A-156 Performance Evaluation of the Maccura Glycosylated Hemoglobin Analyzer G 02 in for Hemoglobin H Disease Screening

Abstract

Hemoglobin H (Hb H) disease is a hereditary hemolytic anemia characterized by the severe deficiency in a-chain synthesis due to a-globin gene deletions or mutations, leading to a relative excess of ß-chains. Due to the high incidence of Hb H disease, which affects the structure, quantity, and glycation capacity of hemoglobin, accurate measurement of glycated hemoglobin (HbA1c) in patients with Hb H disease is critically important. This study aimed to evaluate the performance of the Maccura G 02 in screening for Hb H disease. HbA1c analysis was performed on 20 patients with Hb H disease using the Maccura G 02. These results were compared with Tosoh G11, Bio-Rad D-100, and Mass Spectrometry (MS). Furthermore, genetic testing was conducted to provide definitive confirmation of the patients’ diagnoses. The G 02 analyzer displayed a total of 18 alarm messages, all indicating an abnormal peak of HbA1a, with an alarm rate of 90%. Compared to current mainstream high-end analyzers, the G 02 demonstrated a higher alarm rate for identification, while the Tosoh G11 and Bio-Rad D-100 show rate of 36.4% and 77.2%, respectively. Using MS as the reference standard, the concordance rate of the G 02 was 95%. Notably, compared with the Tosoh G11 (70%) and D-100 (100%), the anti-interference qualification rates of the G 02 was comparable to or better than those of current mainstream instruments. Additionally, genetic testing was performed on all 20 patients, and the diagnostic results were -a3.7/--SEA (n=18) as well as --SEA/aCSa (n=2), validating the G 02’s performance in screening for Hb H disease. This study demonstrates the excellent performance of the Maccura G 02 in screening for Hb H disease. Its early warning capability and result reliability are comparable to or superior to those of current mainstream glycated hemoglobin analyzers (High-Performance Liquid Chromatography method). Furthermore, its robust capability in identifying Hb H disease extends the performance advantages of Maccura’s glycation product line.