Hologic thinprep 2000 User manual

ThinPrep®2000 Processor Operator’s Manual
Operator’s Manual
MAN-02585-001 Rev. 005
LABORATORY SOLUTIONS

ThinPrep
®
2000 System
Operator’s Manual
HOLOGIC, INC.HOLOGIC (UK) LIMITED
250 CAMPUS DRIVE UNIT 2, LINK 10 NAPIER WAY
MARLBOROUGH, MA 01752 USA CRAWLEY, WEST SUSSEX RH10 9RA
TEL: [phone] UNITED KINGDOM
1-508-263-2900 TEL: [phone]
FAX: [phone] FAX: [phone]
WEB: WWW.HOLOGIC.COM
MAN-02585-001

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 2000 System.
Preparation of microscope slides using the ThinPrep 2000 System 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 2000 System 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., 2014. 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, 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, CytoLyt, PreservCyt and ThinPrep are registered trademarks of Hologic, Inc. or its
subsidiaries in the United States and/or other countries. All other trademarks are the property of
their respective companies.
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.
Document number: AW-08263-001 Rev. 004

ThinPrep 2000
Instructions for Use
ThinPrep 2000
Instructions for Use

MAN-02624-001 Rev. 003 page 1 of 15
Instructions For Use

MAN-02624-001 Rev. 003 page 2 of 15
INTENDED USE
The ThinPrep®2000 System is intended as a replacement for the conventional method of Pap
smear preparation for use in screening for the presence of atypical cells, cervical cancer, or its
precursor lesions (Low-grade Squamous Intraepithelial Lesions, High-grade Squamous
Intraepithelial Lesions), as well as all other cytologic categories as defined by The Bethesda
System for Reporting Cervical/Vaginal Cytologic Diagnoses1.
SUMMARY AND EXPLANATION OF THE SYSTEM
The ThinPrep process begins with the patient’s gynecologic sample being collected by the
clinician using a cervical sampling device which, rather than being smeared on a microscope
slide, is immersed and rinsed in a vial filled with 20 ml of PreservCyt®Solution (PreservCyt).
The ThinPrep sample vial is then capped, labeled, and sent to a laboratory equipped with a
ThinPrep 2000 Processor.
At the laboratory, the PreservCyt sample vial is placed into a ThinPrep 2000 Processor and a
gentle dispersion step breaks up blood, mucus, non-diagnostic debris, and thoroughly mixes the
cell sample. The cells are then collected on a ThinPrep Pap Test Filter specifically designed to
collect diagnostic cells. The ThinPrep 2000 Processor 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. A thin layer of cells is then transferred
to a glass slide in a 20 mm-diameter circle, and the slide is automatically deposited into a
fixative solution.
The ThinPrep Sample Preparation Process
(1) Dispersion (2) Cell Collection (3) Cell Transfer
The ThinPrep Pap Test Filter rotates within the
sample vial, creating 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.
A gentle vacuum is created within the ThinPrep
Pap Test Filter, which collects cells on the
exterior surface of the membrane. Cell
collection is controlled by the ThinPrep 2000
Processor’s software that monitors the rate of
flow through the ThinPrep Pap Test Filter.
After the cells are collected on the membrane,
the ThinPrep Pap Test Filter is inverted and
gently pressed against the ThinPrep Microscope
Slide. Natural attraction and slight positive air
pressure cause the cells to adhere to the
ThinPrep Microscope Slide resulting in an even
distribution of cells in a defined circular area.

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As with conventional Pap smears, slides prepared with the ThinPrep®2000 System 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 preparation using the ThinPrep 2000 System should be
collected using a broom-type or endocervical brush/plastic spatula combination collection
devices.
Preparation of microscope slides using the ThinPrep 2000 System 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 2000 System 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.
Supplies used in the ThinPrep 2000 System are those designed and supplied by Hologic
specifically for the ThinPrep 2000 System. These include PreservCyt Solution vials,
ThinPrep Pap Test Filters, and ThinPrep Microscope Slides. These supplies are required for
proper performance of the system and cannot be substituted. Product performance will be
compromised if other supplies are used. After use, supplies should be disposed of in
accordance with local, state, and federal regulations.
A ThinPrep Pap Test Filter must be used only once and cannot be reused.
The performance of HPV DNA and CT/NG testing on reprocessed sample vials has not been
evaluated.

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WARNINGS
For In Vitro Diagnostic Use
PreservCyt Solution contains methanol, which is poisonous and may be fatal or cause
blindness if swallowed. Methanol vapor may be harmful. PreservCyt is flammable; keep
away from fire, heat, sparks, and flame. 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.
Do not process a cerebral spinal fluid (CSF) specimen or other sample type that is suspected
of possessing prion infectivity (PrPsc) derived from a person with a TSE, such as
Creutzfeldt-Jakob disease, on a ThinPrep processor. A TSE-contaminated processor cannot
be effectively decontaminated and therefore must be properly disposed of in order to avoid
potential harm to users of the processor or service personnel.
PRECAUTIONS
Specific processing steps must be followed before and during use of the ThinPrep 2000 processor
if planning to perform Chlamydia trachomatis and Neisseria gonorrhoeae testing, using the Roche
Diagnostics COBAS AMPLICOR CT/NG test, on the residual specimen after a slide has been
prepared using a ThinPrep 2000 processor. Follow the procedures found in Chapter 5B of the
ThinPrep 2000 Operator’s Manual.
This equipment 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.
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.

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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 to evaluate the performance of the ThinPrep
2000 System in direct comparison to the conventional Pap smear. The objective of the ThinPrep
clinical study was to demonstrate that gynecologic specimens prepared using the ThinPrep 2000
System were at least as effective as conventional Pap smears 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 blinded, split sample, matched pair study, for which a
conventional Pap smear was prepared first, and the remainder of the sample (the portion that normally
would have been discarded) was immersed and rinsed into a vial of PreservCyt Solution. At the
laboratory, the PreservCyt sample vial was placed into a ThinPrep 2000 Processor and a slide was then
prepared from the patient’s sample. ThinPrep and conventional Pap smear slides were examined and
diagnosed independently. 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 single
independent pathologist reviewed all discrepant and positive slides from all sites in a blinded fashion to
provide a further objective review of the results.
LABORATORY AND PATIENT CHARACTERISTICS
Cytology laboratories at three screening centers (designated as S1, S2, and S3) and three hospital
centers (designated as H1, H2, and H3) participated in the clinical study. The screening centers in the
study serve 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%.2The hospital centers in the study serve a high risk referral patient population
(hospital populations) characterized by high rates (>10%) of cervical abnormality. Data on race

MAN-02624-001 Rev. 003 page 6 of 15
demographics was obtained for 70% of the patients that participated in the study. The study population
consisted of the following race groups: Caucasian (41.2%), Asian (2.3%), Hispanic (9.7%), African
American (15.2%), Native American (1.0%) and other groups (0.6%).
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-Meno- pausal Previous Abnormal Pap
Smear
Convent.
Prevalence
LSIL+
S1 Screening 300,000 1,386 18.0 - 84.0 10.6% 8.8% 2.3%
S2 Screening 100,000 1,668 18.0 - 60.6 0.3% 10.7% 2.9%
S3 Screening 96,000 1,093 18.0 - 48.8 0.0% 7.1% 3.8%
H1 Hospital 35,000 1,046 18.1 - 89.1 8.1% 40.4% 9.9%
H2 Hospital 40,000 1,049 18.1 - 84.4 2.1% 18.2% 12.9%
H3 Hospital 37,000 981 18.2 - 78.8 11.1% 38.2% 24.2%
CLINICAL STUDY RESULTS
The diagnostic categories of The Bethesda System were used as the basis of the comparison between
conventional and ThinPrep®findings from the clinical study. The diagnostic classification data and
statistical analyses for all clinical sites are presented in Tables 2 through 11. Cases with incorrect
paperwork, patient’s age less than 18 years, cytologically unsatisfactory slides, or patients with a
hysterectomy were excluded from this analysis. Few cases of cervical cancer (0.02%3) were
represented in the clinical study, as is typical in the United States patient population.
Table 2: Diagnostic Classification Table, All Categories
Conventional
NEG ASCUS AGUS LSIL HSIL SQ CA GL CA TOTAL
ThinPrep NEG 5224 295 3 60 11 0 0 5593
ASCUS
318 125 2 45 7 0 0 497
AGUS 13 2 3 0 1 0 1 20
LSIL 114 84 0 227 44 0 0 469
HSIL 11 15 0 35 104 2 0 167
SQ CA 0 0 0 0 0 1 0 1
GL CA 0 0 0 0 0 0 0 0
TOTAL 5680 521 8 367 167 3 1 6747
Abbreviations for Diagnoses: NEG = Normal or negative, ASCUS = Atypical Squamous Cells of
Undetermined Significance, AGUS = Atypical Glandular Cells of Undetermined Significance, LSIL = Low-
grade Squamous Intraepithelial Lesion, HSIL = High-grade Squamous Intraepithelial Lesion, SQ CA =
Squamous Cell Carcinoma, GL CA = Glandular Cell Adenocarcinoma