Laboratory of Pediatric Biology and Research, American Memorial Hospital, CHU Reims, 47, rue Cognacq-Jay, 51092 Reims cedex, France.
Diabetes Metab. 2010 Apr;36(2):158-64. doi: 10.1016/j.diabet.2009.11.005. Epub 2010 Feb 23.
The prominent role of HbA(1c) in the follow-up of glycaemic balance in patients with diabetes mellitus necessitates the use of robust and reliable methods of assay. The purpose of this study was to evaluate the In2it analyzer, a new device allowing HbA(1c) evaluation within 10 min, using 10 microL of blood, in the laboratory or clinical unit, using an affinity-based method.
The analytical performance of the In2it analyzer was tested for precision, interference and linearity, and correlated with two other analyzers - the high-performance liquid chromatography (HPLC)-based Variant II analyzer in a laboratory, and the immunology-based DCA 2000 analyzer in a clinical unit - for practicability and its compliance with good laboratory practices.
HbA(1c) assay is linear from 4 to 14%, with coefficients of variations ranging from 2.4 to 3.9%. In2it correlation was satisfactory with both the HPLC Variant II (r(2)=0.974, P<0.001) and DCA 2000 (r(2)=0.794, P<0.001) analyzers although, with the latter, unpredictable differences were randomly observed. However, the method is free of interference from common haemoglobin variants, labile glycated haemoglobin and carbamylated haemoglobin, hyperbilirubinaemia (<520 micromol/L) and hypertriglyceridaemia (<6 mmol/L). The practicability of the analyzer is good. However, software specifications need to be upgraded, especially for quality-control management, traceability of results and data safety.
The In2it analyzer is suitable for HbA(1c) assay in small laboratory series and for point-of-care testing, and its analytical performance is satisfactory overall. However, several issues related to software need to be improved for optimal application. Also, special attention should be paid concerning the possibility of underestimation of results in cases of high hypertriglyceridaemia.
糖化血红蛋白（HbA1c）在糖尿病患者血糖监测中的重要作用，需要使用稳健可靠的检测方法。本研究旨在评估 In2it 分析仪，这是一种新的设备，可在 10 分钟内使用 10 μL 血液，在实验室或临床单位内，采用基于亲和力的方法评估 HbA1c。
在实验室中，使用高效液相色谱（HPLC）Variant II 分析仪和临床单位中的基于免疫的 DCA 2000 分析仪，评估 In2it 分析仪的分析性能，包括精密度、干扰和线性，以及实用性和符合良好实验室规范的情况。
HbA1c 测定在 4%至 14%范围内呈线性，变异系数为 2.4%至 3.9%。In2it 与 HPLC Variant II（r²=0.974，P<0.001）和 DCA 2000（r²=0.794，P<0.001）分析仪的相关性均令人满意，尽管与后者相比，随机观察到不可预测的差异。然而，该方法不受常见血红蛋白变异体、不稳定糖化血红蛋白和碳化血红蛋白、高胆红素血症（<520 μmol/L）和高三酰甘油血症（<6 mmol/L）的干扰。分析仪的实用性良好。然而，需要升级软件规格，特别是质量控制管理、结果溯源性和数据安全性。
In2it 分析仪适用于小实验室系列的 HbA1c 测定和床边检测，总体分析性能令人满意。然而，与软件相关的几个问题需要改进，以实现最佳应用。此外，还应特别注意高甘油三酯血症情况下结果可能被低估的可能性。
