Hologic ThinPrep 3000 Operator's Manual

ThinPrep® 3000 Processor
Operator’s Manual

HOLOGIC, INC.
250 C

AMPUS DRIVE

MARLBOROUGH, MA 01752 USA
T

EL: 1-800-442-9892

1-508-263-2900

F

AX: 1-508-229-2795

W

EB: WWW.HOLOGIC.COM

For Use With Version 1.x.y Software

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

®

®

Processor

The ThinPrep

Instructions for Use

MAN-03939-001 Rev. 004 page 1 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 Diagnoses

1

(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
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 mm­diameter 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

®

Solution sample vial. The PreservCyt sample

1. Dispersion 2. Cell Collection 3. Cell Transfer

(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.

MAN-03939-001 Rev. 004 page 2 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
collection and transport medium for gynecologic specimens tested with the Cervista

®

Solution component of the ThinPrep 2000 System is an alternative

®

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
Assay, and the BD ProbeTec

®

CT/NG Assays, the Hologic APTIMA® Trichomonas vaginalis

™

CT Qx Amplified 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 AMPLICOR

TM

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-

 Preparation of slides on the TP-3000 should be performed only by personnel who

 The staining procedure using the CellFyx

 Evaluation of slides prepared on the TP-3000 should be performed only by

 Supplies used for TP-3000 gynecologic slide preparations are those designed by

 All supplies, with the exception of CellFyx Fixative Solution, are single-use

 The performance of HPV DNA and CT/NG testing on reprocessed sample vials has

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.

have been trained by Hologic or by organizations or individuals designated by
Hologic.

®

Fixative Solution has been demonstrated

for Papanicolaou stain only.

cytotechnologists and pathologists who have been trained to evaluate ThinPrep Pap
Test slides by Hologic or by organizations or individuals designated by Hologic.

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.

disposable items and cannot be reused.

not been evaluated.

MAN-03939-001 Rev. 004 page 3 of 13

CONTRAINDICATIONS

 Chlamydia trachomatis and Neisseria gonorrhoeae testing using the Roche

Diagnostics COBAS AMPLICOR and Gen-Probe APTIMA COMBO 2
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 15

 PreservCyt Solution with cytologic sample intended for CT/NG testing using the Roche

Diagnostics COBAS AMPLICOR CT/NG test must be stored between 4

o

(77

F) and tested within 6 weeks of collection.

 Excessively bloody samples may result in a higher unsatisfactory

oC

(59oF) and 30oC (86oF) and tested within 6 weeks of collection.

1

rate.

®

CT/NG

o

C (39oF) and 25oC

MAN-03939-001 Rev. 004 page 4 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

Candida albicans 5.5 x 105 CFU/mL >4.7

Aspergillus niger* 4.8 x 105 CFU/mL 2.7

Escherichia coli 2.8 x 105 CFU/mL >4.4

Staphylococcus aureus 2.3 x 105 CFU/mL >4.4

Pseudomonas aeruginosa 2.5 x 105 CFU/mL

Mycobacterium tuberculosis** 9.4 x 105 CFU/mL 4.9

Rabbitpox virus 6.0 x 106 PFU/mL 5.5***

HIV-1 1.0 x 10

* After 1 hour >4.7 log reduction

** After 1 hour >5.7 log reduction

*** Data is for 5 minutes

Log Reduction after

15 min.

>4.4

7.5

TCID50/mL 7.0***



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). 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.

®

2000 Processor (TP-

MAN-03939-001 Rev. 004 page 5 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%.
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
laboratories and the patient populations.

Table 1: Site Characteristics

Laboratory Characteristics Clinical Study Demographics

Site Type of Patient

Population

S1 Referral 44,709 1188 18-85 11.8 51.8 35.2

Screening/Refer

S2

ral

Laboratory

Volume -

Smears per

Year

62,195 1141 18-77 6.0 21.8 15.1

Cases Patient

Age Range

Post

Menopausal

%

3

The referral center in the

Previous

Abnormal

Pap Smear

%

1 describes the

Con-current

Infection

%

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 TP­3000 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

MAN-03939-001 Rev. 004 page 6 of 13

Table 2: Unadjudicated 7 x 7 Classification Table, All Categories

TP-3000

TP- NEG 2570

2000 ASCUS

AGUS
LSIL
HSIL
SQ CA
GL CA
TOTAL

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

NEG ASCUS AGUS LSIL HSIL SQ CA GL CA TOTAL

104 6 26 3 0 0 2709

119

4 1

17 29 1

0 10 0 17
0 0 0 0 0
0 0 0 0 0 0

2710 234 7 198 73 2 0

90

0 23 6 0 0 238

0

0 0 0 0 5

132

10 0 0 189

54

0 0 81

2

0 2

0

0

3224

Tables 3 - 9 show the adjudicated descriptive diagnosis results from all sites for the TP­3000 and TP-2000.

Table 3: Adjudicated 7 x 7 Diagnostic Classification Table, All Categories (Includes adjudicated cases only)

TP-3000

TP- NEG 258

2000 ASCUS

AGUS
LSIL
HSIL
SQ CA
GL CA
TOTAL

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

NEG ASCUS AGUS LSIL HSIL SQ CA GL CA TOTAL

25 0 5 1 0 0 289

29

0 0
6 9 0
1 2 0 3
0 0 0 0 0
0 0 0 0 0 0

294 47 0 29 6 0 0

11

0 11 0 0 0 51

0

0 0 0 0 0

10

2 0 0 27

3

0 0 9

0

0 0

0

0

376

The diagnostic data analysis from all sites is summarized in Table 4 for adjudicated
cytologic results of LSIL+.

Table 4: Adjudicated Two-Category Diagnostic Classification Table, LSIL and More Severe Lesions

(Includes adjudicated cases only)

TP-3000

NEG/ASCUS/

AGUS

TP- NEG/ASCUS/AGUS 323 17 340

2000 LSIL+ 18 18 36

TOTAL 341 35 376

The diagnostic data analysis from each site is summarized in Table 5 for adjudicated
cytologic results of LSIL+. When the p-value is significant (p < 0.05), the method
favored is indicated in the tables.

LSIL+ TOTAL

MAN-03939-001 Rev. 004 page 7 of 13

Table 5: Adjudicated Results by Site, LSIL and More Severe Lesions (Includes adjudicated cases only)

Site

S1
S2

S3

For LSIL and more severe lesions, the adjudicated
diagnostic comparison was statistically equivalent at all
sites.

Cases TP-3000

LSIL+

240 13 15 0.791 Neither

65 16 16 1.000 Neither
71 6 5 1.000 Neither

TP-2000

LSIL+ p-Value

Method

Favored

The diagnostic data analysis from all sites is summarized in Table

6 for adjudicated

cytologic results of HSIL+.

Table 6: Adjudicated Two-Category Diagnostic Classification Table, HSIL and More Severe Lesions

(Includes adjudicated cases only)

TP-3000

NEG/ASCUS/

AGUS/LSIL

TP-

2000 HSIL+ 6 3 9

TOTAL 370 6 376

NEG/ASCUS/

AGUS/LSIL

364 3 367

HSIL+ TOTAL

The diagnostic data analysis from each site is summarized in Table 7 for adjudicated
cytologic results of HSIL+. When the p-value is significant (p < 0.05), the method favored
is indicated in the tables.

Table 7: Adjudicated Results by Site, HSIL and More Severe Lesions (Includes adjudicated cases only)

Site

S1
S2

S3

Cases TP-3000

HSIL+

240 1 1 1.000 Neither

65 3 5 0.625 Neither
71 2 3 1.000 Neither

For HSIL and more severe lesions, the adjudicated
diagnostic comparison was statistically equivalent at all sites.

TP-2000

HSIL+

p-Value Method

Favored

MAN-03939-001 Rev. 004 page 8 of 13

Table 8 below shows the summary of the Bethesda System categories of the
unadjudicated descriptive diagnosis data for all sites.

Table 8: Unadjudicated Summary of Descriptive Diagnosis

Descriptive Diagnosis TP-2000 TP-3000

Number of Patients: 3224

Benign Cellular Changes:

Infection:
Trichomonas Vaginalis
Candida spp.
Coccobacilli
Actinomyces spp.
Herpes
Other

Reactive Cellular Changes
Associated with:

Inflammation
Atrophic Vaginitis
Radiation
IUD
Other
Epithelial Cell Abnormalities:
Squamous Cell:
ASCUS (combined)

Favor reactive
Favor neoplastic

Undetermined
LSIL
HSIL
Carcinoma
Glandular Cell:
Benign Endometrial cells in
Postmenopausal Women
AGUS (combined)

Favor reactive
Favor neoplastic
Undetermined

Note: Some patients had more than one descriptive diagnosis subcategory.
ASCUS=Atypical Squamous Cells of Undetermined Significance

AGUS=Atypical Glandular Cells of Undetermined Significance

N % N %

903

69
208
346

313

16

89

526

239

82

81

76
189

81

11

28.0

2.1

6.5

10.7
0
2
7

1
0

2

6
2
0
4

0.0

0.1

0.2

9.7

0.5

0.0

0.0

2.8

16.3

7.4

2.5

2.5

2.4

5.9

2.5

0.1

0.3

0.2

0.1

0.0

0.1

848

67
193
347

292

16

72

525

236

73

69

94
198

73

11

23.6

1
2
2

0
0

2

8
2
1
5

2.1

6.0

10.8

0.0

0.1

0.1

9.1

0.5

0.0

0.0

2.2

16.3

7.3

2.3

2.1

2.9

6.1

2.3

0.1

0.3

0.3

0.1

0.0

0.2

MAN-03939-001 Rev. 004 page 9 of 13

Table 9 shows the summary of the Bethesda System categories of the adjudicated
descriptive diagnosis data for all sites.

Table 9: Adjudicated Summary of Descriptive Diagnosis

(Includes adjudicated cases only)

Descriptive Diagnosis TP-2000 TP-3000

Number of Patients: 376

Benign Cellular Changes:

Infection:
Trichomonas Vaginalis
Candida spp.
Coccobacilli
Actinomyces spp.
Herpes
Other

Reactive Cellular Changes
Associated with:

Inflammation
Atrophic
Vaginitis

Radiation
IUD
Other

Epithelial Cell Abnormalities:
Squamous Cell:

ASCUS (combined)

Favor reactive
Favor neoplastic

Undetermined
LSIL
HSIL
Carcinoma
Glandular Cell:
Benign Endometrial cells in
Postmenopausal Women
AGUS (combined)

Favor reactive
Favor neoplastic
Undetermined

Note: Some patients had more than one descriptive diagnosis subcategory.
ASCUS=Atypical Squamous Cells of Undetermined Significance

AGUS=Atypical Glandular Cells of Undetermined Significance

N % N %

163

35
62

89

88

87

33
45
27

43.4

8

0
0
2

1
0
0
4

9

9
0

1
0
0
0
0

2.1

9.3

16.5

0.0

0.0

0.5

23.7

0.3

0.0

0.0

1.1

23.4

23.2

2.4

8.8

12.0

7.2

2.4

0.0

0.3

0.0

0.0

0.0

0.0

174

11
30
72

96

82

78

31
40
29

46.3

0
0
0

0
0
1
0

7

6
0

0
0
0
0
0

2.9

8.0

19.1

0.0

0.0

0.0

25.5

0.0

0.0

0.3

0.0

21.8

20.7

1.9

8.2

10.6

7.7

1.6

0.0

0.0

0.0

0.0

0.0

0.0

The Bethesda System delineates specimen adequacy in three categories: satisfactory,
satisfactory but limited by (SBLB) and unsatisfactory. Of the 3,527 total patients enrolled
in the study, 3,489 were included in the specimen adequacy analysis after all data integrity
sorting was applied.

MAN-03939-001 Rev. 004 page 10 of 13

Tables 10 and 11 show the summary of the Bethesda System categories of the unadjudicated and
adjudicated specimen adequacy data for all sites.

Table 10: Unadjudicated Summary of Specimen Adequacy Results

Specimen Adequacy TP-2000 TP-3000

Number of Patients: 3489

N % N %
Satisfactory 2985 85.6 2951 84.6
Satisfactory for Evaluation but Limited by:

Air-Drying Artifact
Thick Smear
Endocervical Component A bsent
Scant Squamous Epithelial Component
Obscuring Blood
Obscuring Inflammation
No Clinical History
Cytolysis
Other

Unsatisfactory for Evaluation:

Air-Drying Artifact
Thick Smear
Endocervical Component A bsent
Scant Squamous Epithelial Component
Obscuring Blood
Obscuring Inflammation
No Clinical History
Cytolysis
Other

385

244
125

22
15

119

109

20

11.0

0

0.0

1

0.0

7.0

3.6

0.6

0.4

0

0.0

1

0.0

0

0.0

3.4

0

0.0

0

0.0

2

0.1

3.1

0.6

3

0.1

0

0.0

0

0.0

0

0.0

398

237
122

29
24

140

126

36

11.4

1

0.0

2

0.1

6.8

3.5

0.8

0.7

2

0.1

4

0.1

0.1

2

4.0

0

0.0

0

0.0

3

0.1

3.6

1.0

5

0.1

0

0.0

0

0.0

1

0.0

Note: Some patients had more than one subcategory.

Table 11: Adjudicated Summary of Specimen Adequacy Results

(Includes adjudicated cases only)

Specimen Adequacy TP-2000 TP-3000

Number of Patients: 57

N % N %

Satisfactory 12 21.1 9 15.8
Satisfactory for Evaluation but Limited by:

Air-Drying Artifact
Thick Smear
Endocervical Component A bsent
Scant Squamous Epithelial Component
Obscuring Blood
Obscuring Inflammation
No Clinical History
Cytolysis
Other

Unsatisfactory for Evaluation:

Air-Drying Artifact
Thick Smear
Endocervical Component A bsent
Scant Squamous Epithelial Component
Obscuring Blood
Obscuring Inflammation
No Clinical History
Cytolysis
Other

24

24

21

13
21

42.1

0
0
6

0
1
0
0
0

0.0

0.0

10.5

42.1

0.0

1.8

0.0

0.0

0.0

36.8

0
0

0
1
0
0
0

0.0

0.0

22.8

36.8

0.0

1.8

0.0

0.0

0.0

18

18

30

30
10

31.6

0
0
4

1
3
0
0
0

0.0

0.0

7.0

31.6

1.8

5.3

0.0

0.0

0.0

52.6

0
0
9

3
0
0
0

0.0

0.0

15.8

52.6

17.5

5.3

0.0

0.0

0.0

Note: Some patients had more than one subcategory.

Table 12 shows the adjudicated specimen adequacy results, respectively, from all sites for the
TP-3000 and TP-2000.

Table 12: Adjudicated Two-Category Diagnostic Classification Table, Specimen Adequacy Results

(Includes adjudicated cases only)

TP-3000

SBLB/SAT UNSAT TOTAL

TP-2000 SBLB/SAT 23 13 36

UNSAT 4 17 21
TOTAL 27 30 57

MAN-03939-001 Rev. 004 page 11 of 13

The adjudicated specimen adequacy results from each site are presented in Table 13 as SAT/SBLB
versus UNSAT.

Table 13: Adjudicated Specimen Adequacy Results by Site (Includes adjudicated cases only)

SAT/SBLB UNSAT*

Site

S1

Cases

TP-3000

Cases

50 24 33 26 17

TP-2000

Cases

TP-3000

Cases

TP-2000

Cases

S2
S3

All Sites

*Note: Excessively bloody samples may result in a higher unsatisfactory rate.

1 0 0 1 1
6 3 3 3 3

57 27 36 30 21

The TP-3000 provides similar results to the TP-2000 System in a variety of patient populations.
The TP-3000 may be used as a replacement for the TP-2000 System in the preparation of cervical
cytology samples on glass microscope slides used in the detection of atypical cells, cervical cancer,
or its precursor lesions, as well as all other cytologic categories as defined by The Bethesda System.

TECHNICAL SERVICE AND PRODUCT INFORMATION

For technical service and assistance related to use of the ThinPrep® 3000 Processor, contact
Hologic:
Telephone: [phone]
Fax: [phone]

For international or toll-free blocked calls, please contact 1-508-263-2900.
Email: [e-mail]

REQUIRED MATERIALS

The TP-3000 consists of the following components:

 The ThinPrep

®

3000 Processor (Model TP-3000)

 ThinPrep 3000 Processor Operator’s Manual
 Power Cord
 Program Memory Card
 Staining Rack Adapters
 Accessory Kit

MATERIALS REQUIRED BUT NOT PROVIDED

 Slide staining system
 Coverslips and mounting media

®

 20 ml PreservCyt

Solution vials

 ThinPrep Pap Test Filters
 CellFy x™ Fixative Solution
 ThinPrep Microscope Slides

MAN-03939-001 Rev. 004 page 12 of 13

STORAGE

 Store PreservCyt Solution between 15°C (59°F) and 30°C (86°F). Do not use beyond the

expiration date printed on the container.

 Store PreservCyt Solution with cytologic sample intended for ThinPrep Pap testing between 15°C

(59°F) and 30°C (86°F) for up to 6 weeks.

 Store PreservCyt Solution with cytologic sample intended for CT/NG using the Roche

Diagnostics COBAS AMPLICOR CT/NG test testing between 4°C (39°F) and 25°C (77°F) for
up to 6 weeks.

 Store CellFyx Solution between 15C and 30C. Do not use beyond the expiration date printed

on the container.

 CellFyx Solution preserves cells on slides up to 5 days at 15C to 30C prior to staining.

BIBLIOGRAPHY

1. Kurman RJ, Solomon D. The Bethesda System for Reporting Cervical/Vaginal Cytologic

Diseases, Springer-Verlag, New York 1994.

2. United States Pharmacopeia (U.S.P.), Preservative Antimicrobial Effectiveness Test, U.S.P. XXII

(51).

3. Jones HW. Impact of The Bethesda System, Cancer 77 pp. 1914-1918, 1995.

4. American Cancer Society. Cancer Facts and Figures, 1995.

Hologic, Inc.
250 Campus Drive
Marlborough, MA 01752, USA
1-800-442-9892
www.hologic.com

 2017 Hologic, Inc. All rights reserved.

AW-07101-001 Rev. 006

MAN-03939-001 Rev. 004 page 13 of 13

Table of Contents

Table of Contents

Table of Contents

Chapter One

INTRODUCTION

TABLE OF CONTENTS

SECTION A:

SECTION B:

SECTION C:

SECTION D:

SECTION E:

SECTION F:

SECTION G:

Chapter Two

THINPREP 3000 INSTALLATION

SECTION A:

SECTION B:

SECTION C:

SECTION D:

Overview and Function of the
ThinPrep® 3000 Processor 1.1

Overview of Instrument Systems 1.4

Material Requirements 1.8

ThinPrep 3000 Processor

Technical Specifications 1.9

Internal Quality Control 1.12

ThinPrep 3000 Processor Hazards 1.12

Disposal 1.17

General 2.1

Action Upon Delivery 2.1

Preparation Prior to Installation 2.3

Storage and Handling Post Installation 2.3

SECTION E:

SECTION F:

SECTION G:

SECTION H:

SECTION I:

SECTION J:

Connect Power 2.4

How to Turn the Processor On/Off 2.4

System Startup 2.6

Setting the Time and Date 2.7

Setting the Slide Printer Output 2.10

Setting the Audible Key Press 2.11

ThinPrep® 3000 Processor Operator’s Manual

i

TABLE OF CONTENTS

Chapter Three

PRESERVCYT AND CELLFYX SOLUTIONS

SECTION A:

SECTION B:

SECTION C:

Introduction 3.1

PreservCyt® Solution 3.2

CellFyx™ Solution 3.5

Chapter Four

GYNECOLOGIC SAMPLE COLLECTION AND PREPARATION

SECTION A:

SECTION B:

SECTION C:

SECTION D:

SECTION E:

Introduction 4.1

Specimen Collection 4.2

Special Precautions 4.4

Specimen Processing 4.4

Sample Processing Troubleshooting 4.6

Chapter Five

INSTRUMENT OPERATION

SECTION A:

SECTION B:

Chapter Overview 5.1

Optional Instructions for Ancillary Testing 5.2

SECTION C:

SECTION E:

SECTION E:

SECTION F:

SECTION G:

SECTION H:

SECTION I:

ii

ThinPrep® 3000 Processor Operator’s Manual

Instrument Doors 5.4

Items Required to Begin Batch Processing 5.5

Begin Batch Processing 5.14

Completing a Batch 5.18

Reading the Batch Report 5.20

Pausing a Batch in Process 5.22

Canceling a Batch in Process 5.23

Chapter Six

INSTRUMENT MAINTENANCE

TABLE OF CONTENTS

SECTION A:

SECTION B:

SECTION C:

SECTION D:

SECTION E:

SECTION F:

SECTION G:

SECTION H:

SECTION I:

SECTION J:

SECTION K:

SECTION L:

SECTION M:

SECTION N:

SECTION O:

Recommended Maintenance Schedule 6.2

Fixative System Preventative Maintenance 6.5

Emptying the Slide Waste Bin 6.9

Lubricating the

Sample Processing Arm O-Rings 6.10

Pneumatic System Testing 6.13

Cleaning the Slide Path 6.17

Replacing the Fixative Shield 6.23

General Cleaning 6.24

Pinch Valve Tubing Replacement 6.26

Waste System Maintenance 6.28

Emptying the Filter Waste Box 6.31

Replenishing CellFyx™ Solution 6.32

Replacing the Slide Printer Ribbon 6.34

Replacing the User-Accessible Fuses 6.36

Replacing the Results Printer Paper 6.38

Chapter Seven

TROUBLESHOOTING

SECTION A:

SECTION B:

SECTION C:

SECTION D:

Chapter Overview 7.1

Sample Errors 7.2

System Fault Errors, Reprocessing Required 7.30

‘’Batch Canceled Due To’ Reporting 7.53

Chapter Eight

STAINING AND COVERSLIPPING

SECTION A:

SECTION B:

SECTION C:

SECTION D:

Introduction 8.1

Recommended Staining Guidelines 8.2

Coverslipping Recommendations 8.4

Common Artifacts 8.5

ThinPrep® 3000 Processor Operator’s Manual

iii

TABLE OF CONTENTS

Chapter Nine

THINPREP PAP TEST TRAINING PROGRAM 9.1

Chapter Ten

USER INTERFACE SCREENS

SECTION A:

SECTION B:

Overview of the User Interface Screens 10.1

Menu Trees 10.1

INDEX INDEX.1

SERVICE INFORMATION SERVICE.1

O

RDERING INFORMATION

O

RDERING

MATERIAL SAFETY DATA SHEETS SERVICE.1

PreservCyt Solution

CellFyx Solution

Versa-Clean™ Solution

APPENDIX

ThinPrep 3000 Processor: Laboratory Flow

.1

Barcode Label Specifications for the ThinPrep 3000 Processor

Sample Vial Label Application Guide

ThinPrep 3000 Processor Quick Reference Guide

iv

ThinPrep® 3000 Processor Operator’s Manual

1. Introduction

1. Introduction

1

Chapter One

SECTION

A

Introduction

CONTENTS

INTRODUCTION

SECTION A:

SECTION B:

SECTION C:

SECTION D:

SECTION E:

SECTION F:

SECTION G:

Overview and Function of the
ThinPrep® 3000 Processor 1.1

Overview of Instrument Systems 1.4

Material Requirements 1.8

ThinPrep 3000 Processor
Technical Specifications 1.9

Internal Quality Control 1.12

ThinPrep 3000 Hazards 1.12

Disposal 1.17

OVERVIEW AND FUNCTION OF THE THINPREP® 3000 PROCESSOR

The ThinPrep 3000 processor (refer to Figure 1-1) automates key steps in the batch processing of

®

fluid-based gynecologic specimens for use with the ThinPrep
processed, transferred and fixed onto microscope slides in preparation for staining, cover slipping
and screening. Key system components include The ThinPrep 3000 processor, sample vials of

PreservCyt
use, CellFyx™ Solution, and ThinPrep microscope slides.

®

Solution for use with the ThinPrep Pap test, ThinPrep Pap test filters for gynecologic

Pap test. The samples are collected,

ThinPrep® 3000 Processor Operator’s Manual

1.1

1

INTRODUCTION

ThinPrep microscope slides

ThinPrep Pap
test filters

Gynecologic samples in
ThinPrep Pap test
PreservCyt Solution

ThinPrep 3000 processor

CellFyx Solution

Figure 1-1 The ThinPrep 3000 Processor

The ThinPrep® Pap Test

The ThinPrep Pap test is a fluid-based method for the collection and preparation of gynecologic
samples.

The ThinPrep Pap test begins at the physician’s office where, using a broom-type collection device or
endocervical brush/plastic spatula, cervical cells are collected from the patient. Rather than
smearing the patient’s sample directly onto a microscope slide, the collection device is immediately
immersed and rinsed in a vial of PreservCyt Solution for use with the ThinPrep Pap test.

The sample vial is then capped and tightened. Patient information is recorded onto the vial of
solution containing the sample and forwarded to a laboratory equipped to process the ThinPrep Pap
test.

At the laboratory, matching barcoded labels are applied to the sample vial and accompanying test
request form. The sample vial is then placed in a sample vial tray and loaded into the ThinPrep 3000
processor.

(Refer to Figure 1-2.) During the slide preparation process, a gentle dispersion step breaks up blood,
mucus and non-diagnostic debris and thoroughly mixes the cell sample. The cells are then collected
onto a ThinPrep Pap test filter. A thin layer of cells is then transferred to a ThinPrep microscope slide.
The ThinPrep 3000 processor then applies CellFyx Fixative Solution to the slide, after which the slide
is delivered to a staining rack.

1.2

ThinPrep® 3000 Processor Operator’s Manual

INTRODUCTION

1

Dispersion

The sample vial is
rotated, dispersing
debris and mucus
while thoroughly
mixing the cell
sample.

Cell Collection

A gentle vacuum is
created in the
ThinPrep Pap test
filter, which collects
cells on the exterior
surface of the
membrane.

Cell Transfer

The ThinPrep Pap test
filter is inverted and
the collected cells are
gently and evenly
transferred onto the
ThinPrep microscope
slide in a defined area.

Figure 1-2 The ThinPrep Sample Preparation Process

ThinPrep® 3000 Processor Operator’s Manual

1.3

1

INTRODUCTION

SECTION

B

Sample processing armFilter elevator

(TOP VIEW)

Power cord
connection

Filter gripper

Filters

Filter tray
handler

Results printer

Display & keypad

Slide
cartridges

Slide
translator

Slide printer

Slide
ejector

Slide output
system

OCR
reader

Fixative
dispenser

Slide cell transfer arm

Filter waste bin

Sample vials

Sample vial
gripper

Vial tray
handler

Barcode
reader

Sample processing station

THINPREP 3000 PROCESSOR

(FRONT OF INSTRUMENT)

Electronic and pneumatic systems

Filter robot Sample vial robot

OVERVIEW OF INSTRUMENT SYSTEMS

Figure 1-3 Overview of Instrument Systems

1.4

ThinPrep® 3000 Processor Operator’s Manual

1

Vial Handling System

005532

1

005532

2

3

4

5

6

005532

7

INTRODUCTION

Figure 1-4 Vial Handling System

1. The sample vial is picked from the tray.

2. The barcode is scanned and read.

3. The sample vial is delivered to the sample processing station and the sample is dispersed by
spinning the vial.

4. The vial is uncapped.

5. The filter is introduced for cell collection.

6. The vial is recapped.

7. The sample vial is returned to the sample tray.

ThinPrep® 3000 Processor Operator’s Manual

1.5

1

INTRODUCTION

1

4

5

6

2

3

Disposal chute

Filter elevator (detail)

New filter
position

Used filter
position

Filter Handling System

Figure 1-5 Filter Handling System

1. A ThinPrep Pap test filter is picked from the tray.

2. The filter is delivered to the filter elevator.

3. The sample processing arm retrieves the filter.

4. The filter is brought to the sample processing station and placed in the vial for sample collection.

5. The sample processing arm rotates and precisely meets with the slide cell transfer arm, bearing a
slide. Cell transfer occurs.

6. The used filter is returned to the filter elevator for disposal.

1.6

ThinPrep® 3000 Processor Operator’s Manual

1

Slide Handling System

ThinPrep

Slide

1

7

2

3

6

4

5

INTRODUCTION

Figure 1-6 Slide Handling System

1. Slide cartridge(s) loaded with slides are placed in the instrument.

2. The slide translator picks a slide from the cartridge and carries it to the slide printer.

3. The barcode number scanned from the sample vial is printed onto the slide, along with the time,
date and facility name (optional).

4. The slide translator hands the slide off to the slide cell transfer arm.

5. The slide cell transfer arm pivots to convey the slide to meet the ThinPrep Pap test filter for cell
transfer.

6. The slide cell transfer arm delivers the slide to the fixative dispenser, where fixative is applied.

7. The prepared slide is placed into a staining rack.

ThinPrep® 3000 Processor Operator’s Manual

1.7