title: Validation of a hospital-laboratory workstation for immunohematologic methods.
abstract: BACKGROUND
  The FREELYS Nano system (Diagast) is a manual workstation for ABO/D grouping, Rh phenotyping, K typing, and antibody screening (ABS) for immunoglobulin G (IgG) antibodies only and works with the erythrocyte-magnetized technology (EMT). The principle of EMT is based on magnetization of red blood cells and avoids centrifugation and washing steps.
  
  
  METHODS
  A total of 304 samples were tested with our routine blood bank methods, 100 samples for ABO/D grouping, 196 samples (100 at first evaluation, 96 at second evaluation) for Rh phenotyping and K typing (PK7200, Olympus), and 108 samples for ABS (DiaMed). All samples were tested in parallel with the FREELYS Nano.
  
  
  RESULTS
  We found a 100% concordance between the observed (FREELYS Nano) and the expected (Olympus PK7200) results for ABO/D grouping in all 100 samples. For Rh phenotyping and K tests, in 24 of 100 samples false-positive reactions were observed in the first evaluation by the FREELYS Nano. After changing the test kit batch for Rh phenotyping by the manufacturer, a complete concordance in Rh phenotyping and K tests was observed in a second evaluation. For ABS, the FREELYS Nano showed in 4 of 108 samples (3.7%) false-negative reactions for IgG antibodies (two anti-K, one anti-E, one anti-C(w)), and one (0.9%) false-positive reaction.
  
  
  CONCLUSIONS
  The FREELYS Nano is reliably suited to ABO/D grouping, Rh phenotyping, and K testing. The rate of false-negative reactions for IgG antibodies should be reduced.
authors.affiliation: Department of Anesthesiology and Intensive Care Medicine and the Institute of Transfusion Medicine, Charité-Universitätsmedizin Berlin, Berlin, Germany. helge.schoenfeld@charite.de
authors.forename: Helge
authors.initials: H
authors.lastname: Schoenfeld
authors.forename: Karin J
authors.initials: KJ
authors.lastname: Pretzel
authors.forename: Christian
authors.initials: C
authors.lastname: von Heymann
authors.forename: Bruno
authors.initials: B
authors.lastname: Neuner
authors.forename: Ulrich
authors.initials: U
authors.lastname: Kalus
authors.forename: Holger
authors.initials: H
authors.lastname: Kiesewetter
authors.forename: Axel
authors.initials: A
authors.lastname: Pruss
mesh_terms: D000017:ABO Blood-Group System; D057205:Automation, Laboratory / Q000592:standards; D001771:Blood Banks / Q000592:standards*; D001788:Blood Grouping and Crossmatching / Q000379:methods* / Q000592:standards*; D005188:False Negative Reactions; D005189:False Positive Reactions; D006801:Humans; D007074:Immunoglobulin G / Q000097:blood; D007626:Kell Blood-Group System; D007755:Laboratories, Hospital / Q000592:standards*; D012204:Rh-Hr Blood-Group System; D000094902:Blood Banking / Q000379:methods*
chemical_list: D000017:ABO Blood-Group System; D007074:Immunoglobulin G; D007626:Kell Blood-Group System; D012204:Rh-Hr Blood-Group System