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M Tominaga
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ABSTRACT: In Japan, the standardization of measurement of hemoglobin A1c(HbA1c) has been successfully achieved using the standard material(JDS Lot 1, lyophilized, two levels) produced and distributed by the former Shima Committee of the Japan Diabetes Society(JDS). However, methods for measurement of HbA1c other than the HPLC method, for example immunoassay, have been commonly used in the laboratory. Peptide mapping, a candidate method of analytical chemistry for determination of HbA1c, cannot be applied to a lyophilized sample. The present JDS Committee, which continues the work of the Shima Committee, recently certified a deeply-frozen material as the primary standard reference material(five levels) and named it JDS Lot 2. The Lot 2 value of HbA1c is the same as Lot 1, and is different from the National Glycohemoglobin Standardization Program(NGSP) value by -0.3%. It is likely that the standardization of measurement of HbA1c in the future in Japan will be continued using with JDS Lot 2.
Rinsho byori. The Japanese journal of clinical pathology 01/2002; 49(12):1199-204.
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M Tominaga
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ABSTRACT: As the point of care testing(POCT), devices for self-monitoring blood glucose(SMBG) are most common. The problems in SMBG can be found in the popularity of SMBG itself. The reasons for the problems are three. First is the innovation of technology. As each maker has developed devices based on their own intention, device to device difference is too large, so that the standardization is needed. The second reason is the immediate measurement which, done independently of laboratory technicians, is insufficient in the quality control. The third reason is that although the health insurance covers the cost of SMBG, medical institutions buy devices and give them to patients who have limited right to choose for themselves. It is expected that specialists in laboratory medicine should be positively concerned with the standardization, introduction, and quality control of SMBG devices.
Rinsho byori. The Japanese journal of clinical pathology 06/2001; 49(5):461-4.
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M Tominaga
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ABSTRACT: In the last three years, new diagnostic criteria for diabetes mellitus have been proposed by the American Diabetes Association (ADA, 1997), the World Health Organization (WHO) consultation (1998), and the Japan Diabetes Society (JDS, 1999). The most important change from the previous WHO criteria (1985) to these criteria is a decrease in fasting plasma glucose level (FPG) from 140 mg/dl to 126 mg/dl, which defines diabetes mellitus. These criteria attach more importance to FPG than to plasma glucose levels 2 hours after 75 g glucose load (2 hPG). According to these criteria, for example, in one instance with FPG > or = 126 mg/dl, the diagnosis of diabetes mellitus is warranted, if the postprandial plasma glucose > or = 200 mg/dl or another FPG > or = 126 mg/dl were reconfirmed on a subsequent day. The ADA criteria did not recommend an oral glucose tolerance test (OGTT) for routine clinical use. These criteria has established a new category of impaired fasting glucose (IFG) (> or = 110 mg/dl and 126 < mg/dl), similar to impaired glucose tolerance (IGT) which is recognized by performing OGTT. We have reported from a cohort study that there was only one risk factor for IGF: worsening of metabolic derangement progressing to overt diabetes. With IGT, however, there are two risks: a risk for progression to diabetes, and a risk for development of cardiovascular disease. Therefore it seems that whether or not OGTT should be performed depends on the purpose: simply diagnosing for overt diabetes, or detecting risk factors for cardiovascular disease. The JDS criteria proposed the use of HbA1C as a supporting diagnostic tool, because JDS has achieved a fruitful standardization in Japan to a considerable extent. According to the JDS criteria, a diagnosis of diabetes mellitus can be made by an FPG > or = 126 mg/dl when HbA1C > or = 6.5% is confirmed. It is expected that these new criteria will promote further efforts against the increasing number of patients with diabetes mellitus.
Rinsho byori. The Japanese journal of clinical pathology 11/1999; 47(10):901-8.
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M Tominaga
Nippon rinsho. Japanese journal of clinical medicine 01/1998; 56 Suppl 3:719-24.
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Nippon rinsho. Japanese journal of clinical medicine 01/1998; 56 Suppl 3:273-8.
