Performance evaluation of in-house magnetized red cells prepared by Regional Blood Centre II Lopburi Province, Thai Red Cross Society for ABO serum grouping using the QWALYS® 3 EVO automated analyzer

Abstract

Abstract:

Introduction:  ABO blood group testing using the QWALYS^® 3 EVO analyzer employs erythrocyte-magnetized technology (EMT) with HEMALYS A1, B cells manufactured, imported from France. However, dependency on imported products poses risks, especially during crises, including the COVID-19 pandemic, which caused delivery delays and quality issues including hemolysis. Objective: This study aimed to evaluate the performance of ready-to-use in-house magnetized A1, B and O cells for ABO serum grouping. Materials and Methods: This prospective experimental study evaluated the performance of two formulations of in-house magnetized A1, B and O cells: standard formula (diluentlys 5 mL + magnelys reagent 75 µL + standard cells 80 µL each) and EDTA-supplemented formula (diluentlys 4 mL + magnelys reagent 75 µL + standard cells 80 µL each + EDTA 1.8 g/L, 1 mL). Performance was compared with HEMALYS A1, B using 1,123 known samples and 560 routine unknown samples. Cell stability was evaluated for 35 days. Testing was performed on the QWALYS^® 3 EVO analyzer and confirmed with standard tube test (STT) for uninterpreted reactions. Results: Among 1,123 known samples, in-house magnetized cells with EDTA showed 98.04% accuracy (1,101 samples), comparable to HEMALYS A1, B cells at 98.13% (1,102 samples), with very high agreement (Kappa = 0.9462). Standard in-house magnetized cells without EDTA showed 90.29% accuracy (1,014 samples) with Kappa = 0.8412. Parallel testing with unknown samples showed 100% concordance. Both formulations demonstrated good stability for 35 days without contamination or hemolysis. Conclusion: In-house magnetized cells with EDTA demonstrated performance equivalent to imported products and can serve as a cost-effective alternative to reduce import dependency and enhance national blood service system security efficiently.