Hologic ThinPrep, Operator'S Manual

Page: 13 / 230

MAN-08723-001 Rev. 001 page 9 of 28
Among the 138 cases determined by the adjudication panel to be HSIL, 108 (78.3%) cases in the
Imager Review arm and 100 (72.5%) cases in the Manual Review arm were diagnosed as HSIL and
2 (1.4%) cases in the Imager Review arm and 6 (4.3%) cases in the Manual Review arm were
diagnosed as Negative.
There was one (1) squamous cell carcinoma (SQ CA) case resulting from adjudication. It was
diagnosed as HSIL in the
Imager Review arm and SQ CA in the Manual Review arm.
Table 10 shows the study subjects unadjudicated descriptive diagnosis marginal frequencies for
benign cellular changes for all sites combined.
Table 10: Unadjudicated Marginal Frequencies Summary of Descriptive Diagnosis
for Benign Cellular Changes – All Sites Combined.
Manual Review Imager Review
Number of Patients: 9550 9550
Descriptive Diagnosis N % N %
Benign Cellular Changes:
405 4.2 293 3.1
Infection:
Trichomonas Vaginalis 8 0.1 8 0.1
Fungal organisms consistent with Candida spp. 47 0.5 31 0.3
Predominance of coccobacilli 71 0.7 60 0.6
Bacteria consistent with Actinomyces spp. 1 0.0 1 0.0
Cellular Changes associated with Herpes virus 1 0.0 1 0.0
Other Infection 1 0.0 0 0.0
Reactive Cellular Changes Associated with:
Inflammation 218 2.3 156 1.6
Atrophic with inflammation (atrophic vaginitis) 68 0.7 46 0.5
Radiation 0 0.0 0 0.0
Intrauterine contraceptive device (IUD) 0 0.0 0 0.0
Other Reactive Cellular Change 34 0.4 14 0.1
Note: Some patients had more than one diagnostic subcategory .
The Manual Review showed a higher rate of Benign Cellular Changes (405) than the Imager
Review cases (293).
G.3 ANALYTICAL PERFORMANCE OF THINPREP IMAGING SYSTEM FOR
DETECTION OF CERVICAL CANCER USING THINPREP ® PAP TEST SLIDES
FRESHLY PREPARED FROM ARCHIVAL SAMPLES
This analytical study was conducted to compare the Bethesda System 2001 results, obtained by a
Cytotechnologist and a Cytopathologist, when their review was limited to 22 fields that were selected
by the ThinPrep Imaging System, to their diagnostic results obtained from their independent blinded
review of the entire cell spot on the ThinPrep Pap Test slides. All of the reviews were performed in an
independent and blinded manner. The test materials consisted of 33 archival PreservCyt-preserved
cervical samples that had been previously diagnosed as AGUS or cancer. One ThinPrep Pap Test slide
was freshly prepared from each of the 33 original PreservCyt vials. All of the ThinPrep slides used in
the study were made on the TP-2000 processor and stained with ThinPrep Stain. Based on the current
cervical cancer prevalence rate in the United States, 33 cases of cervical cancer would represent the
number of invasive cervical cancer cases in a population of approximately 275,000 women
4
.
Initially, a board-certified Cytopathologist manually reviewed all of the fields on the ThinPrep Pap Test
slides and identified and recorded the number of individual cancer cells and clusters of cancer cells that
were present. For this part of the study, the Cytopathologist was not required to record any other cells
with other Bethesda System 2001 diagnoses. The 33 cases included slides that represented both rare
numbers of cancer cells (5-20 per slide), and numerous cancer cells (>20/slide). Cancer cells were
categorized according to Bethesda System 2001 criteria for Glandular Cancer, Adenocarcinoma- in-
situ and Squamous Cell Cancer. Each slide was then processed on a ThinPrep Imaging System. The
Cytotechnologist then reviewed
only the 22 fields of view presented by the Autolocate mode of the
Review Scope. No review outside of the selected 22 fields of view was permitted. For each field of
view, the Cytotechnologist counted and recorded all abnormal cell types based on the following