High accuracy analysis of glucose in human serum by isotope dilution liquid chromatography-tandem mass spectrometry

Chen, Yizhao; Liu, Qinde; Yong, Sharon; Lee, Tong Kooi

doi:10.1016/j.cca.2012.01.025

Cited by 37 publications

(16 citation statements)

References 22 publications

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“…The commonality of these two methods is that both are traceable to certified reference material where the true glucose value has been determined by the primary NIST glucose reference measurement procedure [177,178], isotope dilution gas chromatography mass spectrometry (ID/GC/MS). Although ID/GC/MS is the gold standard for determining glucose values, it is unsuitable for the large volume of samples which are processed during product processing and performance evaluation [51].…”

Section: Reference Methodologymentioning

confidence: 99%

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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Section: Reference Methodologymentioning

confidence: 99%

Electrochemical Glucose Biosensors for Diabetes Care

Ocvirk¹,

Buck²,

DuVall³

2016

Trends in Bioelectroanalysis

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show abstract

“…As ion pairs with lower mass were more prone to potential interferences, ion pairs with higher mass were used for quantification and ion pairs with lower mass were used for confirmation. To minimize the impact of the instrument drift on the results, a stratified random injection sequence was set as previously reported [24,33].…”

Section: Gc-ms Settingsmentioning

confidence: 99%

“…Linear regression IDMS procedure was used throughout the measurements as previously described [24,33]. Two IDMS procedures were performed.…”

Section: Idms Proceduresmentioning

confidence: 99%

“…Isotope dilution mass spectrometry (IDMS) is recognized to be a primary method [16][17][18], which has been widely used to establish reference measurement procedures for organic biomarkers such as creatinine [19][20][21], glucose [22][23][24], cholesterol [25][26][27], urea [28,29], uric acid [30,31] and triglycerides [32,33]. A GC-IDMS method for free glycerol measurement was reported previously [13].…”

Section: Introductionmentioning

confidence: 99%

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Developing a reference measurement procedure for free glycerol in human serum by two-step gas chromatography–isotope dilution mass spectrometry

Chen

Teo

Liu

et al. 2015

Clinical Biochemistry

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“…The isotope dilution gas chromatography/mass spectrometry (ID GC/MS) method has been used as a primary method for the quantification of glucose in serum. [5][6][7][8][9][10][11] However, because the GC/MS method requires complex sample pretreatment such as derivatization, the isotope dilution liquid chromatography tandem mass spectrometry ( 12 The main dvantage of ID LC/MS/MS is its simple sample preparation without derivatization.…”

Section: 4mentioning

confidence: 99%

Development and Validation of Primary Method for the Determination of Glucose in Human Serum by Isotope Dilution Liquid Chromatography Tandem Mass Spectrometry and Comparison with Field Methods

Lee¹,

Lee²,

Park³

et al. 2013

Bulletin of the Korean Chemical Society

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Glucose is a common medical analyte measuring in human serum or blood samples. The development of a primary method is necessary for the establishment of traceability in measurements. We have developed an isotope dilution liquid chromatography tandem mass spectrometry as a primary method for the measurement of glucose in human serum. Glucose and glucose- 13C 6 in sample were ionized in ESI negative mode and monitored at mass transfers of m/z 179/89 and 185/92 in MRM, respectively. Glucose was separated on NH 2 P-50 2D column, and the mobile phase was 20 mM NH 4 OAc in 30% acetonitrile/70% water. Verification of this method was performed by the comparison with NIST SRMs. Our results agreed well with the SRM values. We have developed two levels of glucose serum certified reference material using this method and distributed them to the clinical laboratories in Korea as samples for proficiency testings. The expended uncertainty was about 1.2% on 95% confidence level. In proficiency testings, the results obtained from the clinical laboratories showed about 3.6% and 3.9% RSD to the certified values. Primary method can provide the traceability to the field laboratories through proficiency testings or certified reference materials.

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High accuracy analysis of glucose in human serum by isotope dilution liquid chromatography-tandem mass spectrometry

Cited by 37 publications

References 22 publications

Electrochemical Glucose Biosensors for Diabetes Care

Electrochemical Glucose Biosensors for Diabetes Care

Developing a reference measurement procedure for free glycerol in human serum by two-step gas chromatography–isotope dilution mass spectrometry

Development and Validation of Primary Method for the Determination of Glucose in Human Serum by Isotope Dilution Liquid Chromatography Tandem Mass Spectrometry and Comparison with Field Methods

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