Pharmaceutical Services, Radix BioSolutions, Georgetown, TX, United States.
J Pharm Biomed Anal. 2010 Nov 2;53(3):729-34. doi: 10.1016/j.jpba.2010.04.022. Epub 2010 Apr 24.
Outsourcing and multi-site testing has increased for ligand binding assays supporting protein therapeutic measurement. It is common to combine and compare data across studies with data from multiple bioanalytical sites. We designed a prospective study to determine the benefits of increasing control over the transfer process to improve ruggedness. The experiment involved the testing of 30 incurred samples at 3 stages with incremental laboratory harmonization in standard/quality controls and assay components: Stage I represented a transfer of a detailed protocol and critical reagents. Stage II, a single source of standards and quality controls were provided to each site. Stage III, standards and quality controls plus a ready-to-use kit were provided. The results indicated that all testing facilities failed agreement testing using the stage I procedure. The introduction of standards from a single source improved the agreement. The modification reduced variation by 33% compared to the stage I approach. There was no additional benefit when a packaged kit was provided. In conclusion, introduction of a single source of standards and quality controls reduced the inter-site component of variation and should allow for combinability of data.
外包和多点检测已增加，以支持蛋白质治疗测量的配体结合检测。将来自多个生物分析场所的数据与多个研究中的数据相结合并进行比较是很常见的。我们设计了一项前瞻性研究，以确定增加对转移过程的控制以提高稳健性的好处。该实验涉及在 3 个阶段测试 30 个既得样本，在标准/质量控制和检测组件方面逐步实现实验室协调：第 I 阶段代表详细方案和关键试剂的转移。第 II 阶段，向每个地点提供单一来源的标准和质量控制品。第 III 阶段，提供标准和质量控制品以及即用型试剂盒。结果表明，所有测试设施均未通过使用第 I 阶段程序的一致性测试。单一来源的标准的引入提高了一致性。与第 I 阶段方法相比，该修改将变异减少了 33%。当提供包装试剂盒时，没有额外的好处。总之，引入单一来源的标准和质量控制品减少了站点间的组件变异，并且应该允许数据的组合。
