The test has been clinically tested in patients after more than one year after transplant. The reason is that currently the major challenge for clinicians is to improve the graft survival after one year, reducing the risk of chronic allograft injury due to rejection, and avoiding at the same time the adverse effects of immunosuppression like infections and malignancies. It is planned to be studies in patients before transplantation as well.
The IMMUNOBIOGRAM® can be used to identify and monitor patients at risk of rejection (who might require an increase of immunosuppression or a change in the immunosuppressive regime prescribed), and in patients with low risk who could profit from a gradual reduction of immunosuppression to avoid severe side effects. The estimated monitorization frequency is twice/three times a year. This estimation is based in the frequency of DSA de novo determinations in routine clinical practice. The development of de novo (dn) DSA beyond one-year post-transplantation has been demonstrated to be strongly associated with graft loss through antibody-mediated rejections.