Blood group genotyping in Germany

BACKGROUND: Molecular methods for blood group genotyping became available more than 10 years ago as one major aspect of immunogenetics. Since then, the clinical applications have been expanded and refined. Their implementation varies considerably among different health-care systems, notably between North America and Europe. STUDY DESIGN: This summary is based on studies published mostly during the last 3 years and on workshop reports from the German and Swiss transfusion societies. It represents an edited transcript of the author's presentation given at the Workshop on Molecular Methods in Immunohematology organized by the Food and Drug Administration (FDA) in Bethesda on September 25, 2006. RESULTS: Current applications of blood group genotyping in Germany, Switzerland, and Austria are detailed: weak D testing in patients and pregnant women; blood group genotyping in perinatal care, in patients who received a transfusion, and in patients with immunohematologic problems; RHD genotyping in donors for DEL and D+/- chimera; and RHD zygosity testing. CONCLUSION: Since around 2000, molecular tests for blood groups have been widely offered as a routine service. Many samples are shipped to reference laboratories in the German-speaking countries with the specific request for such testing. The advent of Conformite Europeenne (CE)-labeled test kits renders it technically and legally possible, within the specifications of the CE-certification process for in vitro diagnostic devices in the European Union, to replace several blood group serology tasks by genotyping.