scholarly journals A Multi-Institutional Feasibility Study on the Use of Automated Screening Systems for Quality Control Rescreening of Cervical Cytology

2016 ◽  
Vol 60 (5) ◽  
pp. 451-457 ◽  
Author(s):  
Yuko Sugiyama ◽  
Hiroshi Sasaki ◽  
Kyoko Komatsu ◽  
Ryuji Yabushita ◽  
Mizue Oda ◽  
...  
Keyword(s):  
Quality Control ◽  
False Negative ◽  
Cervical Cytology ◽  
High Grade ◽  
Squamous Intraepithelial Lesion ◽  
False Negatives ◽  
Intraepithelial Lesion ◽  
Liquid Based Cytology ◽  
Automated Screening ◽  
Screening Systems

Objective: To evaluate the efficacy of the automated screening system FocalPoint for cervical cytology quality control (QC) rescreening. False-negative rates (FNRs) were evaluated by a multi-institutional retrospective study. Study Design: Cervical cytology slides that had already been reported as negative for intraepithelial lesion or malignancy (NILM) were chosen arbitrarily for FocalPoint rescreening. Slides stratified into the highest 15% probability of being abnormal were rescreened by a cytotechnologist. The slides that were abnormal were reevaluated by a cytopathologist to be false negatives. Results: Rescreening of 12,000 slides, i.e. 9,000 conventional slides and 3,000 liquid-based cytology (LBC) slides, was performed; 9,826 (7,393 conventional and 2,433 LBC) were satisfactory for FocalPoint (2,174 were determined unsatisfactory) and those within the highest 15% of probability (1,496, i.e. 1,123 conventional and 373 LBC) were rescreened. As a result, 117 (96 conventional and 21 LBC) were determined as abnormal (other than NILM) and the FNR was 1.19%. Among these 117 slides, 40 (35 conventional and 5 LBC) were determined as high-grade squamous intraepithelial lesion and greater (HSIL+). Conclusion: Of 117 (1.19%) abnormal slides detected, 40 (0.41%) were determined to be HSIL+. This result suggests that FocalPoint is effective for QC rescreening of cervical cytology.

scholarly journals Results of a control quality strategy in cervical cytology

2012 ◽  
Vol 10 (1) ◽  
pp. 86-91 ◽  
Author(s):  
Caio Eduardo Gullo ◽  
Anna Luiza Tannús Dami ◽  
Amanda Pires Barbosa ◽  
Aline Maria de Vita Marques ◽  
Marianna Angelo Palmejani ◽  
...  
Keyword(s):  
Quality Control ◽  
Control Strategy ◽  
Pap Smear ◽  
False Negative ◽  
Cervical Cytology ◽  
High Grade ◽  
Squamous Intraepithelial Lesion ◽  
Intraepithelial Lesion ◽  
Analytical Phase ◽  
Quality Control Strategy

OBJECTIVE: To determine the efficacy of a quality control strategy in cervical cytology in the detection of high-grade squamous intraepithelial lesions. METHODS: Forty-two patients were selected who underwent a Pap smear and cervical uterine biopsy between April 2008 and December 2009, with evidence of a high-grade squamous intraepithelial lesion in one or both tests. The statistical parameters of the smear test were calculated before and after systematic meetings for review of the archived test results (6 years), in which the following was done: interobserver diagnostic consensus; cytohistological correlation, with the latter as gold standard; and evaluation of the therapeutic status of each patient. RESULTS: Once these controls were applied, it was noted that sensitivity and positive likelihood ratio of the test for high-grade squamous intraepithelial lesion increased 9.5% (34.5 to 44%) and 0.45% (1.64 to 2.09%), respectively, while specificity remained at 79%. Reduction in interference of false-negative results associated with errors in the analytical phase of the cytological productive process gave an estimate of failures in collection of the specimens (pre-analytical phase). CONCLUSION: In addition to improving the performance of the cytological diagnosis of the high-grade squamous intraepithelial lesion, the proposed quality control strategy allows a reflection on the causes of incorrect or conflicting scrutiny.

scholarly journals Low-Grade Squamous Intraepithelial Lesion or High-Grade Squamous Intraepithelial Lesion? Concordance Between the Interpretation of Low-Grade Squamous Intraepithelial Lesion and High-Grade Squamous Intraepithelial Lesion in Papanicolaou Tests: Results From the College of American Pathologists PAP Education Program

2018 ◽  
Vol 143 (1) ◽  
pp. 81-85 ◽  
Author(s):  
Barbara A. Crothers ◽  
Mohiedean Ghofrani ◽  
Chengquan Zhao ◽  
Leslie G. Dodd ◽  
Kelly Goodrich ◽  
...  
Keyword(s):  
Education Program ◽  
Repeated Measures ◽  
False Negative ◽  
Misclassification Rate ◽  
Low Grade ◽  
High Grade ◽  
Squamous Intraepithelial Lesion ◽  
Significant Difference ◽  
Intraepithelial Lesion ◽  
Diagnostic Concordance

Context.— Obtaining diagnostic concordance for squamous intraepithelial lesions in cytology can be challenging. Objective.— To determine diagnostic concordance for biopsy-proven low-grade squamous intraepithelial lesion (LSIL) and high-grade squamous intraepithelial lesion (HSIL) Papanicolaou test slides in the College of American Pathologists PAP Education program. Design.— We analyzed 121 059 responses from 4251 LSIL and HSIL slides for the interval 2004 to 2013 using a nonlinear mixed-model fit for reference diagnosis, preparation type, and participant type. We evaluated interactions between the reference diagnosis and the other 2 factors in addition to a repeated-measures component to adjust for slide-specific performance. Results.— There was a statistically significant difference between misclassification of LSIL (2.4%; 1384 of 57 664) and HSIL (4.4%; 2762 of 63 395). There was no performance difference between pathologists and cytotechnologists for LSIL, but cytotechnologists had a significantly higher HSIL misclassification rate than pathologists (5.5%; 1437 of 27 534 versus 4.0%; 1032 of 25 630; P = .01), and both were more likely to misrepresent HSIL as LSIL (P < .001) than the reverse. ThinPrep LSIL slides were more likely to be misclassified as HSIL (2.4%; 920 of 38 582) than SurePath LSIL slides (1.5%; 198 of 13 196), but conventional slides were the most likely to be misclassified in both categories (4.5%; 266 of 5886 for LSIL, and 6.5%; 573 of 8825 for HSIL). Conclusions.— More participants undercalled HSIL as LSIL (false-negative) than overcalled LSIL as HSIL (false-positive) in the PAP Education program, with conventional slides more likely to be misclassified than ThinPrep or SurePath slides. Pathologists and cytotechnologists classify LSIL equally well, but cytotechnologists are significantly more likely to undercall HSIL as LSIL than are pathologists.

Liquid-Based Cytology: Evaluation of Effectiveness, Cost-Effectiveness, and Application to Present Practice

2004 ◽  
Vol 2 (6) ◽  
pp. 597-611 ◽  
Author(s):  
J. Thomas Cox
Keyword(s):  
Cost Effectiveness ◽  
Cervical Screening ◽  
Pap Test ◽  
Representative Specimen ◽  
Low Grade ◽  
High Grade ◽  
Squamous Intraepithelial Lesion ◽  
Split Sample ◽  
Intraepithelial Lesion ◽  
Liquid Based Cytology

This article reviews the data available as of 2004 on the effectiveness and cost-effectiveness of cervical screening with the two available cytologic methods, the conventional Papanicolaou (Pap; CP) smear and liquid-based cytology (LBC), and discusses the application of LBC to current practice. The majority of LBC studies are on the ThinPrep Pap Test (CYTYC, Boxsborough, MA) and the remainder are on SurePath (TriPath, Burlington, NC), which was previously known as AutoCyte Prep. LBC identified more low-grade squamous intraepithelial lesion (LSIL) Pap test results compared with paired conventional cytology in 17 of 21 ThinPrep and 9 of 12 SurePath “split-sample” studies considered to fulfill the criteria for inclusion in the British NHS Health Technology Assessment (HTA) evaluation of cervical cytology. In four of the six recent ThinPrep and one of two SurePath split-sample studies, more high-grade squamous intraepithelial lesion-positive (HSIL+) results were identified by LBC than by CP. All 15 “direct-to vial studies” meeting HTA criteria reported more LSIL+ results for LBC compared with CP, and all eight of the direct-to-vial studies reporting HSIL+ results separately showed increased detection of high-grade cytology interpretations. Fifteen studies met the criteria for evaluating sensitivity and specificity. Aggregate sensitivity for the CP was 71.5% and for LBC was 80.1%. Indirect comparisons of the two LBC methods did not detect a difference in sensitivity, and a meta-analysis of the six studies comparing specificity between CP and LBC found no difference. Other capabilities of LBC are improved specimen adequacy and the ability to do ancillary testing out of the liquid-based vial. In cost-effective analyses based on models of disease natural history and/or the clinical effectiveness of each screening modality, screening with CP was always dominated by screening with LBC. Primary cervical screening guidelines issued by the American Cancer Society in 2002 recommend repeating the cytology biannually if liquid-based and annually if conventional. The gain in sensitivity, apparent cost-effectiveness, and advantage of having a representative specimen for ancillary testing, support the use of LBC.

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.

Comparison of Performance of Conventional and ThinPrep Gynecologic Preparations in the College of American Pathologists Gynecologic Cytology Program

2004 ◽  
Vol 128 (1) ◽  
pp. 17-22 ◽  
Author(s):  
Andrew A. Renshaw ◽  
Nancy A. Young ◽  
George G. Birdsong ◽  
Patricia E. Styer ◽  
Diane D. Davey ◽  
...  
Keyword(s):  
Squamous Cell Carcinoma ◽  
Cell Carcinoma ◽  
Squamous Cell ◽  
Error Rate ◽  
False Negative ◽  
Error Rates ◽  
High Grade ◽  
Squamous Intraepithelial Lesion ◽  
Exact Match ◽  
Intraepithelial Lesion

Abstract Context.—Results of clinical trials suggest that interpretation of liquid-based cytology preparations is more accurate and is associated with less screening error than interpretation of conventional preparations. Objective.—In this study, the performance of participants in interpreting ThinPrep (TP) preparations was compared with participants' performance on conventional Papanicolaou tests in the College of American Pathologists Interlaboratory Comparison Program in Cervicovaginal Cytology (PAP). Design.—The results of the PAP from the year 2002 were reviewed, and the discordancies to series and exact-match error rates for the 2 cytologic methods were compared. Results.—For this study, a total of 89 815 interpretations from conventional smears and 20 886 interpretations from TP samples were analyzed. Overall, interpretations of TP preparations had both significantly fewer false-positive (1.6%) and false-negative (1.3%) rates than those of conventional smears (P = .001 and P = .02, respectively) for validated or validated-equivalent slides, as assessed by concordance with the correct diagnostic series. In this assessment of concordance to series, interpretations of educational TP and conventional preparations were similar, except for high-grade squamous intraepithelial lesion, in which the performance was significantly worse for educational TP preparations (false-negative rate of 8.1% vs 4.1% for conventional smears, P < .001). When interpretations were matched to the exact diagnosis, validated-equivalent TP preparations were generally more accurate for diagnoses in the 100 series and 200 series than were conventional smears. Notably, for the reference diagnosis of squamous cell carcinoma, the exact-match error rate on validated equivalent TP slides was significantly greater than that of conventional slides (44.5% vs 23.1%, P < .001). Interpretations of educational TP preparations also had a significantly higher error rate in matching to the exact reference diagnosis for squamous cell carcinoma (33.7% vs 22.8%, P = .007). Conclusions.—Overall, TP preparations in this program were associated with significantly lower error rates than conventional smears for both validated and educational cases. However, unlike the negative for intraepithelial lesion and malignancy, not otherwise specified, low-grade squamous intraepithelial lesion, and adenocarcinoma cytodiagnostic challenges, participants' responses indicated some difficulty in recognizing high-grade squamous intraepithelial lesion and squamous cell carcinoma.

Detection of Adenocarcinoma In Situ of the Cervix in Papanicolaou Tests: Comparison of Diagnostic Accuracy With Other High-Grade Lesions

2004 ◽  
Vol 128 (2) ◽  
pp. 153-157 ◽  
Author(s):  
Andrew A. Renshaw ◽  
Dina R. Mody ◽  
Richard L. Lozano ◽  
Emily E. Volk ◽  
Molly K. Walsh ◽  
...  
Keyword(s):  
Squamous Cell Carcinoma ◽  
Cell Carcinoma ◽  
Squamous Cell ◽  
Interlaboratory Comparison ◽  
False Negative ◽  
Adenocarcinoma In Situ ◽  
High Grade ◽  
Squamous Intraepithelial Lesion ◽  
Intraepithelial Lesion

Abstract Context.—Adenocarcinoma in situ of the cervix is a recently recognized interpretation in the Bethesda 2001 system. Although specific morphologic criteria have been published, recognizing this entity is still difficult. Objective.—To compare pathologists' ability to correctly identify and categorize adenocarcinoma in situ with their ability to identify and categorize adenocarcinoma, high-grade squamous intraepithelial lesion, and squamous cell carcinoma. Design.—Pathologists' reviews in the 2001 and 2002 College of American Pathologists Interlaboratory Comparison Program in Cervicovaginal Cytology Program, an interlaboratory comparison program for gynecologic cytology, were examined. Cases were usually reviewed by multiple pathologists. False-negative rates, the percentage of reviews with exact agreement with reference interpretations, and the percentage of cases in which all reviews were in exact agreement with the reference interpretation for adenocarcinoma in situ, adenocarcinoma, high-grade squamous intraepithelial lesion, and squamous cell carcinoma were compared. Results.—A total of 213 reviews of cases categorized as adenocarcinoma in situ were compared with 2821 reviews of adenocarcinoma, 7535 reviews of high-grade squamous intraepithelial lesion, and 1886 reviews of squamous cell carcinoma. The false-negative rate for adenocarcinoma in situ (11.7%) was significantly higher than that for high-grade squamous intraepithelial lesion (4.6%, P < .001) and squamous cell carcinoma (3.3%, P < .001) but not for adenocarcinoma (8.9%, P = .16). Of all the reviews of adenocarcinoma in situ cases, 46.5% were interpreted specifically as adenocarcinoma in situ, compared to 72.2% of reviews of adenocarcinoma, 73.2% of high-grade squamous intraepithelial lesion, and 75.1% of squamous cell carcinoma. No individual case of adenocarcinoma in situ was always specifically recognized as adenocarcinoma in situ; 26.5% of cases of adenocarcinoma were specifically recognized as such in all reviews. Findings were similar with and without the inclusion of high-grade squamous intraepithelial lesion/carcinoma, not otherwise specified, as an acceptable review interpretation for cases of adenocarcinoma, squamous cell carcinoma, and high-grade squamous intraepithelial lesion. Conclusion.—These data from expert-referenced and biopsy-proven cases suggest that adenocarcinoma in situ is not as easily recognized or categorized as other serious diagnoses.

scholarly journals Comparison between Thin Prep® Preparation (Liquid Based Cytology) and Conventional Pap Smears of Cervical Smear Cytology Lesions – A Study from Kanyakumari, Tamilnadu, India

2021 ◽  
Vol 10 (21) ◽  
pp. 1611-1615
Author(s):  
Premalatha A. ◽  
Velayutham Sumathi
Keyword(s):  
Pap Smear ◽  
Cervical Cytology ◽  
Pap Smears ◽  
Low Grade ◽  
Age Group ◽  
Squamous Intraepithelial Lesion ◽  
Cervical Smear ◽  
Intraepithelial Lesion ◽  
Liquid Based Cytology ◽  
Pap Method

BACKGROUND The major cause of mortality among women is cancer of the uterine cervix. It is the second most common cancer worldwide. Pap smear is done as a method of cervical screening to detect precancerous and cancerous lesions of the cervix. Early detection of these lesions prevent the number of deaths from cervical cancer. Liquid based cervical cytology was developed to improve the diagnostic accuracy of pap smears. The main purpose of this study was to compare the profile of distribution of cervical smear cytology lesions obtained by thin prep preparation (liquid based cytology) and conventional pap method among women in the age group of 25 – 60 yrs. METHODS This is a cross sectional study done among 110 women from the outpatient department of Obstetrics and Gynaecology. Conventional and liquid based cytology smears were taken simultaneously from the same women and reported according to the 2001 Bethesda system. RESULTS Majority of the women included in this study fall in the age group of 41 - 50 years [65 (59.1 %)]. Women with a history of persistant vaginal infection were 13 (11.8 %). Out of the 110 pap smears taken by both conventional and liquid based methods, unsatisfactory smears were not detected in liquid based cytology and 6 (5.5 %) unsatisfactory smears were found in conventional pap method. In liquid based cytology, inflammatory smears were detected more (80 %), atrophic smears (2.7 %), smears with features of atypical squamous cells of undetermined significance (ASCUS) were 4.5 %, low-grade squamous intraepithelial lesion (LSIL) were 3.6 %, and smears with high-grade squamous intraepithelial lesion (HSIL) were 0.9 %. Epithelial cell abnormalities were found to be high in liquid based cytology. CONCLUSIONS Abnormal epithelial lesions were detected more in liquid based cytology (thin prep method). The number of unsatisfactory smears were found to be decreased when compared to conventional pap method. KEY WORDS Bethesda Cervical Cytology, Cervical intraepithelial lesion, Conventional Pap Smear, Liquid Based Cytology Smear

scholarly journals Misinterpretation Rates of High-Grade Squamous Intraepithelial Lesion in the College of American Pathologists Gynecologic PAP Education and PAP Proficiency Test Program

2016 ◽  
Vol 140 (11) ◽  
pp. 1221-1224 ◽  
Author(s):  
Chengquan Zhao ◽  
Barbara A. Crothers ◽  
Mohiedean Ghofrani ◽  
Zaibo Li ◽  
Rhona J. Souers ◽  
...  
Keyword(s):  
Proficiency Test ◽  
False Negative ◽  
False Negative Rate ◽  
Daily Practice ◽  
Low Grade ◽  
High Grade ◽  
Squamous Intraepithelial Lesion ◽  
Related Factors ◽  
Test Taking ◽  
Intraepithelial Lesion

Context.— Misinterpretation of high-grade squamous intraepithelial lesion (HSIL) is an important problem in daily practice and in the College of American Pathologists (CAP) PAP Proficiency Test (PAP-PT). Objective.— To investigate factors related to misinterpretation of HSIL through responses in a proficiency test versus an educational environment. Design.— We retrospectively evaluated 28 000 responses in the PAP Education Program (PAP-Edu) and 59 140 responses in PAP-PT from 1147 field-validated HSIL slides from 2007 to 2014. The related factors, such as program types, preparation types, participant types, and program years, were evaluated. Results.— Overall, 4.0% (2379 of 59 140) of responses for HSIL slides from PAP-PT were misinterpreted as either low-grade squamous intraepithelial lesion (LSIL) or negative, significantly more than those from PAP-Edu (3.2%; 898 of 28 000). However, the false-negative rate (misinterpreted as negative) was 0.9% (519 of 59 140) for PAP-PT, lower than that for PAP-Edu (1.0%; 266 of 28 000). The misinterpretation rates in PAP-PT trended down with time. Misinterpretation rates did not vary significantly by preparation methods. The misinterpretation rate for HSIL in the pathologists' responses was lower than that in cytotechnologists' responses in PAP-PT. More HSIL was misinterpreted as LSIL than as benign in both programs. Cytotechnologists interpreted HSIL as LSIL twice as much as pathologists. The most common false-negative misinterpretations were negative for intraepithelial lesion or malignancy and reparative change. Conclusions.— The higher LSIL misinterpretation rate by cytotechnologists may be related to the differences in reporting responsibilities and proficiency test grading criteria. The trend of gradually decreasing misinterpretation rates of a reference diagnosis of HSIL in the PAP-PT program may be related to higher test-taking confidence and better preparation through educational programs. The fact that pathologists performed better than cytotechnologists in PAP-PT, but not in PAP-Edu, may reflect a heightened approach and attentiveness in the test-taking environment for pathologists.

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