AutoPap System Performance in Screening for Low Prevalence and Small Cell Abnormalities

• Published in: Acta cytologica Vol. 41; no. 1; pp. 56 - 64
• Main Authors: Lee, James S.J., Wilhelm, Paul, Kuan, Leonard, Ellison, Dayle G., Lei, Xingye, Oh, Seho, Patten, Jr, Stanley F.
• Format: Journal Article
• Language: English
• Published: Basel, Switzerland Science Printers and Publishers 01-01-1997
• Subjects: Algorithms; Automation; Biological and medical sciences; Carcinoma, Squamous Cell - diagnosis; Carcinoma, Squamous Cell - pathology; Cell Size; Cervical Intraepithelial Neoplasia - diagnosis; Cervical Intraepithelial Neoplasia - pathology; Cervix Uteri - pathology; Clinical Trials as Topic; Evaluation Studies as Topic; Female; Genital system. Mammary gland; Humans; Image Interpretation, Computer-Assisted - instrumentation; Investigative techniques, diagnostic techniques (general aspects); Mass Screening - instrumentation; Medical sciences; Multicenter Studies as Topic; Original Articles; Pathology. Cytology. Biochemistry. Spectrometry. Miscellaneous investigative techniques; Prospective Studies; Quality Control; Sensitivity and Specificity; Severity of Illness Index; Uterine Cervical Neoplasms - diagnosis; Uterine Cervical Neoplasms - pathology; Vaginal Smears - instrumentation; AutoPap; cervical smears; mass screening; Performance evaluation; Human; Premalignant lesion; Poverty; Small dimension; Cervical smear; Medical screening; Female genital diseases; Pathology; Image analysis; Cervical dysplasia; Automatic analyzer; Cytopathology; Atypical; Technique; Cell; Uterine cervix diseases
• ISSN: 0001-5547; 1938-2650
• DOI: 10.1159/000332306

To summarize the design principles of the AutoPap System evaluation score by evaluating slides having a low prevalence of abnormal cells and small cell abnormalities and assessing the evaluation score as a diagnostic tool.
Data from two clinical studies conducted using the AutoPap System and data obtained from the evaluation score training slides were analyzed to demonstrate the effectiveness of the evaluation score. The clinical studies included a prospective, intended-use study involving approximately 13,000 slides and a comprehensive sensitivity study using approximately 1,200 slides from five laboratories. The evaluation score training set consisted of 4,174 slides from 10 laboratories.
The robust design of the AutoPap evaluation score was demonstrated by similar detection capabilities and sensitivities to slides having either a low or high prevalence of abnormal cells. No significant difference in performance was detected between the small cell slides and the comparison groups of carcinoma in situ and invasive squamous carcinoma having normal-sized abnormal cells. In addition, the evaluation scores corresponded well to the diagnostic severity of the slides.