Dynamic Electrochemistry Corrects for Hematocrit Interference on Blood Glucose Determinations with Patient Self-Measurement Devices

Abstract

As hematocrit variations occur in daily routine (e.g., because of smoking, exercise, hypermenorrhea, pregnancy, stay in mountains, and hemodialysis), our results may encourage use of meters with stable performance under these conditions. Dynamic electrochemistry as used in the BGStar device (sanofi-aventis) appears to be an effective technology to correct for potential hematocrit influence on the meter results.

Determination of Hematocrit Interference in Blood Samples Derived from Patients with Different Blood Glucose Concentrations

“…It is calculated by adding the highest observed mean deviation over the entire glucose range above the 45% result to the highest absolute deviation below the 45% result, as described previously. 10,12 The result and ranking of the devices based on this parameter is provided in Figure 3. An HIF <15% for the individual glucose level and a mean HIF over the entire glucose ranges <0% was defined as indicative for no clinically relevant influence of HCT on the BG readings.…”

“…21 Recently, a first thorough investigation of the HCT distribution in an urban community has been published demonstrating a range 30-50% in Using artificially produced samples in a laboratory setting, we have been able to demonstrate that devices employing dynamic electrochemistry are unaffected by HCT variation. 10,12 Laboratory tests with devices employing dynamic electrochemistry, however, require an extremely careful handling of the sample. The composition of whole blood samples deteriorates with aggressive centrifugation or vigorous shaking of samples as requested by many laboratory protocols applied during sample preparation for proficiency testing of BG meters.…”

“…This dynamic adjustment results in a much richer output signal that forms the basis for a "fingerprint" that the meter's algorithms can analyze to develop correction factors to minimize distortion caused by interfering factors. 12,13 All our investigations, however, were performed in artificial laboratory settings with manipulated venous samples to achieve different BG and HCT ranges. While sample specimen and environmental factors were controlled in our experiments for all devices, other factors, such as the complexity of chemical reactions, the involvement of different co-enzymes, and additional unknown strip components may have further influenced the results.…”

Evaluation of the Effects of Insufficient Blood Volume Samples on the Performance of Blood Glucose Self-Test Meters

“…This dynamic adjustment results in a richer output signal that the meter's algorithms can analyze to develop correction factors to minimize the distortion caused by interfering factors. 7,8 We have been able to demonstrate that this technology corrects for hematocrit interference 4 and results in very accurate and stable performance data for the BGStar and iBGStar when tested with patients in a clinical setting. 9 The technology, however, could potentially also correct for environmental conditions and other sources of error, including low blood sample volume.…”

“…3 Advances in blood glucose reading technologies by several manufacturers have improved the robustness of the readings against interfering substances (e.g., hematocrit) in some meters. 4 One technical solution to correct for a possible biochemical interference includes parallel measurement, e.g., of hematocrit with a subsequent correction algorithm. 5,6 Another more general solution is the application of a mathematical algorithm, which is derived from dynamic electrochemistry as employed by the BGStar and iBGStar (Sanofi, Frankfurt, Germany).…”