Nakanishi Ryosuke, Sakayori Tasuku, Matsui Daichi, Kono Mai, Maki Minase, Dunois Claire, Komiyama Yutaka, Morisaki Hiromi
Medical & Scientific Affairs, Sysmex Corporation, Kobe, 651-2271, Japan.
Global Management, Sysmex Corporation, 1-3-2 Murotani, Nishi-ku, Kobe, Hyogo, 651-2241, Japan.
Sci Rep. 2025 Mar 28;15(1):10797. doi: 10.1038/s41598-025-95389-w.
Coagulation test results are influenced by many pre-analytical variables, including clinical sample storage conditions. This study investigated the effects of storage time and temperature on coagulation factor (FII, FV, FVII, FX, FVIII, FIX, FXI, FXII, and FXIII) and natural anticoagulant (antithrombin, protein C, and free protein S) activities. Blood samples were collected from 78 healthy individuals, and 3 samples were used for each coagulation factor and natural anticoagulant. Plasma was tested after centrifugation and storage at room temperature (18 to 25 °C) or refrigerated (2 to 8 °C) for 2, 3, 4, and 5 h, or frozen (- 15 to - 25 °C) for 1, 2, 3, and 4 months. For all storage conditions, the mean percentage change from baseline in evaluated activities was < 15%, except for FV and FVIII. For FV activities after frozen storage at - 15 to - 25 °C and FVIII activities at all storage conditions, the mean percentage change was > 15%. For FV and FVIII activities, the mean percentage change was < 15% after frozen storage at - 75 to - 85 °C for 1, 2, 3, and 4 months. To ensure appropriate clinical testing results, especially for FV and FVIII activity, storage condition and time should be critically controlled.
凝血试验结果受许多分析前变量的影响，包括临床样本的储存条件。本研究调查了储存时间和温度对凝血因子（FII、FV、FVII、FX、FVIII、FIX、FXI、FXII和FXIII）以及天然抗凝剂（抗凝血酶、蛋白C和游离蛋白S）活性的影响。从78名健康个体采集血样，每个凝血因子和天然抗凝剂使用3份样本。血浆经离心后，在室温（18至25°C）或冷藏（2至8°C）条件下储存2、3、4和5小时，或在-15至-25°C冷冻1、2、3和4个月后进行检测。在所有储存条件下，除FV和FVIII外，所评估活性相对于基线的平均百分比变化<15%。在-15至-25°C冷冻储存后的FV活性以及在所有储存条件下的FVIII活性，平均百分比变化>15%。对于FV和FVIII活性，在-75至-85°C冷冻储存1、2、3和4个月后，平均百分比变化<15%。为确保获得合适的临床检测结果，尤其是对于FV和FVIII活性，应严格控制储存条件和时间。
