Department of Laboratory Medicine, Konkuk University School of Medicine, Seoul, Korea.
Department of Laboratory Medicine, Green Cross Laboratories, Yongin, Gyeonggi, Korea.
Vox Sang. 2019 Jul;114(5):487-494. doi: 10.1111/vox.12784. Epub 2019 May 5.
The 30-min rule has been used to maintain a core temperature (CT) of red-blood-cell (RBC) units below 10°C during transportation. We evaluated the utility of temperature-sensitive indicators (TIs) to monitor the surface temperature (ST) of RBC units and to explore whether TIs can help with compliance with the 30-min rule by extrapolating or correlating temperature change with time.
Two US FDA-approved TIs, Safe-T-Vue 10 (STV10; Temptime Corporation, Morris Plains, NJ, USA) and Timestrip Blood Temp 10 (BT10; Timestrip UK Ltd, Cambridge, UK), were attached to 50 RBC units. After issue, their colour change indicating 10°C was monitored, and temperature excursions were measured by standard reading. In additional 18 RBC units, both ST and CT were monitored simultaneously.
In 50 RBC units, 94% of STV10 and 100% of BT10 showed colour change indicating 10°C within 30 min; 4% of STV10 and 18% of BT10 showed it during transportation. The time for colour change indicating 10°C differed significantly between STV10 and BT10 (19·0 vs. 5·6 min, P < 0·001). In additional 18 RBC units, 83·3% of STV10, 100% of BT10 and 88·9% of CT reached 10°C within 30 min, and the time for colour change indicating 10°C was 24·4 min in STV10, 14·6 min in BT 10 and 24·2 min in CT (P < 0·001).
In two TIs, the time for colour change indicating 10°C varied considerably. To enhance the utility of TIs, further improvement and standardization would be needed.
在运输过程中，人们使用 30 分钟规则将红细胞（RBC）单位的核心温度（CT）保持在 10°C 以下。我们评估了温度敏感指示剂（TI）监测 RBC 单位表面温度（ST）的效用，并探讨了 TI 是否可以通过外推或关联温度变化与时间来帮助遵守 30 分钟规则。
使用两种美国食品和药物管理局（FDA）批准的 TI，Safe-T-Vue 10（STV10；Temptime Corporation，Morris Plains，NJ，USA）和 Timestrip Blood Temp 10（BT10；Timestrip UK Ltd，Cambridge，UK），将其附着于 50 个 RBC 单位上。在发出后，监测其指示 10°C 的颜色变化，并通过标准读数测量温度偏移。在另外 18 个 RBC 单位中，同时监测 ST 和 CT。
在 50 个 RBC 单位中，94%的 STV10 和 100%的 BT10 在 30 分钟内显示指示 10°C 的颜色变化；4%的 STV10 和 18%的 BT10 在运输过程中显示。STV10 和 BT10 之间指示 10°C 的颜色变化时间差异显著（19.0 分钟与 5.6 分钟，P<0.001）。在另外 18 个 RBC 单位中，83.3%的 STV10、100%的 BT10 和 88.9%的 CT 在 30 分钟内达到 10°C，指示 10°C 的颜色变化时间分别为 STV10 的 24.4 分钟、BT10 的 14.6 分钟和 CT 的 24.2 分钟（P<0.001）。
在两种 TI 中，指示 10°C 的颜色变化时间差异较大。为了提高 TI 的效用，需要进一步改进和标准化。
