UPATH ENTERPRISE SOFTWARE, IVD

Description of Event or Problem

A CUSTOMER FROM THE UNITED STATES WAS DOING A COMPARISON OF THE VIRTUOSO VERSUS THE UPATH VIEWERS AND OBSERVED DISCREPANT RESULTS WITH THE UPATH SOFTWARE IVD - 1.X. THE ALGORITHM ER (SP1) IS USED TO DETECT ESTROGEN RECEPTOR (ER), A MARKER OF BREAST CANCER. THE RESULT PROVIDED BY THE ALGORITHM ANALYSIS IS THE PERCENT OF ER POSITIVITY. THE CUSTOMER IS USING ER (SP1) FOV ALGORITHM TO ANALYZE BREAST SLIDES. WHEN COMPARING THE RESULTS OF THE ALGORITHM ANALYSIS USING VIRTUOSO 5.6.2 AND UPATH 1.X, THEY OBSERVED THAT UPATH PROVIDED A LOWER PERCENT POSITIVITY THAN VIRTUOSO. THE SAME VERSION OF THE ALGORITHM IS USED IN VIRTUOSO AND UPATH. THE UPATH RESULT WAS NOT REPORTED OUT TO THE PATIENT.

Additional Manufacturer Narrative

THE ISSUE WAS ABLE TO BE REPRODUCED. IT HAS BEEN CONFIRMED THAT DUE TO A SOURCE CODE ERROR IN THE UPATH VIEWER, THE INPUT PARAMETERS WERE NOT SENT TO THE ALGORITHM. WHEN THE ALGORITHM DOES NOT RECEIVE THE NECESSARY INPUT PARAMETERS, IT USES THE DEFAULT VALUE FOR THOSE PARAMETERS. THEREFORE, THE RESULTS BETWEEN VIRTUOSO AND UPATH FOR THE SAME REGION OF INTEREST (ROI) WERE DISCREPANT. NOTE, VIRTUOSO WAS CORRECTLY SENDING THE INPUT PARAMETERS, AND THEREFORE THE ALGORITHM ANALYSIS WAS PERFORMED AS EXPECTED. COMMON DEVICE NAME TRUNCATED DUE TO CHARACTER LIMIT: MICROSCOPE, AUTOMATED, IMAGE ANALYSIS, IMMUNOHISTOCHEMISTRY,OPERATOR INTERVENTION,NUCLEAR INTENSITY & PERCENT POSITIVITY.