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 ◽  
...  

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.

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Bei Zhang ◽  
Shuhui Hong ◽  
Guihui Zhang ◽  
Fengnian Rong

Abstract Background Colposcopy offers an accurate way to the diagnose of cervical precancerous lesions. However, the diagnostic accuracy of colposcopy is unsatisfied. This study was to evaluate colposcopic accuracy according to the 2011 International Federation of Cervical Pathology and Colposcopy (IFCPC) terminology. Methods A retrospective cohort study was performed in 1,838 patients who underwent colposcopy in Shandong Qianfoshan Hospital, Cheeloo College of Medicine, Shandong University from October 2013 to April 2018. Using conization or cervical biopsy pathology as the gold standard, the agreement between colposcopic diagnosis and pathologic diagnosis was calculated, and correlations between variables were analyzed. Results As an authoritative and widely used terminology for colposcopy diagnosis, the 2011 IFCPC terminology has certain clinical practicality and diagnostic accuracy. However, some signs such as mosaic, punctation, sharp border, inner border sign and ridge sign had high specificity but unsatisfactory sensitivity, which limited the diagnostic value. Therefore, we discussed the Lugol’s staining, a very common sign in colposcopy, and analyzed the diagnostic significance of bright yellow staining in low-grade squamous intraepithelial lesion (LSIL) and mustard yellow staining in high-grade squamous intraepithelial lesion (HSIL). The results showed that mustard yellow may be a valuable indicator in the diagnosis of HSIL. Conclusion The 2011 IFCPC colposcope terminology has standardized interpretations of the colposcopic findings and improved the accuracy of colposcopy diagnosis. The aceto-white epithelium still has important diagnostic value; however, the value of a few signs is needed to be discussed and new signs are expected to be discovered. Although the significance of Lugol’s staining was diminishing, mustard yellow might be a valuable indicator for the diagnosis of HSIL.


2017 ◽  
Vol 53 (4) ◽  
pp. 258
Author(s):  
Rizki Eko Prasetyo ◽  
Gondo Mastutik ◽  
Sjahjenny Mustokoweni

HPV infection is known to cause cervical cancer. This study aimed to identify the variant of HPV genotypes of cervical precancerous lesions from low grade squamous intraepithelial lesion  (LSIL) and high grade squamous intraepithelial lesion (HSIL). This was an explorative study using formalin fix paraffin embedded (FFPE) from cervical precancerous lesions at Dr. Soetomo Hospital, Surabaya. DNA was extracted from FFPE and hybridized for HPV genotyping using Ampliquality HPV Type Express kit (AB ANALITICA) by reverse line blot techniques. The results showed that there were variants of HPV genotype in LSIL. The variants were HPV16 (8/15), HPV18 (3/15), HPV52 (1/15), HPV6+31 (1/15), HPV6+18 (1/15), and HPV72+68 (1/15), and in HSIL which were HPV16 (4/10), HPV18 (2/10), HPV59 (1/10), HPV6+45 (1/10), HPV61+26 (1/10), and HPV16+31 (1/10). The characteristics of infection in LSIL were single infection of high-risk (hr) HPV and multiple infection of  low-risk (lr)+hr HPV, and in HSIL were single infection of HPVhr, multiple infection of HPVhr+hr and HPVlr+hr. In conclusion, HPV prevalence in cervical precancerous lesions is single infection by HPV16 (48%), HPV18 (20%), HPV52 (4%), HPV59 (4%), and multiple infection by HPV6+31, HPV6+18, HPV6+45, HPV16+31, HPV61+26, HPV72+68 is 4%.


2019 ◽  
Author(s):  
Li Song ◽  
Yuanjing Lyu ◽  
Ling Ding ◽  
Xiaoxue Li ◽  
Wen Gao ◽  
...  

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.


2019 ◽  
Vol 143 (10) ◽  
pp. 1196-1202 ◽  
Author(s):  
Diane Davis Davey ◽  
Rhona J. Souers ◽  
Kelly Goodrich ◽  
Dina R. Mody ◽  
Sana O. Tabbara ◽  
...  

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.


2011 ◽  
Vol 2011 ◽  
pp. 1-5 ◽  
Author(s):  
Ling Yang ◽  
Wen-Tao Liu ◽  
Hao Wu ◽  
Cheng Wang ◽  
Bo Ping ◽  
...  

Confocal light absorption and scattering spectroscopic (CLASS) microscopy can detect changes in biochemicals and the morphology of cells. It is therefore used to detect high-grade cervical squamous intraepithelial lesion (HSIL) cells in the diagnosis of premalignant cervical lesions. Forty cervical samples from women with abnormal Pap smear test results were collected, and twenty cases were diagnosed as HSIL; the rest were normal or low-grade cervical squamous intraepithelial lesion (LSIL). The enlarged and condensed nuclei of HSIL cells as viewed under CLASS microscopy were much brighter and bigger than those of non-HSIL cells. Cytological elastic scattered light data was then collected at wavelengths between 400 and 1000 nm. Between 600 nm to 800 nm, the relative elastic scattered light intensity of HSIL cells was higher than that of the non-HSIL. Relative intensity peaks occurred at 700 nm and 800 nm. CLASS sensitivity and specificity results for HSIL and non-HSIL compared to cytology diagnoses were 80% and 90%, respectively. This study demonstrated that CLASS microscopy could effectively detect cervical precancerous lesions. Further study will verify this conclusion before the method is used in clinic for early detection of cervical cancer.


2020 ◽  
Vol 15 (1) ◽  
Author(s):  
Shintaro Sukegawa ◽  
Sawako Ono ◽  
Keisuke Nakano ◽  
Kiyofumi Takabatake ◽  
Hotaka Kawai ◽  
...  

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.


2020 ◽  
Author(s):  
Shintaro Sukegawa ◽  
Sawako Ono ◽  
Keisuke Nakano ◽  
Kiyofumi Takabatake ◽  
Hotaka Kawai ◽  
...  

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.


2020 ◽  
Author(s):  
Shintaro Sukegawa ◽  
Sawako Ono ◽  
Keisuke Nakano ◽  
Kiyofumi Takabatake ◽  
Hotaka Kawai ◽  
...  

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.


2004 ◽  
Vol 128 (11) ◽  
pp. 1224-1229 ◽  
Author(s):  
Diane D. Davey ◽  
Margaret H. Neal ◽  
David C. Wilbur ◽  
Terence J. Colgan ◽  
Patricia E. Styer ◽  
...  

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.


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