A-137 Performance Evaluation of the Maccura Glycosylated Hemoglobin Analyzer G 01 in Screening Hemoglobinopathies

Abstract Background Hemoglobinopathies are inherited disorders which caused by mutations in a or ß-globin genes, representing the most prevalent monogenic disorders worldwide. Since hemoglobinopathies can affect hemoglobin*s structure, amount and glycation capacity, it is crucial to identify glycated hemoglobin (HbA1c) accurately. The Maccura glycosylated hemoglobin analyzer G 01 claimed to be able to indicate most hemoglobin variants and some types of thalassemia, including HbH disease, which is a moderate form of a-thalassemia. Meanwhile, traditional HPLC platforms frequently fail to identify HbH disease due to lack of alarm information. The aim of this study was to evaluate the performance of Maccura*s G 01 in screening haemoglobinopathies. Methods A retrospective analysis was conducted on 30,061 cases that underwent glycosylated hemoglobin testing at Guilin People*s Hospital from July to December 2024, utilizing Maccura’s G 01 for analysis. The cases with instrument error, age < 2 and total peak area illegal were excluded, and the cases triggered an abnormal alarm were further confirmed using capillary electrophoresis or genetic testing. Alarm triggers included: large peak area of an unknown peak in front of A1a (suspected Hb H), elevated Hb F peak, and large peak area of an unknown peak behind A0 (suspected hemoglobin variant). Results There were 141 alarm messages indicated by G01 analyzer: 30 cases showed a large peak area in front of A1a (suspected Hb H). 41 cases had elevated Hb F peaks. 70 cases showed a large peak area behind A0 (suspected hemoglobin variant). Subsequently the results of 141 cases were confirmed using capillary electrophoresis: 30 cases were suspected Hb H (Zone 15). 12 cases component were detected in Zone 12. 56 cases component were detected in the F zone (Zone 7). 13 cases component were detected in the D zone (Zone 6). 1 case component was detected in the S zone (Zone 5). 26 cases component were detected in the E zone (Zone 4). 3 cases were normal. The overall accordance rate of the G 01 hemoglobinopathy alert system was verified to be 97.87% through capillary electrophoresis. Among 141 cases, patients in 55 cases had genetic test and were diagnosed with the following diseases: Hb H disease (n=14): -a3.7/--SEA (n=6), -a3.7/-a4.2 (n=1), aCSa/--SEA (n=5), -a3.7/aWSa (n=1), aCSa/aQSa (n=1). a-Thalassemia carrier (n=2). ß-Thalassemia (n=12). Other variants: Hb Q-Thailand (n=6), Hb J-Bangkok (n=6), Hb D-Los Angeles (n=4), Hb G-Honolulu (n=1), Hb E (n=10). The results of genetic test validated the efficacy of G 01 in screening for hemoglobinopathies. Conclusion This study validated the utility of Maccura’s G 01 in clinical application and demonstrated its performance in screening hemoglobinopathies. Its capacity to identify Hb H disease fills the critical gap in current HPLC-based detection systems.