Objective To establish the internal quality control standard of leukocyte-depleted suspended red blood cell volume in our center,so as to guide the preparation of components,strengthen the internal quality control and improve the quality of blood preparations.Methods A total of 1 523 bags of whole blood collected using two manufacturers'leukocyte-depleted blood bags from March to August 2023 at our center were extracted.The blood before and after filtration were weighed,and the volume of whole blood collected,the volume of filtration loss and the product volume based on the formula and measured specific gravity were calculated.According to the data distribution characteristics,the reference range of leu-kocyte-depleted suspended red blood cell volume was determined,and the differences of whole blood collection volume,fil-tration loss capacity and product capacity between the two manufacturers were analyzed.The quality control data of leuko-cyte-depleted red blood cells over the past year with the difference between another 100 bags of these cells and the reference interval were compared,and the effectiveness of reference interval was validated.Results The median whole blood collec-tion volume in the sample size was 402.0 mL,with a median filtration loss of 42.4 mL,and an average volume of leukocyte-depleted suspended red blood cells at 322.5 mL.The whole blood collection volume(A:median 404.4 mL;B:median 397.7 mL,P<0.01)and the volume of leukocyte-depleted suspended red blood cell products(A:mean 331.4 mL;B:mean 312.0 mL,P<0.01)using manufacturer A's leukocyte-depleted blood bag were both higher,with a lower filtration loss capacity(A:median 39.5 mL;B:median 46.6 mL,P<0.01).The standard deviation of the volume of leukocyte-depleted suspended red blood cell was 19.6,and the reference interval was 284.1-360.9 mL.The validation samples and quality control sampling data showed no difference from the interval samples(P>0.05).Conclusion According to the actual situation of our center,the volume standard of leukocyte-depleted suspended red blood cells in our center is determined to be 284.1-360.9 mL.

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.

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.

Objective To establish a new method for the determination of fibrinogen content in cryoprecipitated antihemophilic factor. Methods Fibrinogen (Fib) could bind with sheep anti-human fibrinogen (anti-Fib) specifically and further form antigen-antibody complex. When the Fib was present in the solution, the fluorescence of fluorescein isothiocyanate (FITC) labeled on the anti-Fib (FITC-anti-Fib) was quenched due to the formation of immune complex. The fluorescence quenching degree of FITC-anti-Fib was positively correlated with Fib concentration (cFib) in a certain concentration range. Results The linear relationship between fluorescence quenching degree [(I0-I)/I0] of FITC-anti-Fib and ln(cFib) was (I0-I)/I0=15.53ln(cFib)+ 80.79 (R2=0.99) when the cFib was in the range of (0.007 8-0.560 0) g/L. The recovery of Fib was (96.77-102.43) %. When the method was applied to determine Fib at high, medium, and low concentrations, the obtained intra-day variation coefficients were 0.31%, 0.56%, and 0.49%, respectively, and the inter-day variation coefficients were 3.81%, 3.06%, and 4.13%, respectively. There was no significant difference between the results measured by fluorescence quenching method and coagulation method (t=-0.075, P>0.05). Conclusion In this work, a new fluorescence method for the determination of Fib in cryoprecipitated antihemophilic factor was successfully established based on the specific combination of fib and FITC-anti-Fib. The method is simple and rapid. The obtained results were accurate and reliable by using this method to determine Fib.

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.