Dupuy Anne Marie, Badiou Stéphanie, Elong-Bertard Cécile, Bargnoux Anne Sophie, Cristol Jean Paul
Clin Lab. 2014;60(3):369-76. doi: 10.7754/clin.lab.2013.130209.
As the implementation of POC analyzers in clinical department is growing and HbA1c has been included in diagnostics, it appears mandatory to evaluate the accuracy of the POC method to be used. The aim of our study is to evaluate the analytical performance and usefulness of the Afinion analyzer, and the impact of HbF, hemoglobin variants, and changes of reagent lots.
The Afinion analyzer (Axis-Shield, Oslo, Norway) is based on affinity separation methodology. Analytical performances including imprecision studies and correlation with currently used HPLC were performed on Biochemistry laboratory. We evaluated the effects of presence of variants on the results of HbA1c. Two reagent lots were evaluated on samples without variant as well as on samples with in the presence of hemoglobin variants HbA/S. The practicability of the system was also tested installing the instrument on pediatric consultation.
Imprecision studies of Afinion were acceptable. Linear regression analysis indicated good correlation between HbA1c values with Afinion (r > 0.97) in comparison with HPLC method. Overall, the Afinion overestimated the HbA1 compared to the MenariniHA8140. These differences were confirmed when the estimated average glucose was calculated. In addition, the variance of cartridge lots requires its use with caution and the problem of lot number instability must be resolved, requiring an adjustment of the calibration by the manufacturer.
The Afinion analyzer met the acceptance criteria of analytical performance, requires minimal operator interaction and presents good correlation with the laboratory method. Beyond the analytical performance, the different regression lines for different lots is a matter of concern. The reproductibility of the production of the different reagent lots for POC devices appears inadequate for its use in a clinical department.
随着即时检验分析仪在临床科室的应用日益广泛，且糖化血红蛋白（HbA1c）已被纳入诊断指标，评估所使用的即时检验方法的准确性显得至关重要。我们研究的目的是评估阿菲尼分析仪的分析性能和实用性，以及胎儿血红蛋白（HbF）、血红蛋白变异体和试剂批次变化的影响。
阿菲尼分析仪（Axis-Shield，挪威奥斯陆）基于亲和分离方法。在生物化学实验室进行了包括不精密度研究以及与当前使用的高效液相色谱法（HPLC）相关性的分析性能评估。我们评估了变异体的存在对HbA1c结果的影响。对不含变异体的样本以及存在血红蛋白变异体HbA/S的样本评估了两个试剂批次。还通过在儿科门诊安装该仪器测试了该系统的实用性。
阿菲尼分析仪的不精密度研究结果可接受。线性回归分析表明，与HPLC法相比，阿菲尼分析仪测得的HbA1c值之间具有良好的相关性（r>0.97）。总体而言，与美纳里尼HA8140相比，阿菲尼分析仪高估了HbA1。计算估计平均血糖时证实了这些差异。此外，试剂盒批次的差异需要谨慎使用，且批次号不稳定的问题必须解决，这需要制造商调整校准。
阿菲尼分析仪符合分析性能的验收标准，需要最少的操作员干预，并且与实验室方法具有良好的相关性。除分析性能外，不同批次的不同回归线是一个值得关注的问题。即时检验设备不同试剂批次生产的可重复性似乎不足以在临床科室使用。
