Analytical evaluation of the ADAMS super((TM)) A1c HA 8180 thalassemia mode high-pressure liquid chromatography analyser for the measurement of HbA sub(2) and HbF

Background ADAMS super((TM)) A1cHA-8180T is a HPLC system; within 3.5 min, it quantifies HbF, HbA sub(2), and HbA sub(0) and flags abnormal peaks. We evaluate its analytical performance for routine estimation of HbA sub(2) and HbF, and critical tests were performed for identifying beta -thalassemia carriers. Methods Trueness imprecision, carry over, linearity, and effect of anemia were evaluated according to ICLH, ICLS, or manufacture's guidelines. Comparison (ADAMS super((TM)) A1c HA-8160T) was performed by running 400 samples from healthy subjects, 30 alpha and 80 beta carriers (range: 1.9-5.7 %). Results Trueness - HbA sub(2) 2.7 %, bias 0.81 %; HbA sub(2) 5.8 %, bias 0.38 %. HbA sub(2) 4.0% is not affected by Hb in the range 221-40 g/L. Carry over was negligible. Within run: normal control - CV 1.5 %, high control - CV 0.9 %.Within laboratory: normal control - total CV% 1.59%; high control - 0.92 %. Linearity - y = 1.034x - 0.17, R super(2 )= 0.99 8 (range: 2.8-4.8%).Method comparison - y = 0.93x + 0.22, R super(2) = 0.99 7. HbF imprecision CVs between 0.66 and 1.24% and trueness between 0 and 2.8%. Linearity - y = 1.088x - 0.27, R super(2) = 0.99 9 (0.1-5.7%). Conclusions ADAMS super((TM)) A1c HA-8180T provides a rapid and reliable separation of HbA sub(2). The measurement is accurate and reproducible, which is needed because of the slight difference between normal and pathological values. The gap in HbA sub(2) values between normal subjects and beta -thalassemia carriers makes this an appropriate method for rapid screening for carriers.