Performance evaluation of pre-transfusion compatibility tests on automated blood grouping analyzer Vision Max
-
摘要: 目的 对Vision Max全自动血型分析仪输血前相容性检测(包括ABO和RhD血型鉴定、意外抗体筛查和交叉配血试验)进行性能评价，评价其是否满足临床应用要求。方法 收集已用BIORAD-IH1000全自动血型分析仪确定ABO和RhD血型、意外抗体筛查和交叉配血试验结果的临床样本97例和血型检测质控品DiaMed Basic QC 2例，在Vision Max全自动血型分析仪上使用配套微柱卡分别从配套试剂细胞与非配套试剂细胞(反定型和筛选细胞)比对、方法符合率、重复性、携带污染和抗干扰能力5个方面对其进行输血前相容性检测性能评价。结果 对Vision Max全自动血型分析仪输血前相容性检测性能进行评价，在配套试剂细胞与非配套试剂细胞比对中，用2个厂家反定细胞进行ABO反定型检测结果一致，仅1(1/10)例样本反定型出现1+凝集强度差异，2个厂家筛选细胞进行意外抗体筛查检测中有1(1/11)例样本出现差异，配套筛选细胞检测结果为弱阳性，非配套筛选细胞检测结果为阴性，对于该例样本应用非配套细胞厂家另一批次筛选细胞进行检测，结果为阳性；ABO和RhD血型、意外抗体筛查检测方法符合率均为100%(10/10)、交叉配血试验方法符合率为81.8%(9/11)，2(2/11)对相合样本Vision Max全自动血型分析仪次侧交叉配血结果为±；输血前相容性检测项目(包括ABO和RhD血型鉴定、意外抗体筛查和交叉配血试验)重复性均为100%，且凝集强度无明显差异；Vision Max全自动血型分析仪进行输血前相容性检测过程中未发现携带污染；抗干扰试验中黄疸和脂血对ABO和RhD血型鉴定、意外抗体筛查结果无明显影响，但溶血样本需人工判读结果。3种干扰物质中各有1对已知交叉配血试验相合的样本，这3对样本在该仪器上次侧均提示±到1+凝集。结论 在Vision Max全自动血型分析仪使用非配套试剂细胞和配套微柱卡进行ABO和RhD血型鉴定、意外抗体筛查的性能评价通过，可应用于临床检测；但该仪器应用于交叉配血试验时次侧易出现弱阳性凝集，尚需进一步优化。
-
关键词:
- Vision Max全自动血型分析仪 /
- 输血前相容性检测 /
- 性能评价
Abstract: Objective To evaluate the performance of pre-transfusion compatibility tests on automated blood grouping analyzer Vision Max, and assess whether it meets clinical application requirements.Methods The analytic performance of the system including automated blood grouping analyzer Vision Max and matching micro-column was evaluated from five aspects: comparing non-matching reagent cells with matching reagent cells, concordance rate, repeatability, carryover contamination and anti-interference ability using 97 whole blood samples and 2 DiaMed Basic QC detected by BIORAD IH-1000 automated blood grouping analyzer for ABO and RhD blood group typing, unexpected antibody screening and cross-matching.Results The detection results of 10 samples for ABO and RhD blood group typing on automated blood grouping analyzer Vision Max using non-matching reagent cells and matching reagent cells were consistent, and there was 1+ agglutination intensity difference in 1(1/10) sample. The detection results of 10(10/11) samples for unexpected antibody screening on automated analyzer Vision Max using non-matching screening cells and matching screening cells were consistent, and there was 1(1/11) sample with weakly positive result for matching screening cells, negative result for one batch of non-matching screening cells and positive result for another batch of non-matching screening cells. The concordance rates of pre-transfusion compatibility tests including ABO and RhD blood group typing, unexpected antibody screening and cross-matching on automated blood grouping analyzer Vision Max and BIORAD IH-1000 were 100%(10/10), 100%(10/10) and 81.8%(9/11), respectively. The 2(2/11) pairs of compatible cross-matching samples tested by BIORAD IH-1000 were weakly reactive in Vision Max automated minor cross-matching. The repeatability of pre-transfusion compatibility tests including ABO and RhD blood group typing, unexpected antibody screening and cross-matching on automated blood grouping analyzer Vision Max were all 100%, and there was no significant difference in agglutination intensity for the tests on Vision Max analyzer. No carryover contamination was found in pre-transfusion compatibility tests on automated analyzer Vision Max. No significant interference was found in the jaundice and lipid blood samples for ABO, RhD blood group typing and unexpected antibody screening on automated analyzer Vision Max, but manual interpretation was needed for the hemolytic samples. There was from ± to 1+ agglutination intensity difference in Vision Max automated minor cross-matching for 3(3/3) pairs of BIORAD IH-1000 compatible cross-matching samples with jaundice, lipid and hemolysis.Conclusion The automated analyzer Vision Max for ABO, RhD blood group typing and unexpected antibody screening with non-matching reagent cells and matching micro-column had good analytic performance with high precision and accuracy, anti-cross contamination ability and anti-interference capability, and exhibited good agreement with the automated BIORAD IH-1000 system, and could meet the clinical needs. The weak reaction occurred in Vision Max automated minor cross-matching, which need to be optimized further. -
-
[1] Javadzadeh Shahshahani H, Hayati A. Blood group discrepancies at a regional blood center[J]. Int J Hematol Oncol Stem Cell Res, 2020, 14(1): 38-44.
[2] Blomme S, De Maertelaere E, Verhoye E. A comparison of three column agglutination tests for red blood cell alloantibody identification[J]. BMC Res Notes, 2020, 13(1): 129. doi: 10.1186/s13104-020-04974-x
[3] Chung HJ, Hur M, Choi SG, et al. Benefits of VISION Max automated cross-matching in comparison with manual cross-matching: a multidimensional analysis[J]. PLoS One, 2019, 14(12): e0226477. doi: 10.1371/journal.pone.0226477
[4] Cheng YW, Wilkinson JM. An experience of the introduction of a blood bank automation system(Ortho AutoVue Innova)in a regional acute hospital[J]. Transfus Apher Sci, 2015, 53(1): 58-63. doi: 10.1016/j.transci.2015.03.007
[5] Lazarova E, Scott Y, van den Bos A, et al. Multicentre evaluation of the new ORTHO VISION® analyser[J]. Transfus Med, 2017, 27(Suppl 5): 354-361.
[6] 张敏, 孙浩然, 李坚, 等. AUTOVUE INNOVA全自动血型分析仪意外抗体筛查性能评价[J]. 临床血液学杂志, 2022, 35(6): 402-403, 409. https://lcxy.whuhzzs.com/article/doi/10.13201/j.issn.1004-2806.2022.06.003
-
计量
- 文章访问数: 730
- PDF下载数: 367
- 施引文献: 0
下载: