ARKRAY ADAMS A1c HA-8180T analyzer for diagnosis of thalassemia and hemoglobinopathies common in southeast Asia

Abstract

Objective: To evaluate the ARKRAY ADAMS A1c HA-8180T analyzer for diagnosis of thalassemias and hemoglobinopathies commonly found in the Southeast Asian population. Methods: Our cohort consisted of 557 specimens from adults referred for thalassemia diagnosis. From these, we selected 457 specimens and subjected them to DNA analysis to determine various thalassemia genotypes. Also, to confirm the reference range for HbA2, we obtained an additional 48 specimens from healthy individuals. We estimated the diagnostic range for Hb E from specimens from another 52 subject individuals previously diagnosed with heterozygous HbE. All of these individuals had negative results in DNA testing for all common a-thalassemia alleles found in Thailand. We performed hemoglobin (Hb) analysis and compared the results with those we derived from testing the CAPILLARYS 2 Flex Piercing device. We defined genotypes via by DNA analysis. Results: Performance evaluation revealed the within-and betweenrun precision for analysis of HbA2 and HbE, with coefficients of variation (CVs) ranging from 0.6% to 2.5%. We determined the reference ranges of HbA2 and HbE in the HbE heterozygote to be 2.2% to 3.4 % and 25.7% to 31.0%, respectively. We were able to identify all cases of ß-thalassemia and HbE disorders. We coeluted HbH and Hb Bart and interfered with acetylated HbF. Conclusion: The ARKRAY ADAMS A1c HA-8180T analyzer could accurately identify which individuals had ß-thalassemia and HbE disorders. However, compared with other high-performance liquid chromatography instruments in diagnosing a-thalassemia disease with HbH and Hb Bart, this analyzer is relatively difficult to use.