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Chapter III.  Results



                       1.     HPV specimen obtained or processed (or both) only for women with abnormal

                              cytologic diagnoses on Pap testing;


                       2.     Performance of HPV for predicting presence of CIN evaluated by colposcopy

                              and/or histology as the reference standard;


                       3.     HPV test and reference standard applied within an average of 3 months; and

                       4.     A validation of negative HPV results, such that a complete 2x2 table relating the


                              HPV test findings to the reference standard can be completed.

                       Table 10 summarizes the study populations and severity of disease identified in


               populations included in the studies relevant to HPV testing as a triage tool.  Although the

               majority of these studies required an abnormal Pap test for enrollment, we required only that the


               HPV test and the colposcopy and/or histology, and not Pap testing, occur within an average of 3

               months’ time.  Two of these studies were conducted in countries in which initial ASCUS and/or

               low grade cytologic findings are followed by repeat Pap testing.  Colposcopy is only done if


               repeat cytology suggests risk of a high grade lesion. 66,67   This approach lengthens the time

               between the index Pap and the use of HPV testing and colposcopy.  It also increases the


               probability that women undergoing colposcopy will have a histologic lesion.  As a result of such

               cytology-based triage, the studies from Iceland and the Netherlands reflect a comparatively high


               prevalence of high grade lesions. 66,67   This finding has implications for this report because the

               prevalence of high grade lesions in these studies is higher than one would expect if HPV testing


               were used as initial triage at the time of a first abnormal Pap test, and prevalence does influence

               diagnostic test characteristics.  These studies may not be as informative for US clinicians


               because within our screening approach, HPV is most attractive as a triage tool for guiding









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