AutoPap system detection of infections and benign cellular changes: Results from primary screener clinical trials

Primary screening devices for cervical cytology must show performance data for the detection of infections organisms and benign cellular changes (BCC) for cytologists who routinely report these findings. The data on infection and BCC from the AutoPap primary screening clinical trials are presented h erein. The presence of infectious organisms (candida, trichomonas, shift in bacterial flora, herpes, actinomyces) and BCC were noted in each of the cl inical trial arms (current practice, CP; AuroPap-assisted practice, AP). Fo r the purposes of these analyses, a report of infection or BCC from either arm was considered to be "truth." In 25,124 slides analyzed, there were 2,9 25 cases of infection identified. Of these, CP identified 2,141, and AP ide ntified 1,985. The overall detection results are statistically equivalent. Of 17 cases of actinomyces, CP detected 8, while AP detected 12. Of 1,282 c ases of candida, CP detected 983, and AP detected 865. Of 1,375 cases of sh ift of bacterial flora, CP detected 897, and AP detected 869. Of 14 cases o f herpes, CP detected 9, and AP detected 11. Of 343 cases of trichomonas, C P detected 293, and AP detected 275. There were 5,156 cases of BCC identifi ed in the trial. CP detected 3,431, and AP detected 3,276. The detection ra tes for BCC are statistically equivalent. The results show that the AuroPap -assisted practice for the primary screening of conventional cervical cytol ogy slides is equivalent to the current practice for the detection of cervi cal infections and benign cellular changes. Diagn. Cytopathol. 1999; 21.355 -358. (C) 1999 Wiley-Liss, Inc.