Hologic thinprep 2000 - Conclusions; Materials Required

MAN-02624-001 Rev. 003 page 14 of 15
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
4-9
report on the improved ability of the ThinPrep 2000 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.
CONCLUSIONS
The ThinPrep
®
2000 System is as effective as the conventional Pap smear in a variety of patient
populations and may be used as a replacement for the conventional Pap smear method for the detection
of atypical cells, cervical cancer, or its precursor lesions, as well as all other cytologic categories as
defined by The Bethesda System.
The ThinPrep 2000 System is significantly more effective than the conventional Pap smear for the
detection of Low-grade Squamous Intraepithelial (LSIL) and more severe lesions in a variety of patient
populations.
Specimen quality with the ThinPrep 2000 System is significantly improved over that of conventional
Pap smear preparation in a variety of patient populations.
MATERIALS REQUIRED
MATERIALS PROVIDED
The ThinPrep 2000 System consists of the following components:
 ThinPrep Processor Instrument (Model TP 2000)  2 filter Caps
 PreservCyt
®
Solution vial  2 spare filter seal O-rings
 ThinPrep Pap Test Filter for Gynecologic Applications  Power cord
 Program Memory Card for Gynecologic Applications  ThinPrep Microscope slides
 Waste bottle assembly - includes bottle, bottle cap,
tubing set, fittings, waste filter
Additional items supplied:
 ThinPrep 2000 Operator’s Manual
 10 fixative vials
MATERIALS REQUIRED BUT NOT PROVIDED
 Slide staining system and reagents  20 ml PreservCyt
®
Solution vial
 Standard laboratory fixative  ThinPrep
®
Pap Test Filter for Gynecologic Applications
 Coverslips and mounting media  Cervical collection device