Performance of Laboratories after 10 Years of Participating in External Quality Monitoring in Cervical Cytology

2019 ◽  
Vol 64 (3) ◽  
pp. 224-231
Author(s):  
Leonarda Silvestre Faria de Morais ◽  
Juliana Cristina Magalhães ◽  
Iara da Silva Braga ◽  
Luiza Alessandra Marega ◽  
Suelene Brito do Nascimento Tavares ◽  
...  
Keyword(s):  
False Negative ◽  
National Health System ◽  
Quality Monitoring ◽  
Internal Quality ◽  
Fisher Exact Test ◽  
Low Grade ◽  
Squamous Intraepithelial Lesion ◽  
External Quality ◽  
Squamous Cells ◽  
Intraepithelial Lesion

Objective: To evaluate the performance of laboratories accredited by the National Health System that perform cytopathology examination of the uterine cervix after 10 years of participation in external quality monitoring (eQM). Study Design: Seven laboratories were assessed in this study. To assess the concordance of the representation of epithelia and results, 6,536 examinations (3,433 in 2007 and 3,103 in 2017) were reviewed. Statistical analysis was performed using the κ coefficient as well as the χ2 and the Fisher exact test (p < 0.05). Results: All laboratories showed adequate infrastructure and internal quality monitoring. Regarding the representation of the epithelia, the concordance remained excellent (κ between 0.84 and 0.94). In 2007, 26 false-negative results (FN), 157 false-positive results (FP), and 79 delays in clinical conduct (DCC) were identified (κ = 0.80). In 2017, 24 FN, 42 FP, and 38 DCC were identified (κ = 0.90). Five laboratories showed improvement in concordance from 2007 to 2017. We observed significant improvement in cytomorphological criteria of the results: atypical squamous cells of undetermined significance (p < 0.001), atypical squamous cells cannot exclude high-grade squamous intraepithelial lesion (p < 0.016), and low-grade squamous intraepithelial lesion (p < 0.001). We also observed a considerable improvement in the results of cellular abnormalities in glandular epithelium (p < 0.0504). Conclusions: Ten years after the implementation of eQM, improvements in the concordance of results were observed as well as reductions in FN, FP, and DCC in all laboratories monitored.

Human Papillomavirus Testing and Reporting Rates: Practices of Participants in the College of American Pathologists Interlaboratory Comparison Program in Gynecologic Cytology in 2006

2008 ◽  
Vol 132 (8) ◽  
pp. 1290-1294 ◽  
Author(s):  
Ann T. Moriarty ◽  
Mary R. Schwartz ◽  
Galen Eversole ◽  
Marilee Means ◽  
Amy Clayton ◽  
...  
Keyword(s):  
Human Papillomavirus ◽  
Interlaboratory Comparison ◽  
Low Grade ◽  
Hpv Testing ◽  
Squamous Intraepithelial Lesion ◽  
Papanicolaou Test ◽  
Frequency Distributions ◽  
Squamous Cells ◽  
Hpv Test ◽  
Intraepithelial Lesion

Abstract Context.—Oncogenic, high-risk human papillomavirus (HR-HPV) testing is used to evaluate women who are older than 20 years with atypical squamous cells of undetermined significance (ASC-US) and in conjunction with a screening Papanicolaou test in women older than 30 years. Objectives.—To evaluate the 2006 laboratory practice data from laboratories incorporating human papillomavirus (HPV) testing with the Papanicolaou test. Design.—To use the College of American Pathologists (CAP) Supplemental Questionnaire Survey for 2006 to determine laboratory practices of participants in the CAP Interlaboratory Comparison Program in Cervicovaginal Cytology. Results.—A total of 679 laboratories responded to the questionnaire. Most (73%) refer HPV testing to reference laboratories. Nine percent perform HPV testing in cytology. Forty-five percent offer low-risk HPV (LR-HPV) testing. The most common reflex is ASC-US, although HR-HPV is also offered with low-grade squamous intraepithelial lesion (LSIL), high-grade squamous intraepithelial lesion (HSIL), or any other Papanicolaou test result. Digene Hybrid Capture II is the most common method. Human papilloma virus median test volumes are 55 monthly. Frequency distributions of HPV test volumes are significantly different from those found in 2003. Laboratories performing in-house testing reported significantly higher monthly HPV volumes (P &lt; .001). Median rates for HR-HPV positivity are 36.6% for ASC-US, 50.0% for atypical squamous cells, cannot exclude HSIL (ASC-H), and 4% for women 30 years of age and older in conjunction with a screening Papanicolaou test. Conclusions.—Reference HPV testing remains the most common pattern. The most common reflex indication is for ASC-US, but HPV testing is modified locally to include a variety of scenarios. LR-HPV testing is commonly offered despite its lack of clinical significance. These data form a baseline for ongoing monitoring of HPV testing practice trends.

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 &lt; .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.

scholarly journals Clinical study on primary screening of oral cancer and precancerous lesions by oral cytology

2020 ◽  
Vol 15 (1) ◽  
Author(s):  
Shintaro Sukegawa ◽  
Sawako Ono ◽  
Keisuke Nakano ◽  
Kiyofumi Takabatake ◽  
Hotaka Kawai ◽  
...  
Keyword(s):  
False Positive ◽  
Precancerous Lesions ◽  
False Positive Rate ◽  
False Negative ◽  
False Negative Rate ◽  
Clinical Findings ◽  
Low Grade ◽  
Severe Dysplasia ◽  
Squamous Intraepithelial Lesion ◽  
Intraepithelial Lesion

Abstract Background This study was conducted to compare the histological diagnostic accuracy of conventional oral-based cytology and liquid-based cytology (LBC) methods. Methods Histological diagnoses of 251 cases were classified as negative (no malignancy lesion, inflammation, or mild/moderate dysplasia) and positive [severe dysplasia/carcinoma in situ (CIS) and squamous cell carcinoma (SCC)]. Cytological diagnoses were classified as negative for intraepithelial lesion or malignancy (NILM), oral low-grade squamous intraepithelial lesion (OLSIL), oral high-grade squamous intraepithelial lesion (OHSIL), or SCC. Cytological diagnostic results were compared with histology results. Results Of NILM cytology cases, the most frequent case was negative [LBC n = 50 (90.9%), conventional n = 22 (95.7%)]. Among OLSIL cytodiagnoses, the most common was negative (LBC n = 34; 75.6%, conventional n = 14; 70.0%). Among OHSIL cytodiagnoses (LBC n = 51, conventional n = 23), SCC was the most frequent (LBC n = 31; 60.8%, conventional n = 7; 30.4%). Negative cases were common (LBC n = 13; 25.5%, conventional n = 14; 60.9%). Among SCC cytodiagnoses SCC was the most common (LBC n = 16; 88.9%, conventional n = 14; 87.5%). Regarding the diagnostic results of cytology, assuming OHSIL and SCC as cytologically positive, the LBC method/conventional method showed a sensitivity of 79.4%/76.7%, specificity of 85.1%/69.2%, false-positive rate of 14.9%/30.7%, and false-negative rate of 20.6%/23.3%. Conclusions LBC method was superior to conventional cytodiagnosis methods. It was especially superior for OLSIL and OHSIL. Because of the false-positive and false-negative cytodiagnoses, it is necessary to make a comprehensive diagnosis considering the clinical findings.

The Evaluation of p16ink4a Immunoexpression/Immunostaining and Human Papillomavirus DNA Test in Cervical Liquid-Based Cytological Samples

2011 ◽  
Vol 21 (1) ◽  
pp. 79-85 ◽  
Author(s):  
Maria Nasioutziki ◽  
Angelos Daniilidis ◽  
Kostos Dinas ◽  
Maria Kyrgiou ◽  
George Valasoulis ◽  
...  
Keyword(s):  
High Risk ◽  
Hpv Infection ◽  
Low Grade ◽  
Squamous Intraepithelial Lesion ◽  
Dna Test ◽  
Hpv Dna ◽  
Squamous Cells ◽  
Intraepithelial Lesion ◽  
High Risk Hpv ◽  
Hpv Dna Test

Aim:To evaluate the role of p16INK4a immunoexpression and human papillomavirus (HPV) DNA test for the detection of dyskaryotic cells in high-risk women.Materials and Methods:This work was a retrospective diagnostic study conducted in the University Hospital of Thessaloniki from January to December 2008. The subjects were women with current or previous HPV infection and current or previous cervical intraepithelial lesion (with or without treatment) or clinical warts. All liquid-based cytological samples were tested for P16INKa and HPV DNA test. The accuracy parameters used for the outcome included sensitivity, specificity, and positive predictive value.Results:A total of 226 women were included; the mean age was 29 years. Expression of p16INK4a was detected in the cytological samples of 13% of the negative cases, 44% of the cases of atypical squamous cells of undetermined significance, 46% of the cases of low-grade squamous intraepithelial lesion, and 78% of the cases of high-grade squamous intraepithelial lesion. A total of 91 women tested positive for high-risk HPV infection, and 54 of those had p16INK4a-positive staining reaction cells. The concordance between the 2 tests, HPV DNA and p16, was 59% regarding infection-positive cases. Diffuse strong parabasal p16INK4a immunostaining (nuclear score >2) was observed in 17 cases of the abnormal cytological findings (atypical squamous cells of undetermined significance, 2 cases; low-grade squamous intraepithelial lesion, 8 cases; high-grade squamous intraepithelial lesion, 7 cases). Colposcopy-directed biopsies were used as the criterion standard for the detection of cervical intraepithelial neoplasia in 91 women. The sensitivity of p16INK4a was 95% and the specificity was 92%, whereas the sensitivity of high-risk HPV was 100% and the specificity was 78%. The positive predictive value of p16INK4a was 71%, whereas that of HPV DNA was 44%.Conclusion:The findings suggest that p16INK4a immunostaining can improve the accuracy of cytological examination and HPV DNA test and may be particularly useful in the triage of low-grade lesions.

scholarly journals Clinical study on primary screening of oral cancer and precancerous lesions by oral cytology

2020 ◽  
Author(s):  
Shintaro Sukegawa ◽  
Sawako Ono ◽  
Keisuke Nakano ◽  
Kiyofumi Takabatake ◽  
Hotaka Kawai ◽  
...  
Keyword(s):  
False Positive ◽  
Precancerous Lesions ◽  
False Positive Rate ◽  
False Negative ◽  
False Negative Rate ◽  
Clinical Findings ◽  
Low Grade ◽  
Severe Dysplasia ◽  
Squamous Intraepithelial Lesion ◽  
Intraepithelial Lesion

Abstract BackgroundThis study was conducted to compare the histological diagnostic accuracy of conventional oral-based cytology and liquid-based cytology (LBC) methods.MethodsHistological diagnoses of 251 cases were classified as negative (no malignancy lesion, inflammation, or mild/moderate dysplasia) and positive [severe dysplasia/carcinoma in situ (CIS) and squamous cell carcinoma (SCC)]. Cytological diagnoses were classified as negative for intraepithelial lesion or malignancy (NILM), oral low-grade squamous intraepithelial lesion (OLSIL), oral high-grade squamous intraepithelial lesion (OHSIL), or SCC. Cytological diagnostic results were compared with histology results.ResultsOf NILM cytology cases, the most frequent case was negative [LBC n = 50 (90.9%), conventional n = 22 (95.7%)]. Among OLSIL cytodiagnoses, the most common was negative (LBC n = 34; 75.6%, conventional n = 14; 70.0%). Among OHSIL cytodiagnoses (LBC n = 51, conventional n = 23), SCC was the most frequent (LBC n = 31; 60.8%, conventional n = 7; 30.4%). Negative cases were common (LBC n = 13; 25.5%, conventional n = 14; 60.9%). Among SCC cytodiagnoses SCC was the most common (LBC n = 16; 88.9%, conventional n = 14; 87.5%). Regarding the diagnostic results of cytology, assuming OHSIL and SCC as cytologically positive, the LBC method/conventional method showed a sensitivity of 79.4%/76.7%, specificity of 85.1%/69.2%, false-positive rate of 14.9%/30.7%, and false-negative rate of 20.6%/23.3%.ConclusionsLBC method was superior to conventional cytodiagnosis methods. It was especially superior for OLSIL and OHSIL. Because of the false-positive and false-negative cytodiagnoses, it is necessary to make a comprehensive diagnosis considering the clinical findings.

scholarly journals Clinical study on primary screening of oral cancer and precancerous lesions by oral cytology

2020 ◽  
Author(s):  
Shintaro Sukegawa ◽  
Sawako Ono ◽  
Keisuke Nakano ◽  
Kiyofumi Takabatake ◽  
Hotaka Kawai ◽  
...  
Keyword(s):  
Conventional Method ◽  
False Positive ◽  
Precancerous Lesions ◽  
False Positive Rate ◽  
False Negative ◽  
False Negative Rate ◽  
Intraepithelial Neoplasia ◽  
Low Grade ◽  
Squamous Intraepithelial Lesion ◽  
Intraepithelial Lesion

Abstract Background This study was conducted to compare histological diagnostic accuracy between conventional method and liquid-based cytology (LBC) method and to clarify the effectiveness of cytology. Methods Histological diagnoses of 251 cases were classified as negative (no malignancy lesion, inflammation, and mild/moderate dysplasia) and positive [oral intraepithelial neoplasia/carcinoma in situ (OIN/CIS) and squamous cell carcinoma (SCC)]. Cytological diagnoses were classified as negative for intraepithelial lesion or malignancy (NILM), oral low-grade squamous intraepithelial lesion (OLSIL), oral high-grade squamous intraepithelial lesion (OHSIL), or SCC. Cytological diagnostic results were compared with histology results. Results Of NILM cytology cases, the most frequent case was negative [LBC n = 50 (90.9%), conventional n = 22 (95.7%)]. Among OLSIL cytodiagnoses, the most common was negative (LBC n = 34; 75.6%, conventional n = 14; 70.0%). Among OHSIL cytodiagnoses (LBC n = 51, conventional n = 23), SCC was the most frequent (LBC n = 31; 60.8%, conventional n = 7; 30.4%). Negative cases were common (LBC n = 13; 25.5%, conventional n = 14; 60.9%). Among SCC cytodiagnoses SCC was the most common (LBC n = 16; 88.9%, conventional n = 14; 87.5%). Regarding the diagnostic results of cytology, assuming HSIL and SCC as cytologically positive, the LBC method/conventional method showed a sensitivity of 79.4%/76.7%, specificity of 85.1%/69.2%, false positive rate of 14.9%/30.7%, and false negative rate of 20.6%/23.3%. Conclusions LBC method was superior to conventional method in cytodiagnosis. It was especially superior for LSIL and HSIL. Because of the false positive and false negative cytodiagnoses, it is necessary to make a comprehensive diagnosis considering the clinical findings.

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