Hologic ThinPrep 3000 User manual

HOLOGIC, INC.
250 CAMPUS DRIVE
MARLBOROUGH, MA 01752 USA
TEL: [phone]
1-508-263-2900
FAX: [phone]
WEB: WWW.HOLOGIC.COM
For Use With Version 1.x.y Software
ThinPrep
®
3000 Processor
Operator’s Manual
MAN-02586-001

Caution: Federal law restricts this device to sale by or on the order of a physician, or any other
practitioner licensed by the law of the State in which the practitioner practices to use or order the use
of the device and are trained and experienced in the use of the ThinPrep
®
3000 processor.
Preparation of microscope slides using the ThinPrep 3000 processor should be performed only by
personnel who have been trained by Hologic or by organizations or individuals designated by
Hologic.
Evaluation of microscope slides produced with the ThinPrep 3000 processor should be performed
only by cytotechnologists and pathologists who have been trained to evaluate ThinPrep-prepared
slides by Hologic or by organizations or individuals designated by Hologic.
© Hologic, Inc., 2017. All rights reserved. No part of this publication may be reproduced,
transmitted, transcribed, stored in a retrieval system, or translated into any language or computer
language, in any form, or by any means, electronic, mechanical, magnetic, optical, chemical, manual,
or otherwise, without the prior written permission of Hologic, Inc., 250 Campus Drive, Marlborough,
Massachusetts, 01752, United States of America.
Although this guide has been prepared with every precaution to ensure accuracy, Hologic assumes
no liability for any errors or omissions, nor for any damages resulting from the application or use of
this information.
This product may be covered by one or more U.S. patents identified at
http://hologic.com/patentinformation
Hologic, CellFyx, PreservCyt, and ThinPrep are trademarks or registered trademarks of Hologic, Inc.
and/or its subsidiaries in the United States and/or other countries. All other trademarks, registered
trademarks, and product names are the property of their respective owners.
Caution: Changes or modifications to this unit not expressly approved by the party responsible
for compliance could void the user’s authority to operate the equipment.
This equipment has been tested and found to comply with the limits for a Class A digital device,
pursuant to Part 15 of the FCC Rules. These limits are designed to provide reasonable protections
against harmful interference when the equipment is operated in a commercial environment. This
equipment generates, uses, and can radiate radio frequency energy; and if not installed and used
in accordance with the instruction manual, may cause harmful interference to radio
communications. Operation of this equipment in a residential area is likely to cause harmful
interference, in which case the user will be required to correct the interference at his own expense.
For Use with Model: ThinPrep
®
3000
Document Number: AW-07494-001 Rev. 006

The ThinPrep®
Processor
The ThinPrep®
Processor

MAN-03939-001 Rev. 004 page 1 of 13
Instructions for Use

MAN-03939-001 Rev. 004 page 2 of 13
INTENDED USE
The ThinPrep®3000 Processor (TP-3000) is a device that produces cytologic preparations
on glass microscope slides from gynecologic (cervical) samples, and is intended for use in
cervical cytologic examinations of material collected for the ThinPrep Pap Test. TP-3000
prepared microscope slides are examined by trained cytotechnologists and pathologists 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 cytologic criteria as defined by The Bethesda System for
Reporting Cervical/Vaginal Cytologic Diagnoses1(Bethesda System).
SUMMARY AND EXPLANATION OF THE SYSTEM
The ThinPrep process begins with the patient’s gynecologic sample being collected by the clinician,
which is then immersed and rinsed in a PreservCyt®Solution sample vial. The PreservCyt sample
vial is then capped, labeled, and sent to a laboratory equipped with a TP-3000.
At the laboratory, the PreservCyt sample vial is bar-coded along with the test request form to
establish a sample chain of custody and is placed into a TP-3000. A gentle dispersion step mixes
the cell sample by currents in the fluid that are strong enough to separate debris and disperse mucus,
but gentle enough to have no adverse effect on cell appearance.
The cells are then captured on a Gynecological ThinPrep Pap Test Filter that is specifically designed
to collect cells. The TP-3000 constantly monitors the rate of flow through the ThinPrep Pap Test
Filter during the collection process in order to prevent the cellular presentation from being too scant
or too dense. The TP-3000 will label the glass slide with the sample identification number read from
the bar-code on the sample vial. A thin layer of cells is then transferred to a glass slide in a 20 mm-
diameter circle. The slide is completed when its cells are fixed in place by a fixative solution
(CellFyx™Solution) that is applied automatically by the processor.
The ThinPrep Pap Test Slide Preparation Process
(1) Dispersion (2) Cell Collection (3) Cell Transfer
The cell sample is mixed by currents created
in the preservation fluid that are strong
enough to separate debris and disperse mucus,
but gentle enough to have no adverse effect
on cell appearance.
A gentle vacuum is applied to the ThinPrep
Pap Test Filter to collect cells. The ThinPrep Pap Test Filter is gently pressed against the ThinPrep Microscope Slide.
Positive pressure applied to the inside of the
filter assists in transferring the cells from the
filter membrane to the surface of the slide.
1. Dispersion 2. Cell Collection 3. Cell Transfer

MAN-03939-001 Rev. 004 page 3 of 13
As with conventional Pap smears, slides prepared with the TP-3000 are examined in the
context of the patient’s clinical history and information provided by other diagnostic
procedures such as colposcopy, biopsy, and human papillomavirus (HPV) testing, to
determine patient management.
The PreservCyt®Solution component of the ThinPrep 2000 System is an alternative
collection and transport medium for gynecologic specimens tested with the Cervista®
HPV HR Test, the Cervista®HPV 16/18 Test, the Roche cobas®HPV Test and the
Digene Hybrid CaptureSystem HPV DNA. Refer to the respective manufacturer’s
package inserts for instructions for using PreservCyt Solution for collection, transport,
storage, and preparation of specimens for use in those systems.
The PreservCyt Solution component of the ThinPrep 2000 System is an alternative
collection and transport medium for gynecologic specimens tested with the Hologic
APTIMA COMBO 2®CT/NG Assays, the Hologic APTIMA®Trichomonas vaginalis
Assay, and the BD ProbeTec™CT QxAmplified DNA Assay. Refer to the respective
manufacturer’s package inserts for instructions for using PreservCyt Solution for
collection, transport, storage, and preparation of specimens for use in those systems.
The PreservCyt Solution component of the ThinPrep 2000 System is also an alternative
collection and transport medium for gynecologic specimens tested with the Roche
Diagnostics COBAS AMPLICORTM CT/NG assay. Refer to Hologic’s labeling
(Document #MAN-02063-001) for instructions for using PreservCyt Solution for
collection, transport, storage, and preparation of specimens and to the Roche Diagnostics
COBAS AMPLICOR CT/NG package insert for instructions for use of that system.
LIMITATIONS
Gynecologic samples collected for the TP-3000 should be collected using a broom-
type or endocervical brush/plastic spatula combination collection devices. Refer to
the instructions provided with the collection device for warnings, contraindications,
and limitations associated with specimen collection.
Preparation of slides on the TP-3000 should be performed only by personnel who
have been trained by Hologic or by organizations or individuals designated by
Hologic.
The staining procedure using the CellFyx®Fixative Solution has been demonstrated
for Papanicolaou stain only.
Evaluation of slides prepared on the TP-3000 should be performed only by
cytotechnologists and pathologists who have been trained to evaluate ThinPrep Pap
Test slides by Hologic or by organizations or individuals designated by Hologic.
Supplies used for TP-3000 gynecologic slide preparations are those designed by
Hologic specifically for use on the instrument. These supplies include PreservCyt®
Solution vials for use with the ThinPrep Pap Test, ThinPrep Pap Test Filters,
ThinPrep Microscope Slides, and CellFyx Fixative Solution. For proper performance
of the system these supplies cannot be substituted. After use, supplies should be
disposed of in accordance with local, state, and federal regulations.
All supplies, with the exception of CellFyx Fixative Solution, are single-use
disposable items and cannot be reused.
The performance of HPV DNA and CT/NG testing on reprocessed sample vials has
not been evaluated.

MAN-03939-001 Rev. 004 page 4 of 13
CONTRAINDICATIONS
Chlamydia trachomatis and Neisseria gonorrhoeae testing using the Roche
Diagnostics COBAS AMPLICOR and Gen-Probe APTIMA COMBO 2®CT/NG
assays should not be performed on a sample that has already been processed using
the ThinPrep 3000 processor.
WARNINGS
For In Vitro Diagnostic Use.
Danger. PreservCyt Solution contains methanol. Toxic if swallowed. Toxic if
inhaled. Causes organ damage. Keep away from heat, sparks, open flames and hot
surfaces. Other solutions must not be substituted for PreservCyt Solution. PreservCyt
Solution should be stored and disposed of in accordance with local, state, and federal
regulations.
PRECAUTIONS
A TP-3000 generates, uses and can radiate radio frequency energy, and if not
installed and used in accordance with the Operator’s Manual, may cause interference
to radio communications. Operation of this equipment in a residential area is likely
to cause harmful interference, in which case, the user will be required to correct the
interference at his/her own expense.
PreservCyt Solution with cytologic sample intended for ThinPrep Pap testing must be stored
between 15oC(59oF) and 30oC (86oF) and tested within 6 weeks of collection.
PreservCyt Solution with cytologic sample intended for CT/NG testing using the Roche
Diagnostics COBAS AMPLICOR CT/NG test must be stored between 4oC (39oF) and 25oC
(77oF) and tested within 6 weeks of collection.
Excessively bloody samples may result in a higher unsatisfactory1rate.

MAN-03939-001 Rev. 004 page 5 of 13
PreservCyt Solution was challenged with a variety of microbial and viral organisms.
The following table presents the starting concentrations of viable organisms, and the
number of viable organisms found after 15 minutes in the PreservCyt solution. The
log reduction of viable organisms is also presented. As with all laboratory
procedures, universal precautions should be followed.

Organism Initial Concentration Log Reduction after
15 min.
Candida albicans 5.5 x 105CFU/mL >4.7
Aspergillus niger* 4.8 x 105CFU/mL 2.7
Escherichia coli 2.8 x 105CFU/mL >4.4
Staphylococcus aureus 2.3 x 105CFU/mL >4.4
Pseudomonas aeruginosa 2.5 x 105CFU/mL >4.4
Mycobacterium tuberculosis** 9.4 x 105CFU/mL 4.9
Rabbitpox virus 6.0 x 106PFU/mL 5.5***
HIV-1 1.0 x 107.5 TCID50/mL 7.0***

* After 1 hour >4.7 log reduction
** After 1 hour >5.7 log reduction
*** Data is for 5 minutes
PERFORMANCE CHARACTERISTICS: REPORT OF CLINICAL
STUDIES
A prospective multi-center clinical study was conducted at three sites to evaluate the
performance of the TP-3000 in direct comparison to the ThinPrep®2000 Processor (TP-
2000). The objective of this clinical study was to demonstrate that gynecologic specimens
prepared using both instruments were equivalent when used for the detection of atypical
cells and cervical cancer or its precursor lesions in a variety of patient populations. In
addition, an assessment of specimen adequacy was performed.
The initial clinical study protocol was a single-masked, direct-to-vial, matched-pair study,
for which the order of preparation for each instrument was randomized. At the laboratory,
the PreservCyt sample vial was placed into both a TP-3000 and a TP-2000 and two slides
were prepared (one per instrument) from the patient’s sample. All slides were examined
and diagnosed independently. The same cytotechnologist and pathologist (if referred)
reviewed each matched-paired slide set. To minimize slide recognition bias there was a
minimum one-day lag between the cytotechnologist and pathologist review of all slides
from a matched-pair set. Reporting forms containing patient history as well as a checklist
of all possible categories of the Bethesda System were used to record the results of the
screening. A panel of three independent pathologists adjudicated all discordant cases (a
one-grade or higher cytologic difference) in a masked fashion to determine a consensus
diagnosis.

MAN-03939-001 Rev. 004 page 6 of 13
LABORATORY AND PATIENT CHARACTERISTICS
The cytology laboratories participating in the study were comprised of one referral center
(designated as S1), one screening/referral center (designated as S2) and one screening
center (designated as S3).
The screening center in the study served patient populations (screening populations) with
rates of abnormality (Low-grade Squamous Intraepithelial Lesion [LSIL] and more severe
lesions) similar to the United States average of less than 5%.3The referral center in the
study served a high risk referral patient population (referral populations) characterized by
high rates (>10%) of cervical abnormality. The screening/referral center’s abnormality rate
was a combination of the two previously mentioned rates. Table 1 describes the
laboratories and the patient populations.
Table 1: Site Characteristics
Laboratory Characteristics Clinical Study Demographics
Site Type of Patient
Population Laboratory Volume -
Smears per
Year
Cases Patient
Age Range Post Menopausal
%
Previous
Abnormal
Pap Smear
%
Con-current
Infection
%
S1 Referral 44,709 1188 18-85 11.8 51.8 35.2
S2 Screening/Refer
ral 62,195 1141 18-77 6.0 21.8 15.1
S3 Screening 90,639 1198 18-82 12.5 22.7 10.2
Cases with patient’s age less than 18 years or patients with a hysterectomy were
excluded from this analysis.
CLINICAL STUDY RESULTS
The diagnostic classes of the Bethesda System are used to present the comparison between
the TP-3000 and TP-2000 findings from all of the clinical trial sites.
Three independent pathologists served as an adjudication panel for the three clinical sites.
The panel reviewed all discordant cases (a one-grade or higher cytologic difference) for
descriptive diagnosis and specimen adequacy. Since a true reference cannot be determined
in such studies and therefore true sensitivity cannot be calculated, the use of an independent
adjudicated review provides an alternative to histologic confirmation by biopsy or human
papillomavirus (HPV) testing as a means for determining the reference diagnosis.
Consensus was determined when a minimum of 2 out of 3 independent pathologists
rendered an equivalent diagnosis. If a majority vote could not be obtained, a consensus was
achieved during a review by all three pathologists at a multi-headed scope.
Table 2 shows the unadjudicated descriptive diagnosis results from all sites for the TP-
3000 and TP-2000. Of the 3,527 total patients enrolled in the study, 3,224 were included
in the descriptive diagnosis analysis after all data integrity sorting was applied.
Few cases of cervical cancer were represented in the clinical study, as is typical in the
United States patient population.4