title: Analytical evaluation of the ADAMS™A1c HA 8180 thalassemia mode high-pressure liquid chromatography analyser for the measurement of HbA2and HbF.
abstract: BACKGROUND
  ADAMS™A1cHA-8180T is a HPLC system; within 3.5 min, it quantifies HbF, HbA2, and HbA0and flags abnormal peaks. We evaluate its analytical performance for routine estimation of HbA2and HbF, and critical tests were performed for identifying β-thalassemia carriers.
  
  
  METHODS
  Trueness imprecision, carry over, linearity, and effect of anemia were evaluated according to ICLH, ICLS, or manufacture's guidelines. Comparison (ADAMS™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 - HbA22.7 %, bias 0.81 %; HbA25.8 %, bias 0.38 %. HbA24.0% 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, R2= 0.998 (range: 2.8-4.8%).Method comparison - y = 0.93x + 0.22, R2= 0.997. HbF imprecision CVs between 0.66 and 1.24% and trueness between 0 and 2.8%. Linearity - y = 1.088x - 0.27, R2= 0.999 (0.1-5.7%).
  
  
  CONCLUSIONS
  ADAMS™A1c HA-8180T provides a rapid and reliable separation of HbA2. The measurement is accurate and reproducible, which is needed because of the slight difference between normal and pathological values. The gap in HbA2values between normal subjects and β-thalassemia carriers makes this an appropriate method for rapid screening for carriers.
authors.affiliation: Hematology Laboratory, Hospital Galdakao - Usansolo, Galdakao, Vizcaya, Spain.
authors.forename: E
authors.initials: E
authors.lastname: Urrechaga
mesh_terms: D016022:Case-Control Studies; D002851:Chromatography, High Pressure Liquid / Q000295:instrumentation; D005319:Fetal Hemoglobin / Q000032:analysis*; D006580:Genetic Carrier Screening; D006443:Hemoglobin A2 / Q000032:analysis*; D057166:High-Throughput Screening Assays / Q000295:instrumentation / Q000379:methods; D006801:Humans; D017086:beta-Thalassemia / Q000175:diagnosis
chemical_list: D006443:Hemoglobin A2; D005319:Fetal Hemoglobin
keywords: HbA2 analysis; high-pressure liquid chromatography; β-thalassemia screening