Performance and reliability of a benchtop automated instrument for transfusion testing: a comparative multicenter clinical study in the US population

Abstract

BACKGROUND: Heavy workload in hospital transfusion services and blood centers necessitates the implementation of automated platforms. We evaluated the performance of Erytra Eflexis (Diagnostic Grifols), a recently developed midsize automated instrument for pretransfusion testing, in comparison with a US Food and Drug Administration (FDA)-cleared device (Erytra). Reproducibility and repeatability of the results were also investigated.STUDY DESIGN AND METHODS: Studies were conducted using the same card technology and reagents at three US sites. Tests were performed on 9174 specimens from hospital patients (55.61%) and blood donors (43.39%). Evaluations included 18,413 ABO/D/ reverse typing; 9084 Rh phenotypes, 4640 K phenotypes, 2052 antibody screenings, 1232 antibody identifications, 469 direct antiglobulin tests, 612 IgG crossmatches, and 700 ABO-compatibility crossmatches. A reference blood panel was also sent to each center, for a total of 3900 replicate tests. Concordance between results with the two instruments and performance among the different centers were statistically evaluated.RESULTS: Agreement between instruments was 99.84% for 37,202 test results, with 61 discrepancies (0.16%). Percentages of positive and negative agreement were 99.82% and 99.85%, respectively. No discrepancies were observed in 12,276 tests for direct ABO/D grouping. Discrepancies were observed during antibody identification (n = 19), antibody screening (n = 15), and reverse grouping (n = 10). Investigations of the discrepancies were resolved in favor of the study instrument in 55.73% of the cases. Erytra Eflexis obtained the expected results in the reproducibility analysis.CONCLUSION: This multicenter study demonstrates that Erytra Eflexis with its gel card technology and reagents is reliable and substantially equivalent to the FDA-cleared instrument used as the reference. ABBREVIATIONS: DAT = direct antiglobulin test; FDA = US Food and Drug Administration; LBC = LifeShare Blood Center; LCB = lower confidence bounds (95%); NP = negative result obtained by the method under test but positive by the Predicate; NPA = negative percent agreement; OPA = overall percent agreement; PN = positive result obtained by the method under test but negative by the Predicate; PPA = positive percent agreement; TRI = TriCore Research Institute. From the

Multicenter evaluation of a high‐throughput microarray platform for extensive red blood cell phenotyping and antibody screening

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Comparison of Column Agglutination Technique and Tube Test for ABO Antibody Titration and Crossmatching

“…아주대병 원은 2020년 1월 말에 이 장비를 도입하여 국내 대 학병원으로서는 처음으로 사용하고 있다 [1]. 이 장 비는 혈액형 검사, 비예기항체 선별 및 동정검사 및 교차시험용으로 통상적으로 이용되고 있다 [2,3].…”

Design and Development of an Electronic Controller for Accurate Temperature Management for Storage of Biological and Chemical Samples in Healthcare

“…Other facilities such as blood banks, transfusion centers, and biobanks cannot operate without carefully setting and executing policies for the large-scale storage of the accumulated blood and cell samples [10][11][12]. From a technical viewpoint, this needs specialized devices that are capable of achieving and maintaining a desired temperature level with a very high degree of accuracy, reliability, and traceability [13,14]. As a rule, medical care facilities set appropriate policies and standards for the operation of these devices within the framework imposed by government regulatory agencies, but they do not have the necessary technical expertise to design and develop the devices themselves [15][16][17].…”