Impact of a Location-Guided Imaging System on the Frequency Distribution of Diagnostic Categories in Gynecologic Cytology Using SurePath Preparation
AW Levi, M Harigopal, KM Schofield, DC Chhieng. Yale University School of Medicine, New Haven, CT
Background: Recently, the FDA has approved the use of the location-guided imaging system, FocalPoint GS, (Becton Dickinson, Burlington NC) on SurePath Pap tests (Becton Dickinson) for primary screening. The objective of the current study was to evaluate the impact of the use of the FocalPoint GS on the distribution frequency of diagnostic categories before and after implementation of the location-guided imaging system.
Design: A search of the laboratory information system (Co-Path) was performed to identify all SurePath Pap tests processed in our laboratory the first 4 months (from 5/09 to 9/09) after implementation of the location-guided imaging system. We also collected data from 5/08 to 9/08 on all SurePath Pap tests processed in our laboratory, as the control. During the period from 5/08 to 9/08, the FocalPoint Slide Profiler (Becton Dickinson) was used for imaging. The number of cases in each diagnostic category was obtained, percentages were calculated, and then compared. Diagnostic categories included the following: negative, ASCUS, LSIL, HSIL, ASC-H, AGC, positive for malignancy, and unsatisfactory.
Results: The results are summarized in TABLE 1. The use of the location-guided imaging system resulted in higher percentage of LSIL, ASCUS, ASC-H, and AGC. However, the difference was not statistically significant (2 tailed paired student t-test, p>0.05). The ASC to SIL ratio was 1.4 and 1.9, before and after implementation of the FocalPoint GS imaging system, respectively. Again, the difference was not statistically significant (z test, p>0.05).
|FocalPoint Slide Profiler||FocalPoint GS|
|Diagnostic Category||No. of Cases||Percentage||No. of Cases||Percentage|