title: Performance evaluation of the Helena V8 capillary electrophoresis system.
abstract: OBJECTIVE
  To compare the performance characteristics of the Helena V8® and Sebia CAPILLARYS2® automated capillary electrophoresis systems to agarose gel serum protein electrophoresis (SPE) and immunofixation electrophoresis (IFE) using the Helena SPIFE3000®.
  
  
  METHODS
  Serum protein electrophoresis and immunosubtraction was performed on 100 consecutive patient samples comparing two capillary-electrophoresis platforms with agarose-gel SPE and IFE; IFE was used as the gold standard. Chart review was performed on patients where results were discordant between methods. Analytical precision was determined using Sebia's normal and abnormal controls.
  
  
  RESULTS
  The sensitivities of the CAPILLARYS2, V8, and SPIFE3000 agarose gel for identification of monoclonal gammopathies were respectively 97.4 (95%CI 91.1-100), 92.3 (95%CI 82.2-100), and 89.9 (95%CI 79.1-97.6). The specificities of the CAPILLARYS2, V8, and SPIFE3000 agarose gel were respectively 57.6 (95%CI 45.0-70.2), 72.2 (95%CI 61.0-83.3), and 75.4 (95%CI 60-82.8). These analytical performance characteristics were statistically equivalent between systems (P>0.05). The analytical precision of the capillary-based methods was also statistically equivalent. Chart review of available data from discordant samples revealed that 7/10 patients had a history of multiple myeloma or known monoclonal gammopathy and were being treated or monitored. All discordant samples had low concentration monoclonal proteins (<0.3g/dL). Both capillary-based methods performed poorly (collectively <50% accuracy) at detecting low concentration non-IgG antibodies (IgA, IgM, and light chain monoclonal gammopathies) compared to IFE.
  
  
  CONCLUSIONS
  The Helena V8 and Sebia CAPILLARYS2 were analytically equivalent to the SIFE3000 for identification of IgG monoclonal gammopathies >0.3g/dL. Interpreters using the automated immunotyping/immunosubstraction systems performed poorly at detecting low concentration and non-IgG monoclonal gammopathies.
authors.affiliation: University of North Carolina School of Medicine, Department of Pathology and Laboratory Medicine, Chapel Hill, NC, USA.
authors.forename: Jessica
authors.initials: J
authors.lastname: Poisson
authors.forename: Yuri
authors.initials: Y
authors.lastname: Fedoriw
authors.forename: Matthew P A
authors.initials: MP
authors.lastname: Henderson
authors.forename: Shirley
authors.initials: S
authors.lastname: Hainsworth
authors.forename: Kenneth
authors.initials: K
authors.lastname: Tucker
authors.forename: Zia
authors.initials: Z
authors.lastname: Uddin
authors.forename: Christopher R
authors.initials: CR
authors.lastname: McCudden
mesh_terms: D004587:Electrophoresis, Agar Gel / Q000379:methods; D019075:Electrophoresis, Capillary / Q000295:instrumentation / Q000379:methods*; D006801:Humans; D007122:Immunoelectrophoresis / Q000379:methods; D007136:Immunoglobulins / Q000097:blood*; D057230:Limit of Detection; D009101:Multiple Myeloma / Q000097:blood / Q000150:complications / Q000175:diagnosis*; D010265:Paraproteinemias / Q000097:blood / Q000150:complications / Q000175:diagnosis*
chemical_list: D007136:Immunoglobulins