Effect of Thin Prep® imaging system on laboratory rate and relative sensitivity of atypical squamous cells, high-grade squamous intraepithelial lesion not excluded and high-grade squamous intraepithelial lesion interpretations
ABSTRACT Automated screening of Thin Prep(®) Papanicolaou Tests has become increasingly common in clinical practice. Increased productivity has initiated laboratory use of the Thin Prep(®) Imaging System (TIS). Increased sensitivity is a potential additional benefit of TIS. Published studies have shown an increase in discovery of dysplastic cells. This study evaluates the effect of TIS on the incidence of atypical squamous cells high-grade squamous intraepithelial lesion not excluded (ASC-H) and high-grade squamous intraepithelial lesion (HGSIL) results on Thin Prep(®) Pap Tests by comparing TIS-assisted and manual screening findings and the diagnoses on subsequent follow-up in a screening population over a 1-year time period.
A compilation of all ASC-H and HGSIL cases was prepared by conducting a computerized search over a 1-year period (7/06-6/07). The accumulated cases include Thin Prep Pap tests that were both TIS and manually screened. Follow-up results of cytologic and histologic cervical specimens were obtained for a time period extending to 2010. Interpretation utilizing TIS was in place 10 months prior to the study's initiation.
During the study period 70,522 Pap tests were performed in our laboratory. One third (33%) of Pap tests were screened with assistance of TIS. Manual screening was performed on 47,380 Pap tests of which 153 (0.32%) were interpreted as ASC-H and 164 (0.35%) were interpreted as HGSIL. During the same time period automated screening (TIS) was performed on 23,111 Pap tests. Interpretation of 62 (0.27%) cases provided an ASC-H result, while 71 (0.31%) were HGSIL. Follow-up cervical dysplasia by colposcopic biopsy and cone biopsy was distributed proportionally between TIS and manual screening for both ASC-H and HGSIL categories. Cervical intraepithelial neoplasia (CIN II/III) was identified on follow-up biopsy of 41% TIS cases and 45% manually screened cases for ASC-H. In the HGSIL subset 71% of TIS cases and 69% manually screened cases showed CIN II/III on follow-up. TIS was 26% less sensitive relative to manual screening for ASC-H cases and 3% less sensitive for HGSIL.
The similar rate of detection using TIS with an equal percentage of histologic correlation for ASC-H and HGSIL lesions on follow-up histology suggests patients screened by the TIS method are being sent for appropriate follow-up surveillance and treatment. A high-grade or possible high-grade lesion is as likely to be detected by TIS as by a manual screen. The similarities in relative sensitivity and specificity in a direct comparison between manual and TIS screening methodologies indicate that TIS compared to manual screening does not affect detection in patients with high-grade cervical lesions.
- CytoJournal 03/2014; 11:6. DOI:10.4103/1742-6413.129186
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ABSTRACT: Leveraging advances in consumer electronics and wireless telecommunications, low-cost, portable optical imaging devices have the potential to improve screening and detection of disease at the point of care in primary health care settings in both low- and high-resource countries. Similarly, real-time optical imaging technologies can improve diagnosis and treatment at the point of procedure by circumventing the need for biopsy and analysis by expert pathologists, who are scarce in developing countries. Although many optical imaging technologies have been translated from bench to bedside, industry support is needed to commercialize and broadly disseminate these from the patient level to the population level to transform the standard of care. This review provides an overview of promising optical imaging technologies, the infrastructure needed to integrate them into widespread clinical use, and the challenges that must be addressed to harness the potential of these technologies to improve health care systems around the world.Science translational medicine 09/2014; 6(253):253rv2. DOI:10.1126/scitranslmed.3009725 · 14.41 Impact Factor
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ABSTRACT: This study evaluated the effectiveness of the ThinPrep(®) Imaging System (TIS) and ThinPrep(®) Pap Stain (TPPS). A comparative analysis was conducted to determine the detection rates of atypical squamous cells, cannot exclude high-grade squamous intraepithelial lesion (ASC-H), the ASC:squamous intraepithelial lesion (SIL) ratio, biopsy follow-up for ASC-H in terms of the screening method used (manual screening [MS] vs. TIS screening [TISS]) and the staining protocol (regular Pap stain [RPS] vs. TPPS). This study was performed over two periods. The RPS period included manually screened slides, whereas the TPPS period included TIS + manually screened slides. All data from the study periods were compared using statistical analysis. The detection rate of ASC-H was significantly higher during the TPPS period than during the RPS period (0.49% vs. 0.23%); this finding is in contrast to the insignificant difference between the screening method periods. The positive predictive value (PPV) of ASC-H cytodiagnosis for cervical intraepithelial neoplasia of grade 2 or more severe histologies was significantly different between manually screened and TIS slides (22.10% vs. 38.55%), in contrast to an insignificant difference between RPS and TPPS periods (37.14% vs. 29.77%). Implementation of the TIS did not change the ASC-H detection rates appreciably. However, the new technology improved PPV for ASC-H cytodiagnosis and enabled the detection of true disease. Our laboratory statistics indicate that the TPPS is not a superior staining protocol and did not increase our diagnostic accuracy for ASC-H compared with RPS. Diagn. Cytopathol. 2015. © 2015 Wiley Periodicals, Inc. © 2015 Wiley Periodicals, Inc.Diagnostic Cytopathology 07/2015; DOI:10.1002/dc.23311 · 1.52 Impact Factor