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
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
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DOI：
10.1258/0004563053026835
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发表时间：
2005-01-01
影响因子：
2.2
通讯作者：
Ono, J
中科院分区：
文献类型：
--
作者：
Tominaga, M;Makino, H;Ono, J
背景日本糖尿病学会(JDS)糖尿病相关实验室检测标准化委员会(JDS)先前建议使用前糖化血红蛋白标准化委员会(JDS Lot 1)准备的初级校准剂(JDS Lot 1)来标准化HbA1c(HbA1c)的测量。由于2001年3月批次1的瓶子耗尽，本委员会认证了一种新的标准物质，批次2，现在由保健技术基金会(HECTEF)分发。日本的糖化血红蛋白测量标准化方案目前以批次2为基础，从批次1中分配数值；批次1的数值是基于日本国家质量控制计划中实验室化验的共识数值。为了进行国际比较和标准化，JDS美国国家糖蛋白标准化计划(NGSP)和国际临床化学和检验医学联合会(IFCC)批准的参考实验室测定了Lot 2的HbA1c。方法在JDS委员会批准的3个实验室中，使用高分辨率高效液相色谱法K0500将JDS Lot 2的HbA1c值从分配到Lot 1的HbA1c值转移，然后，结果JDS指定的HbA1c值(批次1)为4.04，2级为5.38，3级为7.32，4级为9.88，5级为12.63，均以总血红蛋白的百分比表示。IFCC值(%)=1.068 x JDS值(%)-1.741%。结论尽管IFCC实验室获得的值明显低于JDS分配给Lot 2的值，但这种关系是线性的。此外，基于JDS第二批的HbAlc的标准化目前在日本处于令人满意的水平。因此，重新分配2号地块的价值以符合IFCC值应该是相对容易的，并将在所有相关方同意更改后进行。
Background The Committe, 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 K0500, 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 (%) = 1.068 x JDS 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 HbAlc 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.