PRA Health Sciences, 10836 Strang Line Road, Lenexa, KS 66215, USA.
Bioanalysis. 2020 May;12(10):655-663. doi: 10.4155/bio-2020-0080. Epub 2020 Jun 3.
A major challenge for flow cytometry assays supporting clinical trials is postcollection sample stability. Here we present an approach that could mitigate the stability issue while preserving sample integrity and cellular markers, especially when enumerating rare populations such as Tregs. Stability was evaluated using whole blood stored at room temperature and lysed whole blood stored at -80°C. Freezing of lysed whole blood preserved sample integrity and prolonged sample stability for Treg percentage, absolute cell count and median fluorescent intensity values to 11 versus 3 days at room temperature storage. Frozen storage of lysed whole blood can extend sample stability, improve data quality and facilitate sample batch processing during clinical study sample analysis.
流式细胞术检测在支持临床试验方面面临的主要挑战是采集后样本的稳定性。在这里，我们提出了一种方法，在保持样本完整性和细胞标志物，特别是在计数罕见群体如 Tregs 时，能够减轻稳定性问题。通过室温下储存的全血和 -80°C 储存的裂解全血来评估稳定性。裂解全血的冷冻保存可保持样品完整性，并将 Treg 百分比、绝对细胞计数和中荧光强度值的样品稳定性延长至 11 天，而室温储存则为 3 天。裂解全血的冷冻储存可以延长样本稳定性，提高数据质量，并在临床研究样本分析中方便样本批处理。
