title: Evaluation of the V8 E-Class, a Novel Automated Capillary Isoelectric Focusing Instrument for Hemoglobinopathy Screening.
abstract: OBJECTIVE
  We evaluated the performance of a novel capillary isoelectric focusing (CIEF) application for hemoglobinopathy screening on the recently introduced V8 E-Class platform.
  
  
  METHODS
  Analytical performance of the V8 E-Class was evaluated and included assessment of hemoglobin A2 (HbA2) imprecision; linearity for HbA2, fetal hemoglobin (HbF), and sickle hemoglobin (HbS); and carryover for HbS. Furthermore, a method comparison with the Minicap Flex Piercing (Sebia, Lisses, France), the Variant Classic (Bio-Rad Laboratories, Hercules, CA), and the G8 (Tosoh Europe, Amsterdam, the Netherlands) was done to assess analytical and clinical concordance.
  
  
  RESULTS
  Total HbA2 imprecision was 3.26% and 3.14% for normal and elevated HbA2 controls and 5.16% and 3.58% for a normal and a heterozygous HbS patient sample, respectively. HbA2, HbF, and HbS showed acceptable linearity, and no carryover was observed. The method comparison showed good analytical concordance (r > 0.95) except for a homozygous HbS subset (r = 0.532-0.704). A comparable phenomenon was seen for the clinical concordance with good agreement in samples without variants (weighted κ > 0.80) but poorer agreement in HbS samples (κ < 0.30).
  
  
  CONCLUSIONS
  Good analytical performance was demonstrated for this novel CIEF application for hemoglobinopathy screening. Method comparison showed generally good correlation but highlights the need for standardization. Finally, software optimization could further add to its use for routine hemoglobinopathy screening.
authors.affiliation: From the Laboratory Medicine, University Hospitals Leuven, Leuven, Belgium toon.schiemsky@uzleuven.be.
authors.forename: Toon
authors.initials: T
authors.lastname: Schiemsky
authors.affiliation: From the Laboratory Medicine, University Hospitals Leuven, Leuven, Belgium.
authors.forename: Caroline
authors.initials: C
authors.lastname: Brusselmans
authors.affiliation: From the Laboratory Medicine, University Hospitals Leuven, Leuven, Belgium.
authors.forename: Elke
authors.initials: E
authors.lastname: Nackers
authors.affiliation: From the Laboratory Medicine, University Hospitals Leuven, Leuven, Belgium Department of Cardiovascular Medicine.
authors.forename: Pieter
authors.initials: P
authors.lastname: Vermeersch
authors.affiliation: From the Laboratory Medicine, University Hospitals Leuven, Leuven, Belgium Department of Neurosciences, Laboratory for Molecular Neurobiomarker Research.
authors.forename: Koen
authors.initials: K
authors.lastname: Poesen
authors.affiliation: From the Laboratory Medicine, University Hospitals Leuven, Leuven, Belgium.
authors.forename: Koen J O
authors.initials: KJ
authors.lastname: Desmet
authors.affiliation: From the Laboratory Medicine, University Hospitals Leuven, Leuven, Belgium Department of Oncology.
authors.forename: Nancy
authors.initials: N
authors.lastname: Boeckx
authors.affiliation: From the Laboratory Medicine, University Hospitals Leuven, Leuven, Belgium Department of Microbiology and Immunology, KU Leuven-University of Leuven, Leuven, Belgium.
authors.forename: Davy M J
authors.initials: DM
authors.lastname: Kieffer
mesh_terms: D019075:Electrophoresis, Capillary / Q000295:instrumentation / Q000379:methods; D005319:Fetal Hemoglobin / Q000032:analysis*; D006443:Hemoglobin A2 / Q000032:analysis*; D006451:Hemoglobin, Sickle / Q000032:analysis*; D006453:Hemoglobinopathies / Q000175:diagnosis*; D006801:Humans; D007525:Isoelectric Focusing / Q000295:instrumentation / Q000379:methods; D015203:Reproducibility of Results
chemical_list: D006451:Hemoglobin, Sickle; D006443:Hemoglobin A2; D005319:Fetal Hemoglobin
keywords: Capillary isoelectric focusing; Capillary zone electrophoresis; Cation-exchange HPLC; Helena Biosciences V8 E-Class; Hemoglobinopathy screening