Validation of a hospital-laboratory workstation for immunohematologic methods

Transfusion. 2010 Jan;50(1):26-31. doi: 10.1111/j.1537-2995.2009.02359.x. Epub 2009 Aug 26.

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.

Study design and 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.

Publication types

  • Evaluation Study
  • Research Support, Non-U.S. Gov't
  • Validation Study

MeSH terms

  • ABO Blood-Group System
  • Automation, Laboratory / standards
  • Blood Banking / methods*
  • Blood Banks / standards*
  • Blood Grouping and Crossmatching / methods*
  • Blood Grouping and Crossmatching / standards*
  • False Negative Reactions
  • False Positive Reactions
  • Humans
  • Immunoglobulin G / blood
  • Kell Blood-Group System
  • Laboratories, Hospital / standards*
  • Rh-Hr Blood-Group System

Substances

  • ABO Blood-Group System
  • Immunoglobulin G
  • Kell Blood-Group System
  • Rh-Hr Blood-Group System