Bibliography - Gynecologic - References Prior to 1996

Note: Information contained in articles described below may refer to the ThinPrep® 2000 System or to a predecessor processor and system which uses similar technology but was not approved by the U.S. Food and Drug Administration ("FDA") for gynecological applications. The ThinPrep 2000 System was approved by the FDA for gynecological applications in May 1996.

Background on Cervical Cancer
Isacson C, Kurman RJ: The Bethesda System: a new classification for managing Pap smears. Contemporary Ob/Gyn 1995;40:67-74.

Larsen NS: Invasive cervical cancer rising in young white females. Journal of the National Cancer Institute 1994;86:6-7.

Scientific Basis of the Need for Improvement
Davey DD, et al: Terminology and specimen adequacy in cervicovaginal cytology. The College of American Pathologists Interlaboratory Comparison Program experience. Archives of Pathology and Laboratory Medicine 1992;116:903-907.

Gay JD, et al: False-negative results in cervical cytologic studies. Acta Cytologica 1985;29:1043-1046.

Joseph MG, et al: Cyto-histologic correlates in a colposcopic clinic: a 1-year prospective study. Diagnostic Cytopathology 1991;7:477-481.

ThinPrep Gynecologic studies Prior to FDA approval
Agarwal P et al: New cervical cytology preparation device shows clearer presentation and improved sensitivity to abnormal findings over conventional Papanicolaou smears. Acta Cytologica 1991;35:653-654.

Aponte-Cipriani, Teplitz C et al: Cervical smears prepared by an automated device versus the conventional method. Acta Cytologica 1995;39:623-630.

Ashfaq R, Vela C et al: ThinPrep vs. conventional smears for routine gynecologic cytology. Acta Cytologica 1995;39:986.

Awen C, Hathway S et al: The efficacy of ThinPrep preparation of cervical smears: A 1,000-case, investigator-sponsored study. Acta Cytologica 1993;37:779.

Awen C, Hathway S et al: Efficacy of ThinPrep preparation of cervical smears: A 1,000-case investigator-sponsored study. Diagnostic Cytopathology 1994;11:33-37.

Bonfiglio TA et al: Fluid-based cervical cytology specimens: Clinical trials of the ThinPrep Processor. Platform presentation. Acta Cytologica 1992;36:578.

Briscoe D, Isenstein LM et al: Optical resolution requirements for computer detection of malignancy associated changes. Acta Cytologica 1995;39:1055-1056.

Bur M, Knowles K et al: Comparison of ThinPrep preparations with conventional cervicovaginal smears. Acta Cytologica 1995;39:631-642.

Cibas ES et al: The accuracy of a new cervical cytology preparation device compares favorably to conventional smears as correlated with colposcopically directed biopsy results. Platform presentation. Acta Cytologica 1992; 36:579.

Evans SK and Wilbur DC: Identification of endocervical cells and microorganisms on cervical thin-layer cytology specimens: Comparison to paired conventional smears. Acta Cytologica 1993;37:776.

Ferenczy A: Viral testing for genital human papillomavirus infections: Recent progress and clinical potentials. Int J Gynecol Cancer 1995;5:321-328.

Hurley AA, Mui KK et al: A comparative study of reproducibility in the preparation of cervical cytology samples. Cytometry 1993;6:17.

Hurley AA, Douglass KL, Zahniser DJ: Improved technology for cytology specimen preparation. American Clinical Laboratory 1991;10:20-22.

Hurley AA, Douglass KL et al: A new slide preparation system for cytology. Am J Clin Pathol 1991;95:286.

Hurley AA, Douglass KL et al: A new automated slide preparation system for cytology. Cytometry 1991;5:57.

Hurley AA, Stelzer GT et al: Total cell Recovery of cervical samples when collected in solution. Cytometry 1991;5:57.

Hurley AA, Bain KM et al: A novel cell preparation instrument for image cytometry. Cytometry 1990;4:67.

Hutchinson ML, Schiffman MH et al: Evaluation of conventional vs. ThinPrep cervical smears in a population-based study of 10,000 women in Costa Rica. Acta Cytologica 1995;39:969.

Hutchinson ML, Isenstein LM et al: Managing the ASCUS patient through automated image analysis: A pilot study. Acta Cytologica 1995;39:968-969.

Hutchinson ML, Dias L et al: Continuous quality improvement in the cytology laboratory: Frequent blinded challenges: A pilot study. Acta Cytologica 1995;39:994.

Hutchinson ML, Lapidus SN: Use of receiver operator characteristic (ROC) curves to analyze cervical cytology trial data: ThinPrep vs. smeared slide. Acta Cytologica 1995;39:1054.

Hutchinson ML, et al: Homogeneous sampling accounts for the increased diagnostic accuracy using the ThinPrep Processor. Am J Clin Pathol 1994;101:215-219.

Hutchinson ML, et al: A new look at cervical cytology: ThinPrep multicenter results. Acta Cytologica 1992;36:499-504.

Hutchinson ML, Cassin CM et al: The efficacy of an automated preparation device for cervical cytology. Am J Clin Pathol 1991;96:300-305.

Hutchinson ML, Douglass KL et al: A comparison of conventional versus thin preparations for cervical cytology smears. Cytometry 1991;5:57.

James LP, Knapp D: New cervical cytology preparation device shows improved sensitivity to abnormal findings over the conventional Pap smear. Acta Cytologica 1992;36:579.

Kish J, Vallera D et al: ThinPrep gynecologic study: A review of 488 cases. Acta Cytologica 1994;38:806.

Knowles K et al: Comparison between conventional Papanicolaou smears and ThinPrep preparations for evaluation of cervicovaginal cytology. Platform presentation. Acta Cytologica 1992;36:582.

Linder J: The coming era of cytologic automation. Am J Clin Pathol 1991;96:293-294.

Martin J et al: Densitometric analysis of cervical thin-layer preparations. Acta Cytologica 1993;37:790.

Masada CT, Bohl K et al: Application of monolayer preparation techniques to imaging cytometry. Laboratory Investigation and Modern Pathology 1992;66:120A.

Mui KK, Hutchinson ML et al: A reproducibility study of the ThinPrep sample preparation process. Am J Clin Pathol 1992;98:356.

Mui KK, Hutchinson ML et al: The ThinPrep sample preparation process: A matter of reproducibility. Acta Cytologica 1992;36:587.

Oud PS, Hurley AA, Douglass KL: Sample preparation in diagnostic cytology: Present status and new developments. Diagnostics & Clinical Testing 1990;28:16-19.

Renshaw AA, Sheets EE et al: New ThinPrep method compares favorably to conventional Papanicolaou smears in the detection of abnormal cells. Acta Cytologica 1991;35:589.

Sheets EE, Douglass KL et al: Comparison of cytologic diagnoses using conventional Papanicolaou smears and parallel thin layer cervical preparations using four collection device modalities. Am J Clin Pathol 1992;98:356.

Sheets EE, Constantine NM et al: Colposcopically directed biopsies provide a basis for comparing the accuracy of ThinPrep and Papanicolaou smears. Journal of Gynecologic Techniques 1995;1:27-33.

Sherman ME, Schiffman M et al: Evaluation of conventional and novel cervical cancer screening methods in a population-based study of 10,000 Costa Rican women. Acta Cytologica 1995;39:983.

Vooijs GP, Nieuwenhuis F et al: Comparison of cytologic diagnoses on conventional and parallel monolayer cervical smears. Am J Clin Pathol 1991;95:286.

Wilbur DC, Cibas ES et al: ThinPrep processor clinical trials demonstrate an increased detection rate of abnormal cervical cytologic specimens. Am J Clin Pathol 1994;101:209-214.

Wilbur DC, Dawson A et al: Interpretation of cervical cytology utilizing thin-layer processing: Comparison of results with conventional smears. Laboratory Investigation and Modern Pathology 1992;66:30A.

Zahniser DJ, Hurley AA, Hutchinson ML: Specialized slide preparation for cervical cytology: Requirements and an historical perspective. Analytical and Quantitative Cytology and Histology 1992;14:287-288.

Zahniser DJ: The Cytyc system for automated analysis of cervical samples. Analytical Cellular Pathology 1992;4:252-253.

Zahniser DJ, Hurley AA: An automated system for the preparation and analysis of cervical samples. Analytical and Quantitative Cytology and Histology 1992;14:288.

Zahniser DJ, Lapidus SN et al: An automated system for the preparation and analysis of cervical smears. Cytometry 1991;5:56-57.

Zahniser DJ, Wong KL et al: Contextual features enhance automated Pap smear screening. Cytometry 1991;5:57.

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