Page 61 - Screening for Cervical Cancer: Systematic Evidence Review
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Chapter III.  Results



                       These Hybrid Capture II estimates include an easily delineated group of women with

               HIV infection who had high prevalence of HSIL — 17.3% among the HIV-infected women in


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               the Womack and colleagues cohort.   Excluding HIV-infected women from the aggregate test
               performance estimates should have the largest influence on the predictive values, because these


               are determined by prevalence.  However, these women make up a small portion of the overall

               total and the estimates of performance characteristics are essentially unchanged.  To further


               describe Hybrid Capture II performance in low-prevalence populations, we calculated aggregate

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               data for only those studies 21,62,64  or arms of studies  in which the prevalence of HSIL was 10%

               or lower.  In these conditions, sensitivity is somewhat lower at 81.6%; specificity is similar at

               78.2%; positive predictive value is reduced to 18.2% and negative predictive value is 98.6%,


               essentially unchanged compared to the estimates that include all studies using Hybrid Capture II

               regardless of prevalence.




               HPV Screening for Detection of Low-Grade Cervical Changes



                       Four of the screening studies include data that allow estimation of test performance if


               LSIL is included among the lesions targeted for detection by HPV testing.  The sensitivity of a

               positive Hybrid Capture II test for high-risk HPV types for detecting histology-proven LSIL or


               greater ranged from 45.2% to 85.9%. 21,62,64   Specificities were between 47.0% and 96.7%. 21,62,64

               Details of test performance for detecting low-grade and higher lesions are provided in Table 9.

                       Cuzick and colleagues study of women having screening at their primary care providers’


               offices in the United Kingdom is likely the most comparable to screening in the United States,

               the relative performance of the SHARP (Digene Corp.) microtiter format PCR test and the


               Hybrid Capture II is of interest.  Both tests delivered similar performance: sensitivity of 64.3%





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