Hologic ThinPrep Operator's Manual page 35

H. Clinical Investigation Conclusions

When ThinPrep Integrated Imager is compared to ThinPrep Imaging System, reviewers achieved
higher sensitivity in all abnormal categories. There was some decrease in specificity.

For ASCUS+ slides, the increase of sensitivity was 3.8% with 95% confidence interval of
2.6% to 5.0% and a decrease of specificity was -1.9% with 95% confidence interval of
-2.8% to -1.0%.

For LSIL+ slides, the increase in sensitivity was 5.8% with 95% confidence interval of
4.1% to 7.5% and a decrease of specificity was -1.9% with a 95% confidence interval of
-2.6 to -1.2%

For HSIL+ the increase in sensitivity was 7.9% with a 95% confidence interval of 4.5% to
11.2% and a decrease in specificity of -1.1% with a 95% confidence interval of -1.6% to
-0.6%.

Considering the technological similarity of the ThinPrep Imaging System and the comparative
clinical study results, it is concluded that the ThinPrep Integrated Imager is similar to the ThinPrep
Imaging System and may be used as replacement for manual review of ThinPrep
prepared on the ThinPrep 2000 System and the ThinPrep 5000 processor for the presence of atypical
cells, cervical neoplasia, including its precursor lesions (Low Grade Squamous Intraepithelial
Lesions, High Grade Squamous Intraepithelial Lesions), and carcinoma as well as all other
cytological criteria as defined by the Bethesda System.

The screening volume for the CTs when using the Integrated Imager for the imaging and review of
slides is within the Clinical Laboratory Improvement Amendments (CLIA) guidelines for total
number of slides that can be screened in one day.

In order to increase the number of slides that can be reviewed by a cytotechnologist in one day,
slides can be imaged in advance (in batched modality) and then reviewed by the CT in a batch.

The number of slides that a cytotechnologist can scan and review in one day is less on the Integrated
Imager than the ThinPrep Imaging System.

Performance may vary from site to site as a result of differences in patient populations and
reading practices. As a result each laboratory using this device should employ quality
assurance and control systems to ensure proper use and selection of appropriate workload
limits.

For these clinical sites and these study populations, the data from the clinical trial
demonstrate that the use of the ThinPrep Integrated Imager to assist in primary cervical
cancer screening of ThinPrep
neoplasia, including its precursor lesions, and carcinoma as well as all other cytological
criteria as defined by the Bethesda System, is safe and effective for the detection of cervical
abnormalities.
Bibliography
1. Nayar R, Wilbur DC. (eds). The Bethesda System for Reporting Cervical Cytology: Definitions,
Criteria, and Explanatory Notes. 3rd ed. Cham, Switzerland: Springer: 2015
2. Hologic, Inc. ThinPrep
number MAN-03938-001.
®
Pap Test slides for the presence of atypical cells, cervical
®
Imaging System Operation Summary and Clinical Information. Part
®
Pap Test slides
MAN-05359-001 -001 Rev. 001 page 31 of 32