Abstract
ObjectiveSince the introduction of the liquid-based ThinPrep testing in 1996, most cytology laboratories across the country have adopted the liquid-based cytology (LBC) for Pap test screening. Subsequent to wide-spread adoption of the ThinPrep Pap test, the ThinPrep Imaging System (TIS) Cytyc Corp, Marlborough, MA was introduced to improve the accuracy and efficiency of screening interpretation. We report our initial experience with the TIS at Magee Women's Hospital. We introduced the TIS in December 2004.MethodsThe imager assisted Pap test results over the first 12 months (December 2004 to December 2005) of implementation were reviewed and analyzed. Our implementation protocol included each cytotechnologist manually prescreening 200 negative slides to gain experience with the imager slides and serve as a quality check for the TIS. We re-screened 3400 slides (200 slides each for 17 cytotechnologists) manually which were initially determined to be negative using the TIS. 104,457 Pap tests were imaged on the TIS. 95,899 manually screened Pap tests, 12 months prior to the introduction of the TIS (December 2003–November 2004) are taken as the historic control group for our study.ResultsThe mean ASC-US rate employing the automated imager was 8.70% [9088/104,457]. The mean LSIL detection rate was 4.22% [4409/104,457]. The imager did not miss any detectible high-grade lesions during these months, with a HSIL (+) detection rate of 0.68% in comparison to 0.60% by manual screening confirmed by follow-up biopsies. The difference is statistically significant with a p value of 0.022. The definition of false negative rate for purposes of this study is calculated as the number of false negative cases identified out of number of negatives re-screened. The TIS false negative rate was estimated at 0.012% [4/3400].ConclusionThe overall performance of the TIS in our lab appears to be highly satisfactory in terms of improving sensitivity in screening cervical precursor lesions. The increased accuracy of detection of HSIL indicates a positive impact of the TIS in our laboratory.
Highlights
Introduction of the Thin Prep ImagingSystemTM (TIS): experience in a high volume academic practiceMamatha Chivukula*, Reda S Saad, Esther Elishaev, Susan White, Nancy Mauser and David J DabbsAddress: Department of Pathology, Magee-Womens Hospital of University of Pittsburgh Medical Center, Pittsburgh, PA, USAPublished: 8 February 2007 CytoJournal 2007, 4:6 doi:10.1186/1742-6413-4-6Received: 3 March 2006 Accepted: 8 February 2007This article is available from: http://www.cytojournal.com/content/4/1/6 Abstract
The imager did not miss any detectible high-grade lesions during these months, with a HSIL (+) detection rate of 0.68% in comparison to 0.60% by manual screening confirmed by follow-up biopsies
A multicenter clinical trial has shown that the ThinPrep® Imaging system (TIS) is more sensitive than manual screening for Atypical Squamous Cells of Undetermined Significance or Higher [ASC-US (+)], while its sensitivity in the clinical trials was equivalent for Low grade squamous intraepithelial lesion (LSIL (+)) and High-grade squamous intraepithelial lesion (HSIL (+)) results
Summary
The review scope is a microscope connected to the imager with an automated stage and a control pad connected via Ethernet cables to enable locating 22 fields of interest These fields are screened by the cytotechnologist for the presence of abnormal cells. Of the centers which have validated and reported their experiences with the TIS imager, most are still in the form of abstracts [8,9,10,11,12,13,14,15,16,17,18,19], with available peer-reviewed papers reflecting data from the clinical trial studies [3,4]. Pap Tests that were manually screened during the 12-month period prior to the introduction of the TIS in our laboratory were used as the historical control group for our study
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