Method validation of the Capillarys 2 Flex Piercing hemoglobin analyzer to investigate thalassemia and hemoglobinopathies
Objective: The study aimed to evaluate the accuracy of hemoglobin analysis by the Capillarys 2 Flex Piercing using capillary electrophoresis (CE) method compared with the Variant II using high pressure liquid chromatography (HPLC) for reference method.
Material and Method: A total of 344 routine EDTA blood samples were collected to diagnose thalassemia and hemoglobinopathies.
Results: Regarding normal Hb typing, carrier, thalassemia and hemoglobinopathies as the percentage of HbA2, Hb E and Hb F detected by Capillarys 2 Flex Piercing (CE) and the reference method (HPLC) did not significantly differ (p > 0.05), i.e., 337 samples agreed with the hemoglobin typing interpretation and 7 samples disagreed (6 of the Capillarys 2 Flex Piercing reported CSA2A, a suspected Hb CS trait). However, Variant II reported A2A and 1 of the Hb type = A2EA from Capillarys 2 Flex Piercing but Variant II reported A2A (A2 = 3.8%) indicating the β-thal trait. Using the coefficient of variation the within-run and between-run precision was less than 5%
Conclusion: The Capillarys 2 Flex Piercing is capable of identifying and quantifying hemoglobin species. The major advantage of the CE method is its ability to separate and quantitate HbA2, Hb E which are important parameter required to diagnose β-thal trait. Alternatively a blood transfusion could successfully detect unstable Hb as Hb CS in the heterozygous state. This instrument proved useful in providing relevant data to investigate thalassemia and hemoglobinopathies.
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