在质量控制实验室中使用ACL TOP™ 止血检测系统开发并实施组织型纤溶酶原激活剂（tPA）凝块溶解活性测定法。

Global Biologic Quality Control, Genentech.

Biotechnol Rep (Amst). 2017 Oct 27;16:58-64. doi: 10.1016/j.btre.2017.10.002. eCollection 2017 Dec.

This report describes the design, development, validation and long-term performance of tPA clot lysis activity assay using Advanced Chemistry Line Total Operational Performance (ACL TOP)™ Homeostasis Testing System. The results of the study demonstrated robust and stable performance of the analytical method. The accuracy of the assay, expressed by percent recovery is 98-99%. The intermediate precision and repeatability precision, expressed as Relative Standard Deviation (RSD), was 3% and less than 2% respectively. The validated range is from 70% to 130% of the target potency of 5.8 × 10 IU/mg. The linearity of this range, expressed in correlation coefficient, is 0.997. After the assay is transferred to a QC laboratory, the assay retained high accuracy and precision with a success rate of >99%.

本报告描述了使用高级化学分析总运行性能（ACL TOP）™ 稳态测试系统的组织型纤溶酶原激活剂（tPA）凝块溶解活性测定法的设计、开发、验证及长期性能。研究结果表明该分析方法性能稳健且稳定。以回收率百分比表示的测定法准确度为98 - 99%。以相对标准偏差（RSD）表示的中间精密度和重复性精密度分别为3%和小于2%。验证范围为目标效价5.8×10 IU/mg的70%至130%。该范围的线性，以相关系数表示，为0.997。该测定法转移至质量控制实验室后，仍保持高准确度和精密度，成功率>99%。