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Katsuhiko Kuwa

Publications and source records attributed to Katsuhiko Kuwa.

13 recordsLinked to original sources
PubMed2006

Recommendation for measuring and reporting chloride by ISEs in undiluted serum, plasma or blood.

The proposed recommendation for measuring and reporting chloride in undiluted plasma or blood by ion-selective electrodes (ISEs) will provide results that are identical to chloride concentrations measured by coulometry for standardized normal plasma or blood samples. It is applicable to all current ISEs dedicated to chloride measurement in undiluted samples that meet the requirements. However, in samples with reduced water concentration, results by coulometry are lower than by ion-selective electrode due to volume displacement. The quantity measured by this standardized ISE procedure is called the ionized chloride concentration. It may be clinically more relevant than the chloride concentration as determined by coulometry, photometry or by ISE after dilution of the sample.

Analysis of Variance↗
PubMed2006

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).

In 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.

Biosensing Techniques↗
PubMed2006

[Noninvasive blood glucose monitoring: new technology using metabolic heat conformation method].

Self-monitoring of blood glucose has become an essential aspect of management of patients with diabetes mellitus. Although several approaches for noninvasive blood glucose monitoring(NIGM) have been proposed including near infrared spectrophotometry. Body heat generated by glucose oxidation is based on the subtle balance of capillary glucose and oxygen supply to the cells. Hence, the blood glucose can be estimated by measuring the body heat and the oxygen supply. Development of the metabolic heat conformation (MHC) method consists of a sensor pickup and a calibration model. The calibration model incorporates mathematical procedures to process signals from the sensor pickup to final glucose value. The patients group was classified into clusters (calibration functions). Each subject patient was assigned to one of calibration functions. The assigned calibration function for the patient was later used for calculating the glucose values. Regression analysis involving 127 data points at random timing (109 data points from diabetic patients, 18 data points from non-diabetic patients) ranging 54mg/dl to 405mg/dl by the non-invasive method against the hexokinase photometric method for plasma as a reference method was performed. The correlation coefficient (r) was 0.91. Repeatability of the non-invasive method was measured for healthy fasting persons. The standard deviations were ranged from 5 to 6mg/dl around the concentration of 100mg/dl. These data provide preliminary evidence that the MHC method can be used to estimate blood glucose concentrations non-invasively.

Adult↗
PubMed2006

[Establishment of working reference materials in laboratory medicine].

It is recognized that the establishment of reference materials is the most important factor for standardization in laboratory medicine. In particular, working reference materials for routine measurement procedures are effective tools to maintain the commutability of measured values. Working reference materials are dealt with in a traceability chain system issued by ISO 17511 (in vitro diagnostic medical devices--measurement of quantities in biological samples--metrology traceability of values assigned to calibrators and control materials). The JCCLS is strongly promoting standardization in laboratory medicine by using working reference materials. Working groups for standardization are organized by the JCCLS in cooperation with the NMIJ (National Metrology Institute of Japan) with a grant from the NEDO (New Energy and Industrial Technology Development Organization). The objective is the establishment of working reference materials for routine use. Standardization criteria using the reference materials are being established. Research and development and investigation studies of matrix reference materials have been started. In investigation studies, the production protocol of reference materials are being prepared. After being established, reference materials will be presented to the JCTLM (Joint Committee on Traceability in Laboratory Medicine). These activities will enhance standardization in laboratory medicine. As a results, they will contribute to maintaining the reliability of measured values in routine laboratory procedures.

Clinical Laboratory Techniques↗
PubMed2005

Japanese standard reference material for JDS Lot 2 haemoglobin A1c. I: Comparison of Japan Diabetes Society-assigned values to those obtained by the Japanese and USA domestic standardization programmes and by the International Federation of Clinical Chemistry reference laboratories.

BACKGROUND: The Committee on Standardization of Laboratory Testing Related to Diabetes Mellitus of the Japan Diabetes Society (JDS) previously recommended use of the primary calibrator (JDS Lot 1) prepared by the former Committee for Standardization of Glycohemoglobin for standardizing the measurement of haemoglobin A1c (HbA1c). Owing to the depletion of vials of Lot 1 in March 2001, the present committee certified a new reference material, Lot 2, now distributed by the Health Care Technology Foundation (HECTEF). The standardization programme for HbA1c measurement in Japan is currently based on Lot 2, which has values assigned from within Lot 1; the Lot 1 values were consensus values based on assays by laboratories in the Japanese national quality control programme. In this study, for the purpose of international comparison and standardization, Lot 2 was assayed by the JDS reference laboratories, the National Glycoprotein Standardization Program (NGSP) in the USA, and by reference laboratories approved by the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC). METHOD: The HbA1c values of JDS Lot 2 were transferred from those assigned to Lot 1 using KO500, a high-resolution HPLC method, at three laboratories approved by the JDS committee. Subsequently, vials of JDS Lot 2 were shipped to and assayed by the NGSP in the USA and 10 IFCC reference laboratories. RESULT: The JDS-assigned HbA1c values (from Lot 1) are 4.04 for Level 1, 5.38 for Level 2, 7.32 for Level 3, 9.88 for Level 4, and 12.63 for Level 5, all expressed as a percentage of total haemoglobin. The values obtained by NGSP and the IFCC laboratories gave the following formulas: NGSP value(%)=JDS value(%)+0.3%; IFCC value(%)=1.068xJDS value(%)-1.741%. CONCLUSION: Although the values obtained by the IFCC laboratories are significantly lower than the values assigned to Lot 2 by the JDS, the relationship is linear. In addition, standardization of HbA1c based on JDS Lot 2 is currently at a satisfactory level in Japan. As a result, the reassignment of values for Lot 2 to agree with the IFCC values should be relatively easy and will be done after all relevant parties agree to the change.

Blood Chemical Analysis↗
PubMed2005

Japanese standard reference material JDS Lot 2 for haemoglobin A1c. II: Present state of standardization of haemoglobin A1c in Japan using the new reference material in routine clinical assays.

BACKGROUND: In 2001, the Committee on Standardization of Laboratory Testing Related to Diabetes Mellitus of the Japan Diabetes Society (JDS) prepared and certified a new reference material for haemoglobin A1c (HbA1c), Lot 2. The standardization programme for HbA1c measurement in Japan is currently based on Lot 2, although some laboratories still use the previous material (Lot 1). The values assigned to Lot 2 were based on the consensus values for Lot 1 and should give the same results. Therefore, there should be no difference in the measured values no matter which calibrators are used. The Committee conducted a domestic survey in order to confirm this relationship. METHOD: In November 2002, four samples for HbA1c assay were sent to 795 laboratories as part of a national survey in Japan. Assays were performed using the laboratories' routine clinical methods. The coefficients of variation (CVs) of the reported values from all laboratories for the samples were calculated in order to determine the current level of standardization in Japan. RESULTS: The overall CVs in the measured values for the four samples ranged from 2.7% to 4.0%. Values from laboratories using calibrators based on Lots 1 and 2 were similar. CONCLUSION: The present state of standardization for the routine measurement of HbA1c in Japan, as indicated by the 2002 survey, is excellent. This should aid in the eventual conversion of Lot 2 to IFCC-based values from the results of the 2002 national HbA1c survey.

Blood Chemical Analysis↗
PubMed2005

Approved IFCC recommendation on reporting results for blood glucose (abbreviated).

In current clinical practice, plasma and blood glucose are used interchangeably with a consequent risk of clinical misinterpretation. In human blood, glucose, like water, is distributed between erythrocytes and plasma. The molality of glucose (amount of glucose per unit of 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 calibrators, plasma, and erythrocyte fluid can explain some of the differences. Results of glucose measurements depend on sample type and on whether methods require sample dilution or use biosensors in undiluted samples. If the results are mixed up or used indiscriminately, the differences may exceed the maximum allowable error of glucose determinations for diagnosing and monitoring diabetes mellitus, and complicate the treatment. The goal of the IFCC 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 (with 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 the pertinent plasma. The conversion will provide harmonized results, facilitating the classification and care of patients and leading to fewer therapeutic misjudgments.

Blood Chemical Analysis↗
PubMed2005

Guidelines for sampling, measuring and reporting ionized magnesium in undiluted serum, plasma or blood: International Federation of Clinical Chemistry and Laboratory Medicine (IFCC): IFCC Scientific Division, Committee on Point of Care Testing.

All analyzers with ion-selective electrodes for ionized magnesium (iMg) should yield comparable and unbiased results. The prerequisite to achieve this goal is to reach consensus on sampling, measurement and reporting. The recommended guidelines for sampling, measurement and reporting iMg in plasma ("plasma" refers to circulating plasma and the forms in which it is sampled: the plasma phase of anticoagulated whole blood, plasma separated from blood cells, or serum) or blood, referring to the substance concentration of iMg in the calibrants, will provide results for iMg that are approximately 3% greater than its true concentration, and 4% less than its true molality. Binding of magnesium to proteins and ligands in plasma and blood is pH-dependent. Therefore, pH should be simultaneously measured to allow adjustment of iMg concentration to pH 7.4. The substance concentration of iMg may be physiologically and consequently clinically more relevant than the substance concentration of total magnesium.

Blood Chemical Analysis↗
PubMed2005

[Procedure for accurate evaluation of laboratory data and its international trends].

From the work at ISO/TC212 (Clinical laboratory testing and in vitro diagnostic test systems), the international standards on medical laboratories--particular requirements for quality and competence and reference materials were issued. The accreditation of clinical laboratory was started using ISO 15189. Furthermore, on setting and usage of reference materials were constituted with compatibility global harmonization by newly organizing JCTLM (Joint Committee on Traceability in Laboratory Medicine). As the results, the work of the standardization based on reliability such as validation of reagent's kits and the measured values and uncertainty evaluation would be internationally advanced.

Accreditation↗
PubMed2004

Noninvasive measurement of glucose by metabolic heat conformation method.

BACKGROUND: We developed a method, called the metabolic heat conformation (MHC) method, for the noninvasive measurement of blood glucose. The MHC method involves the measurement of physiologic indices related to metabolic heat generation and local oxygen supply, which correspond to the glucose concentration in the local blood supply. METHODS: We used noninvasive thermal and optical sensors on the fingertip of an individual to measure thermal generation, blood flow rate, hemoglobin (Hb) concentration, and oxyhemoglobin concentration. The calibration model incorporates mathematical procedures to convert signals from the sensor pickup to final glucose concentrations. The mathematical procedures are multivariate statistical analyses, involving values from sensor signals, polynomials from various values, regression analyses of individual patients, and cluster analyses of patient groups. The glucose value is calculated for each patient measurement, applying one of the clusters by discriminant analysis. RESULTS: Regression analysis was performed to compare the noninvasive method with the hexokinase method, using 127 data points (109 data points from diabetic patients, 18 data points from nondiabetic patients) with glucose concentrations ranging from 3.0 to 22.5 mmol/L (54-405 mg/dL). The correlation coefficient (r) was 0.91. Reproducibility was measured for healthy fasting persons; the CV was 6% at 5.56 mmol/L (100 mg/dL). CONCLUSIONS: These data provide preliminary evidence that the MHC method can be used to estimate blood glucose concentrations noninvasively.

Blood Glucose↗
PubMed2003

[Laboratory accreditation and proficiency testing].

ISO/TC 212 covering clinical laboratory testing and in vitro diagnostic test systems will issue the international standard for medical laboratory quality and competence requirements, ISO 15189. This standard is based on the ISO/IEC 17025, general requirements for competence of testing and calibration laboratories and ISO 9001, quality management systems-requirements. Clinical laboratory services are essential to patient care and therefore should be available to meet the needs of all patients and clinical personnel responsible for human health care. If a laboratory seeks accreditation, it should select an accreditation body that operates according to this international standard and in a manner which takes into account the particular requirements of clinical laboratories. Proficiency testing should be available to evaluate the calibration laboratories and reference measurement laboratories in clinical medicine. Reference measurement procedures should be of precise and the analytical principle of measurement applied should ensure reliability. We should be prepared to establish a quality management system and proficiency testing in clinical laboratories.

Accreditation↗