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MULTICENTER STUDY

Olerup XM-ONE endothelial cell crossmatch was evaluated in a multicenter study in kidney transplantation designed to detect donor specific AECA associated with allograft rejection (Breimer, M, Rydberg, L, Jackson, AM et al, Transplantation 2009, 87(4):549-556). The multicenter study shows that Olerup XM-ONE® contributes valuable information in transplantation diagnostics.

The main objectives of the international multicenter study were to determine the frequency of Olerup XM-ONE® positive patients in the transplanted population and investigate the difference in occurrence of rejection episodes after transplantation between patients with a positive and a negative Olerup XM-ONE result.

Patient enrollment was based on acceptance for transplantation as determined by conventional cytotoxic and/or flow cytometry based lymphocyte crossmatch results. A total of 147 patients were evaluated in six transplant centres, both in the US and in Sweden.

 

Olerup XM-ONE POSITIVE PATIENTS EXPERIENCED MORE EARLY REJECTIONS.

krea_kurva_mc_studie.jpgA number of publications have highlighted the importance of antibodies against endothelial cells and its association to rejections and graft loss. In the study 24% (35/147) of the patients had a positive Olerup XM-ONE test result. These patients had a significantly higher risk for rejection episodes than those negative with Olerup XM-ONE. All acute rejections in the Olerup XM-ONE positive patients occurred within the first three weeks of the study (46%, 16/35) while the Olerup XM-ONE negative patients had a lower incidence of rejections and only 5% of the rejections occurred within the first three weeks (total 12%, 13/112 entire study period).

 

OLERUP XM-ONE POSITIVE PATIENTS DEVELOPED MORE SEVERE TYPES OF REJECTIONS.

Six of seven C4d positive biopsies were found in the Olerup XM-ONE positive group. Only one graft loss occurred in the study and this patient had a positive Olerup XM-ONE test.

 

SUSTAINED INCREASE IN SERUM CREATININE LEVELS

da51b5d1cc188c608add50b3b5df4a3b.jpgSerum creatinine is the most commonly used indicator of renal function. An early sustained increase in serum creatinine is a known risk factor for graft loss in kidney transplant patients. Olerup XM-ONE® positive patients in the multicenter study had significantly higher levels of serum creatinine at 3 (p<0.05) as well as 6 months (p<0.05) after the transplantation.

 

POSITIVE PATIENTS EXPERIENCE REJECTIONS ALSO IN THE ABSENCE OF DONOR SPECIFIC HLA ANTIBODIES

In the study 113 patients had flow cytometry LXM in addition to CDC. Among patients being Olerup XM-ONE positive and Flow LXM negative 42% of the patients had a rejection episode. 14 patients were positive in Flow LXM but still considered safe for transplantation. None of these patients being positive in Flow LXM and negative in XM-ONE experienced a rejection (0/7 patients). Of those being positive in both Olerup XM-ONE and in Flow LXM 4/7 patients (57%) had an early rejection episode (27).

 

CONCLUSION

The study showed that the Olerup XM-ONE test can detect an antibody population not possible to detect with lymphocyte crossmatch tests that is strongly associated with rejection episodes and reduced kidney function after transplantation. Thus the Olerup XM-ONE test can identify patients at risk of early rejections and reduced kidney function post transplantation.