Valeri C Robert, Ragno Gina, Van Houten Paul, Rose Leslie, Rose Michael, Egozy Yair, Popovsky Mark A
Naval Blood Research Laboratory, Boston, Massachusetts 02118, USA.
Transfusion. 2005 Oct;45(10):1621-7. doi: 10.1111/j.1537-2995.2005.00588.x.
The FDA has approved a closed-system red blood cell (RBC) glycerolization procedure with the ACP 215 (Haemonetics), which requires a centrifuge to prepare RBCs before and after glycerolization. In the study reported here, the Haemonetics high-separation bowl was evaluated in an attempt to automate these two concentration steps.
Ten units of nonleukoreduced citrate phosphate dextrose (CPD)-anticoagulated whole blood were stored at 4 degrees C for 2 to 6 days before glycerolization and freezing as nonrejuvenated RBCs. Twenty-five units of nonleukoreduced CPD whole blood were stored at 4 degrees C for 2 to 8 days and then biochemically treated with a solution containing pyruvate, inosine, phosphate, and adenine (PIPA) before glycerolization and freezing as indated-rejuvenated RBC. Twenty units of leukoreduced CPD and AS-1 RBCs were stored at 4 degrees C for a mean of 48 days and treated with PIPA solution before glycerolization and freezing as outdated-rejuvenated RBCs. The glycerolized RBCs were frozen for at least 2 weeks at -80 degrees C, deglycerolized in the Haemonetics ACP 215 with the 325-mL bowl, and stored in AS-3 at 4 degrees C for 21 days.
It took approximately 50 minutes to glycerolize the nonrejuvenated and rejuvenated RBCs. After freezing, deglycerolization, and postwash storage at 4 degrees C in AS-3 for 2 weeks, the quality was similar to that of RBCs processed by the current FDA-approved method.
Processing time and need for technical expertise were significantly reduced with the completely automated functionally closed glycerolization procedure with the high-separation bowl in the Haemonetics ACP 215 instrument.
美国食品药品监督管理局(FDA)已批准使用ACP 215(Haemonetics公司生产)进行封闭系统红细胞甘油化程序,该程序在甘油化前后都需要离心机来制备红细胞。在本报告的研究中,对Haemonetics高分离碗进行了评估,试图实现这两个浓缩步骤的自动化。
十单位未去除白细胞的枸橼酸盐磷酸盐葡萄糖(CPD)抗凝全血在甘油化和冷冻为非复壮红细胞之前,于4℃储存2至6天。二十五单位未去除白细胞的CPD全血在4℃储存2至8天,然后在甘油化和冷冻为有效期复壮红细胞之前,用含有丙酮酸、肌苷、磷酸盐和腺嘌呤(PIPA)的溶液进行生化处理。二十单位去除白细胞的CPD和AS-1红细胞在4℃平均储存48天,并在甘油化和冷冻为过期复壮红细胞之前用PIPA溶液处理。甘油化红细胞在-80℃冷冻至少2周,在Haemonetics ACP 215中使用325毫升碗进行去甘油化,并在4℃的AS-3中储存21天。
甘油化非复壮和复壮红细胞大约需要50分钟。在冷冻、去甘油化并在4℃的AS-3中洗涤后储存2周后,其质量与目前FDA批准方法处理的红细胞相似。
使用Haemonetics ACP 215仪器中的高分离碗进行完全自动化的功能封闭甘油化程序,显著减少了处理时间和对技术专长的需求。