Hologic ThinPrep 5000 Instruction Manual page 16

Glandular Disease Detection – Published Studies
The detection of endocervical glandular lesions is an essential function of the Pap test. However, abnormal glandular
cells in the Pap sample may also originate from the endometrium or from extrauterine sites. The Pap test is not
intended to be a screening test for such lesions.
When suspected glandular abnormalities are identified, their accurate classification as true glandular versus squamous
lesions is important for proper evaluation and subsequent treatment (e.g. choice of excisional biopsy method versus
conservative follow-up). Multiple peer-reviewed publications
system to detect glandular disease versus the conventional Pap smear. Although these studies do not consistently
address sensitivity of different Pap testing methods in detecting specific types of glandular disease, the reported
results are consistent with more frequent biopsy confirmation of abnormal glandular findings by the ThinPrep Pap
test compared to conventional cytology.
Thus, the finding of a glandular abnormality on a ThinPrep Pap test slide merits increased attention for
definitive evaluation of potential endocervical or endometrial pathology.
ThinPrep 5000 Processor Compared to ThinPrep 2000 System
A study was conducted to estimate the Positive Percent Agreement (PPA) and Negative Percent Agreement
(NPA) for specimens processed on the ThinPrep 5000 processor as compared with processing using the
ThinPrep 2000 System.
Clinical Study Design
The study was a prospective, multi-center, split-sample, blinded evaluation of ThinPrep slides of known
diagnoses generated from residual cytological specimens. The study was conducted at Hologic, Inc.,
Marlborough, MA and at two external laboratories in the United States.
One thousand two hundred sixty (1260) specimens were procured for and selected from Hologic's Residual
Specimen Inventory for Hologic's laboratory. At the external study sites specimens were from residual
cytological specimens from the clinical laboratory (after the laboratory has prepared a slide from the vial and has
signed-out the case per standard practice). The laboratory's specimens were only supplemented from Hologic's
inventory with the rarest cytologic diagnostic categories (AGUS and Cancer), if needed. Slides prepared for the
study were from specimens processed within 6 weeks of specimen collection.
All study specimens were processed both on a ThinPrep 5000 processor and a ThinPrep 2000 system. The order in
which the slides were processed was alternated in blocks of 20. All slides were stained, coverslipped, and read
manually following standard laboratory procedures; all slides prepared at a site were reviewed independently by
each of the three (3) pairs of cytotechnologists/pathologists. All cytologic diagnoses were determined in
accordance with the Bethesda System 2001 criteria for all slides
4-9
report on the improved ability of the ThinPrep 2000
1
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