Derion Toniann
Roche Molecular Systems, Inc., 4300 Hacienda Drive, Pleasanton, CA 94588, USA.
Biotechnol Annu Rev. 2003;9:249-58. doi: 10.1016/s1387-2656(03)09004-5.
The US Food and Drug Administration (FDA) requires reproducibility studies for premarket approval of in vitro diagnostic (IVD) tests. Results of reproducibility studies provide an estimate of the variability of the IVD test among study sites, reagent lots, site operators, within a single test run, and over multiple test days. In planning the study, discuss the product registration strategy, including the intended use of the product and desired label claims, and define the study team. Design the sample panel according to the limit of detection or quantitation of the test, dynamic range of the test, FDA guidelines, sample matrix, and genotype. Consider legal and ethical issues for obtaining the panel parent specimen, such as minimizing the privacy risk and keeping promises to donors. During the study, review data promptly to determine invalid runs, discover trends in the data that may require additional operator training, ensure correct completion of case report forms, and resolve queries quickly. At the end of the study, gather the study team to review and improve processes. Use the outcome to set expectations of other functional areas and to provide product feedback.
美国食品药品监督管理局（FDA）要求对体外诊断（IVD）测试进行上市前批准的再现性研究。再现性研究结果提供了IVD测试在研究地点、试剂批次、现场操作人员之间、单次测试运行期间以及多个测试日的变异性估计。在规划研究时，讨论产品注册策略，包括产品的预期用途和期望的标签声明，并确定研究团队。根据测试的检测或定量限、测试的动态范围、FDA指南、样本基质和基因型设计样本面板。考虑获取面板母体样本的法律和伦理问题，例如将隐私风险降至最低并兑现对捐赠者的承诺。在研究期间，及时审查数据以确定无效运行，发现可能需要额外操作人员培训的数据趋势，确保病例报告表正确填写，并迅速解决疑问。在研究结束时，召集研究团队审查并改进流程。利用研究结果设定其他功能领域的期望并提供产品反馈。
