The AutoPap 300 QC system multicenter clinical trials for use in quality control rescreening of cervical smears: II. Prospective and archival sensitivity studies

Cancer

Volumn 81, Issue 6, 1997, Pages 343-347

  Patten Jr , Stanley F ^a   Lee, James S J ^a   Wilbur, David C ^a,b   Bonfiglio, Thomas A ^b   Colgan, Terence J ^c   Richart, Ralph M ^d   Cramer, Harvey ^e   Moinuddin, Shamin ^f  

^a NeoPath Inc   (United States)

^b UNIVERSITY OF ROCHESTER MEDICAL CENTER   (United States)

^c MDS Laboratories   (Canada)

^d Kyto Diagnostics   (United States)

^e WISHARD MEMORIAL HOSPITAL   (United States)

^f BAPTIST MEMORIAL HOSPITAL   (United States)

Author keywords

Automation; AutoPap; Cervix; Cytology; Quality control

Indexed keywords

ARTICLE; AUTOMATION; CANCER SCREENING; CLINICAL TRIAL; CONTROLLED STUDY; FEMALE; HUMAN; HUMAN TISSUE; LABORATORY DIAGNOSIS; MULTICENTER STUDY; PAPANICOLAOU TEST; PRIORITY JOURNAL; PROSPECTIVE STUDY; QUALITY CONTROL; SQUAMOUS CELL; UTERINE CERVIX CARCINOMA; UTERINE CERVIX CYTOLOGY;

AUTOMATION; CARCINOMA; CARCINOMA, SQUAMOUS CELL; CERVICAL INTRAEPITHELIAL NEOPLASIA; FALSE NEGATIVE REACTIONS; FEMALE; HUMANS; IMAGE PROCESSING, COMPUTER-ASSISTED; MASS SCREENING; PREDICTIVE VALUE OF TESTS; PROSPECTIVE STUDIES; QUALITY CONTROL; RETROSPECTIVE STUDIES; SENSITIVITY AND SPECIFICITY; UTERINE CERVICAL NEOPLASMS; VAGINAL SMEARS;

EID: 15444340055     PISSN: 0008543X     EISSN: None     Source Type: Journal    
DOI: 10.1002/(SICI)1097-0142(19971225)81:6<343::AID-CNCR8>3.0.CO;2-M     Document Type: Article

References (6)

1. Patten SF, Lee JSJ, Wilbur DC, Bonfiglio TA, Colgan TJ, Richart RM, et al. The AutoPap 300 QC System multicenter clinical trials for use in quality control rescreening of cervical smears. I. Prospective intended use study. Cancer (Cancer Cytopathol) 1997;81:337-42.
2. Wilbur DC, Bonfiglio TA, Rutkowski MA, Atkison KM, Richart RM, Lee SJS, et al. Sensitivity of the AutoPap 300 QC System for cervical cytologic abnormalities: biopsy data confirmation. Acta Cytol 1996;40:127-31.
3. Kurman RJ, Solomon D. The Bethesda system for reporting cervical/vaginal cytologic diagnoses. New York: Springer-Verlag, 1994.
4. Premarket Approval Application to the United Stated Food and Drug Administration. AutoPap 300 QC Automated Pap Smear Screener (P950009). NeoPath, Inc., 1995.
5. Patten SF, Meyer M, Lee JSJ, Oh S, Wilhelm P. Evaluation of the NeoPath AutoPap 300 Automatic Pap smear primary screening algorithm [abstract]. Presented at the Fourth International Conference on Computerized Cytology, Chicago, Illinois, March 17-20, 1996.
6. Proposed guidelines for primary screening instruments for gynecologic cytology. Developed by the Intersociety Working Group for Cytology Technologies. Acta Cytol 1997; 41:924-34.