Abstract
Background - Red cell antibodies can cause severe or fatal hemolytic transfusion reactions and hemolytic disease of the fetus and newborn. Screening for antibodies, such as anti-D, has been applied over decades for any transfusions and pregnancies. A comparison of sensitivities across laboratories is lacking for such antibody assays.
Materials and methods - We investigated the detection rates for defined antibody concentrations of anti-D, the most common trigger of adverse outcomes. In a concerted effort among 10 providers of external quality assessment and proficiency testing programs, 4 spiked samples were tested by exactly 2,500 laboratories applying their clinical routine procedures, covering 4 test principles, more than 24 test cells, and diagnostic devices from 5 manufacturers.
Results - The sensitivity of the assay depended on the test principle. Detection rates correlated with anti-D antibody concentrations: 0.1 IU/mL and 0.025 IU/mL can reliably be recognized. Some assays enabled detection at 0.01 IU/mL, and only a few at 0.005 IU/mL. Erythrocyte-magnetized technology and solid phase red cell adhesion performed better than various modifications of the column agglutination technology. The conventional test tube technology, depending on visual reading, was least sensitive.
Discussion - The results show options for action to improve antibody detection, may support a practice change to optimize routine strategies of red cell antibody screening, and can guide studies to evaluate the clinical impact.
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Authors
Christoph Buchta
Österreichische Gesellschaft für Qualitätssicherung und Standardisierung medizinisch-diagnostischer Untersuchungen (ÖQUASTA), Vienna, Austria
Willy A Flegel
Department of Transfusion Medicine, NIH Clinical Center, National Institutes of Health, Bethesda, MD, United States of America; Gesellschaft zur Förderung der Qualitätssicherung in medizinischen Laboratorien (INSTAND), Düsseldorf, Germany
Wim Coucke Sciensano, Brussels, Belgium
Cécile Toly-Ndour
Centre National de Référence en Hémobiologie Périnatale (CNRHP), Paris, France
Agnès Mailloux
Centre National de Référence en Hémobiologie Périnatale (CNRHP), Paris, France
Karina Hellbert
Maybach Bechter Hellbert Rechtsanwälte, Vienna, Austria
Gianfranco Avveduto Centro Regionale di Riferimento per il Controllo di Qualità, AOU-Careggi, Firenze, Italy
Isabelle Bertin-Jung Biologie Prospective, Villers-les-Nancy, France
Anna Bode Stiftung für Pathobiochemie und Molekulare Diagnostik, Referenzinstitut für Bioanalytik (RfB), Bonn, Germany
Lobna Bouacida
Sciensano, Brussels, Belgium
Stefanie Gemein Stiftung für Pathobiochemie und Molekulare Diagnostik, Referenzinstitut für Bioanalytik (RfB), Bonn, Germany
Sabine Goseberg
Gesellschaft zur Förderung der Qualitätssicherung in medizinischen Laboratorien (INSTAND), Düsseldorf, Germany
Andrea Griesmacher Zentralinstitut für Med. u Chem. Labordiagnostik (ZIMCL), Landeskrankenhaus Innsbruck, Universitätskliniken, Innsbruck, Austria
Richard Haggas UK National External Quality Assessment Services (UK NEQAS), Blood Transfusion Laboratory Practice (BTLP), West Herts Hospitals NHS Trust, Watford, United Kingdom
Junho Kim Royal College of Pathologists of Australasia Quality Assurance Program (RCPAQAP), St Leonards, NSW, Australia
Truscha Niekerk South African National Blood Service (SANBS), Johannesburg, South Africa
Jean-Pascal Siest Biologie Prospective, Villers-les-Nancy, France
Nanna Skeie Nasjonalkontrollen (Norwegian EQA Immunohematology), Oslo University Hospital, Oslo, Norway
Heidi Støen Nasjonalkontrollen (Norwegian EQA Immunohematology), Oslo University Hospital, Oslo, Norway
Renate Becker
ANTITOXIN GmbH, Bammental, Germany
Thomas Wagner
Universitätsklinik für Blutgruppenserologie und Transfusionsmedizin, Landeskrankenhaus Universitätsklinikum Graz, Graz, Austria
Günther F. Körmöczi
Universitätsklinik für Transfusionsmedizin und Zelltherapie, Medizinische Universität Wien, Vienna, Austria
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