Abstract
BackgroundAutomated screening of Papanicolaou tests (Pap tests) improves the productivity of cytopathology laboratories. The ThinPrep® Imaging System (TIS) has been widely adopted primarily for this reason for use on ThinPrep® Pap tests (TPPT). However, TIS may also influence the interpretation of Pap tests, leading to changes in the frequency of various interpretive categories. The effect of the TIS on rates of TPPT interpretation as atypical squamous cells of undetermined significance (ASC-US) is of concern because any shift in the frequency of ASC-US will alter the sensitivity and specificity of the Pap test. We have sought to determine whether automated screening of TPPT has altered ASC-US rates in our institution when compared with manual screening (MS) of TPPT.MethodsA computerized search for all ASC-US with reflex Human Papillomavirus (HPV) testing over a one-year-period (7/1/06 to 6/30/07) was conducted. Cases included both TPPT screened utilizing TIS and screened manually. HPV test results for both groups were recorded. Pertinent follow-up cervical cytology and histology results were retrieved for the period extending to 11/30/07. Automated screening was in clinical use for 10 months prior to the start of the study.ResultsAutomated screening was performed on 23,103 TPPT, of which 977 (4.23%) were interpreted as ASC-US. Over the same period, MS was performed on 45,789 TPPT, of which 1924 (4.20%) were interpreted as ASC-US. Reflex HPV testing was positive for high risk (HR) types in 47.4% of the TIS cases and 50.2% of MS cases. Follow-up cervical dysplasia found by colposcopy was also distributed proportionally between the two groups. Cervical intraepithelial neoplasia (CIN) was found on follow-up biopsy of 20.1% of the TIS cases (5.2% CIN 2/3) and 21.2% of MS cases (5.1% CIN 2/3). None of these differences were statistically significant.ConclusionUse of the ThinPrep® Imaging System did not appreciably change ASC-US rates or follow-up reflex HPV test results in our laboratory. This demonstrates that the benefits of automated screening may be obtained without increasing the rate of referral to colposcopy for ASC-US follow-up.
Highlights
Automated screening of ThinPrep® Papanicolaou Tests (TPPT) has become increasingly common in clinical practice
This study evaluates the effect of the ThinPrep® Imaging System (TIS) on atypical squamous cells of undetermined significance (ASC-US) rates on ThinPrep® Pap tests (TPPT) and subsequent follow-up in a screening population arbitrarily divided between manual and TIS-assisted screening, over a single time period, with reflex Human Papillomavirus (HPV) test result feedback
Our results indicate that use of the TIS has had no appreciable effect on the ASC-US rate in our laboratory
Summary
Automated screening of ThinPrep® Papanicolaou Tests (TPPT) has become increasingly common in clinical practice. Published studies have consistently shown that this system leads to the discovery of a higher proportion of slides with dysplastic cells leading to an interpretation of either low-grade or high-grade squamous intraepithelial lesion (LSIL or HSIL) [2,3,4,5,6,7,8]. This increase in sensitivity does not appear to come at the expense of specificity, as follow-up biopsies show a corresponding increase in the frequency of discovery of dysplastic lesions [3]. We have sought to determine whether automated screening of TPPT has altered ASC-US rates in our institution when compared with manual screening (MS) of TPPT
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