Department Transfusion Monitoring, Sanquin Research, Groningen; Department Product and Process Development, Sanquin Blood Supply, Amsterdam, the Netherlands.
Transfusion. 2013 Oct;53(10):2287-92. doi: 10.1111/trf.12099. Epub 2013 Jan 30.
Developing new quality control methods for platelet concentrates (PCs) can contribute to increasing transfusion safety and efficiency. The aim of this study was to investigate in a large field test the quality of expired PCs and whether 100% noninvasive pH monitoring can be used to predict PC quality.
The pH of 13,693 PCs produced for transfusion was monitored daily using Blood Storage, Inc.'s pH sterile, automated fluoroscopic evaluation technology. Upon indication of compromised quality or expiration, PCs were returned and in vitro tests were performed.
A total of 998 PCs were returned, of which 962 outdated, 26 had a positive BacT/ALERT reaction, seven had aggregates, one was without swirl, one had low pH, and one had high pH. BacT/ALERT was faster in identifying bacterial contamination than pH measurements. The pH at the end of the storage period was significantly lower than at the beginning. In vitro tests indicated that while the PC quality was acceptable upon expiration, it rapidly declined after expiration.
In this setting where the vast majority of PCs were of good quality and within acceptable pH limits, daily, noninvasive routine pH measurement has limited added value in identifying quality-compromised PCs.
开发新的血小板浓缩物(PC)质量控制方法有助于提高输血的安全性和效率。本研究的目的是在大规模现场试验中调查过期 PC 的质量,以及 100%非侵入性 pH 监测是否可用于预测 PC 质量。
使用 Blood Storage, Inc. 的 pH 无菌、自动化荧光评估技术,每天监测用于输血的 13693 个 PC 的 pH 值。一旦出现质量受损或过期的迹象,就会将 PC 收回并进行体外测试。
共收回 998 个 PC,其中 962 个过期,26 个 BacT/ALERT 反应阳性,7 个有聚集物,1 个无涡流,1 个 pH 值低,1 个 pH 值高。BacT/ALERT 比 pH 值测量更快地识别细菌污染。储存期末的 pH 值明显低于开始时。体外测试表明,尽管在过期时 PC 质量是可接受的,但过期后质量迅速下降。
在这种情况下,绝大多数 PC 质量良好,且 pH 值在可接受范围内,日常非侵入性常规 pH 值测量在识别质量受损的 PC 方面的附加值有限。