Technical considerations during validation of the Genius® Digital Diagnostic System

The aim of this study was to document technical errors encountered during validation of the Genius Digital Diagnostics System (GDDS).

A total of 909 cases of archived ThinPrep Pap slides with follow-up biopsies were retrieved. Slides were cleaned, relabeled, and scanned with GDDS. Digital imager errors, including slide events and imager errors, were documented and evaluated.

Of the 909 slides scanned, 21 (2.3 %) demonstrated slide events. For 5 cases, the slides had cell focus errors, 12 failed due to quality control (QC) errors, 2 had barcode issues, 1 showed an oversaturated frame, and 1 presented a problem because it was a duplicate. Some errors could be corrected, of which 8 cases with various diagnostic cytology interpretations were successfully rescanned. There were 13 (1.4%) cases that could not be scanned and thus were excluded from the study, predominantly because of focus QC errors due to scratched coverslips from long-term storage. There were 43 imager errors including failure of motor movement, cancellation of slide handling action, and failure to pick slides from the carrier station for which the scanning process had to be paused. Imager errors were solved by rebooting the system, correcting the positioning of the slide on the system, and technical help provided by the vendor.

Minor errors are to be expected when digitizing large volume of Pap slides. Total number of rescanned cases to address such technical problems were low in number and did not compromise the interpretation of Pap test slides using GDDS.