Abstract
The XM-ONE PT program is designed to emulate and evaluate clinical testing for Non-HLA antigen present on endothelial cells (EPC). The PT program was initiated in 2011 with the motion to assess performance of the EPC crossmatch within the US. We report here results of the initial 2011 and the second, the 2012-I Survey. In 2011 five centers received and reported results for IgG and IgM. The 2012-I was sent out to 10 centers. Seven of them reported both IgG and IgM results while two others reported results for the IgG only. One laboratory did not submit results. Both surveys included two whole blood target cells specimens and five analytes. In addition, a negative control and positive control for IgG and IgM was supplied with each shipped kit. In the assessment and evaluation, only the clinical diagnosis (Positive or Negative) was taken into consideration. Nevertheless, all steps of the test were meticulously examined to explain the posted diagnosis. The 2011 survey had 100% successful participation for all centers. IgG had a 100% consensus while IgM showed some minor difficulties due to the methods and technicalities in the setting of the “cut off channels” or “ratios” for IgM by the different centers. In the 2012-I there was 100% successful participation for all participants. For IgG one center missed 1/5 analytes while for IgM two lab missed 1/5 analytes (in both cases with one of the cell targets). The survey results indicate solid base consensus but there is still room for improvements. We continue our commitment to maximize the educational aspects of these exercises and improve future XM-ONE PT surveys. Implementation of the more complete T cell (TC) and B cell (BC) Lymphocytes and EPC combined XM-ONE assay (3-in-1) into the XM-ONE PT program is planned for future PT exercises. The 3-in-1 version of XM-ONE can reduce cost and time in many laboratories by covering HLA and Non-HLA specific antigens within one test. In future PT exercises PT participants may choose to report results for the XM-ONE test (EPC) or the 3-in-1 XM-ONE test (EPC), (TC), (BC).
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