Enhancing the performance of the AutoPap 300 QC system with optimal staining and presentation of cervical smears

OBJECTIVE: To optimize the staining and presentation of slides for the AutoPap 300 QC System, an automated cytology screening system which examines conventionally prepared cervical smears, and to assess subsequent scanning and scoring rates and compare them to those of laboratories not adopting these changes. STUDY DESIGN: In this study, procedures were developed for optimal presentation and staining of slides for the AutoPap System in response to observations made in preclinical trials. Three thousand eight hundred fifty-five slides were then submitted to the device for analysis in a prospective, blind, clinical evaluation study. The scanning and scoring rates were compared to those of a cohort of 12,525 slides that were analyzed in other laboratories which had not adopted these procedures. RESULTS: Two hundred forty (6.2%) slides failed scanning due to physical defects. An additional 70 slides (2.0% of scanned slides) did not complete scoring due to staining limitations. The laboratories in the clinical trials that had not adopted these preanalytic method changes had higher scanning failure rates due to physical limitations (15.0%) and incomplete scoring rates due to staining limitations (6.2%). CONCLUSION: The present study demonstrated that the performance of the AutoPap 300 is enhanced by meticulous attention to preanalytic staining and presentation procedures.