Effective January 3, 2017, a portion of the Celiac and Gluten Sensitivity Panel will run on a new, more automated platform, Phadia 250. Phadia 250 is an FDA-cleared fluorescence enzyme immunoassay (FEIA). New reference ranges will be provided by the manufacturer, however report algorithms and clinical interpretation of the test will remain the same.
Minor changes to the language and graphics on the Celiac and Gluten Sensitivity Panel will occur. Instead of reporting "weak positive" results, Phadia 250 will report "equivocal" and this result will be represented with a colorimetric change to yellow on the report. "Equivocal" will signify that results fall within the intermediate range and require further investigation. Additionally, the graphic algorithmic tree will also reflect the language change of "equivocal or positive" to represent how to proceed with further work up required for diagnosis.
Please note that the isolated markers of total IgA and the reflex measurement of Anti-EMA are not available on Phadia 250 and will continue to be run using the previous platform.