Roback John D, Barclay Sheilagh, Moulds JoAnn M, Denomme Gregory A
Department of Pathology and Laboratory Medicine, Emory University Hospital, Atlanta, Georgia.
LifeShare Blood Centers, Shreveport, Louisiana.
Transfusion. 2015 Jun;55(6 Pt 2):1522-8. doi: 10.1111/trf.13053. Epub 2015 Mar 9.
Moving to automation is a major focus of transfusion centers. Erytra (Grifols) is a walk-away analyzer with high-performance and -throughput capacity for pretransfusion testing. Efficiency and performance of Erytra with its cards and reagents were evaluated in comparison to Food and Drug Administration (FDA)-approved reference methods.
A total of 5279 blood samples (46% patients; 54% donors) were obtained from US blood establishment facilities. Samples were analyzed with Erytra and results were compared with the routine FDA-licensed automated platforms used by the clinical study sites. A total of 25,217 tests were performed (15,322 ABO/D/reverse typing; 4916 Rh phenotypes, 669 K typing, 838 antibody screens, 759 antibody identifications, 250 cross-matches, 244 ABO compatibilities by immediate-spin cross-match, and 219 direct antiglobulin tests [DATs]).
Global agreement between Erytra and the comparison platforms was 99.66%, with 99.82% positive percent agreement (95% lower confidence bound [LCB], 99.75%) and 99.50% negative percent agreement (95% LCB, 99.37%). There were 85 discrepancies (0.34%), including cross-matches (n = 13), antibody screens (n = 10), antibody identifications (n = 21), and DATs (n = 5), whereas an excellent concordance was obtained in blood grouping determinations (ABO/D/C/E/c/e/K, 0.04%-0.22% discrepancies). Analysis of the discrepancies showed that Erytra provided the correct result in 51 of them (60%), with only five false negatives (one O patient transplanted with A, one mixed-field reaction in a very weak D, one anti-Vel, two A2rr). Erytra results were 100% reproducible in a series of 3760 repetition tests.
Grifols' Erytra analyzer showed reliable efficacy compared with equivalent FDA-licensed reagents and FDA-cleared instruments.
向自动化转型是输血中心的主要关注点。Erytra（杰特贝林公司）是一款用于输血前检测的高性能、高吞吐量的自动分析仪。将Erytra及其配套的卡片和试剂的效率及性能与美国食品药品监督管理局（FDA）批准的参考方法进行了比较评估。
从美国血液采集机构共获取了5279份血液样本（46%为患者样本；54%为献血者样本）。使用Erytra对样本进行分析，并将结果与临床研究地点使用的常规FDA许可的自动化平台的结果进行比较。总共进行了25217次检测（15322次ABO/D/反向血型鉴定；4916次Rh血型分型，669次K血型鉴定，838次抗体筛查，759次抗体鉴定，250次交叉配血，244次通过立即离心交叉配血进行的ABO相容性检测，以及219次直接抗球蛋白试验[DAT]）。
Erytra与对比平台之间的总体一致性为99.66%，阳性百分比一致性为99.82%（95%下限置信区间[LCB]，99.75%），阴性百分比一致性为99.50%（95% LCB，99.37%）。存在85处差异（0.34%），包括交叉配血（n = 13）、抗体筛查（n = 10）、抗体鉴定（n = 21）和DAT（n = 5），而在血型鉴定（ABO/D/C/E/c/e/K）中一致性极佳（差异为0.04% - 0.22%）。对差异的分析表明，其中51处（60%）Erytra给出了正确结果，仅有5例假阴性（1例O型患者接受A型输血，1例极弱D型中的混合视野反应，1例抗-Vel，2例A2rr）。在一系列3760次重复检测中，Erytra的结果100%可重复。
与同等FDA许可的试剂和FDA批准的仪器相比，杰特贝林公司的Erytra分析仪显示出可靠的效能。
