Multicentre evaluation of Erytra Eflexis®, a benchtop fully automated analyser with a compact design for routine use in blood transfusion laboratory

Elliott, Chris; Carrascosa, T.; Souchet, J.‐L.; Smith, Delia E.; Malaxetxebarria, I.; You, Ja Yeon; Bendahan, M.; Barnes, Stephen J.; Lisle, F.; Whitehouse, N.

doi:10.1111/tme.12619

Cited by 6 publications

(8 citation statements)

References 17 publications

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“…In addition to improvement of efficiency, documentation, traceability and archiving of results, the most prominent advantage of ABGA is recognized as the accuracy of blood group identification. Nevertheless, when blood samples containing weak antigen/antibody, UAb or subtype blood are screened, the ABGA may misjudge or fail to detect in blood group typing 9 .…”

Section: Introductionmentioning

confidence: 99%

Establishment and application of suspension static method in blood group screening of automated blood group analyzer

Huang

et al. 2023

Sci Rep

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The accuracy of blood group identification is the basis of blood transfusion safety. In order to increase the detection rate of weak agglutination, unexpected antibodies (UAb) and blood subtypes for pre-transfusion testing, the blood group screening process of automated blood group analyzer (ABGA) is ameliorated by introducing one static step and establishing a suspension static method (SSM). One static step was introduced in the blood group screening process of ABGA and three static time conditions were designed: 300 s, 400 s and 500 s, from which the optimal static time was selected and SSM was established; By comparing the detection of weak agglutination and UAb before and after the application of SSM, the feasibility and effect of suspension static method were verified and evaluated. The last two steps of the automatic blood group screening process were replaced with static, light centrifugation and imaging. The optimal static time parameter was selected as 400 s and SSM was established; After the application of SSM, it was verified that: (1) The detection level of weak antibodies (anti-A and anti-B) and weak antigens (weak D phenotype) could be improved by SSM, including antibodies in plasma of known type O samples with 0, 2, 4, 8, 16 and 32 times serial dilutions(simulating weak anti-A and weak anti-B), weak antibodies (anti-B) in plasma of one normal A-type sample and weak antigens on red blood cells (RBC) of 5 weak D phenotype samples (weak D antigen); (2) Three blood donor samples (type A, O and B) with known UAb were detected by SSM. The results showed that SSM could detect both weak antibodies (anti-A and anti-B) and UAb; (3) SSM was applied to detect the samples of 3 A2B and 3 subtype B blood donors and the blood subtypes could be clearly detected; (4) The number of screening samples was 95,314 and 106,814 before SSM (2018) and after (2020) the application of SSM and the positive rate of UAb (63/95,314 and 187/106,814) increased after SSM, discrepancy of which was statistically significant (χ2 = 48.42, P < 0.01). The above results demonstrate that SSM of ABGA is conducive to the detection of weak agglutination, UAb and blood subtypes in blood samples, which can improve the sensitivity of blood group detection and ensure the safety of clinical blood transfusion to a certain extent.

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Section: Introductionmentioning

confidence: 99%

Establishment and application of suspension static method in blood group screening of automated blood group analyzer

Huang

et al. 2023

Sci Rep

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“…Erytra Eflexis (Eflexis; Grifols, Barcelona, Spain) is an immunohematology autoanalyzer suitable for pre-transfusion routine testing in small-to-medium sized laboratories [ 1 , 2 ]. Ajou University Hospital, Suwon, Korea, was the first to introduce Eflexis analyzers in Korea in 2019.…”

Section: Introductionmentioning

confidence: 99%

“…Ajou University Hospital, Suwon, Korea, was the first to introduce Eflexis analyzers in Korea in 2019. There are several reports on the performance and reliability of Erytra or Erytra Eflexis in pre-transfusion testing [ 1 - 4 ]. However, there is a paucity of comprehensive studies evaluating failed cases of ABO grouping using Eflexis or autoanalyzers from other companies [ 5 - 9 ].…”

Section: Introductionmentioning

confidence: 99%

Investigation of Discrepant ABO Blood Grouping Results from an Autoanalyzer

2022

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Background A paucity of studies evaluating failed cases of ABO grouping using autoanalyzers exists. We investigated autoanalyzer rejected cases, including serologically suspicious ABO subgroups and discrepant ABO blood grouping results from Erytra Eflexis (Grifols, Spain), to demonstrate efficient use of autoanalyzers for ABO grouping. Methods Samples requested for ABO grouping throughout 2020 were tested using two Eflexis instruments and standard ABO RhD and reverse grouping cards. Neonatal cards were not used. When necessary, a conventional tube technique (TUBE) was used to resolve rejected/discrepant Eflexis ABO grouping results. Results The overall sample rejection rate (RR) was 3.2% (628/19,466), 1.3% of which were due to various error flags and 1.9% for discrepant results. Cases from neonates ≤1 year old accounted for 35.3% of the rejected cases based on Eflexis results. The ABO groups with the highest and lowest RR (excluding neonates) were A and O, respectively. The 628 samples resulted in 682 rejections, which were frequently associated with reverse grouping, including 28.4% against A 1 and 54.5% for B red cells. Among 14 serologically weakened A and/or B blood groups, six A 2 BW and two ABw, which had been missed by Eflexis, were detected using TUBE and our follow-up laboratory criteria. Conclusions The ABO group and a proportion of neonatal samples influenced the RR due to weak reverse grouping reactivity, especially toward B red cells. Confirmatory ABO grouping by TUBE in a new patient and/or extra rejection criteria for forward grouping are needed to detect cis -AB, which is relatively common in Korea.

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“…It has also been shown to have reliable efficacy compared with microplate and solid‐phase technologies in other automated platforms . Diagnostic Grifols' Erytra Eflexis is a newer, midsized, also gel test–based, automated instrument that has been in use throughout European Union countries since 2017 and has been demonstrated to be a suitable instrument for performing immunohematology tests . The US Food and Drug Administration (FDA) requires crossover validation of new instruments to a predicate device already on the market for a similar intended use.…”

mentioning

confidence: 99%

“…14 Diagnostic Grifols' Erytra Eflexis is a newer, midsized, also gel testbased, automated instrument that has been in use throughout European Union countries since 2017 and has been demonstrated to be a suitable instrument for performing immunohematology tests. 15 The US Food and Drug Administration (FDA) requires crossover validation of new instruments to a predicate device already on the market for a similar intended use. Clinical data are customarily required by the regulatory authority to support the manufacturer's intended use.…”

mentioning

confidence: 99%

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

Roback¹,

Denomme

Billingsley³

et al. 2019

Transfusion

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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

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Multicentre evaluation of Erytra Eflexis®, a benchtop fully automated analyser with a compact design for routine use in blood transfusion laboratory

Cited by 6 publications

References 17 publications

Establishment and application of suspension static method in blood group screening of automated blood group analyzer

Establishment and application of suspension static method in blood group screening of automated blood group analyzer

Investigation of Discrepant ABO Blood Grouping Results from an Autoanalyzer

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

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