摘要
目的探析采血后12—24 h制备的原料血浆经全自动冷沉淀制备仪制备的冷沉淀质量。方法随机选取95袋于2018年1月21—25日采集规格为400 mL/袋的全血(CPDA保存液)制备的血浆作为原料血浆,以采血到血浆制备的时间分组,12—18 h为新鲜冰冻血浆组(45袋),>18—24 h为普通冰冻血浆组(50袋);原料血浆经速冻后在-20℃以下保存48 h,再经全自动冷沉淀制备仪制备成冷沉淀,检测原料血浆的FⅧ含量、冷沉淀的FⅧ和FIB含量。计量资料以均数±标准差(x±s)表示,采用单样本t检验,P<0.05为差异有统计学意义。结果对照GB18469-2012《全血及成分血质量要求》(来源于400 mL全血的冷沉淀FⅧ含量≥80 IU,FIB含量≥150 mg)和WS/T550-2017《全血和成分血质量监测指南》(冷沉淀标本FⅧ和FIB含量符合率≥75%),FⅧ含量≥0.7 IU/mL的新鲜冰冻血浆组(12—18 h)制备的冷沉淀(FⅧ:121.80 IU,P<0.01;FIB:204.33 mg,P<0.01)和普通冰冻血浆组(>18—24 h)制备的冷沉淀(FⅧ:119.17 IU,P<0.01;FIB:222.74 mg,P<0.01)符合质量控制标准且符合率均高于75%;FⅧ含量<0.7 IU/mL的新鲜冰冻血浆组(12—18 h)制备的冷沉淀FⅧ和FIB含量均值达标(FⅧ:84.81 IU,P>0.05;FIB:187.22 mg,P<0.05)但FⅧ(53%)符合率低于75%;FⅧ含量<0.7 IU/mL的普通冰冻血浆组(>18—24 h)制备的冷沉淀FⅧ(72.37 IU,P>0.05)含量均值低于标准且符合率(37%)低于75%,FIB(200.82 mg,P<0.05)含量均值达标但符合率(68%)低于75%。结论采血后12—24 h制备的原料血浆(FⅧ含量≥0.7 IU/mL)经全自动冷沉淀制备仪制备的冷沉淀质量符合GB18469-2012《全血及成分血质量要求》和WS/T550-2017《全血和成分血质量监测指南》质量控制要求和检查标准,经该制备仪制备冷沉淀的原料血浆不需仅限制于新鲜冰冻血浆。
Objective To explore the quality of cryoprecipitate prepared from raw plasma frozen within 12—24 hours after collection through a new type of cryoprecipitate preparation equipment(Auto Cryopreper). Methods 95 bags of whole blood(400 mL/bag with CPDA preservation solution) collected during January 21—25, 2018 were randomly selected to prepare raw plasma. These raw plasmas were grouped by the time from blood collection to plasma preparation. 45 bags of raw plasmas frozen within 12—18 hours after collection were classified into fresh frozen plasma(FFP) group and 50 bags of raw plasmas frozen within 24 hours but longer than 18 hours after collection were classified into ordinary frozen plasma(FP) group. The raw plasmas were preserved for 48 hours below-20℃ after frozen and then for the preparation of cryoprecipitate through Auto Cryopreper. The contents of FⅧ in raw plasma and the contents of FⅧ and FIB in cryoprecipitate were measured respectively. The measurement data were expressed as mean±standard deviation(x±s) and given the single sample T-test by the SPSS 22.0 software. The significant difference was defined as P<0.05. Results Compared to the standard in Quality Requirements for Whole Blood and Blood Components(GB18469-2012)(contents of FⅧ≥80 IU and contents of FIB≥150 mg in cryoprecipitate derived from 400 mL/bag whole blood) and Guidelines on Quality Monitoring of Whole Blood and Blood Components(WS/T550-2017)(the qualification ratio of FⅧ and FIB contents in cryoprecipitate sample≥75%),firstly, the cryoprecipitate(FⅧ:121.80 IU,P<0.01;FIB:204.33 mg, P<0.01) prepared from FFP group(12—18 h) with the contents of FⅧ≥0.7 IU/mL and the cryoprecipitate(FⅧ:119.17 IU,P<0.01;FIB:222.74 mg, P<0.01) prepared from FP group(>18—24 h) with the contents of FⅧ≥0.7 IU/mL were both higher than the standard and followed by the qualification ratio of FⅧ and FIB higher than 75%;secondly, the cryoprecipitate(FⅧ:84.81 IU,P>0.05;FIB:187.22 mg,P<0.05) prepared from FFP group(12—18 h) wit
作者
梁明月
骆宏
黄伯泉
范斌
谭爱玲
黄可君
曾四海
LIANG Mingyue;LUO Hong;HUANG Boquan;FAN Bin;TAN Ailing;HUANG Kejun;ZENG Sihai(Guangzhou Blood Center,the Key Medical Laboratory of Guangzhou,Guangzhou 510095,China)
出处
《中国输血杂志》
CAS
2020年第5期466-469,共4页
Chinese Journal of Blood Transfusion
基金
广州市医学重点学科建设项目(血液安全重点实验室)、广东省医学科学技术研究基金项目(A2017568、B2017024)。
