An extensive parallel blind clinical study on our multidimensional slit-scan prescreening system is proposed. The purpose of this important study is to compare the performance of multidimensional slit-scan flow analysis to conventional cytological evaluation using clinical gynecological specimens. The clinical gynecologic specimens will be collected through the existing health care system of Strong Memorial and affiliated hospitals with an attempt to collect as many abnormal specimens as possible. For the purpose of this study, an abnormal specimen is defined as one containing cells derived from slight dysplasia, or a more serious disease process of the female genital tract. Following parallel blind analysis, the results of multidimensional slit-scan analysis will be compared to those of conventional cytopathology and to the results of biopsy when available. Positive predictive value for both manual and automated techniques, and estimates of their relative sensitivity and specificity will be determined. The emphasis of the proposed studies will be to determine a false negative and false positive rate with reasonable confidence intervals for the automated system to permit its comparison with results from any cytopathology laboratory. Additionally, a data base will be created as a result of the parallel blind clinical study. It will contain clinical information including follow-up, diagnostic cytology results, specimen collection information, and multidimensional slit-scan data. This data base will be used for correlation of clinical data with multidimensional slit-scan features.
| Wheeless Jr, L L; Reeder, J E; O'Connell, M J (1990) Slit-scan flow analysis of cytologic specimens from the female genital tract. Methods Cell Biol 33:501-7 |
