Hologic ThinPrep, Руководство оператора

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MAN-08723-001 Rev. 001 page 10 of 28
seven Bethesda System classifications: ASCUS, LSIL, HSIL, AGUS, Glandular Cancer, Squamous
Cell Carcinoma and Adenocarcinoma-In-Situ.
Finally, the same Cytopathologist who had conducted the manual review of the entire ThinPrep ® Pap
Test slide, independently re-reviewed the slides using the identical method used by the
Cytotechnologists. The Cytopathologist was blinded from the original manual review results. For each
of the 22 fields of view selected by the ThinPrep Imaging System, the Cytopathologist verified and
recorded the number of individual cancer cells, clusters of cancer cells, and any other abnormalities
present.
Table 11 summarizes the results from this study:
Table 11: Summary of Results From Restricted Analytical Cancer Study
Cytopathologist Full Manual
Review
Cytotechnologist Review of Imager
Identified 22 Fields of View *
Cytopathologist Review of
Imager Identified 22 Fields
of View **
10 Glandular Cancer
5 Glandular Carcinoma
1
Squamous Cell Carcinoma
1 Adenocarcinoma In-situ
2
HSIL/AGUS
1 ASC-H/ASC-US
7 Glandular Carcinoma
1 Squamous Cell Carcinoma
1 AGUS
1 HSIL
1 Adenocarcinoma In-situ 1 Adenocarcinoma In-Situ 1 Adenocarcinoma In-Situ
22 Squamous Cell Carcinoma
3 Glandular Carcinoma
12 Squamous Cell Carcinoma
1 Squamous/Glandular Carcinoma
2 Adenocarcinoma In-situ
4 HSIL
21 Squamous Cell Carcinoma
1 Adenocarcinoma In-situ
Total = 33 Total = 33 Total = 33
* In the intended use of the ThinPrep Imaging System (Imager), the Cytotechnologist would perform a full manual slide review
of each of these cases and pass them on to a Cytopathologist for further review.
* *In the intended use of the ThinPrep Imaging System (Imager), the Cytopathologist would perform a full manual slide review of
each of these cases.
The results in Table 11 demonstrate the ability of the ThinPrep Imaging System to successfully identify
abnormalities in the 22 fields of view presented during the Autolocate mode of slide review. In all 33
cases in this study, the ThinPrep Imaging System identified and presented cells among the 22 fields of
view that were categorized as Cancer, HSIL, AGUS or ASCUS. In addition, the Cytopathologists’
confirming review of the identical 22 fields of view showed consistent, but slightly improved results
with all cases being categorized as Cancer, HSIL or AGUS. Consistent with the intended use of the
ThinPrep Imaging System, the Cytotechnologists’ diagnoses in every one of these 33 cases would have
invoked the full slide Autoscan mode that would require a Cytotechnologist to screen the entire slide
before making a final diagnosis. The results of this study indicate that ThinPrep Imaging System will
accurately lead to a full manual slide review for the detection of cervical cancer or its precursor lesions.
G.4 SPECIMEN ADEQUACY STUDY
Of the 10,359 subjects in the study, 9627 met the requirements for inclusion in the specimen adequacy
analysis.