Evolution of Pap Testing at a
Community Hospital—
A Ten Year Experience
Keith V. Nance, M.D.1,2*
Over a 10-year period the Pap program at our community hos-
pital laboratory progressed from the use of 100% conventional
smears to predominantly ThinPrep1 (TP) and then to nearly
100% SurePath1 (SP). During this period the annual Pap vol-
ume grew from less than 20,000 to nearly 50,000. This retro-
spective review focuses on improvements in high-grade squa-
mous intraepithelial lesion (HSIL) detection rates and specimen
adequacy rates during the 10-year period.
The laboratory database was used to identify 310,080 Pap
test records between 1995 and 2004 inclusive. Pap type differen-
ces in HSIL detection rates and specimen adequacy rates were
examined using the Cochran–Mantel–Haenszel test, with year as
the stratification variable. The Breslow–Day test was used to
evaluate the consistency of differences across the years. The
overall results are summarized below in tabular format.
Results of Combined 10-Year Data for Total Number of Cases,
HSIL Rate, and Unsatisfactory Specimen Rate by Pap Method
are given:
Pap Method Total Paps Total % HSIL Total % Unsat
Conv Smear 128,630 0.28 0.30
ThinPrep1 88,575 0.38 0.64
SurePath1 92,875 0.50 0.17
HSIL detection rates were significantly higher for liquid-based
Pap tests compared with conventional smears (P < 0.0001). In
addition, SP was associated with higher HSIL detection rates
than TP with an estimated common odds ratio (OR) of 1.37
(95% confidence interval (CI), 1.10
1.71; P ¼ 0.005), and
higher specimen adequacy compared with TP or conventional Pap
methods (P < 0.0001). Diagn. Cytopathol. 2007;35:148–153.
' 2007 Wiley-Liss, Inc.
Key Words: Pap smear; liquid-based Pap test
Dr. Nance is on the Speaker’s Bureau for TriPath Imaging, Inc.
Presented in part at the 53rd annual scientific meeting of the American
Society of Cytopathology, November 4–9, 2005, San Diego, CA.
1
Medical Director of Cytology, Rex Hospital, Raleigh, North Carolina
2
Adjunct Associate Professor of Pathology, The University of North
Carolina School of Medicine, Chapel Hill, North Carolina
*Correspondence to: Keith V. Nance, M.D., Department of Pathology,
Rex Hospital, 4420 Lake Boone Trail, Raleigh, NC 27607-7505.
E-mail: keith.nance@rexhealth.com
Received 11 July 2006; Accepted 1 December 2006
DOI 10.1002/dc.20607
Published online in Wiley InterScience (www.interscience.wiley.com).
148 Diagnostic Cytopathology, Vol 35, No 3
Introduction
The Papanicolaou (Pap) smear has done an excellent job
of reducing morbidity and mortality from cervical carci-
noma. Despite this, there are well-known sources of error
involved with the collection, preparation, and screening of
traditional Pap smears. These errors can include both
false-positive and false-negative results. In an attempt to
help reduce these limitations of the conventional Pap
smear, liquid-based cytology preparations have been deve-
loped. Two of these products, ThinPrep1 (TP) and Sure-
Path1 (formerly Autocyte1 Prep) (SP) are currently
available. The Food and Drug Administration (FDA) has
approved each as replacements for the conventional Pap
smear. TP was FDA-approved on May 1996 with SP
receiving FDA approval in June 1999. The FDA position
is that both methods have been approved as safe and
effective alternatives to the conventional Pap smear.1 Sub-
sequent to initial FDA approval, based on direct to vial
studies, TP was allowed to enhance their product labeling
to indicate 59.7% increased detection of high-grade squa-
mous intraepithelial lesions (HSIL) and above (HSILþ)
compared with conventional Pap smears and SP was
allowed to specify 64.4% increased HSILþ detection
compared with conventional preparations.2,3 The literature
is replete with additional studies that individually com-
pare these liquid-based methodologies to the conventional
Pap smear but there are no peer-reviewed published stud-
ies that directly compare SP to TP. Also of note is that
many of these previous studies are based solely on com-
paring 1 year of data to the previous year. None represent
multiyear longitudinal data.4–10 This study is a 10-
year retrospective review of data from the cervical cytol-
ogy program at a private urban nonprofit community hos-
pital. During this period the methodology used at the
institution evolved from 100% conventional Pap smears
to nearly 100% liquid-based Pap tests. Both TP and SP
liquid-based Pap methods were used in the laboratory.
Over the same 10-year period the volume of Pap tests
screened grew dramatically from 17,356 to 47,419.
' 2007 WILEY-LISS, INC.
 Diagnostic Cytopathology DOI 10.1002/dc
EVOLUTION OF PAP TESTING AT A COMMUNITY HOSPITAL

Materials and Methods Table I. Total Number of Pap Tests by Year and Pap Method

Archived computerized Pap test records for the period Total Paps Total CS Total TP Total SP
extending from January 1, 1995 through December 31, 1995 17356 17356 0 0
2004 were retrieved from the system of the Rex Hospital 1996 19526 19526 0 0
1997 14278 14278 0 0
Department of Pathology, Raleigh, North Carolina. The 1998 16576 15581 995 0
cytotechnologist team grew from three individuals in 1999 23502 20548 2954 0
1995 to seven in 2004 with turnover of two positions. Six 2000 33515 15186 18329 0
2001 47885 10934 33172 3779
pathologists including one cytopathologist signed out Pap 2002 49298 8447 25057 15794
tests during the entire 10-year period during which there 2003 40725 4706 8021 27998
was turnover of only one of these positions. All speci- 2004 47419 2068 47 45304
mens were received from community-based clinicians CS, conventional smear; TP, ThinPrep1; SP, SurePath1.
with a predominance of obstetrician/gynecologists. No
specimens were received from training programs or from between Pap test type and cytologic disease detection and
high-risk clinics. Rex Hospital is fortunate to serve a specimen adequacy rates. The Breslow–Day test was used
relatively affluent patient population, which because of to assess the homogeneity (consistency) of the odds ratio
the high employment rate enjoys a very low uninsured across years. For comparisons in which the homogeneity
rate. The laboratory’s patient self-pay rate for the entire test is not rejected, a common odds ratio and confidence
study period remained below 2%, which indicates a very interval (CI) were computed to show the relative odds of
high insurance coverage rate and serves as an indirect HSIL detection or specimen adequacy using the liquid
indicator of socioeconomic status in the community. The Pap tests relative to the conventional smear, and between
study results were sorted by type of Pap test used and the two liquid Pap tests.
into categories of ASC-US and above, HSIL, satisfactory
for evaluation and unsatisfactory for evaluation. All HSIL Results
diagnoses were correlated with any subsequent tissue Table I lists the total number of Pap tests done each year
diagnoses. The latter material was readily available by type of Pap test performed. The total number of Pap
through a high-grade look back database that incorporates tests performed by the institution increased dramatically
not only all of the institution’s HSIL Pap specimens and over the 10-year period of the study. This correlated with
the corresponding previous Pap specimens but also all the institution and the laboratory becoming known as
subsequent tissue specimens including colposcopic bio- centers of excellence for women’s health during this time
psies, cone excisions, and hysterectomy specimens with period. The gradual conversion to liquid-based Pap tests
statements as to degree of correlation. is evident. Because of consistent laboratory satisfaction
Conventional Pap smear specimens were processed and with the performance of SP compared with other Pap
interpreted by the laboratory throughout the entire study methods, TP and conventional Pap smears were nearly
period. TP specimens were received beginning May of phased out by the end of 2004.
1998 through December of 2004 with SP specimens Table II details the annual total HSIL rates and the
received beginning June of 2001 through December of annual HSIL rates for each type of Pap test performed
2004. FocalPointTM automated primary screening of all during the corresponding year. The HSIL detection rates
SP Pap specimens with 100% manual re-screening was were significantly higher for the liquid Pap tests compared
fully implemented in early April of 2004.11 with the CS, with a common odds ratio (OR) of 1.53
Diagnostic reporting criteria, terminology, and ade- (95% confidence interval [CI]: 1.26
1.86; P < 0.0001).
quacy criteria were adopted from the original Bethesda In addition, SP had higher HSIL detection compared with
System for the period January 1995 through April 2002.12 TP, with a common OR of 1.37 (95% CI: 1.10
1.71;
From May 2002 through the end of 2004 the diagnostic P ¼ 0.005). The ASCUSþ rates, shown by year in
reporting criteria, terminology, and adequacy criteria were Table III, were also significantly higher for liquid versus
derived from Bethesda 2001.13 In an attempt to standard- conventional Pap tests (P < 0.0001), and SP versus TP
ize the data obtained during the two different periods, the (P < 0.0001). Although the direction of the association
disease detection data in this study was based only on for these comparisons was consistent across years the
the two categories of ASC-US and above (ASCUSþ), and magnitude of the difference in ASCUSþ rates was found
HSIL. No attempt to retrofit new Bethesda 2001 diagnos- to vary significantly across years (Breslow–Day test of
tic categories such as ASC-H into the older Bethesda homogeneity P < 0.0001). Odds ratios ranged from 1.92
terminology was made. For statistical purposes ASC-H
5.93 and 1.13
1.64 for the comparison of liquid
diagnoses are included in the ASCUS category. versus conventional smears and SP versus TP, respec-
The Cochran–Mantel–Haenszel test, with year as strati- tively. These data convincingly demonstrate improved
fication factor, was used to evaluate the relationship disease detection rates for both types of liquid-based Pap

Diagnostic Cytopathology, Vol 35, No 3 149

Diagnostic Cytopathology DOI 10.1002/dc
NANCE

Table II. Total HSIL Rates by Year and Pap Method Table IV. Annual HSIL Pap to Tissue Diagnosis Correlation Percen-
tages
Year Total% HSIL CS% HSIL TP% HSIL SP% HSIL
Adequate Complete % With no tissue
1995 0.3 0.3 NA NA Year correlation % correlation % follow up
1996 0.26 0.26 NA NA
1997 0.23 0.23 NA NA 1995 91 79 14
1998 0.45 0.45 0.50 NA 1996 91 79 17
1999 0.26 0.23 0.38 NA 1997 94 80 14
2000 0.43 0.34 0.47 NA 1998 94 82 8
2001 0.37 0.34 0.37 0.42 1999 90 80 15
2002 0.32 0.12 0.30 0.42 2000 93 83 12
2003 0.57 0.34 0.44 0.65 2001 94 83 9
2004 0.43 0.05 NA 0.44 2002 98 81 8
2003 98 84 10
HSIL, cases with diagnosis of high-grade squamous intraepithelial lesion;
2004 97 82 9
CS, conventional smear; TP, ThinPrep1; SP, SurePath1.
Adequate Correlation: HSIL Pap followed by tissue diagnosis of at least
mild dysplasia. Complete Correlation: HSIL Pap followed by tissue diag-
Table III. Percentage of Cases with a Diagnosis of ASCUS or Higher nosis of at least moderate dysplasia.
by Year
%ASCUS %ASCUS %ASCUS %ASCUS Table V. Total HSIL Pap to Tissue Diagnosis Correlation by Pap
Year >Total >CS >TP >SP Method
1995 3.4 3.4 NA NA Method Conventional ThinPrep SurePath
1996 3.4 3.4 NA NA
1997 3.6 3.6 NA NA Total cases 128,630 88,575 92,875
1998 3.4 3.0 15.5 NA HSIL cases 369 335 467
1999 4.0 3.2 8.4 NA Adequate 297 (91.7%) 289 (96.0%) 413 (97.2%)
2000 3.3 3.2 6.6 NA correlation
2001 4.6 1.6 4.8 5.4 Complete 264 (81.5%) 248 (82.4%) 349 (82.1%)
2002 4.8 2.3 3.5 5.6 correlation
2003 6.0 2.0 5.1 6.2 No follow-up 45 (12%) 34 (10%) 42 (9%)
2004 5.7 1.3 NA 5.6
ASCUS>, Paps with a diagnosis of ASCUS or higher; CS, conventional
smear; TP, ThinPrep1; SP, SurePath1. Table VI illustrates the total percentage of unsatisfac-
tory cases by year and type of Pap method. SP consis-
when compared with the conventional smear. The data tently outperformed the other two Pap methods in terms
also indicates higher rates of abnormality detection for SP of specimen adequacy both before and after the adoption
relative to TP. By the year 2004 the laboratory processed of Bethesda 2001 criteria in May of 2002. Overall, SP
only 47 TP specimens with no HSIL diagnoses. Therefore specimens were 8.9 times more likely to be satisfactory
this data set is not included in the annual statistics. (95% CI: 7.0
11.4, P < 0.0001) than TP specimens,
Included in the SP statistics are 34,581 specimens that and 9.8 times more likely than CS (95% CI: 7.7
12.5,
were primarily screened using the FocalPointTM during a P < 0.0001). By the year 2003 only one clinician still
period extending from early April through December submitted conventional Pap smears to the laboratory. His
2004. Within this subset of cases there were 137 HSIL patient population is heavily weighted toward postmeno-
(0.396%), 1872 ASC-US or higher cases (5.4%) and 48 pausal patients, which accounts, in part, for the high
unsatisfactory samples (0.14%). Statistical analysis results percentage of unsatisfactory conventional smears during
both inclusive and exclusive of the FocalPointTM screened the last 2 years of the study. A nearly 60% success rate
samples are similar for all three categories measured. in the conversion of initially unsatisfactory TP Paps into
Table IV reviews the year-by-year HSIL overall corre- satisfactory specimens when reprocessed using the SP
lation rates for the cases with tissue follow-up at our insti- technique led to a reduction in the number of ultimately
tution. Table V details the same data stratified by Pap unsatisfactory TP specimens beginning in the year 2002.14
Method. Complete or exact correlation is defined as a The reprocessing protocol consists of pouring residual
HSIL Pap test followed by tissue confirmation of at least Preservcyt into a 50 ml centrifuge tube and then centri-
moderate dysplasia (CIN-2). Adequate correlation is fuging for 10 min at 2,155 rpm. The supernatant is deca-
defined as tissue confirmation of at least mild dysplasia nted and the cell pellet is resuspended in SP preservative,
(CIN-1). The trend toward increased overall tissue speci- vigorously vortexed for 10 s, allowed to sit overnight, and
men correlation since the adoption of liquid-based Pap then processed using the standard SP method.
tests in the laboratory and the consistent correlation per- In terms of patient demographics, there were no outliers
centages by Pap method provide additional confidence except for the student health service at a large state
that the increased Pap HSIL detection represents predomi- university. This client utilized conventional Pap smears
nantly true positive cases and should not be attributed to from 1995 until November of 2000, followed by TP until
overcalls (false-positives). September of 2002, and SP thereafter. Unfortunately the

150 Diagnostic Cytopathology, Vol 35, No 3


Table VI. Annual Unsatisfactory Specimen Rates by Pap Method
Year CS% Unsat TP% Unsat SP% Unsat
1995 0.11 NA
1996 0.10 NA
1997 0.11 NA
1998 0.10 0.50
1999 0.12 0.54
2000 0.24 0.33
2001 0.26 0.33
2002* 0.89 0.88
2003 2.18 1.97
2004 2.37 NA
*
Bethesda 2001 specimen adequacy criteria adopted May 2002.
CS, conventional smear; TP, ThinPrep1; SP, SurePath1.
computerized records are unable to sort results by client
prior to May of 2002 therefore specific data for this client
is not available prior to that date. The available ASCUSþ
rates from this client were consistently higher than other
clients, with an ASCUSþ rate ranging from 6.8 to 11.2%
and HSIL detection rates ranging from 0.4 to 0.8%.
Nevertheless, the influence of this data on the study find-
ings is expected to be minimal as it is estimated to com-
prise less than 3% of the total Pap volume received by
the laboratory and the client’s results are evenly distrib-
uted throughout all three Pap methods.
Discussion
The utilization of liquid-based Pap tests is predicated on
their demonstrable superiority over conventional Pap
smears in terms of disease detection. Indeed, the literature
contains numerous split-sample and direct-to-vial studies
supporting the superiority of both SP and TP over the
conventional smear.4–10 The results of this study support
those prior results and do so over a multi-year period.
Both liquid-based methodologies consistently outperformed
the conventional smear in terms of overall disease detec-
tion as exemplified by higher ASC-US and above rates
and high-grade dysplasia detection rates.
SP’s increased HSIL detection rate relative to TP is
probably multifactorial in basis. One factor leading to in-
creased HSIL detection for SP relative to TP may involve
the disparity in specimen adequacy rates between the two
methods. It is likely that some unrecognized HSIL cases
are included in the unsatisfactory TP cohort. This premise
is validated by our experience with reprocessing of unsat-
isfactory TP specimens using the SP method, which be-
came our standard procedure in mid 2002 and which we
reported on in 2003.14 This reprocessing procedure has
identified one HSIL case and one squamous cell carci-
noma amongst the previously unsatisfactory TP samples.
Sample collection and cell transfer directly relate to spe-
cimen adequacy with problems related to these processes
regarded as major sources for false-negative Pap tests.
Specimen collection devices have improved over the years.
In addition liquid based Pap methodologies have required
Diagnostic Cytopathology DOI 10.1002/dc
EVOLUTION OF PAP TESTING AT A COMMUNITY HOSPITAL
the use of these improved collection devices along with a
standardized sampling protocol. Thus improvements in
NA
standardization of collection methods and improvements
NA in sampling devices may have contributed to increased
NA disease detection over the years particularly when com-
NA
NA
paring liquid based Pap specimens to conventional smears.
NA It is well documented that conventional smear preparation
0.05 techniques may discard up to 80% of the cell sample.15
0.14
0.20 Liquid-based collection methods improve cell yield, how-
0.17 ever it should be noted that TP employs a rinsing method
that has been shown to improve cell yield but still
may discard up to 37% of the cellular material.16 In con-
trast, SP methodology requires that the head of the sam-
pling device be deposited into the collection vial, which
ensures that 100% of the collected material is retained for
processing.
The FocalPointTM automated system was utilized
for primary screening of SP specimens during the last 9
months of the study period. Each of these cases was also
manually rescreened. The diagnostic yield for these cases
(ASC-US or greater rate of 5.4% and HSIL rate of
0.396%) is at the low end of the overall range for all SP
specimens during the study period. Statistical analysis
indicates that the FocalPointTM screened cases had statis-
tically similar results to the cases not primarily screened
by the automated instrument.
Since SP was adopted after several years of prior liquid-
based experience with TP, the increased comfort and/or
skill level with this type of specimen relative to conven-
tional smears may have contributed to an increased detec-
tion of abnormalities. This study extended over many
years and the case volume increased considerably over
those years. Thus it is important to note that the patient
populations are not completely comparable over time and
the changes in the age and demographics of the study
population over time could significantly affect the preva-
lence of disease independent of the type of Pap method
used to detect disease.
The HSIL correlation data, summarized in Tables IV and
V, indicates a trend toward improved overall correlation
with liquid-based methodology compared with conven-
tional smears. This correlation data includes not only fol-
low-up colposcopic biopsy results but also the results of
subsequent cone excision and hysterectomy specimens.
The consistency of the correlation data, particularly
amongst the liquid-based methods, provides confidence
that the increased HSIL detection represents predominantly
true positive cases and is not due to over diagnosis.
Another important observation gleaned from the study
data are that annual HSIL rates in the laboratory fluctuate
regardless of Pap methodology used. This probably relates
partially to population dynamics especially if the patient
population remains relatively stable year to year. Thus
if a large number of HSIL cases are detected and treated
Diagnostic Cytopathology, Vol 35, No 3 151
Diagnostic Cytopathology DOI 10.1002/dc
NANCE
in a given year then a corresponding large number of
HSIL cases are not available for detection the following
year. This year to year fluctuation tends to cast some
doubt on the validity of studies, which are based solely
on the number of dysplasia cases identified by one Pap
method 1 year compared with the number identified in
the same population by a different method the next year.
In addition in most such studies the laboratory has just
converted to a new liquid-based method and thus the
learning curve for the new method is contained within the
statistics for the first year of use of that method. In this
laboratory we experienced a temporary increase in ASCUS
rates with a concomitant decrease in HSIL rates in
2001 during the first 6 months of using SP compared
with TP and conventional smears. We previously reported
this data in abstract form but noted at a subsequent poster
presentation that follow-up tissue correlation data con-
firmed that several HSIL cases had been classified as
ASCUS cases during this brief period and that the HSIL
rates normalized after that first 6 month period.17 We had
experienced similar results during the first 6 months or so
of using TP after years of using only conventional
smears. This learning curve may help to explain some of
the study-to-study variability in relative disease detection
rates seen in published year-to-year comparisons.4–10 In
fact, Colgan et al. described a similar phenomenon during
the first 6 months after their conversion from conventional
smears to SP. They subsequently made a decision to
exclude the data from this first 6 month learning period
from their overall SP to conventional smear comparison
data.10 What is made evident by examining our data over
many years is that the introduction of liquid-based technol-
ogy in the laboratory did produce a long-term trend in
increased HSIL detection compared with the years when
only conventional Pap smears were examined.
Both TP and SP have been shown to improve specimen
adequacy when compared with the conventional Pap
smear.4–10 From a morphologic perspective, SP and TP
have much in common, as both provide a superior speci-
men compared with the traditional Pap smear. SP utilizes
ethanol as a fixative and thus provides cellular detail
more familiar to the cytologist than that provided by the
methanol-based fixative used by TP.
The TP methodology differs significantly from that of
SP. TP obtains a thin layer sample by using a membrane
filter, to which a vacuum is applied. This traps the cells
of interest onto the membrane and allows them to be
applied to a glass slide for examination. Unfortunately, if
the sample contains blood, mucus, inflammation or ne-
crotic debris, this extraneous material can adhere to the
membrane and block the adherence of cells. In some
instances this can lead to an unsatisfactory or less than
optimal specimen. This is especially true for bloody or
mucus-rich samples.18–20
152 Diagnostic Cytopathology, Vol 35, No 3
SP obtains a thin layer sample using a density sedimen-
tation method. This enriches the cell sample by excluding
blood and the majority of inflammatory cells as well as
necrotic debris, mucus and other contaminants. Because
of this enrichment process, SP consistently provides
adequate samples regardless of the presence of extraneous
material in the sample. Because of the density sedimenta-
tion technique, SP has been shown to improve specimen
adequacy relative to TP.17,20–22
Overall, the data in this study supports the premise that
liquid-based Pap tests improve specimen adequacy rela-
tive to the conventional Pap smear. This is especially true
of the data collected from 2002 until 2004. In 2002, the
laboratory adopted the Bethesda 2001 system, which in-
cluded adequacy criteria that were more stringent than
had been used previously.13 These more stringent criteria
led to higher unsatisfactory specimen rates for all three
types of Pap specimen for the years 2002 through 2004
compared with prior years. The data both prior to and
after 2002 consistently demonstrates higher specimen
adequacy rates for SP relative to TP and conventional
samples. Of note is that concomitant with the adoption of
the Bethesda 2001 criteria in mid 2002, the laboratory ini-
tiated a policy of automatically reprocessing unsatisfac-
tory TP specimens using the SP method.14 Using this pro-
cess nearly sixty percent of unsatisfactory TP specimens
were ultimately salvaged as satisfactory samples from
2002 through 2004. The laboratory had previously experi-
mented with various glacial acetic acid regimens for
bloody TP specimens but none produced suitable results.
It is also important to note that the data in this study is
unclear as to whether or not TP improves specimen
adequacy relative to the conventional smear. This uncer-
tainty is based to a large degree on the fact that the pre-
Bethesda 2001 conventional smear adequacy rate in our
patient population is quite high. This unusually high
adequacy rate is explained in part by the fact that experi-
enced clinicians collected all smears with no smears
performed by individuals in training.
In summary, the results of this 10-year retrospective
study demonstrate that, in our community hospital labora-
tory, liquid-based Pap tests increased disease detection,
including HSIL, when compared with conventional Pap
smears. Among the liquid-based methodologies, SP yielded
higher ASC-US and above and HSIL rates compared with
TP. In terms of specimen adequacy, SP had significantly
better results compared with either TP or conventional
smears. In this study population it is unclear whether or
not TP improved specimen adequacy relative to conven-
tional smears.
Acknowledgments
I thank Diane J. Catellier, DrPH, of the Department of
Biostatistics at the University of North Carolina at Chapel

EVOLUTION OF PAP TESTING AT A COMMUNITY HOSPITAL
Hill, for help with data analysis and interpretation of the
data.
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