载脂蛋白A1/B国际参考物质的靶值转移

目的 制备定值可溯源至WHO国际参考物质的载脂蛋白A1／B工作校准品。方法 采用中生北控生物科技股份有限公司生产的载脂蛋白A1／B免疫透射比浊试剂盒，在OLYMPUS AU400全自动生化分析仪上，按照美国西北脂类研究实验室(NWLRL)制定的方案，进行载脂蛋白国际参考物质靶值转移及相关性试验考核。结果 三期试验结果表明，将国际参考物质的靶值转移到中生北控公司制备的工作校准品(Lot 030310)后，载脂蛋白(apo)A1／apoB测定的准确度和精密度达到NWLRL的要求；测定NWLRL提供的40份血清样品。与NWLRL定值相比较，apoA1和apoB的相关系数分别为0．983和0．987，平均绝对偏差分别为2．7％和3．0％，达到方案规定的合格标准。结论 NWLRL已向中生北控公司颁发了WHO apoA1／apoB国际参考物质靶值转移合格证书。

Transfering the target values from the WHO-IFCC reference material for apolipoproteins A1 and B to in-house calibrator

Objective To prepare in-house calibrator of apolipoprotein A1 and apolipoprotein B with the values are traceable to the WHO-International reference materials SP1-01 and SP3-07.Methods We participated in the Northwest lipid research laboratory (NWLRL) protocol for target value transfer of WHO-IFCC apo A1 and apoB reference materials, and evaluated of comparability of the measurement.The analyses were performed on a Olympus AU 400, apo A1 and apoB were determined by immunoturbidimetric endpoint method.Results Through 3-step study, the precision and accuracy of apo A1 and apoB determination of our company met the NWLRL criteria.Correlation coefficients between obtained and assigned values of NWLRL on 40 individual serum samples were 0.983 for apo A1, 0.987 for apoB, the average absolute bias were 2.7 % for apo A1, 3.0 % for apoB, respectively.Conclusion NWLRL issued the certificate to Zhongsheng Beikong Bio-Technology and Science Inc.for the in-house apo A1 and apoB calibrator values are traceable to the WHO- International reference materials.