Development a Rhesus Type Compatibility Test by Means of an Antibody Able to Recognize RH1 Antigen Grafted on a Biochip
Condition: Rh Incompatibility Reaction
Study type: Observational

Summary: 
      Every year, several millions of red cell concentrates are transfused. For each of them, a
      pretransfusional compatibility test is performed. In France, an ABO compatibility test at the
      patient's bedside is performed, but rhesus compatibility is not yet checked. However, rhesus
      antigens are very immunogenic and could lead to Rh incompatibility or Rh disease.

      The objective of ABORDAGE project is to develop another biochip that specifically captures
      RBCs according the presence of the RH1 antigen (also known as D antigen) at their surface.
    

Detailed description: 
      Every year, several millions of red cell concentrates are transfused. For each of them, a
      pretransfusional compatibility test is performed. In France, an ABO compatibility test at the
      patient's bedside is performed, but rhesus compatibility is not yet checked. However, rhesus
      antigens are very immunogenic and could lead to Rh incompatibility or Rh disease. Rh
      incompatibility occurs when a woman with Rh-negative blood type is exposed to Rh-positive
      blood cells. This exposure leads to the sensitization of the women who develop anti-Rh
      immunoglobulin G (IgG). This immunization is one cause of the hemolytic disease of newborns
      (HDN). HDN results from an incompatibility between mother's blood and fetus' blood. It
      happens when fetal red blood cells (RBCs) present antigens inherited from the father but
      missing from the mother. Consequence of this incompatibility is the fetal RBCs destruction by
      mother's antibodies. Antibodies could be natural, like immunoglobulin M (IgM) anti-A or
      anti-B from the ABO system, or from an immunization. Rh incompatibility results from 2 main
      mechanisms. The first one is when a pregnancy Rh-negative woman is exposed to fetal
      Rh-positive RBCs. Rh incompatibility leads to anemia (mild to severe) or ultimately to the in
      utero death. The second occurs when Rh incompatible blood is transfused. This is the subject
      of this communication.

      The investigators previously develop biochips and optical device to realize automatic ABO
      compatibility test at the patient's bedside (references to the Citation field). Based on this
      previously project, the goal of ABORDAGE project is to develop another biochip based on
      selective blood capture. The ABORDAGE chip has to specifically capture RBCs according the
      presence of the RH1 antigen (also known as D antigen) at their surface.
    

Intervention name(s): Blood donation
Intervention type(s): Other
Intervention description(s): Red cell concentrates derived from healthy blood donating people. In France, all blood donation is realized by the Etablissement Français du Sang, so all the study samples are from this center.
Observational model: Case-Control
Sampling method: Non-Probability Sample
Study population: 
        RH1 and RH-1 red cell concentrates, derived from blood donation, is used for this study