Accuracy of ThinPrep Imaging System in Detecting Low-Grade Squamous Intraepithelial Lesions

2007 ◽  
Vol 131 (5) ◽  
pp. 773-776
Author(s):  
Fred Fangyuan Zhang ◽  
Helen Whitler Banks ◽  
Shanna Maria Langford ◽  
Diane Davis Davey
Keyword(s):  
Quality Control ◽  
Imaging System ◽  
Cervical Cytology ◽  
Low Grade ◽  
Federal Regulations ◽  
Squamous Intraepithelial Lesion ◽  
Squamous Intraepithelial Lesions ◽  
Abnormal Cells ◽  
Intraepithelial Lesion ◽  
Intraepithelial Lesions

Abstract Context.—The ThinPrep Imaging System (Imager) for cervical cytology is used in many US laboratories, but the ability of the system to identify classic changes of low-grade squamous intraepithelial lesion (LSIL) has not been independently reported. Objective.—To evaluate the accuracy of this system in detecting classic LSIL cells. Design.—A total of 114 imaged ThinPrep LSIL cases from April to June 2005 were reviewed to determine whether the most diagnostically relevant cells were present in the 22 fields selected by Imager. Those LSIL specimens from January to June 2005 that were initially screened by the Imager and classified as “negative” in the 22 fields were also reviewed. The average number of classic koilocytes per slide was compared among cases that had koilocytes within 22 fields with cases upgraded during full review. Results.—Twelve (10.5%) of 114 LSIL cases from April to June 2005 did not show diagnostic LSIL cells within the initial 22 fields. Full manual rescreening was performed on 1025 cases from January to June (20.4% of negative cases). Nine cases that were initially negative in the 22 fields were revised to LSIL (2.4% of all 381 LSIL cases reported from January to June 2005). An average of 10 to 11 koilocytes were present in these 2 groups, which was significantly lower than the average of 75 koilocytes in cases in which the 22 Imager-selected fields showed LSIL. Conclusions.—Although the ThinPrep Imager finds abnormal cells in most LSIL cases, the system may have limitations in detecting koilocytes in the 22 Imager-selected fields. When 10% quality control rescreening is performed as required by federal regulations, full manual rescreening will provide the most accurate results.

Cytologic Features of Low-Grade Squamous Intraepithelial Lesion in ThinPrep Papanicolaou Test Slides and Conventional Smears: Comparison of Cases That Performed Poorly With Those That Performed Well in the College of American Pathologists Interlaboratory Comparison Program in Cervicovaginal Cytology

2005 ◽  
Vol 129 (1) ◽  
pp. 23-25 ◽  
Author(s):  
Andrew A. Renshaw ◽  
Barbara Dubray-Benstein ◽  
Jennifer Haja ◽  
Jonathan H. Hughes
Keyword(s):  
Interlaboratory Comparison ◽  
Pap Test ◽  
Median Number ◽  
Low Grade ◽  
High Grade ◽  
Squamous Intraepithelial Lesion ◽  
Papanicolaou Test ◽  
Abnormal Cells ◽  
Intraepithelial Lesion ◽  
Intraepithelial Lesions

Abstract Context.—Both conventional and ThinPrep Papanicolaou smears with high-grade squamous intraepithelial lesions that are frequently missed are known to have relatively few abnormal cells. Whether this is also true of cases of low-grade squamous intraepithelial lesion is not known. Objective.—To compare the cytologic features of cases of low-grade squamous intraepithelial lesion that perform poorly with the features of cases that perform well. Design.—The cytologic features of 10 ThinPrep Pap Test and conventional smear cases of low-grade squamous intraepithelial lesion that performed poorly in the College of American Pathologists Interlaboratory Comparison Program were compared with 46 ThinPrep Pap Test and conventional smear cases that performed extremely well. The numbers of abnormal cells were categorized into less than 50, 51 to 100, 101 to 250, 251 to 500, and more than 500. Results.—The median number of abnormal cells for cases that performed poorly was less than 50, whereas the median number of abnormal cells for cases that performed well was between 101 and 250. Overall, cases that performed poorly were significantly more likely to have less than 50, less than 100, and less than 250 abnormal cells than cases that performed well (P < .001, P < .001, and P = .009, respectively). A minority of cases performed well even with very few abnormal cells and groups. The same findings were present when conventional smears and ThinPrep specimens were analyzed separately. Conclusions.—ThinPrep Pap Test cases and conventional smears with a diagnosis of low-grade squamous intraepithelial lesion that perform poorly in this program have significantly fewer abnormal cells than those that perform well. The median number of abnormal cells in cases that performed well is lower than that of comparable high-grade cases in the program.

Practices of Participants in the College of American Pathologists Interlaboratory Comparison Program in Cervicovaginal Cytology, 2006

2010 ◽  
Vol 134 (3) ◽  
pp. 331-335 ◽  
Author(s):  
Galen M. Eversole ◽  
Ann T. Moriarty ◽  
Mary R. Schwartz ◽  
Amy C. Clayton ◽  
Rhona Souers ◽  
...  
Keyword(s):  
Squamous Cell ◽  
Interlaboratory Comparison ◽  
Low Grade ◽  
Squamous Intraepithelial Lesion ◽  
Squamous Intraepithelial Lesions ◽  
Atypical Squamous Cell ◽  
Squamous Cells ◽  
Intraepithelial Lesion ◽  
Intraepithelial Lesions ◽  
Median Rate

Abstract Context.—Liquid-based preparations (LBPs) and human papillomavirus testing have led to changes in cervical cytology practices. The College of American Pathologists attempts to track practice patterns using a supplemental questionnaire, which allows laboratories to report diagnostic practices. Objective.—To analyze the 2006 reporting practices and to compare the results with the 2003 survey data. Design.—Questionnaire was mailed to 1621 laboratories. Participants included laboratories enrolled in the 2006 College of American Pathologists Gynecologic Proficiency Testing Program or the educational Interlaboratory Comparison Program in Gynecologic Cytology. Results.—Of the 679 responding laboratories (response rate, 42%), most (97.8%; n  =  664) had implemented the Bethesda 2001 terminology. The median rate for all preparations with low-grade squamous intraepithelial lesions was 2.5% (2.9% for LBPs) compared with a 2003 median rate of 2.1%; the increase was confined to LBPs. Rates for high-grade squamous intraepithelial lesions (median, 0.5%) and atypical squamous cells have changed little. High-grade squamous intraepithelial lesions and unsatisfactory rates varied at statistically significant levels between types of LBPs. Most atypical squamous cell cases were subclassified as undetermined significance (median, 4.3%). The median ratio of atypical squamous cells to squamous intraepithelial lesions and carcinomas for all specimen types combined was 1.5, similar to the 2003 median ratio of 1.4. The median rates for findings of squamous cell abnormalities for 2006 were significantly higher for LBPs than for conventional smears. Conclusions.—Most responding laboratories have implemented the Bethesda 2001 terminology. There is an increase in LBP low-grade squamous intraepithelial lesion rates when compared with 2003 data. Liquid-based preparations have higher median squamous intraepithelial lesion and atypical squamous cell rates.

Only a Small Fraction of High-Grade Cervical Lesions Are Discovered After an Interpretation of Atypical Squamous Cells of Undetermined Significance When Using Imager-Assisted, Liquid-Based Papanicolaou Tests and the Bethesda 2001 System

2012 ◽  
Vol 137 (7) ◽  
pp. 936-941 ◽  
Author(s):  
Kelly A. Khan ◽  
Debora A. Smith ◽  
Michael J. Thrall
Keyword(s):  
Low Grade ◽  
High Grade ◽  
Test Results ◽  
Squamous Intraepithelial Lesion ◽  
Squamous Intraepithelial Lesions ◽  
Papanicolaou Test ◽  
Squamous Cells ◽  
Intraepithelial Lesion ◽  
Intraepithelial Lesions ◽  
Undetermined Significance

Context.—Previous work has reported that most high-grade cervical neoplasia is seen in patients with preceding Papanicolaou test results of atypical squamous cells of undetermined significance. This information was based on conventional test results and the Bethesda 1991 reporting system and was determined before the current treatment guidelines. Objective.—Our objective was to perform a retrospective review of all histologically confirmed, high-grade cervical neoplasia to determine the diagnosis of the preceding liquid-based Papanicolaou test. Design.—A total of 189 histologically confirmed, high-grade cervical intraepithelial neoplasia (CIN) cases grade 2 and greater were identified for a 1-year period. Results.—Of the 189 cases, 10 (5.3%) had a previous diagnosis of atypical squamous cells of undetermined significance; 55 (29.1%) had low-grade squamous intraepithelial lesions; 31 (16.4%) had low-grade squamous intraepithelial lesions, unable to rule out a high-grade squamous intraepithelial lesion; 21 (11.1%) had atypical squamous cells, unable to rule out a high-grade squamous intraepithelial lesion; 68 (36%) had high-grade squamous intraepithelial lesions; 1 (0.5%) had atypical glandular cells; 1 (0.5%) had adenocarcinoma in situ; and 2 (1%) had invasive carcinoma. Combined “low grade” Papanicolaou test results (atypical squamous cells of undetermined significance and low-grade squamous intraepithelial lesion) preceded 51 of 103 cases of CIN 2 (49.5%) and 14 of 103 cases (13.6%) of CIN 3/cancer, whereas “high grade” Papanicolaou test results (atypical squamous cells, unable to rule out a high-grade squamous intraepithelial lesion; low-grade squamous intraepithelial lesions, unable to rule out a high-grade squamous intraepithelial lesion; high-grade squamous intraepithelial lesions; atypical glandular cells; adenocarcinoma in situ; and invasive carcinoma) preceded 52 of 103 CIN 2 cases (50.5%) and 72 of 103 CIN 3/cancer cases (69.9%). Conclusions.—Our data show that we can now more-reliably predict high-grade dysplasia on routine Papanicolaou tests. Only a small fraction of histologically confirmed CIN 2/3 cases are found following a Papanicolaou test diagnosis of atypical squamous cells of undetermined significance.

scholarly journals The effectiveness of acetic acid wash protocol and the interpretation patterns of blood contaminated cervical cytology ThinPrep® specimens

CytoJournal ◽  
2015 ◽  
Vol 12 ◽  
pp. 23 ◽  
Author(s):  
Nora K. Frisch ◽  
Yasin Ahmed ◽  
Seema Sethi ◽  
Daniel Neill ◽  
Tatyana Kalinicheva ◽  
...  
Keyword(s):  
Acetic Acid ◽  
Statistical Significance ◽  
Cervical Cytology ◽  
Low Grade ◽  
Squamous Intraepithelial Lesions ◽  
Chi Square ◽  
Chi Square Test ◽  
Acid Wash ◽  
The Difference ◽  
Intraepithelial Lesions

Background: ThinPrep® (TP) cervical cytology, as a liquid-based method, has many benefits but also a relatively high unsatisfactory rate due to debris/lubricant contamination and the presence of blood. These contaminants clog the TP filter and prevent the deposition of adequate diagnostic cells on the slide. An acetic acid wash (AAW) protocol is often used to lyse red blood cells, before preparing the TP slides. Design: From 23,291 TP cervical cytology specimens over a 4-month period, 2739 underwent AAW protocol due to initial unsatisfactory smear (UNS) with scant cellularity due to blood or being grossly bloody. Randomly selected 2739 cervical cytology specimens which did not undergo AAW from the same time period formed the control (non-AAW) group. Cytopathologic interpretations of AAW and non-AAW groups were compared using the Chi-square test. Results: About 94.2% of the 2739 cases which underwent AAW were subsequently satisfactory for evaluation with interpretations of atypical squamous cells of undetermined significance (ASCUS) 4.9% (135), low-grade squamous intraepithelial lesions (LSIL) 3.7% (102), and high-grade squamous intraepithelial lesions (HSIL) 1% (28). From the 2739 control cases, 96.3% were satisfactory with ASCUS 5.5% (151), LSIL 5.1% (139), and HSIL 0.7% (19). The prevalence of ASCUS interpretations was similar (P = 0.33). Although there were 32% more HSIL interpretations in the AAW group (28 in AAW vs. 19 in non-AAW), the difference was statistically insignificant (P = 0.18). AAW category; however, had significantly fewer LSIL interpretations (P = 0.02). The percentage of UNS cases remained higher in the AAW group with statistical significance (P < 0.01). Conclusions: While AAW had a significantly higher percent of UNS interpretations, the protocol was effective in rescuing 94.2% of specimens which otherwise may have been reported unsatisfactory. This improved patient care by avoiding a repeat test. The prevalence of ASCUS and HSIL interpretations between AAW and non-AAW groups were comparable. Though not statistically significant, HSIL interpretations were relatively higher in the AAW group. LSIL interpretations showed lower prevalence in AAW group.

Characteristics of high-risk human papillomavirus infection in women with abnormal cervical cytology: a population-based study in Shanxi Province, China

2019 ◽  
Author(s):  
Li Song ◽  
Yuanjing Lyu ◽  
Ling Ding ◽  
Xiaoxue Li ◽  
Wen Gao ◽  
...  
Keyword(s):  
Cervical Cancer ◽  
Human Papillomavirus ◽  
High Risk ◽  
Hpv Infection ◽  
Cervical Cytology ◽  
Shanxi Province ◽  
Low Grade ◽  
Squamous Intraepithelial Lesion ◽  
Abnormal Cervical Cytology ◽  
Intraepithelial Lesion

Abstract Background: High-risk human papillomavirus (HR-HPV) infection is widely known as the major cause of cervical intraepithelial neoplasia (CIN) and cervical cancer and it’s characteristics vary greatly in different population. Women with abnormal cervical cytology could increase the risk of cervical cancer, however, HR-HPV infection characteristics in women with abnormal cervical cytology remains unclear. Methods: This study was based on baseline survey of the CIN Cohort established in Shanxi Province, China. A total number of 2300 women with cervical abnormalities were enrolled in this study. All participants gave informed consent and agreed to HPV and thinprepcytologic test (TCT). Each individual completed a questionnaire about characteristics related to HPV infection. Results: The overall prevalence of HR-HPV in 2300 women was 32.0%, and the proportion of single and multiple HR-HPV infections were 70.2% and 29.8% in HR-HPV infection women, respectively. The top five HR-HPV genotypes were ranked as HPV16, HPV58, HPV52, HPV53 and HPV51. The prevalence of HR-HPV in atypical squamous cells of undetermined significance (ASC-US), low-grade squamous intraepithelial lesion (LSIL) and high-grade squamous intraepithelial lesion and above(HSIL+) were 30.8%, 36.5% and 54.9%, respectively, showing an increasing trend with the severity of cervical cytology ( χ 2 trend =13.952; p <0.001). The women aged 35~45 years, with lower education level, less frequency of bathing, multiple gravidity, multiple parity, history of gynecological diseases and premenopausal women were prone to HR-HPV infection. Conclusions: We defined the characteristics related to HR-HPV infection in abnormal cervical cytology women, and provided an insight for the development and deeply research of HPV vaccine.

scholarly journals Bethesda 2014 Implementation and Human Papillomavirus Primary Screening: Practices of Laboratories Participating in the College of American Pathologists PAP Education Program

2019 ◽  
Vol 143 (10) ◽  
pp. 1196-1202 ◽  
Author(s):  
Diane Davis Davey ◽  
Rhona J. Souers ◽  
Kelly Goodrich ◽  
Dina R. Mody ◽  
Sana O. Tabbara ◽  
...  
Keyword(s):  
Human Papillomavirus ◽  
Education Program ◽  
Cervical Cytology ◽  
Current Status ◽  
Low Grade ◽  
Hpv Testing ◽  
Squamous Intraepithelial Lesion ◽  
Primary Screening ◽  
Intraepithelial Lesion ◽  
Bethesda System

Context.— Cervical cancer screening laboratory practices may evolve with new terminology and technologies. Objective.— To investigate changes in cervical cytopathology practice resulting from the 2014 Bethesda System updates and screening technologies. Design.— Questionnaires accompanied 2016 and 2017 mailings of the College of American Pathologists PAP Education program. Results.— In 2016, most laboratories surveyed had adopted or were planning to adopt 2014 Bethesda System updates, and the majority (53%; 365 of 689) used an age cutoff of 45 for reporting benign-appearing endometrial cells. However, 51.3% (354 of 690) of laboratories used the term low-grade squamous intraepithelial lesion, cannot exclude high-grade squamous intraepithelial lesion, for cases with indeterminate features, and 44.9% (298 of 664) of laboratories used a 5000-cell cutoff for minimum squamous cellularity for posthysterectomy and posttherapy specimens. Reporting rates for cervical cytology metrics changed very little from 2013 to 2016, and the median ratio of atypical squamous cells to squamous intraepithelial lesion cases was 1.9 for ThinPrep and 1.8 for SurePath preparations. Most laboratories (59.4%; 389 of 655) did not offer stand-alone primary human papillomavirus (HPV) testing in 2017, and primary HPV testing accounted for a low proportion of HPV testing volumes. The Roche Cobas method was the most common platform for HPV primary screening. Conclusions.— These questionnaire surveys provide data about the current status of cervical cytology screening, including changes related to the 2014 Bethesda System updates and the adoption of HPV primary screening techniques.

Evaluation of the LC-1000 Flow Cytometry Screening System for Cervical Cancer Screening in Routine Health Checkups

2018 ◽  
Vol 62 (4) ◽  
pp. 279-287
Author(s):  
Ilyeong Heo ◽  
Hyoung-Jung Kwak ◽  
Eun-Hee Nah ◽  
Seon Cho ◽  
Suyoung Kim ◽  
...  
Keyword(s):  
Flow Cytometry ◽  
Precancerous Lesions ◽  
Cervical Cytology ◽  
Proliferation Index ◽  
Low Grade ◽  
Squamous Intraepithelial Lesion ◽  
Normal Cytology ◽  
Cervical Precancerous Lesions ◽  
Intraepithelial Lesion ◽  
Sensitivity Specificity

Objective: This study evaluated the performance of a flow cytometry system (LC-1000) in screening cervical precancerous lesions at routine health checkups. Study design: In total, 928 health examinees were enrolled at 16 health promotion centers in 13 Korean cities between 2016 and 2017. All participants underwent liquid-based cervical cytology and flow cytometry testing to determine the cell proliferation index (CPIx). Results: The positivity rate of the LC-1000 system increased with the severity of the cervical cytology findings (p for trend < 0.001). When low-grade squamous intraepithelial lesion (LSIL) or higher (including LSIL, high-grade squamous intraepithelial lesion [HSIL], and atypical squamous cells without excluding HSIL [ASC-H]) was defined as gold-standard positivity, the sensitivity, specificity, PPV, and NPV of LC-1000 were 75.3% (95% confidence interval [CI], 66.8–83.7), 58.5% (95% CI, 55.2–61.9), 18.1% (95% CI, 14.5–21.8), and 95.1% [95% CI, 93.2–97.0], respectively. The median CPIx increased significantly from normal cytology to HSIL (p < 0.001). The median CPIx was higher in high-risk human papillomavirus (HR-HPV)-positive cases than in HR-HPV-negative cases (0.23 vs. 0.17, p < 0.001), while it did not differ between HR-HPV-positive and HR-HPV-negative cases with normal cytology findings (0.16 vs. 0.16, p = 0.700). Conclusion: The LC-1000 system is potentially useful for screening cervical precancer and cancer, especially when excluding normal or ASC of undetermined significance cases in routinely screened populations.

Bethesda 2001 Implementation and Reporting Rates: 2003 Practices of Participants in the College of American Pathologists Interlaboratory Comparison Program in Cervicovaginal Cytology

2004 ◽  
Vol 128 (11) ◽  
pp. 1224-1229 ◽  
Author(s):  
Diane D. Davey ◽  
Margaret H. Neal ◽  
David C. Wilbur ◽  
Terence J. Colgan ◽  
Patricia E. Styer ◽  
...  
Keyword(s):  
Human Papillomavirus ◽  
Interlaboratory Comparison ◽  
Cervical Cytology ◽  
Low Grade ◽  
High Grade ◽  
Squamous Intraepithelial Lesion ◽  
Reporting Practices ◽  
Human Papillomavirus Testing ◽  
Intraepithelial Lesion ◽  
Reporting Rates

Abstract Context.—The 2001 Bethesda System for the reporting of cervical cytology specimens and the use of new liquid-based and human papillomavirus testing technologies have led to changes in cervical cytology reporting practices. Objectives.—To analyze current laboratory reporting practices using Bethesda 2001 terminology and to compare results with previous survey data from 1996. Design.—Questionnaire survey mailed to 1751 laboratories in mid-2003. Participants.—Laboratories enrolled in the College of American Pathologists Interlaboratory Comparison Program in Cervicovaginal Cytology. Results.—Of the 759 responding laboratories, most (85.5%) had implemented Bethesda 2001 terminology, and the majority had adopted major changes, such as elimination of the benign cellular changes category and the satisfactory but limited category. The median reporting rate for low-grade squamous intraepithelial lesion was 2.1%, compared to a 1996 median rate of 1.6%, but the increase was confined to liquid-based preparations. Reporting rates for high-grade squamous intraepithelial lesion (median, 0.5%) and atypical squamous cells (ASC) had changed little. Most ASC cases were subclassified as “undetermined significance” (median, 3.9%) with ASC, cannot exclude high-grade SIL accounting for a minority (median, 0.2%). The median ratio of ASC to squamous intraepithelial lesions and carcinomas (SIL+) was 1.4 and was lower than the 1996 median ratio of 2.0. Median reporting rates for squamous abnormalities for 2002 were noted to be significantly higher for liquid-based preparations than for conventional smears, while median ASC/SIL+ ratios were lower. Most laboratories offer human papillomavirus testing, but almost half (47%) of laboratories do not know the percentage of positive testing results in patients with ASC. Conclusions.—Most laboratories have implemented Bethesda 2001 terminology. New criteria and liquid-based methods have led to an increase in low-grade squamous intraepithelial lesion reporting rates and a decrease in ASC/ SIL+ ratios when compared with 1996 data. Liquid-based preparations have higher median squamous intraepithelial lesion rates and lower ASC/SIL+ ratios than conventional smears.

scholarly journals Immunohistochemical Expression of p16INK4a and bcl-2 According to HPV Type and to the Progression of Cervical Squamous Intraepithelial Lesions

2005 ◽  
Vol 53 (4) ◽  
pp. 509-516 ◽  
Author(s):  
Márcia C.M. Guimarães ◽  
Maria Alice G. Gonçalves ◽  
Christiane P. Soares ◽  
Jussara S.R. Bettini ◽  
Roberta A. Duarte ◽  
...  
Keyword(s):  
Low Grade ◽  
Immunoperoxidase Method ◽  
Squamous Intraepithelial Lesion ◽  
Immunohistochemical Expression ◽  
Quantitative Expression ◽  
Cervical Squamous Intraepithelial Lesions ◽  
Intraepithelial Lesion ◽  
E6 And E7 ◽  
Intraepithelial Lesions

Inactivation of the cell cycle inhibitor gene p16MTS1 seems to be involved in human papillomavirus (HPV)-related carcinogenesis because E6 and E7 oncoproteins may impair p16INK4a and, indirectly, bcl-2 functions. In this study, we analyzed the role of immunohistochemical expression of p16INK4a and bcl-2 in HPV-infected cervical biopsies as prognostic markers of the progression of squamous intraepithelial lesion (SIL). Sixty-five cervical biopsies were stratified into two subgroups according to the second biopsy: 27 of them maintained a low-grade (LG)-SIL diagnosis, and 38 progressed from LG-SIL to high-grade (HG)-SIL. p16INK4a and bcl-2 quantitative expression levels were measured by the immunoperoxidase method. PCR-DNA techniques were used to detect and type HPV. The Wilcoxon and Fisher exact tests were employed for the statistical analysis. In the group with an LG-SIL diagnosis at the second biopsy, no significant associations were found between p16INK4a and bcl-2 expression and presence of HPV16/18. In the group that progressed to HG-SIL, a significant association was observed between p16INK4a overexpression and HPV16/18 presence ( p=0.021), but none with bcl-2 levels. It is concluded that immunohistochemical bcl-2 expression may not be useful for predicting the progression of HPV-related SIL. In contrast, p16INK4a overexpression seemed to be associated with HPV 16 and 18, suggesting that it may be a good marker for predicting SIL progression.

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