[436] 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).

Comparison of SurePath Pap Diagnoses Before and After Implementation of the FocalPoint GS System

	FocalPoint Slide Profiler		FocalPoint GS
Diagnostic Category	No. of Cases	Percentage	No. of Cases	Percentage
Negative	25,977	91.5	23,621	89.1
ASCUS	1,244	4.4	1,695	6.4
LSIL	841	3.0	883	3.3
HSIL	59	0.2	57	0.2
ASC-H	52	0.2	83	0.3
AGC	19	0.1	45	0.2
Malignancy	6	0.0	1	0.0
Unsatisfactory	202	0.7	140	0.5
Total	28,400	100	26,525	100

Conclusions: In our laboratory, the use of the location-guided imaging system resulted in a small increase in the detection of LSIL, but not HSIL. In addition, there was an increase in the proportion of atypical categories with the use of the FocalPoint GS imaging system. The lack of statistically significant differences may be attributable to the low number of cases.
Category: Cytopathology

Tuesday, March 23, 2010 9:30 AM

Poster Session III # 75, Tuesday Morning