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

Pfützner, Andreas; Schipper, Christina; Ramljak, Sanja; Flacke, Frank; Sieber, Jochen; Forst, Thomas; Musholt, Petra B.

doi:10.1177/193229681300700122

Cited by 15 publications

(21 citation statements)

References 18 publications

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“…This threshold has been applied by us in previous publications and appears to be a suitable benchmark parameter to differentiate between devices with or without hematocrit interference. [17][18][19][20] Our investigation has several important limitations, which prohibit a direct translation of our laboratory results into clinical practice recommendations. First, this investigation was performed in an artificial laboratory setting with manipulated venous samples.…”

Section: Discussionmentioning

confidence: 99%

“…The same meters or meters from the same manufacturers and based on the respective technology have also shown similar results in previous investigations. [17][18][19][20] These blood glucose measurement systems are also known to use mathematical algorithms to correct for hematocrit interference, but the exact nature of these procedures has not been disclosed to the public, but it is tempting to speculate that it may be a similar approach like dynamic electrochemistry. The meters that failed our hematocrit interference test are known to apply static electrochemistry, which explains the observed results.…”

Section: Discussionmentioning

confidence: 99%

“…We have been able to demonstrate in recent investigations that devices for patient self-testing employing dynamic electrochemistry are unaffected not only by hematocrit interference in the laboratory [17][18][19] but also in a clinical accuracy evaluation. 20 A new device employing dynamic electrochemistry, MyStar Extra (Sanofi, Frankfurt), has recently been introduced to the market. The purpose of this investigation was to confirm that the dynamic electrochemistry algorithms established in the MyStar Extra device are suitable to correct for hematocrit interference by using our standardized hematocrit interference testing protocol in comparison to 7 commercially available competitive devices.…”

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confidence: 99%

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Evaluation of Hematocrit Interference With MyStar Extra and Seven Competitive Devices

Demircik¹,

Ramljak²,

Hermanns

et al. 2014

J Diabetes Sci Technol

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Prevalence of abnormal hematocrit values (HCT) in diabetic is a phenomenon that is underestimated by physicians and diabetes nurse educators. HCT is generally considered to be quite stable in the range of 40-45% and blood glucose meters for patient self-testing are usually set to function properly with HCT concentration in this "normal range." However, a thorough investigation of the hematocrit distribution in an urban community has demonstrated a HCT-range of 30-50% in a healthy reference population. In community patients, the observed HCT ranged between 20% and 60%, and in hospital patients it was 10% to 70%. Patients in the intensive care units showed levels between 15% and 40%.1 In older patients also suffering from various diseases, these variations can even be more pronounced and may have an impact on the patient's prognosis, for example, in patients with kidney disease.2 In daily routine, changes in the hematocrit levels can be the result of lifestyle interventions (eg, smoking, prolonged exercise), can come with demographic conditions (eg, age), and can be induced by disease-and drug-related conditions (eg, hematological disorders, hypermenorrhea, pregnancy, or renal disease) and by environmental conditions (eg, stay in high mountains, seasonal variation). [3][4][5] Hematocrit interference has previously been identified as a source for inaccuracies of blood glucose meter readings in daily routine. 6,7 In meters employing static electrochemistry, Method: Venous heparinized blood was freshly drawn, immediately aliquoted, and manipulated to contain 3 different blood glucose concentrations (50-80 mg/dL, 150-180 mg/dL, and 350-400 mg/dL) and 5 different HCT levels (20-25%, 30-35%, 40-45%, 50-55%, and 60-65%). After careful oxygenation to normal blood oxygen pressure, each of the 15 different samples was measured 8 times with 2 devices and 2 strip lots of each meter (32 measurements/meter/sample). YSI Stat 2300 served as laboratory reference method. Next to determination of the mean absolute relative deviation (MARD), stability to HCT influence was assumed, when less than 10% difference occurred between the highest and lowest mean glucose deviations in relation to HCT over all tested glucose ranges (HIF: hematocrit interference factor).

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

mentioning

confidence: 99%

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Evaluation of Hematocrit Interference With MyStar Extra and Seven Competitive Devices

Demircik¹,

Ramljak²,

Hermanns

et al. 2014

J Diabetes Sci Technol

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“…Various hypotheses have been proposed to explain the impact of abnormal HCT levels on glucose testing, including but not limited to, altered viscosity of the blood, prevention of plasma from reaching the reaction surface of the test strip, change in diffusion kinetics, and/or increased packed red cell volume and displacement of plasma volume, leading to insufficient plasma volume for accurate testing. 23 While many health care professionals believe that HCT is usually quite normal in their community patients, it is generally accepted that HCT may be deviating from the reference values in patients with critical diseases or under very specific conditions, such as pregnancy, extensive exercise, or kidney disease. However, one study has now shown that HCT variance, even in patients visiting family doctors, has been underestimated by far.…”

Section: -22mentioning

confidence: 99%

“…Similar results for BGStar were obtained already in two previous investigations with a similar experimental design 13,14 and in one study with naturally occurring BG variations. 23 The method by which the technology of the fifth device with the same stability (OneTouch Verio Pro) reduces the influence of HCT on the meter results has not been disclosed by the manufacturer yet.…”

Section: -22mentioning

confidence: 99%

Blood Glucose Meters Employing Dynamic Electrochemistry are Stable against Hematocrit Interference in a Laboratory Setting

Pfützner

Musholt

Schipper

et al. 2013

J Diabetes Sci Technol

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Electrochemical Glucose Biosensors for Diabetes Care

Ocvirk¹,

Buck²,

DuVall³

2016

Trends in Bioelectroanalysis

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Blood glucose monitoring (BGM) is the most successful application of electrochemical biosensor technology and has motivated tremendous improvements in biology, chemistry, measurement, and fabrication methods of biosensors. The performance of electrochemical biosensors used for BGM has improved greatly over the last four decades. Technological advance has allowed to measure blood glucose (BG) over a wide range of glucose concentration, a wide temperature and hematocrit range in the presence of an abundance of interfering substances with ever-increasing accuracy, and precision in minute sample volumes. The use of optimized enzymes, mediators, and electrochemical measurement methods enables this tremendous progress in performance. Continuous glucose monitoring (CGM) systems based on minimally invasive amperometric sensors, inserted into the subcutaneous tissue, have significantly improved over initial offerings over the last 15 years with regard to time of use, accuracy, reliability, and convenience due to a multitude of parallel advances: materials needed for enzyme immobilization, polymeric cover membranes, and biocompatible coatings needed to tackle the response by the complex body interface have been developed; wireless transfer and processing of unprecedented data volume have been established; effortless and painless insertion schemes of ever smaller sensors have been realized in order to overcome the concerns of persons with diabetes (PwDs) to use a minimally invasive sensor; and scalable manufacturing technologies of miniaturized minimally invasive sensors have allowed for ever improved reproducibility and increased production volume. Looking ahead, the demands on blood glucose system performance G. Ocvirk (*) Roche Diabetes Care GmbH, Mannheim, Germany e-mail: gregor.ocvirk@roche.com H. Buck and S.H. DuVall Roche Diabetes Care, Inc., Indianapolis, IN, USA e-mail: harvey.buck@roche.com; stacy.duvall@roche.com are expected to grow even as the pressures to lower the cost of systems increase. The drive for the future is to continue to push the limits on system performance under real-life conditions while lowering cost, all while finding ways to provide the best medical value to PwDs and healthcare providers. Technical issues of commercially available CGM sensors remain to be solved which currently impede reliable hypo-and hyperglycemic alarms, safe insulin dosing recommendations, or insulin pump control at any time of use. It is realistic to assume that continuous glucose monitoring (CGM) systems will be adopted in the future by a larger population of PwDs. Yet it is also clear that BGM systems will remain a major choice of the great majority of PwDs on a global scale. This review offers a technical overview about user, system, and major regulatory requirements and available suitable sensor technology and demonstrated performance of electrochemical BGM and CGM systems from an industrial R&D perspective.

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

Cited by 15 publications

References 18 publications

Evaluation of Hematocrit Interference With MyStar Extra and Seven Competitive Devices

Evaluation of Hematocrit Interference With MyStar Extra and Seven Competitive Devices

Blood Glucose Meters Employing Dynamic Electrochemistry are Stable against Hematocrit Interference in a Laboratory Setting

Electrochemical Glucose Biosensors for Diabetes Care

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