Vyas Pathik, O'Kane Anthony A, Dowell Dawn
AsureQuality Auckland Laboratory, 131 Boundary Rd, Blockhouse Bay, Auckland, New Zealand.
J AOAC Int. 2012 Mar-Apr;95(2):329-34. doi: 10.5740/jaoacint.cs2011_16.
At the "Standards Development and International Harmonization: AOAC INTERNATIONAL Mid-Year Meeting" on June 29, 2011, an Expert Review Panel (ERP) agreed to further examine AOAC Official Method 2011.01, "Determination of Vitamin B12 by Surface Plasmon Resonance," for use with infant formula and adult nutritionals. The original collaborative study was conducted using the Biacore Q biosensor instrument and the Biacore Q Qflex Kit Vitamin B12 PI. Samples included in the study were infant formula, cereals, premixes, vitamin tablets, dietary supplements, and baby food. Eleven laboratories participated in the collaborative study. The results demonstrated a repeatability RSD (RSDr) of 1.59-27.8 and HorRat values for reproducibility of 0.34-1.89 in samples with levels ranging from ppm to ppb. The assay studied is a label-free protein binding-based assay that uses the principle of surface plasmon resonance to measure the interaction between vitamin B12 and a specific binding protein by passing a portion of the prepared sample extract combined with binding protein solution across a functionalized sensor chip. The response from the functionalized sensor chip is given as free-binding protein, as the mixture binds to the prepared surface of the chip. The ready-to-use Qflex Kit Vitamin B12 PI provides the reagents and accessories necessary to perform this assay. AOAC Method 2011.01 was approved by the AOAC Method Committee on Food Nutrition for Official First Action status, applicable to a wide range of food products, dietary supplements, and multivitamin premixes. After evaluation of the validation data available, an ERP agreed in June 2011 that the method meets standard method performance requirements, as articulated by the Stakeholder Panel on Infant Formula and Adult Nutritionals. The ERP granted the method First Action status, applicable to infant formula and adult/pediatric nutritional formula.
在2011年6月29日举行的“标准制定与国际协调：AOAC国际年中会议”上，一个专家评审小组（ERP）同意进一步审查AOAC官方方法2011.01“通过表面等离子体共振测定维生素B12”，以用于婴儿配方奶粉和成人营养产品。最初的协作研究使用了Biacore Q生物传感器仪器和Biacore Q Qflex试剂盒维生素B12 PI。研究中包含的样品有婴儿配方奶粉、谷物、预混料、维生素片、膳食补充剂和婴儿食品。11个实验室参与了该协作研究。结果表明，在浓度范围从ppm到ppb的样品中，重复性相对标准偏差（RSDr）为1.59 - 27.8，再现性的HorRat值为0.34 - 1.89。所研究的测定方法是一种基于无标记蛋白质结合的测定方法，它利用表面等离子体共振原理，通过使一部分制备好的样品提取物与结合蛋白溶液混合后通过功能化的传感器芯片，来测量维生素B12与特定结合蛋白之间的相互作用。当混合物与芯片的制备表面结合时，功能化传感器芯片的响应以游离结合蛋白的形式给出。即用型Qflex试剂盒维生素B12 PI提供了进行该测定所需的试剂和配件。AOAC方法2011.01被AOAC食品营养方法委员会批准为官方首次采用状态，适用于广泛的食品、膳食补充剂和多种维生素预混料。在评估了现有的验证数据后，一个ERP在2011年6月同意该方法符合婴儿配方奶粉和成人营养产品利益相关者小组所阐述的标准方法性能要求。ERP授予该方法首次采用状态，适用于婴儿配方奶粉和成人/儿童营养配方奶粉。
