目的 对比分析经过X射线辐照与Y射线辐照后悬浮红细胞相关质控指标与理化指标的变化,以评估X射线辐照对悬浮红细胞质量的影响.方法 随机留取谷氨酸氨基转移酶(ALT)检测不合格,其他检测均合格的2 U悬浮红细胞共49袋,分成两组,按照辐照源分别命名为γ组(21袋)与X组(28袋).将γ组与X组在采集后第13天进行相应的辐照处理,并将辐照后的血液置于2～6℃血液冷藏冰箱中保存,分别于辐照后第1天、第22天取样测定相应的质量指标.结果 辐照后第1天,X组与γ组的溶血率、K+浓度、Na+浓度、Cl-浓度与Ca2+浓度分别为(0.10±0.03)％vs.(0.09±0.06)％、(46.50±7.94)mmol/L vs.(45.03±4.65)mmol/L、(99.44±3.86)mmol/L vs.(100.83±4.79)mmol/L、(68.35±2.79)mmol/L vs.(67.59±1.26)mmol/L、(0.40±0.11)mmol/L vs.(0.43±0.08)mmol/L.辐照后第22天,X组与γ组的溶血率、K+浓度、Na+浓度、Cl-浓度与Ca2+浓度分别为(0.29±0.07)％vs.(0.27±0.06)％、(64.22±4.58)mmol/L vs.(63.05±3.57)mmol/L、(81.50±5.56)mmol/L vs.(81.76±3.91)mmol/L、(68.72±1.97)mmol/L vs.(68.28±1.36)mmol/L、(0.39±0.10)mmol/L vs.(0.41±0.04)mmol/L.对X组与 γ组同一保存时间的同一质量指标进行比较,两者均无显著性差异(P＞0.05).随着保存时间的延长,X组与γ组的溶血率与K+浓度均明显增大,Na+浓度均显著降低,而Cl-浓度与Ca2+浓度则无变化.结论 悬浮红细胞经X射线与γ射线辐照后的质控指标与理化指标均无明显差异,基于安全性考虑,X射线辐照仪可完全替代γ射线辐照仪用于制备辐照血液.

目的 探讨亚甲蓝光化学法病毒灭活和(或)滤除白细胞对冷沉淀凝血因子质量的影响.方法 选取陕西省血液中心2020年2月采集的400 ml全血60袋,随机分成冷沉淀组(对照组)、去白冷沉淀组、灭活冷沉淀组和去白灭活冷沉淀组,每组15袋,采用单因素方差分析比较4组凝血因子Ⅷ和F1B含量.结果 对照组、去白冷沉淀组和灭活冷沉淀组Ⅷ因子含量[(141.76±32.66)IU,(135.23±33.78)IU和(117.06±32.39)IU]均高于质量标准(≥80IU),且符合率均＞75.0％;去白灭活冷沉淀组凝血因子Ⅷ含量低于对照组[(101.09±37.47)IU比(141.76±32.66)IU],差异有统计学意义(P＜0.05),符合率(73.3％)低于 75.0％.4组 FIB 含量[(315.21±23.34)mg,(298.87±30.62)mg,(228.33±49.44)mg,(213.62±41.82)mg]均高于质量标准(≥150 mg),且符合率均＞75.0％.结论 病毒灭活或滤除白细胞制备的凝血因子Ⅷ和FIB含量均符合国家相关标准,值得在临床推广应用.

Objective To determine the volume range of suspended erythrocyte and establish its internal control standard. Methods The theoretical value of suspended erythrocyte volume was calculated according to the screening criteria of healthy blood donors and Quality Requirements for Whole Blood and Blood Components. A total of 2 410 bags of 1 U and 2 U suspended erythrocyte were randomly selected and weighed, and the volume range were formulated by x-±2S andx-±10% respectively and then compared to determine the volume range in line with the actual situation of our center. Results The theoretical volume range of 1 U and 2 U suspended erythrocyte were 117-160 mL vs 234-320 mL, and the actual volume range were 142-180 mL vs 276-393 mL. The volume range of 1 U and 2 U suspended erythrocyte formulated by x-±2S were 145-181 mL vs 298-358 mL, and by x-±10% were 147-179 mL vs 295-361 mL. The hematocrit and hemoglobin content of suspended erythrocyte within the actual volume range met the quality requirements. There were fluctuations in the volume of suspended erythrocyte from different regions. Conclusion Based on the actual situation of our center and the sampling results of suspended erythrocytes in recent two years, 163 mL±10% and 328 mL±10% were determined as the internal control standards of 1 U and 2 U suspended erythrocyte, respectively. Blood centers should establish accurate and feasible standard of suspended erythrocyte according to the actual situation.

Objective To establish a simple, economical and rapid method for the determination of methylene blue (MB) release in virus inactivation bag. Methods Based on the fluorescence energy transfer between MB and BSA-stabilized gold nanoclusters (BSA-AuNCs), the standard curve of MB determination was established by measuring the fluorescence quenching degree of MB to BSA-AuNCs in different concentrations to conduct the determination of MB release in virus inactivation bag. Results There was a good linear relationship between the MB concentration (cMB) and the fluorescence quenching degree of BSA-AuNCs[ (I0-I)/I0=0.018cMB+ 0.021(r=0.996)] when the fluorescence emission wavelength was about 620 nm and the cMB was in the range of (0.9-36) μmoL/L. The recovery of MB was 98.00% -101.95 % when applied to determine MB at high, medium, and low concentrations, the obtained intra-day variation coefficients were 0.73%, 0.81% and 0.77% respectively, and the obtained inter-day variation coefficients were 3.92%, 3.81%, and 4.73% respectively. There was no significant difference between the results measured by this method and those measured by combination of solid-phase extraction and spectrophotometry(P>0.05). Conclusion The fluorescence energy transfer method could achieve simple and rapid determination of MB release in virus inactivation bag with accurate and reliable results.

目的 建立冷沉淀凝血因子中纤维蛋白原含量测定的新方法,实现纤维蛋白原含量的简单、快速、准确测定.方法 纤维蛋白原(Fib)与羊抗人纤维蛋白原(抗-Fib)能够发生特异性的结合,进而形成抗原抗体复合物.当溶液中有Fib存在时,标记有异硫氰酸荧光素(FITC)的羊抗人纤维蛋白原(FITC-抗-Fib)因免疫复合物的形成导致FITC的荧光发生猝灭.在一定浓度范围时,FITC-抗-Fib的荧光猝灭程度与Fib浓度(cFib)呈正相关.结果 当CFib为(0.007 8～0.560 0)g/L 时,FITC-抗-Fib 的荧光猝灭程度[(I0-I)/I0]与 ln(cFib)的线性关系为(I0-I)/I0=15.531n(cFib)+80.79(R2=0.99);利用本法测定Fib,回收率为(96.77～102.43)％;利用本法分别测定高、中、低三个浓度的Fib,得到的日内变异系数分别为0.31％、0.56％与0.49％,日间变异系数分别为3.81％、3.06％与4.13％;利用荧光猝灭法测定冷沉淀凝血因子中的Fib含量,测得的结果与使用凝固法测得的结果无显著性差异(t=-0.075,P＞0.05).结论 本文利用纤维蛋白原与FITC-抗Fib的特异性结合成功建立了 1种冷沉淀凝血因子中Fib含量测定的荧光分析新方法,该方法简单、快速,测得的结果准确、可靠.

Objective To detect the anti-SARS-CoV-2 neutralizing antibody levels in convalescent plasma (CP) and to evaluate whether it has specific anti-SARS-CoV-2 S antigen effect, so as to provide laboratory data support for clinical use of CP. Methods Nine CP donors who have recovered from COVID-19 were studied, and 4 volunteers who completed the vaccination and 3 asymptomatic infected blood donors were compared. Anti-SARS-CoV-2 antibodies including total antibody, IgM and IgG were measured by chemiluminescence microparticle immunoassays (CMIA) test in three groups. The VSV pseudovirus-based neutralization assay for evaluating neutralizing antibodies against SARS-CoV-2 was carried out in all samples. Results All samples were tested positive by the total antibody and IgG CMIA in COVID-19 CP donors and recipients of inactivated COVID-19 vaccine. High titers of IgG were observed in CP donors and vaccine recipients compared with asymptomatic blood donors. All vaccine recipients and 8 of 9 CP donors tested positive by SARS-CoV-2 pseudovirus-based neutralization test, whereas all asymptomatic blood donors tested negative. Conclusion The levels and characteristics of neutralizing antibodies among COVID-19 CP donors, vaccine recipients and asymptomatic blood donors were different. When unable to implement the pseudovirus assay to measure neutralizing antibodies, the detection of total antibody can be considered instead.

目的 探讨ABO血型对人体血浆中凝血因子Ⅷ(FⅧ)活性与纤维蛋白原(Fib)含量的影响,为新鲜血浆制剂的质量控制以及相关质量标准的建立提供理论指导.方法 测定的样品包括单采新鲜血浆与手工分离新鲜血浆,FⅧ活性(FⅧ:C)与Fib含量均采用凝固法进行测定;扩增标本的ABO基因第6外显子并测序来确定基因型.结果 单采新鲜血浆中的FⅧ:C为(147.421±45.773)％,手工分离新鲜血浆中的FⅧ:C为(119.083±35.130)％(P＜0.05);而单采新鲜血浆中的Fib含量为(2.252±0.381)g/L,手工分离新鲜血浆中的Fib含量为(2.324±0.470)g/L(P＞0.05);非0型(A、B、AB型)的单采新鲜血浆与手工分离新鲜血浆中FⅧ:C分别为(167.048±40.862)％与(129.251±33.503)％,O型单采新鲜血浆与手工分离新鲜血浆中的FVⅧ:C分别为(121.386±38.632)％与(91.589±22.328)％,非0型血浆中的FⅧ:C均要显著高于0型血浆中的FⅧ:C(P＜0.05);非0型单采新鲜血浆与手工分离新鲜血浆中的Fib含量分别为(2.242±0.385)g/L与(2.329±0.472)g/L,O型单采新鲜血浆与手工分离新鲜血浆中的Fib含量分别为(2.287±0.370)g/L与(2.307±0.462)g/L,非0型血浆的Fib含量与0型血浆的Fib含量均无明显差异(P＞0.05).结论 Fib含量与ABO血型的相关性不大,但FⅧ:C与ABO血型显著相关,在与FⅧ相关血液制剂的制备及质量控制工作中,应当考虑ABO血型对FVⅧ:C的影响,建议根据ABO血型建立血浆制剂有关FⅧ的质量标准.

目的 探讨不同来源的普通血浆制剂中血浆总蛋白(TP)含量、凝血因子Ⅷ(FⅧ)活性及纤维蛋白原(Fib)含量的差异,为普通血浆制剂相关质量标准的建立及细化提供依据.方法 试验涉及的样品包括全血来源的冰冻血浆与去冷沉淀冰冻血浆以及去白细胞全血来源的冰冻血浆与去冷沉淀冰冻血浆;血浆总蛋白含量(TP含量)采用双缩脲法进行测定;FⅧ活性(FⅧ∶C)与Fib含量均采用凝固法进行测定.结果 全血来源冰冻血浆、全血来源去冷沉淀冰冻血浆、去白细胞全血来源冰冻血浆与去白细胞全血来源去冷沉淀冰冻血浆的TP含量分别为(59.64±4.78) g/L、(58.09±4.18)g/L、(52.20±3.57) g/L与(51.89±1.50) g/L,FⅧ∶C分别为(109.63±43.38)％、(27.06±7.09)％、(71.83±21.64)％与(21.66±3.86)％,Fib含量分别为(2.19±0.39) g/L、(1.30±0.24) g/L、(2.04±0.37) g/L与(1.22±0.15)g/L.两两进行比较,除去白细胞全血来源冰冻血浆与去白细胞全血来源去冷沉淀冰冻血浆的TP含量无显著性差异外,其他普通血浆制剂的TP含量均存在明显差异(P＜0.05);4种普通血浆制剂的FⅧ∶C存在明显差异(P＜0.05);去冷沉淀冰冻血浆中的Fib含量均显著低于冰冻血浆中的Fib含量(P＜0.05),其他普通血浆制剂的Fib含量则无明显差异.结论 普通血浆制剂的TP含量、FⅧ∶C与起始血液及制备过程密切相关,建议据此进一步细化普通血浆制剂的质量标准;应考虑制定去冷沉淀冰冻血浆的有关质量标准以及临床适应症.

目的 了解新冠疫情暴发期间西安市无偿献血人群SARS-CoV-2抗体流行情况,为制订新冠病毒传播防制策略提供依据.方法 收集西安市2020年1月1日～6月14日的健康献血者标本共3623份,采用化学发光法对标本进行血清抗SARS-CoV-2抗体检测.并对比西安本土新型冠状病毒肺炎确诊病例数与西安无偿献血人群SARS-CoV-2抗体月流行率趋势的相关性.结果 共检测3623名西安市无偿献血人员,发现3例SARS-CoV-2抗体阳性者,流行率为0.083％ (95％CI:0.00,0.18),最早出现新冠病毒血清阳性的献血者是在2020年2月4日.结论 西安地区无偿献血者的抗SARS-CoV-2阳性率很低,符合西安当地疾病的流行情况.提示对献血者进行血清学检测,可以作为疫情监测的一种方式.

Objective To establish a method to rapidly remove glycerol in frozen red blood cells(RBC).Methods The glycerol in frozen RBC was removed by using three-step method as following:the frozen RBC were diluted by adding salt solution with high concentration.The salt solution was removed through centrifugation.The RBC were resuspended in normal saline of corresponding volume.Three-step method could acbieve the quick removal of glycerol by controlling tbe concentration salt water and action time.The indexes of hemoglobin,free hemoglobin,glycerol residue,residual white blood cell(WBC) and hematocrit of frozen-deglycerolized RBC were compared between conventional and improved methods.Results The traditional method to remove glycerol needed 1h approximately,while the three step method only needed 15 mins approximately,greatly shortening the time and improving the efficiency.The related tests for removing glycerol RBC,except hemoglobin content was slightly lower than the "The quality requirements for whole blood and blood components (2012 edition)",the rest of them all meeted the requirements.Conclusion The three-step method has the advantages of short time and high cfficiency.However,it still needs to be further improved and optimized to make the quality of product meet the national standard.