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猫浓缩红细胞单位在处理后及储存期间的体外质量控制分析。

In vitro quality control analysis after processing and during storage of feline packed red blood cells units.

作者信息

Blasi Brugué C, Ferreira Rui R F, Mesa Sanchez I, Graça Rita M C, Cardoso Inês M, de Matos Augusto J F, Ruiz de Gopegui Rafael

机构信息

Department of Animal Medicine and Surgery, Veterinary Faculty, Autonomous University of Barcelona, 08193, Barcelona, Spain.

Animal Blood Bank, 08023, Barcelona, Spain.

出版信息

BMC Vet Res. 2018 Apr 27;14(1):141. doi: 10.1186/s12917-018-1458-4.

Abstract

BACKGROUND

During the storage of packed red blood cells (pRBC), packed cell volume (PCV), bacterial contamination and percentage of haemolysis [percentage of free haemoglobin (HGB) in relation to the total HGB] are important quality parameters. Both PCV and haemolysis are indicators of the cellular integrity of stored units. There are no published experimental studies that evaluated these parameters during storage of feline pRBC using SAGM (adenine, dextrose, mannitol and sodium chloride) as the additive solution. The present study aims to (1) evaluate the quality of feline pRBCs stored in SAGM; (2) test for the semi-closed system's suitability for use and risk of bacterial contamination; (3) establish the maximum storage time that may be appropriate to meet the criteria established by the United States Food and Drug Administration (US-FDA) guidelines for human blood banking; and (4) evaluate the need to calculate the percentage of haemolysis prior to the administration of units stored for more than 4 weeks. Four hundred eighty nine feline pRBC units were analyzed. Bacterial culture, PCV and percentage of haemolysis were determined within 6 h after processing (t0). One hundred and eighty units were re-tested for haemolysis and PCV after 29-35 days of storage (t1) and 118 units after 36-42 days (t2).

RESULTS

Bacterial contamination was not detected in any pRBC unit. Mean PCV at t0 was 52.25% (SD: ±5.27) and decreased significantly (p < 0.001) during storage to 48.15% (SD: ±3.79) at t1 and to 49.34% (SD: ±4.45) at t2. Mean percentage of haemolysis at t0 was 0.07% (SD: ±0.06) and increased significantly (p < 0.001) to 0.69% (SD: ±0.40) at t1 and to 0.81% (SD: ±0.47) at t2. In addition, 13.88% and 19.49% of pRBC units exceeded 1% haemolysis at t1 and t2, respectively.

CONCLUSIONS

According to the US-FDA guidelines for human blood banking that recommend a maximum of 1% haemolysis, the results of this study show that all feline pRBC units with less than 24 h of shelf life have low levels of haemolysis. However, units preserved up to 28 days can only be administered if tested for haemolysis before use, since 13.88% units exceeded the 1% limit. The semi-closed system was considered safe for use as bacterial contamination was not detected in any pRBC unit.

摘要

背景

在浓缩红细胞(pRBC)储存期间,血细胞比容(PCV)、细菌污染和溶血百分比[游离血红蛋白(HGB)相对于总HGB的百分比]是重要的质量参数。PCV和溶血都是储存单位细胞完整性的指标。目前尚无已发表的实验研究评估使用SAGM(腺嘌呤、葡萄糖、甘露醇和氯化钠)作为添加剂溶液储存猫pRBC期间的这些参数。本研究旨在:(1)评估储存在SAGM中的猫pRBC的质量;(2)测试半封闭系统的适用性和细菌污染风险;(3)确定可能适合满足美国食品药品监督管理局(US-FDA)人类血库指南所确立标准的最长储存时间;(4)评估在输注储存超过4周的单位之前计算溶血百分比的必要性。对489个猫pRBC单位进行了分析。在处理后6小时内(t0)测定细菌培养、PCV和溶血百分比。180个单位在储存29 - 35天后(t1)重新测试溶血和PCV,118个单位在36 - 42天后(t2)重新测试。

结果

在任何pRBC单位中均未检测到细菌污染。t0时的平均PCV为52.25%(标准差:±5.27),储存期间显著下降(p < 0.001),t1时降至48.15%(标准差:±3.79),t2时降至49.34%(标准差:±4.45)。t0时的平均溶血百分比为0.07%(标准差:±0.06),显著增加(p < 0.001),t1时增至0.69%(标准差:±0.40),t2时增至0.81%(标准差:±0.47)。此外,分别有13.88%和19.49%的pRBC单位在t1和t2时溶血超过1%。

结论

根据US-FDA人类血库指南建议最大溶血率为1%,本研究结果表明,所有保质期少于24小时 的猫pRBC单位溶血水平较低。然而,保存长达28天的单位只有在使用前进行溶血测试后才能输注,因为有13.88%的单位超过了1%的限值。由于在任何pRBC单位中均未检测到细菌污染,半封闭系统被认为使用安全。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2994/5922008/4cc0e0f9e139/12917_2018_1458_Fig1_HTML.jpg

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