Scientific Journal and Reference Publication List for

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BD Diagnostics

Diagnostic Systems – TriPath


Scientific Journal and Reference Publication List for

Peer Reviewed and Non–Peer Reviewed Publications

Listed in Each Section by Year Published
1 SurePath® Liquid-Based Pap Test
1.1 SurePath® Performance in Special Patient Populations (Peer Reviewed)
Sweeney BJ, Haq Z, Happel JF, Weinstein B, Schneider D. Comparison of the effectiveness of two liquid-based Papanicolauo systems in the handling of adverse limiting factors, such as excessive blood. Cancer Cytopathol. 2006;108(1):27-31.
Swierczynski AL, Lewis-Chambers S, Anderson JR, Keller JM, Hinkle DA, Ali AZ. Impact of liquid-based gynecologic cytology on an HIV-positive population. Acta Cytol. 2004;48(2):165-172.
Ludicke F, Stalberg A, Vassilakos P, Major AL, Campana A. High- and intermediate risk human papillomavirus infection in sexually active adolescent females. J Pediatr Adolesc Gynecol. 2001;14(4):171-174.
1.2 Adjunctive Testing for STIs with SurePath® (Peer Reviewed)
Ko V, Tambouret RH, Kuebler DL, Black-Schaffer WS, Wilbur DC. Human papillomavirus testing using hybrid capture II with SurePath collection: Initial evaluation and longitudinal data provide clinical validation for this method. Cancer Cytopathol. 2006;108(6):468-474.
Verguts J, Bronselaer B, Donders G, et al. Prediction of recurrence after treatment for high-grade cervical intraepithelial neoplasia: the role of human papillomavirus testing and age at conisation. BJOG. 2006;113:1303-1307.
Depuydt CE, Benoy IH, Bailleul EJ, Vandepitte J, Vereecken AJ, Bogers JJ. Improved endocervical sampling and HPV viral load detection by Cervex-Brush Combi. Cytopathology. 2006;17(6):374-381.
Powell N, Smith K, Fiander A. Recovery of human papillomavirus nucleic acids from liquid-based cytology media. J Virol Methods. 2006;137(1):58-62.
Brink AA, Meijer CJ, Wiegerinck MA, et al. High concordance of results of testing for human papillomavirus in cervicovaginal samples collected by two methods, with comparison of a novel self-sampling device to a conventional endocervical brush. J Clin Microbiol. 2006;44(7):2518-2523.
Davis-Devine S, Day SJ, Freund GG. Test performance comparison of inform HPV and hybrid capture 2 high-risk HPV DNA tests using the SurePath liquid-based Pap test as the collection method. Am J Clin Pathol. 2005;124(1):24-30.
Aslan DL, Gulbahce E, Stelow EB, et al. The diagnosis of Trichomonas vaginalis in liquid-based Pap tests: correlation with PCR. Diagn Cytopathol. 2005;32(6):341-344.
Qureshi MN, Bolick D, Ringer PJ, Spangler FL, Zimmerman G. HPV testing in liquid cytology specimens. Comparison of analytic sensitivity and specificity for in situ hybridization and chemiluminescent nucleic acid testing. Acta Cytol. 2005;49(2):120-126.
Bewtra C, Xie Q, Soundararajan S, Gatalica Z, Hatcher L. Genital human papillomavirus testing by in situ hybridization in liquid atypical cytologic materials and follow-up biopsies. Acta Cytol. 2005;49(2):127-131.
Petignat P, Faltin D, Goffin F, et al. Age-related performance of human papillomavirus testing used as an adjunct to cytology for cervical carcinoma screening in a population with a low incidence of cervical carcinoma. Cancer Cytopathol. 2005;105(3):126-132.
Guo M, Hu L, Baliga M, He Z, Hughson MD. The predictive value of p16 and hybrid capture 2 human papillomavirus testing for high grade CIN. Am J Clin Pathol. 2004;122(6):894-901.
Sekhon HS, Press RD, Schmidt WA, Hawley M, Rader A. Identification of cytomegalovirus in a liquid-based gynecologic sample using morphology, immunochemistry, and DNA real-time PCR detection. Diagn Cytopathol. 2004;30(6):411-417.
Depuydt CE, Vereecken AJ, Salembier GM, et al. Thin-layer liquid-based cervical cytology and PCR for detecting and typing human papillomavirus DNA in Flemish women. Br J Cancer. 2003;88(4):560-566.
Levi AW, Kelly DP, Rosenthal DL, Ronnett BM. Atypical squamous cells of undetermined significance in liquid-based cytologic specimens: results of reflex human papillomavirus testing and histologic follow-up in routine practice with comparison of interpretive and probabilistic reporting methods. Cancer Cytopathol. 2003;99(4):191-197.
Anguenot JL, deMarval F, Vassilakos P, Auckenthaler R, Ibecheole V, Campana A. Combined screening for Chlamydia trachomatis and squamous intra-epithelial lesions using a single liquid-based cervical sample. Hum Reprod. 2001;16(10):2206-2210.
1.3 SurePath® Sample Collection & Specimen Adequacy (Peer Reviewed)
Rinas AC, Mittman BW, Lv L, Hartmann K, Cayless J, Singh HK. Split-sample analysis of discarded cells from liquid-based Pap smear sampling devices. Acta Cytol. 2006;50(1):55-62.
Day SJ, O'Shaughnessy DL, O'Connor JC, Freund GG. Additional collection devices used in conjunction with the SurePath liquid-based Pap test broom device do not enhance diagnostic utility. BMC Womens Health. 2004;4(1):6.
Bigras G, Malgorzata AR, Lambercy JM, et al. Keeping collecting device in liquid medium is mandatory to ensure optimized liquid-based cervical cytologic sampling. J Low Genit Tract Dis. 2003;7(3):168-174.
Tibbs RF, Wong JY, Logrono R. Enhancing recovery of endocervical component on gynecologic cytology specimens processed by thin-layer technology. Acta Cytol. 2003;47(2):172-176.
Day SJ, Deszo EL, Freund GG. Dual sampling of the endocervix and its impact on AutoCyte Prep endocervical adequacy. Am J Clin Pathol. 2002;118(1):41-46.
1.4 Direct to Vial Studies SurePath® (Peer Reviewed)
Nance, K. Evolution of Pap testing at a community hospital – a ten year experience. Diagn Cytopathol. 2007;35(3):148-153.
Fremont-Smith M, Marino JF, Griffin B, Spencer L, Bolick D. Comparison of the SurePath liquid-based Papanicolaou smear with the conventional Papanicolaou smear in a multisite direct-to-vial study. Cancer Cytopathol. 2004;102(5):269-279.
Sass MA. Use of a liquid-based, thin-layer Pap test in a community hospital: impact on cytology performance and productivity. Acta Cytol. 2004;48(1):17-22.
Colgan TJ, McLachlin CM, Cotterchio M, Howlett R, Seidenfeld AM, Mai VM. Results of the implementation of liquid-based cytology-SurePath in the Ontario screening program. Cancer Cytopathol. 2004;102(6):362-367.
Marino JF, Fremont-Smith M. Direct-to-vial experience with AutoCyte® PREP in a small New England regional cytology practice. J Reprod Med. 2001;46:353-358.
Tench W. Preliminary assessment of the AutoCyte® PREP: direct-to-vial performance. J Reprod Med. 2000;45(11):912-916.
Vassilakos P, Schwartz D, de Marval F, et al. Biopsy-based comparison of liquid-based, thin-layer preparations to conventional Pap smears. J Reprod Med. 2000;45(1):11-16.
Vassilakos P, Saurel J, Rondez R. Direct to vial use of the AutoCyte® PREP liquid-based preparation for cervical-vaginal specimens in three European laboratories. Acta Cytol. 1999;43(3):65-68.
1.5 Squamous, Glandular & General Cytology SurePath® (Peer Reviewed)
Chivukula M, Shidham VB. ASC-H in Pap test—definitive categorization of cytomorphological spectrum. CytoJournal. 2006;3:14.
Takei H, Ruiz B, Hicks J. Cervicovaginal flora. Comparison of conventional Pap smears and a liquid-based thinlayer preparation. Am J Clin Pathol. 2006;125(6):855-859.
Saad RS, Takei H, Silverman JE, Lipscomb JT, Ruiz B. Clinical significance of a cytologic diagnosis of atypical glandular cells, favor endometrial origin, in Pap smears. Acta Cytol. 2006;50(1):48-54.
Simsir A, Ioffe O, Sun P, Elgert P, Cangiarella J, Hummel Levine P. Effect of Bethesda 2001 on reporting of atypical squamous cells (ASC) with special emphasis on atypical squamous cells-cannot rule out high grade (ASC-H). Diagn Cytopathol. 2005;34(1):62-66.
Alves VA, Bibbo M, Schmitt FC, Milanezi F, Longatto Filho A. Comparison of manual and automated methods of liquid-based cytology: a morphologic study. Acta Cytol. 2004;48(2):187-193.
Ng WK, Cheung LK, Li AS, Tse SK, Pang SW, Chow JC. Thin-layer cytology findings of small cell carcinoma of the lower female genital tract. Review of three cases with molecular analysis. Acta Cytol. 2003;47(1):56-64.
Ng WK. Thin-layer (liquid-based) cytologic findings of papillary squamotransitional cell carcinoma of the cervix. Review of cases over a 4-year period with emphasis on potential diagnostic pitfalls. Acta Cytol. 2003;47(2):141-148.
Ng WK, Cheung LK, Li AS. Warty (condylomatous) carcinoma of the cervix. A review of 3 cases with emphasis on thin-layer cytology and molecular analysis for HPV. Acta Cytol. 2003;47(2):159-166.
1.6 SurePath® Miscellaneous (Peer Reviewed)
Sahebali S, Depuydt CE, Boulet GA, et al. Immunocytochemistry in liquid-based cervical cytology: analysis of clinical use following a cross-sectional study. Int J Cancer. 2006;118(5):1254-1260.
Kirschner B, Simonsen K, Junge J. Comparison of conventional Papanicolaou smear and SurePath liquid-based cytology in the Copenhagen population screening programme for cervical cancer. Cytopathology. 2006;17(4):187-194.
Longatto-Filho A, Maeda MY, Erzen M, et al. Conventional Pap smear and liquid-based cytology as screening tools in low-resource settings in Latin America: experience of the Latin American screening study. Acta Cytol. 2005;49(5):500-506.
Syrjanen K, Naud P, Derchain S, et al. Comparing PAP smear cytology, aided visual inspection, screening colposcopy, cervicography and HPV testing as optimal screening tools in Latin America. Study design and baseline data of the LAMS study. Anticancer Res. 2005;25(5):3469-3480.
Saqi A, Pasha TL, McGrath CM, Yu GH, Shang P, Gupta P. Overexpression of p16INK4A in liquid-based specimens (SurePath) as marker of cervical dysplasia and neoplasia. Diagn Cytopathol. 2003;27(6)365-370.
Studeman KD, Ioffe OB, Puszkiewicz J, Sauvegeot J, Henry MR. Effect of cellularity on the sensitivity of detecting squamous lesions in liquid-based cervical cytology. Acta Cytol. 2003;47(4):605-610.
Shirata NK, Longatto Filho A, Roteli-Martins C, Espoladore LM, Pittoli JE, Syrjanen K. Applicability of liquid-based cytology to the assessment of DNA content in cervical lesions using static cytometry. Anal Quant Cytol Histol. 2003;25(4):210-214.
Bishop JW. Cellularity of liquid-based, thin-layer cervical cytology slides. Acta Cytol. 2002;46(4):633-636.
Rowe LR, Marshall J, Bentz JS. The PrepMate automated accessory: a comparison of automated and manual methods of liquid-based gynecologic sample preparation. Diagn Cytopathol. 2002;27(5):312-315.
Gupta PK, Baloch ZW, Cobbs C, Bibbo M. Processing liquid-based gynecologic specimens: comparison of the available techniques. Acta Cytol. 2001;45(6);995-998.
Bergeron C, Bishop J, Lemarie A, et al. Accuracy of thin-layer cytology in patients undergoing cervical cone biopsy. Acta Cytol. 2001;45(4):519-524.
Maksem JA, Finnemore M, Belsheim BL, et al. Manual method for liquid-based cytology: a demonstration using 1,000 gynecological cytologies collected directly to vial and prepared by a smear-slide technique. Diagn Cytopathol. 2001;25(5):334-338.
1.7 SurePath®Split-Sample Publication (Peer Reviewed)
Hessling JJ, Raso DS, Schiffer B, Callicott J, Husain M, Taylor D. Effectiveness of thin-layer preparations vs conventional Pap smears in a blinded, split-sample study. Extended cytologic evaluation. J Reprod Med. 2001;46(10):880-886.
Minge L, Fleming M, VanGreen T, Bishop JW. AutoCyte® PREP system vs. conventional cervical cytology: comparison based on 2,156 cases. J Reprod Med. 2000;45(3):179-184.
1.8 SurePath® Publications Prior to Year 2000 (Peer Reviewed)
Saurel J, Rabreau M, Landi M, et al. Cytological screening of uterine cervical cancer by samples in liquid medium (CytoRich). Preliminary study of a series of 111,292 patients [in French]. Contracept Fertil Sex. 1999;27(12):853-857.
Vassilakos P, da Marval F, Munoz M, Broquet G, Campana A. Human papillomavirus (HPV) DNA assay as an adjunct to liquid-based Pap test in the diagnostic triage of women with an abnormal Pap smear. Int J Gynecol Obstet. 1998;81:45-50.
Vassilakos P, Griffin S, Megevand E, Campana A. CytoRich® liquid based cervical cytology test: screening results in a routine cytopathology service. Acta Cytol. 1998;42:198-202.
Takahashi M, Kimura M, Akagi A, Naitoh M. AutoCyte SCREEN interactive automated primary cytology screening system. A preliminary evaluation. Acta Cytol. 1998;42(1):185-188.
Austin RM, Ramzy I. Increased detection of epithelial cell abnormalities by liquid-based gynecologic cytology preparations: a review of accumulated data. Acta Cytol.1998;42(1):178-184.
Bishop J, Bigner S, Colgan T, et al. Multicenter masked evaluation of AutoCyte® PREP thin layers with matched conventional smears: including initial biopsy results. Acta Cytol. 1998;42:180-197.
Howell LP, Davis RL, Belk TI, Agdigos R, Lowe J. The AutoCyte® preparation system for gynecologic cytology. Acta Cytol. 1998;42:171-177.
Stevens M, Nespolon W, Milne A, Rowland R. Evaluation of the CytoRich® Technique for Cervical Smears. Diagn Cytopathol. 1998;18:238-242.
Bishop J. Comparison of the CytoRich® system with conventional cervical cytology: preliminary data on 2,032 cases from a clinical trial site. Acta Cytol. 1997;41:15-23.
Laverty C, Farnsworth A, Thurloe J, Grieves A, Bowditch R. Evaluation of the CytoRich® slide preparation process. Anal Quant Cytol Histol.1997;19:239-245.
Takahashi M, Naito M. Application of the CytoRich® monolayer preparation system for cervical cytology: a prelude to automated primary screening. Acta Cytol. 1997;41:1785-1789.
Wilbur D, Facik M, Rutkowski M, Mulford D, Atkison K. Clinical trials of the CytoRich® specimen preparation device for cervical cytology: preliminary results. Acta Cytol. 1997;41:24-29.
McGoogan E, Reith A. Would monolayers provide more representative samples and improved preparations for cervical screening? Overview and evaluation of systems available. Acta Cytol. 1996;40:107-119.
Sprenger E, Schwarzmann P, Kirkpatrick M, et al. The false-negative rate in cervical cytology: comparison of monolayers to conventional smears. Acta Cytol. 1996;40:81-89.
Vassilakos P, Cossali D, Albe X, et al. Efficacy of monolayer preparations for cervical cytology: emphasis on suboptimal specimens. Acta Cytol. 1996;40:496-500.
Learmonth G, Monson G, Ruotolo N, Geyer J. The efficiency of CytoRich® for the preparation of cervical monolayers. Acta Cytol. 1995;39:322.
Scherr G, Felix J. Comparison of CytoRich® monolayer smears to conventional prepared smears in the detection of cervical dysplasia. Am J Clin Pathol. 1994;102:530.
Geyer J, Hancock F, Carrico C, Kirkpatrick M. Preliminary evaluation of CytoRich®: an improved automated cytology preparation. Diagn Cytopathol. 1993;9:412-422.
1.9 Non–Peer Reviewed SurePath® Publications
College of American Pathologists, Young NA, Moriarty AT, Walsh MK, Wang E, Wilbur DC. The potential for failure in gynecologic regulatory proficiency testing with current slide validation criteria: results from the College of American Pathologists Interlaboratory Comparison in Gynecologic Cytology Program. Arch Pathol Lab Med. 2006;130(8):1114-1118.
Bentz JS. Liquid-based cytology for cervical cancer screening. Expert Rev Mol Diagn. 2005;5(6):857-871.
Prey M, Moriarty A. Using liquid-based cervical cytology specimens to test for Chlamydia. CAP Today. 2005; June (PAP/NGC Programs Review).
Nance KV. Vaginal lubricants do not affect the quality of SurePath Pap specimens. ASCT Voice. 2005;1(4):6.
Prey MU, Abdul-Karim F. Gynecologic cytopathology. In: Atkinson BF. Atlas of Diagnostic Cytopathology. W.B. Saunders Company; 2004.
Colgan TJ. Programmatic assessments of the clinical effectiveness of gynecologic liquid-based cytology: the ayes have it. Cancer Cytopathol. 2003;99(5):263-271.
Klinkhamer PJ, Meerding WJ, Rosier Peter F, Hanselaar AG. Liquid-based cervical cytology. Cancer. 2003;99(5):263-271.
Raab SS, Grzybicki DM, Hart AR, Kiely S, Anderew-JaJa C, Scioscia E. Willingness to pay for new Papanicolaou test technologies. Anat Pathol. 2002;117:524-533.
Felix J. Liquid-based, thin-layer cytology. In: Apgar BS, Brontzman GL, Spitzer M. Colposcopy: Principles and Practice. W.B. Saunders Company; 2002.
Black-Schaffer WS. Choosing between competing technologies in the cytology laboratory. Clin Lab Med. 2003;23:681-694.
Bishop JW, Marshall CJ, Bentz JS. New technologies in gynecologic cytology. J Reprod Med. 2000;45(9):701-719.
Brown AD, Garber AM. Cost-effectiveness of 3 methods to enhance the sensitivity of Papanicolaou testing. JAMA. 1999;27(4):347-353.
2 FocalPoint® slide profiler

2.1 FocalPoint® & SurePath® (Peer Reviewed)
Vassilakos P, Petignat P, Boulvain M, Campana A. Primary screening for cervical cancer precursors by the combined use of liquid-based cytology, computer-assisted cytology and HPV DNA testing. Br J Cancer. 2002;86(3):382-388.
Vassilakos P, Carrel S, Petignat P, Boulvain M, Campana A. Use of automated primary screening on liquid-based, thin-layer preparations. Acta Cytol. 2002;46(2):291-295.

2.2 FocalPoint® & Conventional Pap Smear (Peer Reviewed)
Bulgaresi P, Cariaggi MP, Troni GM, Ciatto S. Quality control of the AutoPap screening system employed as a primary screening device: rapid review of smears coded as no further review. Tumori. 2006;92(4):276-278.
Rowe LR, Marshall CJ, Berry M, Larson MA, Bentz JS. Accuracy of a slide profiler for endocervical cell detection in no-further-review conventional pap smears. Acta Cytol. 2003;47(4):602-604.
Walts AE, Thomas P. Endometrial cells and the AutoPap system for primary screening of cervicovaginal Pap smears. Diagn Cytopathol. 2002;27(4):232-237.
Wilbur DC, Norton M. The primary screening clinical trials of the TriPath AutoPap system. Epidemiology. 2002;13(3)(suppl):S30-S33.
Tench W. Validation of AutoPap primary screening system sensitivity and high-risk performance. Acta Cytol. 2002;46(2):296-302.
Alasio LM, Alphandery C, Grassi P, Ruggeri M, De Palo G, Pilotti S. Performance of the AutoPap primary screening system in the detection of high-risk cases in cervico-vaginal smears. Acta Cytol. 2001;45(5):704-708.
Renshaw AA. Estimating the percentage of Papanicolaou smears that can be reproducibly identified: modeling Papanicolaou smear interpretation based on multiple blinded rescreenings. Cancer. 2001;93(4):241-245.
Renshaw AA, Lezon KM, Wilbur DC. The human false-negative rate of rescreening pap tests. Measured in a two-armed prospective clinical trial. Cancer. 2001;93(2):106-110.
Wiley BB, Matz LR. Use of the AutoPap as a primary automated cervical cancer screening system. Med J Aust. 2001;174(3):151-152.
McQuarrie H, Ogden J, Costa M. Understanding the financial impact of covering new screening technologies: the case of automated pap smears. J Reprod Med. 2000;45(11):898-906.
2.3 FocalPoint® GS Imaging System (Peer Reviewed)
(This section contains articles whose information has not been approved or cleared by the Food and Drug Administration in the United States)
Eichhorn JH, Brauns TA, Gelfand JA, Crothers BA, Wilbur DC. A novel automated screening and interpretation process for cervical cytology using the Internet transmission of low-resolution images: a feasibility study. Cancer. 2005;105(4):199-206.
Parker EM, Foti JA, Wilbur DC. FocalPoint slide classification algorithms show robust performance in classification of high-grade lesions on SurePath liquid-based cervical cytology slides. Diagn Cytopathol. 2004;30(2):107-110.
Stevens MW, Milne AJ, Parkinson IH, et al. Effectiveness of AutoPap system location-guided screening in the evaluation of cervical cytology smears. Diagn Cytopathol. 2004;31(2):94-99.
Ronco G, Vineis C, Montanari G, et al. Impact of the Autopap (currently FocalPoint) primary screening system location guide use on interpretation time and diagnosis. Cancer Cytopathol. 2003;99(2):83-88.
Confortini M, Bonardi L, Bulgaresi P, et al. A feasibility study of the use of the AutoPap screening system as a primary screening and location-guided re-screening device. Cancer Cytopathol. 2003;99(3):129-134.
Wilbur DC, Parker EM, Foti JA. Location-guided screening of liquid-based cervical cytology specimens. A potential improvement in accuracy and productivity is demonstrated in a preclinical feasibility trial. Am J Clin Pathol. 2002;118:399-407.
Chang AR, Lin WF, Chang A, Chong KS. Can technology expedite the cervical cancer screening process? A Hong Kong experience using the AutoPap primary screening system with location guided screening capability. Am J Clin Pathol. 2002;117(3)437-443.
2.4 AutoPap®300 QC System Studies (Peer Reviewed)
(The AutoPap 300 QC System was approved for use in the US as a quality control device in 1996. Effective January 1, 2000. the AutoPap 300 QC device was no longer commercially available. It has been replaced with the FocalPointslide profiler for primary screening for both the SurePathliquid-based Pap test and the conventional Pap smear)
Abulafia O, Sherer DM. Automated cervical cytology: meta-analyses of the performance of the AutoPap® 300 QC system. Obstet Gynecol Surv. 1999;54(7):469-476.
Fetterman B, Pawlick G, Koo H, Hartinger J, Gilber C, Connell S. Determining the utility and effectiveness of the NeoPath AutoPap® 300 QC system used routinely. Acta Cytol. 1999;43(3):13-22.
Marshall CJ, Rowe L, Bentz JS. Improved quality-control detection of false-negative Pap smears using the AutoPap® 300QC system. Diagn Cytopathol. 1999;20(3):170-174.
Berry MC, Bentz J, Farnsworth R, Marshall CJ. Evaluation of the AutoPap® 300 QC system for improving detection of endometrial disease. Acta Cytol. 1998;42:1252.
Colgan T, Bon N, Lee J, Patten S. AutoPap® 300 QC system scoring of cervical smears without “epithelial cell abnormalities.” Acta Cytol. 1997;41:45-49.
Colgan T, Smith J, Patten S, Lee J. Enhancing the performance of the AutoPap® 300 QC system with optimal staining and presentation of cervical smears. Acta Cytol. 1997:41:50-55.
Kaminsky F, Benneyan J, Mullins D. Automated rescreening in cervical cytology: mathematical models for evaluating overall process sensitivity, specificity and cost. Acta Cytol. 1997;41:209-223.
Patten SF, Lee JS, Wilbur DC, et al. The AutoPap® 300 QC system multicenter clinical trials for use in quality control rescreening of cervical smears: I. A prospective intended use study
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