Improvement of therapeutic safety through standardized plasma calibration of blood glucose test systems at the point-of-care1/ Statement of the POCT Working Group of the German Society for Clinical Chemistry and Laboratory Medicine (DGKL)

The OneTouch Verio Reflect blood glucose monitor (BGM) has market clearance in several countries based in part on fulfilling the lay user and system accuracy criteria described in ISO15197:2015. However, the Food and Drug Administration (FDA) does not recognize the accuracy criteria in ISO15197 as a basis for gaining regulatory clearance for these devices. The current study evaluates the BGM using the accuracy guidelines issued by the agency for self-monitoring blood glucose test systems for over-the-counter use. Glucose results were accurate vs comparator over a wide glucose range and met lay user and glucose accuracy criteria at extreme glucose values as described in the FDA guidance. Clinicaltrials.gov NCT03851549

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Approved IFCC recommendation on reporting results for blood glucose: International Federation of Clinical Chemistry and Laboratory Medicine Scientific Division, Working Group on Selective Electrodes and Point-of-Care Testing (IFCC-SD-WG-SEPOCT)

Clinical Chemistry and Laboratory Medicine (CCLM) ◽

10.1515/cclm.2006.275 ◽

2006 ◽

Vol 44 (12) ◽

Cited By ~ 60

Author(s):

Paul D'Orazio ◽

Robert W. Burnett ◽

Niels Fogh-Andersen ◽

Ellis Jacobs ◽

Katsuhiko Kuwa ◽

...

Keyword(s):

Blood Glucose ◽

Working Group ◽

Clinical Chemistry ◽

Point Of Care ◽

Laboratory Medicine ◽

Constant Factor ◽

International Federation ◽

Patient Treatment ◽

Sample Type ◽

Point Of Care Testing

AbstractIn current clinical practice, plasma and blood glucose are used interchangeably with a consequent risk of clinical misinterpretation. In human blood, glucose is distributed, like water, between erythrocytes and plasma. The molality of glucose (amount of glucose per unit water mass) is the same throughout the sample, but the concentration is higher in plasma, because the concentration of water and therefore glucose is higher in plasma than in erythrocytes. Different devices for the measurement of glucose may detect and report fundamentally different quantities. Different water concentrations in the calibrator, plasma, and erythrocyte fluid can explain some of the differences. Results for glucose measurements depend on the sample type and on whether the method requires sample dilution or uses biosensors in undiluted samples. If the results are mixed up or used indiscriminately, the differences may exceed the maximum allowable error for glucose determinations for diagnosing and monitoring diabetes mellitus, thus complicating patient treatment. The goal of the International Federation of Clinical Chemistry and Laboratory Medicine, Scientific Division, Working Group on Selective Electrodes and Point of Care Testing (IFCC-SD-WG-SEPOCT) is to reach a global consensus on reporting results. The document recommends reporting the concentration of glucose in plasma (in the unit mmol/L), irrespective of sample type or measurement technique. A constant factor of 1.11 is used to convert concentration in whole blood to the equivalent concentration in plasma. The conversion will provide harmonized results, facilitating the classification and care of patients and leading to fewer therapeutic misjudgments.Clin Chem Lab Med 2006;44:1486–90.

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Flexible scope for ISO 15189 accreditation: a guidance prepared by the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) Working Group Accreditation and ISO/CEN standards (WG-A/ISO)

Clinical Chemistry and Laboratory Medicine (CCLM) ◽

10.1515/cclm-2015-0257 ◽

2015 ◽

Vol 53 (8) ◽

Cited By ~ 8

Author(s):

Marc H.M. Thelen ◽

Florent J.L.A. Vanstapel ◽

Christos Kroupis ◽

Ines Vukasovic ◽

Guilaime Boursier ◽

...

Keyword(s):

Working Group ◽

Clinical Chemistry ◽

Laboratory Medicine ◽

Position Paper ◽

European Federation ◽

Medical Field ◽

Iso 15189 ◽

Medical Laboratories ◽

Flexible Scope ◽

Scientific Disciplines

AbstractThe recent revision of ISO15189 has further strengthened its position as the standard for accreditation for medical laboratories. Both for laboratories and their customers it is important that the scope of such accreditation is clear. Therefore the European co-operation for accreditation (EA) demands that the national bodies responsible for accreditation describe the scope of every laboratory accreditation in a way that leaves no room for doubt about the range of competence of the particular laboratories. According to EA recommendations scopes may be fixed, mentioning every single test that is part of the accreditation, or flexible, mentioning all combinations of medical field, examination type and materials for which the laboratory is competent. Up to now national accreditation bodies perpetuate use of fixed scopes, partly by inertia, partly out of fear that a too flexible scope may lead to over-valuation of the competence of laboratories, most countries only use fixed scopes. The EA however promotes use of flexible scopes, since this allows for more readily innovation, which contributes to quality in laboratory medicine. In this position paper, the Working Group Accreditation and ISO/CEN Standards belonging to the Quality and Regulation Committee of the EFLM recommends using an approach that has led to successful introduction of the flexible scope for ISO15189 accreditation as intended in EA-4/17 in The Netherlands. The approach is risk-based, discipline and competence-based, and focuses on defining a uniform terminology transferable across the borders of scientific disciplines, laboratories and countries.

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Evaluation of the performance of the OneTouch Select®Plus blood glucose test system against ISO 15197:2013

Expert Review of Medical Devices ◽

10.1586/17434440.2015.1102049 ◽

2015 ◽

Vol 12 (6) ◽

pp. 771-781 ◽

Cited By ~ 2

Author(s):

Steven Setford ◽

Antony Smith ◽

David McColl ◽

Mike Grady ◽

Krisna Koria ◽

...

Keyword(s):

Blood Glucose ◽

Test System ◽

Blood Glucose Test ◽

Glucose Test

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Comparison between the QRMA Measurement with the Anamnesis and the Capillary Blood Glucose Test

Jurnal NERS ◽

10.20473/jn.v14i2.6154 ◽

2020 ◽

Vol 14 (2) ◽

pp. 224

Author(s):

Muflih Muflih ◽

Suwarsi Suwarsi ◽

Fajarina Lathu Asmarani

Keyword(s):

Blood Glucose ◽

Blood Glucose Level ◽

Blood Sugar ◽

Glucose Level ◽

Blood Sugar Level ◽

Capillary Blood ◽

Capillary Blood Glucose ◽

Blood Glucose Test ◽

Significant Difference ◽

Glucose Test

ABSTRACTIntroduction: The examination of patients with diabetes mellitus (DM) can be done by reviewing their complaints and through a capillary blood glucose level test to determine the value of their Random Blood Glucose Level. QRMA (Quantum Resonance Magnetic Analyzer) is claimed to be able to check the patient’s bodily condition (including blood glucose) with an accuracy of 85%. The purpose of this study was to verify the validity of the QRMA tool and its accuracy by comparing the results of the anamnesis and the examination conducted using the capillary blood glucose test method.Methods: The research method used was a cross-sectional design. The total sample consisted of 44 respondents in the working area of the Community Health Centers in Yogyakarta with the risk factor being blood sugar level instability. The sampling technique used was purposive sampling. The main variable in this study was the value of the blood sugar level measured based on the coefficient value of the QRMA tool and the value of Random Blood Glucose obtained through the capillary blood glucose test.Results: The blood glucose value was not correlated significantly with the coefficient value of QRMA. The value of blood glucose when examined alongside the result of the respondent's anamnesis showed there to be a significant difference. The value of the QRMA coefficient when examined against the results from the history of the respondents showed no significant difference. Linear regression showed that the variables of height, body weight, and IMT had a correlation with the QRMA coefficient value.Conclusion: The QRMA tool was not able to provide a picture of the actual condition of the blood glucose level of the respondents when compared with the results of the anamnesis and the blood glucose value from the capillary blood glucose test. Non-invasive health measurement devices such as QRMA are not used by nurses as a standard for determining the health status of DM patients.

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