights are crucial for improving clinical practices and outcomes in neonatal care and pregnancy management.
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