THE AUTOPAP-300 QC SYSTEM MULTICENTER CLINICAL-TRIALS FOR USE IN QUALITY-CONTROL RESCREENING OF CERVICAL SMEARS - II - PROSPECTIVE AND ARCHIVAL SENSITIVITY STUDIES

BACKGROUND, The AutoPap 300 QC System is an automated device for the a nalysis of conventional cervical cytology slides. The AutoPap selects an enriched population of cases for quality control review. These stud ies evaluated the overall sensitivity of AutoPap device to a wider var iety of cytologic abnormalities than could be analyzed in the prospect ive portion of the clinical trials. METHODS, At five clinical trial si tes, positive cases were selected from: 1) archives (historic sensitiv ity study) or 2) current positive cases (current archive sensitivity s tudy). Cases were analyzed by the AutoPap System along with matched ne gative cases and stratified into detection deciles by instrument score for each diagnostic category. RESULTS, For the historic sensitivity s tudy, the percentages of cases present within the top 10% instrument S cores were as follows: atypical glandular cells of undetermined signif icance (AGUS): 33.7% (n = 243); low grade squamous intraepithelial les ion (LSIL): 57% (n = 412); high grade squamous intraepithelial lesion (HSIL): 81.6% (n = 385); and carcinoma: 77.7% (n = 139). For the curre nt archive sensitivity study, the percentage of cases within the top 1 0% of instrument scores were as follows: atypical squamous cells of un determined significance (ASCUS): 37.6% (n = 205); AGUS: 27.3% (n = 22) ; LSIL: 53.7% (n = 410); HSIL: 80.7% (n = 202); and carcinoma: 62.5% ( n = 8). Sensitivities at higher percentiles proportionately were great er. CONCLUSIONS. The AutoPap 300 QC System is detection sensitive, par ticularly at the level of LSIL and greater. When coupled with the data from the prospective intended use study, these results provided confi rmation of the instrument's ability to enhance the false-negative dete ction rate significantly when compared with a 10% random case selectio n process. In addition, high sensitivities to all categories of abnorm ality suggest the possibility of using such instrumentation as a prima ry screening device for cervical cytology. (C) 1997 American Cancel-So ciety.