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ThinPrep Imaging System

Hologic has a long track record of developing innovative solutions that transform the world of cytology.

Our ThinPrep imaging system represents a significant advance in diagnostic capability, blending the best of computer imaging technology and human expertise. The ThinPrep imager automatically scans every cell and cell cluster, highlighting areas of interest for human analysis. When an experienced cytotechnologist reviews an imaged ThinPrep Pap test slide with an automated microscope, such as the Review Scope Manual Plus, the areas of special interest are clearly marked for interpretation. This Dual Review technology improves screening efficiency, combining human interpretive skill with computer analysis.

About

The ThinPrep imaging system provides Dual Review which ensures that every ThinPrep Pap test gets two different reviews: one full review by the ThinPrep imager and another by an experienced cytotechnologist. With every slide analyzed by the ThinPrep imager and screened by an experienced cytotechnologist, two unique components are combined for comprehensive and accurate cervical cancer testing.

Dual Review screening, available for use with the Hologic ThinPrep Pap test, has been proven to reduce false negative rates,2 allowing for greater confidence in test results. With Dual Review screening, computer-assisted automation pre-screens slides and identifies cells of interest based on the DNA content of individual cells and cell clusters. When experienced cytotechnologists review imaged ThinPrep Pap test slides using an automated microscope, the areas of special interest are clearly marked for interpretation, helping them better focus their interpretive skills where they matter most.

Performance Data

The ThinPrep imaging system has been shown to provide increased sensitivity and specificity over manually reviewed ThinPrep Pap test slides.

Imager clinical trial results showed a statistically significant increase in ASCUS+ sensitivity of 6.4% [95% CI: 2.6-10.0], a statistically significant increase in HSIL+ specificity of 0.2% [95% CI: 0.06-0.4],1 while a 2007 study by Miller and colleagues found a 42% increase in HSIL detection and a 37% increase in LSIL detection, compared to manually reviewed ThinPrep Pap test slides.2  

Other improvements were also reported, including a reduced false negative fraction and decreases in the unsatisfactory and ASCUS rates.2

 
Our Technology

Hologic's proprietary DNA stain is used to stain cervical cell nuclei. Abnormal cells have increased amounts of molecular DNA and tend to be larger or irregularly shaped. In addition, the nuclei in abnormal cells take up more stain than the nuclei in normal cells. The presence of irregularly shaped, large and darkly stained cells indicates that the sample may be abnormal.

The ThinPrep imaging system scans each slide and identifies 22 fields that contain cells of interest. The cytotechnologist can then review those 22 fields using the automated Review Scope Manual Plus microscope. If all fields are judged to be normal, "no intraepithelial lesion" is reported. If the cytotechnologist judges cells in any field to be suspicious, the entire slide is manually reviewed, and abnormal cell groups are marked for further review by a pathologist.

Accessories

Review Scope Manual Plus

The Review Scope Manual Plus is the automated microscope for use with the ThinPrep imaging system. It combines the features of an automated review scope with the flexibility of a standard microscope, providing increased comfort and control to the cytotechnologist:

  • Greater control during Autoscan, with the Review Scope Manual Plus allowing the cytotechnologist to move the stage manually for greater flexibility and control.
  • Increased comfort, with ergonomically designed controls that allow for intuitive stage adjustments.
  • Reduced space; can be used as a manual scope for the screening of non-imaged slides, eliminating the need for two scopes within the work station.

Additional features include:

  • Touchscreen control, which creates a modern, user-friendly interface.
  • 4x, 10x and 40x objectives.
  • Automatic alignment of fiducial marks on ThinPrep imaging system slides.
  • Designed to be used with a standard or telescoping head.
References
  1. ThinPrep Imaging System Package Insert
  2. Miller, et al. Implementation of the ThinPrep Imaging System in a High Volume Metropolitan Laboratory. Diag Cytopath. 2007;35:213-7
Bibliography
  • Biscotti C, Dawson A, Dziura B, Galup L, Darragh T, Rahemtulla A, Wills-Frank L. Assisted primary screening using the automated ThinPrep Imaging System. Am J Clin Pathol. 2005;123(2):281-7.

  • Bolger N, Heffron C, Regan I, Sweeney M, Kinsella S, McKeown M, Creighton G, Russell J, O’Leary J. Implementation and evaluation of a new automated interactive image analysis system. Acta Cytol. 2006;50(5):483-91.

  • Chivukula M, Saad RS, Elishaev E, White S, Mauser N, Dabbs DJ. Introduction of the ThinPrep Imaging System (TIS): experience in a high volume academic practice. CytoJournal. 2007;4:6.

  • Cibas E, Hong X, Crum C, Feldman. Age-specific detection of high risk HPV DNA in cytologically normal computer-imaged ThinPrep Pap samples. Gynecol Oncol. 2007;104(3):702-6.

  • Dawson A. Clinical experience with the ThinPrep Imager System. Acta Cytol. 2006;50(5):481-2. Editorial.

  • Dawson AE. The changing face of cervical screening: challenges for the future. Diagn Cytopathol. 2005;33(2):63-4. Editorial.

  • Dawson A. Can we change the way we screen?: The ThinPrep Imaging System. Cancer (Cancer Cytopathol). 2004;102(6):340-4.

  • Davey E, d’Assuncao J, Irwig L, Macaskill P, Chan SF, Richards A, Farnsworth A. Accuracy of reading liquid based cytology slides using the ThinPrep Imager compared with conventional cytology: prospective study. British Medical Journal. 2007;335(7609):28.

  • Davey E, Irwig L, Macaskill P, Chan S, D’Annuncao J, Richards A, Farnsworth A. Cervical cytology reading times: a comparison between ThinPrep Imager and conventional methods. Diagn Cytol. 2007;35(9):550-4.

  • Dziura B, Quinn S, Richard K. Performance of an imaging system vs. manual screening in the detection of squamous intraepithelial lesions of the uterine cervix. Acta Ctyol. 2006;50(3):309-11.

  • Friedlander MA, Rudomina D, Lin O. Effectiveness of the ThinPrep Imaging System in the detection of adenocarcinoma of the gynecologic system. Cancer (Cancer Cytopathol). 2008;114(1):7-12.

  • Holund B, Grinsted P. Screening for cervical cancer in the country of Funen. Status of 25 years of development and experience. Ugeskr Laeger. 2006;168(22):2163-6. Article in Danish.

  • Lozano R. Comparison of computer-assisted and manual screening of cervical cytology. Gynecologic Oncology. 2007;104(3):702-6.

  • Miller FS, Nagel LE, Kenny-Moynihan MB. Implementation of the ThinPrep Imaging System in a high-volume metropolitian laboratory. Diagn Cytopathol. 2007;35(4):213-7.

  • Papillo JL, St. John TL, Leiman G. Effectiveness of the ThinPrep Imaging System: clinical experience in a low risk screening population. Diagn Cytopathol. 2008;38(3):155-60.

  • Roberts J, Thurloe J, Bowditch R, Hyne S, Greenberg M, Clarke J, Biro C. A three-armed trial of the ThinPrep Imaging System. Diagn Cytopathol. 2007;35(2):96-102.

  • Schledermann D, Hyldebrandt T, Ejersbo D, Hoelund B. Automated screening versus manual screening: a comparison of the ThinPrep Imaging System and manual screening in a time study. Diagn Cytopathol. 2007;35(6):348-52.

  • Zhang FF, Banks HW, Langford SM, Davey DD. Accuracy of ThinPrep Imaging System in detecting low-grade squamous intraepithelial lesions. Arch Pahtol Lab Med. 2007;131:773-6.

  • Zhao C, Elishaev E, Yuan K, Yu J, Austin RM. Very low human papillomavirus DNA prevalence in mature women with negative computer-imaged liquid-based Pap tests. Cancer (Cancer Cytopathol). 2007;111(5):292-7.