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Introduction Papanicolaou test quality metrics include the ASC rate, ASC:SIL ratio, and ASC HPV+ rate. What a laboratory should do when metrics show a worrisome trend is not well defined. In 2015, our laboratory noted a worrisome trend in our quality metrics and decided to implement a systemic education program in 2016; we monitored the effectiveness of our program. Methods An educational intervention was designed for March/April 2016. Cytotechnologist education consisted of: group meeting on March 10 to discuss metrics, lecture, and written materials on ASC-US criteria, a quiz on challenging ASC-US cases, encouragement to seek consultation, and each cytotechnologist received quarterly individual metrics. The cytopathologist education consisted of: group meeting on April 16 to discuss metrics, encouragement to bring borderline cases to consensus conference, and each faculty received quarterly individual metrics. The ASC rate, ASC:SIL ratio, and ASC HPV+ rate was collected for the institution and each individual faculty in 2016 for January to March (pre-interventions, Q1), April to June (post-interventions, Q2), and July to September (post-interventions, Q3). ASC-H was included in the calculation of ASC %, ASC:SIL, and ASC HPV+ rates. Results There was a substantial decline in the lab ASC rate and ASC:SIL ratio, and the ASC HPV+ rate increased. Individual faculty changes in ASC:SIL ratio and ASC HPV+ rate also improved. Conclusions In our institution, an educational program has been very effective in improving Papanicolaou test metrics. It is helpful to perform re-education at all levels within the department.

OBJECTIVE The aim of the study was to describe trends in human papillomavirus (HPV) testing preceding diagnosis of cervical precancer during a time of changing screening recommendations. MATERIALS AND METHODS We conducted a cross-sectional analysis of data from active, population-based, laboratory surveillance among 1.5 million residents of 5 areas in the United States. We included women aged 21-39 years diagnosed with cervical intraepithelial neoplasia grades 2, 2/3, or 3 or adenocarcinoma in situ (collectively, CIN2+) during 2008-2016, who had a cytology and/or HPV test before diagnosis (n = 16,359). RESULTS The proportion of women with an HPV test preceding CIN2+ increased from 42.9% in 2008 to 73.3% in 2016 (p < .01); testing increased in all age groups (21-24 y: 35.3% to 47.6%, 25-29 y: 40.9% to 64.1%, 30-39 y: 51.7% to 85.9%, all p < .01). The HPV testing varied by cytology result and was highest among women with atypical squamous cells of unknown significance (n = 4,310/4,629, 93.1%), negative for intraepithelial lesion or malignancy (n = 446/517, 86.3%), and atypical glandular cells (n = 145/257, 56.4%). By 2016, at least half of all cases in every surveillance area had an HPV test before diagnosis. CONCLUSIONS During 2008-2016, the proportion of women with an HPV test preceding CIN2+ increased significantly for all age groups, cytology results, and surveillance areas. By 2016, most (85.9%) women aged 30-39 years had an HPV test, consistent with recommendations. Increasing utilization of HPV tests, which have demonstrated improved sensitivity for detecting cervical disease, may in part explain increasing rates of cervical precancer among women 30 years and older.

This study evaluated the clinical performance of the cobas 4800 HPV Test (Roche Molecular Systems, Pleasanton, CA, USA) for high-risk human papillomavirus (HR-HPV) testing with individual HPV-16/HPV-18 genotyping in women 21 years or older with atypical squamous cells of undetermined significance (ASCUS). Women (N = 47,208) were recruited in the United States during routine screening, and liquid-based cytology and HPV testing were performed. The ASCUS prevalence was 4.1% (1,923/47,208), and 1,578 women underwent colposcopy with valid results. The cobas 4800 HPV Test demonstrated performance comparable to the Hybrid Capture 2 test (QIAGEN, Gaithersburg, MD, USA) for the detection of cervical intraepithelial neoplasia (CIN) grade 2 or worse and grade 3 or worse. HPV-16/HPV-18+ women had a greater absolute risk of CIN 2 or worse compared with pooled HR-HPV+ and HR-HPV- women (24.4%, 14.0%, and 0.8%, respectively).The cobas 4800 HPV Test is clinically validated for ASCUS triage. HPV-16/HPV-18 genotyping can identify women at highest risk for high-grade cervical disease, and this additional risk stratification may be used in formulating patient management decisions.

Background: With the implementation of primary high-risk human papillomavirus (hrHPV) screening in the Netherlands, an increase was observed in the number of unnecessary referrals (≤Cervical Intraepithelial Neoplasia (CIN) 1) to colposcopy. We aimed to investigate which alternative triage strategies safely reduce unnecessary referrals in HPV-based cervical cancer screening programmes. Methods: Microsimulation model MISCAN was used to simulate an unvaccinated cohort of ten million 30-year old Dutch women. We calculated unnecessary referrals, cervical cancer incidence, mortality, costs and QALYs for 24 triage strategies. Condition for direct referral (atypical squamous cells of undetermined significance (ASC-US), low-grade squamous intraepithelial lesions (LSIL), high-grade squamous intraepithelial lesions (HSIL), conditional on HPV-genotype 16/18/other high risk (OHR)), type of triage test (cytology alone or combined with hrHPV) and time to triage test (6 or 12 months) was varied. Results: The 24 triage strategies had varying effects on the number of unnecessary referrals ranging from −72% to +35%. Adjusting conditions for referral to ‘HPV16/18+ and ASC-US+’ and ‘HPVOHR+ and HSIL+’ and extending the interval between tests to 12 months resulted in a reduction in unnecessary referrals of 40% (incidence +0%, mortality −1%). Reduction in unnecessary referrals without genotyping was achieved by adjusting conditions for direct referral to LSIL (12 months to repeat test) (unnecessary referrals −37%, incidence +2%, mortality +0%). Conclusions: To reduce the number of unnecessary referrals without increasing incidence and mortality by more than 2% in the Dutch cervical cancer screening programme, genotyping for HPV16 or HPV16/18 should be implemented with 12 months to repeat testing.

Background and objective Women with human immunodeficiency virus (HIV) infection have an increased risk of HPV infection, cervical neoplasia. This study was undertaken to compare the risk of having high-grade cervical lesions defined as cervical intraepithelial neoplasia grade 2 or worse (CIN2+) in HIV-infected versus HIV-uninfected women who had atypical squamous cells of undetermined significance (ASC-US) on cervical cytology. Methods Fifty-seven HIV-positive women aged 25-65 years with ASC-US cytology undergoing colposcopic examination between January 2008 and December 2020 at Chiang Mai University Hospital were reviewed. By matching 1:5 ratio, 285 HIV-negative women with ASC-US cytology in the same period were recruited as controlled subjects for comparison. The patient characteristics, HIV status, CD4 cell count within 6 months of colposcopy, antiretroviral therapy, parity, contraception, smoking history, number of sexual partners, and histopathology on cervical biopsy were analyzed. Results Mean age ± SD of the HIV-positive and HIV-negative groups was 44.28 ± 8.53 years and 44.28 ± 9.68 years, respectively. HIV-positive women were significantly less likely to use contraceptive methods (36.8 % versus 48.8 % in HIV-negative women; P = 0.002). HIV-infected women significantly had more sexual partners than HIV-uninfected women. Both groups had similar risk for CIN 2+ (5.3 % in HIV-positive women compared with 4.9 % in HIV-negative women; odds ratio [OR] = 1.08, 95% confidence interval [CI] = 0.30 -3.87). After adjustment for no contraception use and number of sexual partners, the risk of CIN2+ in HIV-infected women remained unchanged; adjusted OR= 1.15, 95% CI = 0.27-4.92, P= 0.846). Conclusion The risk of underlying high-grade cervical lesions in women with ASC-US on cervical cytology was approximately 5 %, regardless of HIV status.

Objectives: Atypical squamous cells of undetermined significance (ASC-US) represent a diagnostic challenge during cervical cytology. This study aimed to review and identify high-risk human papillomavirus (HR-HPV) genotypes among previously diagnosed ASC-US cases in Kuwait. Methods: This retrospective study analysed 180 cases diagnosed as ASC-US between June 2017 and May 2018 at the Mubarak Al-Kabeer Hospital, Kuwait. Cervical specimens were assayed to determine the presence of HR-HPV DNA; subsequently, positive cases underwent genotyping and were categorised into three groups (HPV 16, HPV 18/45 and other HR-HPV types). Results: In total, ASC-US was confirmed in only 105 cases (58.3%), with the remaining cases reclassified as negative for intraepithelial lesions or malignancy (NILM; 32.2%) and epithelial cell abnormalities (ECA; 9.4%). Of these, HRHPV DNA was present in 20 ASC-US (19%), one NILM (1.7%) and six ECA (35.3%) cases. There were 62 Kuwaiti and 43 non-Kuwaiti women with confirmed ASC-US; of these, three (4.8%), six (9.7%) and four (6.5%) Kuwaitis and one (2.3%), one (2.3%) and five (11.6%) non-Kuwaitis had HPV 16, both HPV 16 and 18/45 and other HRHPV genotypes, respectively. Of those with HR-HPV DNA, the NILM case had the HPV 18/45 genotype, while the six ECA cases had the HPV 16 (n = 1), both HPV 16 and 18/45 (n = 1) and other HR-HPV (n = 4) genotypes. Conclusion: Overall, HR-HPV DNA was present in 19% of ASC-US cases compared to 1.7% of NILM cases initially misdiagnosed as ASC-US. Re-review of cervical cytology diagnoses may reduce unnecessary costs associated with HR-HPV genotyping. Keywords: Cervical Smears; Atypical Squamous Cells of Undetermined Significance; Human Papilloma Virus; Cytological Techniques; Papanicolaou Test; Kuwait.

Objective: This research compared the effectiveness of Papanicolaou (Pap) smears with biopsies for diagnosing atypical squamous cells of undetermined significance (ASCUS) accurately in postmenopaus...

Aim To compare thermocoagulation and cryotherapy for treatment of high‐grade cervical intraepithelial neoplasia (CIN). Methods From May 2017 to May 2018, women with CIN2/3 were randomized to thermocoagulation or cryotherapy at Peking University Shenzhen Hospital. Follow‐up at 4 and 8 months included cytology and human papillomavirus (HPV) testing. Women who were HPV‐positive or had atypical squamous cells of undetermined significance or higher‐grade disease underwent colposcopy/biopsy. Results Among 149 women enrolled, 74 were randomized to thermocoagulation, and 75 to cryotherapy (excluded four were immediately referred for thermocoagulation due to large lesions). At follow‐up, there was no difference between the thermocoagulation and cryotherapy groups in HPV‐negative (4/8 months: 72.5%/86.2% vs 68.6%/80.6%) and pathology‐negative (97.1%/98.5% vs 94.3%/92.3%) rates (all P > 0.05). The cytology‐negative rate was similar for thermocoagulation and cryotherapy at 4 months (79.7% vs 78.9%, P > 0.05), but higher for thermocoagulation at 8 months (100% vs 88.7%, P

Introduction: Cervical cancer is an important public health problem in the Brazilian female population and its early diagnosis considerably increases the likelihood of a cure. The cure rate is close to 100%, demonstrating that preventive measures, such as the Papanicolau test, are fundamental for overcoming this problem. Objective: The objective of this study is describe the results of the cytopathological tests accomplished in women of 25 the 64 years in the City of Mossoró, the period of 2014 the 2019. Methodology: This is a retrospective study in which we analyzed all citopathological tests that are registered in the System Database Information about cervical cancer – SISCOLO between the period of 2004 and 2019 for their epidemiological profile. Results: A total of 46606 cases were included and analyzed. There has been an increasing trend in testing in recent years. 83.8% of cases represent atypical squamous cells of undetermined importance (ASC-US). 70% of squamous intraepithelial lesions (LIS) were diagnosed as low-grade (LISL). There was no cytopathological diagnosis of squamous cell carcinoma and only 2 cases of adenocarcinoma in situ. Conclusions: Mossoró follows the national pattern of many cytopathological results of atypical cells, represented mainly by ASC-US and LSIL. Suggestive results of a high degree of malignancy are observed less frequently and should be evaluated by more invasive and sensitive tests for the final diagnosis. Keywords: Uterine cervical neoplasms; Papanicolaou test; Women’s health. Introducción: El cáncer de cuello uterino es es um importante problema de salud pública en la población femenina brasileña y su identificación precoz aumenta considerablemente la probabilidad de cura. La tasa de curación es cercana al 100%, lo que demuestra que las medidas preventivas, como la prueba de Papanicolaou, son fundamentales para prevenir ese problema. Objetivo: El objetivo de este estudio fue el de describir los resultados de los exámenes citopatológicos en mujeres de 25 a 64 años en el municipio de Mossoró, de 2014 a 2019. Metodología: Este es un estudio retrospectivo en el que analizamos todas las pruebas citopatológicas que están registradas en la Información de la base de datos del sistema sobre el cáncer de cuello uterino - SISCOLO entre el período de 2004 y 2019 para su perfil epidemiológico. Resultados: Se incluyeron y analizaron un total de 46606 casos. Hubo una tendencia de aumento en las pruebas en los últimos años. El 83,8% de los casos representan células escamosas atípicas de importancia indeterminada (ASC-US). El 70% de las lesiones escamosas intraepiteliales (LIS) fueron diagnosticadas como de bajo grado (LISL). No hubo diagnóstico citopatológico de carcinoma de células escamosas y solo 2 casos de adenocarcinoma in situ. Conclusiones: Mossoró sigue el patrón nacional de muchos resultados citopatológicos de células atípicas, representadas principalmente por ASC-US y LSIL. Los resultados sugestivos de un alto grado de malignidad se observan con menos frecuencia y deben evaluarse mediante pruebas más invasivas y sensibles para el diagnóstico final. Palabras clave: Neoplasias del cuello uterino; Prueba de Papanicolaou; Salud de la mujer. Introdução: O câncer do colo do útero é um importante problema de saúde pública na população feminina brasileira e seu diagnóstico precoce aumenta consideravelmente a probabilidade de cura. A taxa de cura é próxima aos 100%, demonstrando que medidas preventivas, como o exame Papanicolau, são fundamentais para prevenção desse problema. Objetivo: O objetivo desse estudo foi descrever os resultados dos exames citopatológicos em mulheres de 25 a 64 anos no Município de Mossoró/RN. Metodologia: Levantamento retrospectivo analítico dos exames citopatológicos cadastrados no banco de dados do Sistema de Informação do Câncer de Colo de Útero (SICOLO) entre o período de 2014 e 2019 para o seu perfil epidemiológico. Resultados: Um total de 46606 casos foram incluídos e analisados. Houve uma tendência de aumento na realização dos testes ao longo dos anos. 83,8% dos casos representam células escamosas atípicas de significado indeterminado (ASC-US). 70% das lesões intraepiteliais escamosas (LIS) foram diagnosticadas como sendo de baixo grau (LISL). Não houve diagnóstico citopatológico de carcinoma de células escamosas e apenas 2 casos de adenocarcinoma in situ. Conclusões: Mossoró segue um padrão nacional de maiores resultados celulares atípicos representados por ASC-US e LSIL. Resultados sugestivos de alto grau de malignidade existem em menor frequência nos exames preventivos e necessitam ser avaliados por exames mais invasivos. Palavras-Chave: Neoplasias do colo do útero; Teste de Papanicolaou; Saúde da Mulher.

Background The Korean Society for Cytopathology has conducted the Continuous Quality Improvement program for cytopathology laboratories in Korea since 1995. In 2018 as part of the program, an annual survey of cytologic data was administered to determine the current status of cytopathology practices in Korea. Methods A questionnaire was administered to 211 cytopathology laboratories. Individual laboratories submitted their annual statistics regarding cytopathology practices, diagnoses of gynecologic samples, inadequacy rates, and gynecologic cytology-histology correlation review (CHCR) data for 2018. In addition, proficiency tests and sample adequacy assessments were conducted using five consequent gynecologic slides. Results Over 10 million cytologic exams were performed in 2018, and this number has almost tripled since this survey was first conducted in 2004 (compounded annual growth rate of 7.2%). The number of non-gynecologic samples has increased gradually over time and comprised 24% of all exams. The overall unsatisfactory rate was 0.14%. The ratio of the cases with atypical squamous cells to squamous intraepithelial lesions accounted for up to 4.24. The major discrepancy rate of the CHCR in gynecologic samples was 0.52%. In the proficiency test, the major discrepancy rate was approximately 1%. In the sample adequacy assessment, a discrepancy was observed in 0.1% of cases. Conclusions This study represents the current status of cytopathology practices in Korea, illustrating the importance of the Continuous Quality Improvement program for increasing the accuracy and credibility of cytopathologic exams as well as developing national cancer exam guidelines and government projects on the prevention and treatment of cancer.

Background Since 1995, the Korean Society for Cytopathology has overseen the Continuous Quality Improvement program for cytopathology laboratories. The Committee of Quality Improvement has carried out an annual survey of cytology data for each laboratory and set standards for proficiency tests. Methods Evaluations were conducted four times per year from 2008 to 2018 and comprised statistics regarding cytology diagnoses of previous years, proficiency tests using cytology slides provided by the committee, assessment of adequacy of gynecology (GYN) cytology slides, and submission of cytology slides for proficiency tests. Results A total of 206 institutes participated in 2017, and the results were as follows. The number of cytology tests increased from year to year. The ratio of liquid-based cytology in GYN gradually decreased, as most of the GYN cytology had been performed at commercial laboratories. The distribution of GYN diagnoses demonstrated nearly 3.0% as atypical squamous cells. The rate for squamous cell carcinoma was less than 0.02%. The atypical squamous cell/squamous intraepithelial lesion ratio was about 3:1 and showed an upward trend. The major discordant rate of cytology-histology in GYN cytology was less than 1%. The proficiency test maintained a major discordant rate less than 2%. The rate of inappropriate specimens for GYN cytology slides gradually decreased. Conclusions The Continuous Quality Improvement program should be included in quality assurance programs. Moreover, these data can contribute to development of national cancer examination guidelines and facilitate cancer prevention and treatment.

Background Persistent infection with high-risk human papillomavirus (HR-HPV) is the main leading cause of cervical precancerous lesions and cervical cancer. This study aims to explore the epidemiological characteristics of HR-HPV genotypes and their correlation with the ThinPrep cytological test (TCT) results among women in Chongqing, in China. Methods In this retrospective study, cervical exfoliations of 14,548 women who visited Chongqing university cancer hospital were collected for detecting HR-HPV genotypes and TCT. Results Overall, the rate of HR-HPV infection was 14.26%. The three most common HR-HPV genotypes are HPV52 (4.39%), HPV58 (2.21%), and HPV16 (1.94%). In this study, the positive rate of cervical TCT was 4.54%. Atypical squamous cells of undetermined significance (ASC-US), atypical squamous cells that could not exclude high-grade squamous intraepithelial lesion (ASU-H), low-grade squamous intraepithelial lesions (LSIL), high-grade squamous intraepithelial lesions (HSIL), and atypical glandular cells of undetermined significance (AGC) were 2.99%, 0.20%, 0.92%, 0.29%, and 0.14%, respectively. Among the several types of cytological lesions, the HR-HPV infection rates of ASC-US, ASC-H, LSIL, HSIL, and (AGC) were 24.82%, 41.38%, 64.18%, 95.24%, and 23.81%, respectively. Conclusions HPV52, HPV 58, and HPV16 are the most common infection subtypes in Chongqing. When implementing HPV vaccine programs in Chongqing, HPV58 and HPV52 should be attached importance as HPV16 and HPV18.

AimThe Papilloplex high-risk human papillomavirus (hrHPV) test (Genefirst, Oxford, UK) is a single tube real-time HPV test which provides multiplex detection and separate identification of 14 hrHPV types. Here, we present the clinical validation of the test in SurePath samples in comparison to a clinically validated reference test, the GP5+/6+Enzyme ImmunoAssay (GP5+/6+EIA) using the VALGENT (VALidation of HPV GENotyping Tests) framework.MethodsClinical performance was assessed using 998 unselected, cervical screening samples enriched with 297 cytologically abnormal specimens (100 atypical squamous cells of unspecified significance, 100 low-grade squamous intraepithelial lesions, 97 high-grade squamous intraepithelial lesions). Cases were defined as women diagnosed with histologically confirmed cervical intraepithelial neoplasia two or more (≥CIN2, N=119) and controls defined as women with two subsequent negative cytology results (N=834).ResultsThe Papilloplex HR-HPV test has non-inferior sensitivity for detection of cervical precancer (p=0.0001 for ≥CIN2 and p=0.0005 for ≥CIN3) and non-inferior specificity, compared with GP5+/6+EIA (pni=0.0167)). The assay also showed excellent or good agreement for overall hrHPV and nearly all individual HPV types as compared with GP5+/6+EIA/Luminex.ConclusionThe Papilloplex HR-HPV applied on cervical specimens stored in SurePath medium fulfils the international clinical accuracy criteria for use in cervical cancer screening.

Background and aims This study aimed to evaluate whether there is a difference in human papillomavirus (HPV), smear, and cervical biopsy results between patients with and without diabetes mellitus (DM). Methods Retrospectively, 136 patients with positive high risk (HR) HPV screening results with and without DM who underwent colposcopy between 2015 and 2019 were identified. The clinicopathological characteristics and HR HPV screening results were reported and analyzed. The results of the patients with and without DM were compared. Results HPV 16 positivity, Atypical Squamous Cells of Undetermined Significance (ASCUS), and Cervical Intraepithelial Neoplasia 1 (CIN 1) in smear and biopsy results were higher in patients with DM than patients without DM. Conclusions The higher HPV positivity in patients with diabetes may require reforming the frequency and method of cervical cancer screening to be applied to this patient group.

Objective: To assess the psychosocial impact of human papillomavirus (HPV) testing, colposcopy, and Pap-smear, as triage strategies after a Pap-smear with atypical squamous cells of undetermined si...

Background. To explore the feasibility of careHPV (human papillomavirus) with cytology triage as a cervical cancer screening in rural areas of China. Methods. A total of 7138 women aged 35 to 64 years were divided into 2 groups. Women in careHPV group (n = 3536) underwent careHPV and 288 positive subjects underwent cytology, of which 65 women were ≥ASC-US (atypical squamous cells of undetermined significance). Women in the cytology group (n = 3602) underwent cytology and 111 women were ≥ASC-US. All subjects with ≥ASC-US were referred to colposcopy and biopsy. Results. The average age of subjects was 48.2 ± 7.8 years. In the careHPV group, the HPV-positive rate was 8.1%. The detection rate of ≥ASC-US was 1.8% in the careHPV group and 3.1% in the cytology group ( P = .001). There was no significant difference in detection rate of ≥CINII (cervical intraepithelial neoplasia) in the careHPV group (0.7%) and the cytology group (0.6%; P = .416). In addition, to identify 1 case ≥CINII, an average of 2.6 colposcopies were needed in the careHPV group, and 5.3 colposcopies were performed to diagnose 1 case ≥CINII in the cytology group. Conclusions. careHPV with cytology triage offered similar efficiency in identifying abnormalities of CINII and above compared with cytology screening. With the reduced requirement for cytology testing and colposcopy, careHPV may be a more favorable cervical cancer screening strategy in areas of China where there is a lack of cytology services.

Background: Cervical cancer is strongly associated with persistent human papillomavirus (HPV) infections. The ThinPrep cytologic test (TCT), HPV DNA detection, and E6/E7 mRNA testing are widely used to screen for cervical abnormalities. Purpose: This study aimed to find a suitable method for cervical cancer diagnosis (but not for cervical cancer distant metastasis), especially among women whose TCT results are atypical squamous cells of undetermined significance (ASCUS) or worse (including ASCUS). Patients and methods: A total of 301 samples from Wenzhou People's Hospital from June 2014 to September 2017 were collected, we conducted comparative analysis of the diagnostic performance of several conventional screening methods both individually and in combination. Results: We compared the sensitivity, specificity, positive predictive value, negative predictive value, and Youden index retrospectively estimated not only by single TCT, HPV DNA detection, or E6/E7 mRNA testing but also by combination methods, such as TCT+HPV DNA, TCT+E6/E7 mRNA, or TCT+HPV DNA+E6/E7 mRNA. Screening under TCT+E6/E7mRNA was confirmed with relatively higher sensitivity of 76.1% (95% CI: 0.659-0.841), specificity of 74.6% (95% CI: 0.681-0.803), and the highest Youden index of 0.507. Conclusion: The joint screening methods showed relatively reliable specificity and sensitivity for cervical disease screening, and detection by TCT+E6/E7 mRNA has the potential to be a widely used clinical method for cervical cancer screening.

Cervical cancer is a major public health problem that continues to be one of the leading female genital cancers worldwide. In the kingdom of Saudi Arabia (KSA), cervical cancer ranks the fifteenth most frequent cancer among females. This study is the first published research study addressing the screening of cervical cancer in Madinah region of KSA. Aim: To evaluate the abnormal cytological entities detected by cervical Pap smear in Madinah region of KSA and to compare the results with other national and international studies. Methods: This retrospective case-control study was conducted in the Departments of Obstetrics and Gynecology, and Histopathology at the Maternity and Children Hospital (MCH), Madinah, KSA from January 2013 to December 2015. Results: Of the 1594 cases reviewed, only 38 cases (2.4%) had epithelial cell abnormalities. High grade squamous intraepithelial lesions (HSIL) and low grade squamous intraepithelial lesions (LSIL) were the most common diagnosis categories, and cervical cancer accounted for 36.8% of the total cases for each, followed by atypical squamous cells of uncertain significance (ASCUS) found in (15.9%). Squamous cell carcinoma (SCC ) was found in (5.3%) of the cases. Patients with abnormal epithelial changes had higher parity (P=0.021) and presented more with a complaint of postcoital bleeding (P

Objective: To estimate the prevalence and to determine factor associated with abnormal cervical cell among the Hmong and Mien hill tribe women. Methods: A cross-sectional study aimed to estimate the prevalence and to determine the factors associated with abnormal cervical cell among the Hmong and Mien hill tribe women living in Pha Yao province, Thailand was conducted. The data from validated questionnaires and Papanicolaou (Pap) smear test results were collected. Logistic regression was used to detect the associations between variables and abnormal cervical cell at the significant level of alpha = 0.05. Results: Totally, 450 Hmong and Mien women were recruited into the analysis. The overall prevalence of abnormal cervical cell was 2.2%; 1.2% were atypical squamous cells of undetermined significance (ASC-US), 0.4% were atypical squamous cells-cannot exclude HSIL (ASC-H), 0.4% were cervical intraepithelium neoplasia-I (CIN-I) and 0.2% were cervical intraepithelium neoplasia-II (CIN-II). Two variables, the number of their sexual partners and the number of husbands’ sexual partners, were significantly associated with abnormal cervical cell. The women who had ≥ 4 sexual partners had a 7.09 times (95%CI=1.85-27.17) more likely to have abnormal cervical cell than those who had < 4 sexual partners. The women whose husbands had ≥ 4 partners had a 5.63 times (95%CI=1.51-20.90) more likely to have abnormal cervical cell than those whose husbands had < 4 sexual partners. Conclusion: The number of sexual partners is significantly associated with abnormal cervical cell among the Hmong and Mien hill tribe women. Health interventions regarding safe sex should be promoted in the hill tribe people.

Introduction: A causal link between infection with a high-risk strain of human papilloma virus (hrHPV) and the development of cervical squamous cell carcinoma (SCC) is well established. However, a small number of SCCs are hrHPV-negative by either HPV co-DNA testing and/or HPV-in situ hybridization (HPV-ISH) at the time of diagnosis. These apparently hrHPV-negative lesions are poorly understood, specifically whether hrHPV-positive precursor lesions exist, which would be detected through hrHPV-based screening. Methods: A search of the pathology archives at the Johns Hopkins Hospital identified women with a diagnosis of hrHPV-negative cervical SCC on surgical specimen. All prior pathologies, including cervical cytology and surgical pathology specimens, and associated hrHPV DNA test results, p16 immunohistochemistry, and HPV-ISH were reviewed. Results: A total of 25 women were identified having a surgical specimen diagnosed as SCC with either negative or equivocal HPV-ISH. Fifteen had a Pap test in the 6 months preceding a diagnosis of SCC, with cytology diagnoses as follows: high-grade squamous intraepithelial lesion n = 14/15; atypical squamous cells, cannot exclude high-grade squamous intraepithelial lesion n = 1/15. hrHPV co-testing was performed for 5 of these 15 women and was negative in 2/5 cases. Cervical biopsy was performed for 24 women. HPV-ISH testing, performed on 14 of the biopsy specimens, was negative for 11/14 patients. Of 15 specimens stained for p16, 14 were positive. Conclusion: A subset of patients exist in whom hrHPV is not detectable at or near the time of progression to SCC. Additional research is necessary to further describe this population and determine whether maintaining cytological screening would provide benefit.

Objectives: To evaluate prevalence of underlying significant pathologies among women with cervical smears rated as ‘atypical squamous cells cannot exclude high grade squamous intraepithelial lesion (ASC-H)’, as well as associated risk factors. Methods: Medical records were reviewed of all consecutive women with ASC-H smears who had undergone colposcopy at Srinagarind Hospital from January 2008 to July 2016. Significant pathology results included cervical intraepithelial neoplasia (CIN) 2-3, adenocarcinoma in situ (AIS), endometrial hyperplasia, and cancer of any original site. Result: During the study period, 133 women with ASC-H were reviewed. The mean age was 45.3 years (range 21-72). The histopathologic results for the 133 women were as follows: no lesions (58; 43.6%), CIN 1 (34; 25.6%), CIN 2-3 (33; 24.8%), AIS (2; 1.5%), and cervical cancer (6; 4.5%). The overall rate of significant pathology was 30.8% (95% confidence interval, 22.9%-38.8%). Women younger than 40 years old carried a higher risk of harboring significant lesions when compared to older women (41.7% versus 27.8%, respectively). There was no significant impact of parity and menopausal status on the risk of significant pathology results. Conclusion: The rate of significant histopathologies among women with ASC-H smears in this study was approximately 31% and the associated risk factor was patient age.

Background: One of the features of cervical cancer screening using the combination of cytology and human papillomavirus (HPV) testing is the triage for atypical squamous cells of undetermined significance (ASC-US). The effectiveness of the triage has been recognized widely. However, there are few reports evaluating this triage process in Japan. Material and Methods: We retrospectively examined the results of cytology and HPV co-testing for cervical cancer screening in the Oyama area of Tochigi Prefecture between 2012 and 2014. Women who were ASC-US/HPV positive and had cytologic abnormalities [low-grade squamous intraepithelial lesions (LSIL) or worse] were examined by colposcopy. The results of the colposcopy testing were evaluated. In addition, we also examined the results of those who underwent co-testing a year after a ASC-US/HPV-negative result. Results: A total of 21,342 women received their first screening test during the study period, with 542 (2.5%) found to have ASC-US. Of the ASC-US-positive women, 289 (53.3%) were also HPV positive. The prevalence of CIN+ (cervical intraepithelial neoplasia or higher) in the ASC-US/HPV-positive group was 63.2%, with 81.8%, 16.4% and 4.8%. showing CIN 1, CIN 2 and CIN 3+, respectively. The prevalence of CIN+ in the LSIL group was 66.8%, with the majority having a low risk CIN 1 (76.6%) compared to CIN 2 (18.6%), and CIN 3+ (4.8%). No significant difference was observed between the LSIL and ASC-US/ HPV-positive groups. The prevalence of women diagnosed with CIN in the ASC-US/HPV-negative group, following co-testing a year after colposcopy was low (3%). Conclusions: The ASC-US/HPV-positive group was comparable to the LSIL group in terms of prevalence of CIN+ lesions. Furthermore, low CIN prevalence after one year in the ASCUS/ HPV-negative group provides confirmation that the screening interval could be extended. The application of HPV triage (which is routine in other countries) to identify these groups would be of benefit in Japan.

Background: The use of intrauterine contraceptive device (IUCD) generally has been known to be safe and effective but tends to have some side effects. Reproductive tract infection is one of the major complications caused by prolonged usage of an IUCD. Cervical smears have shown an increase in inflammation, inflammatory epithelial changes, or metaplastic cells among the IUCD users as compared to nonusers. There is also a predisposition to higher rate of infections such as Actinomyces, atypical squamous cells of undetermined significance, and low-grade squamous intraepithelial lesion. Aims and Objectives: The aim of this study was to study changes in cervical cytology in IUCD users and to assess the risk of epithelial cell abnormalities among IUCD users compared to nonusers. Materials and Methods: A 2-year cross-sectional study was carried out to screen Papanicolaou (Pap) smears in women of the reproductive age group who were categorized as IUCD and non-IUCD users. Results and Observations: A total of 1100 (550 + 550) Pap smears from IUCD and non-IUCD users were analyzed. Among IUCD users, 544 cases (98.90%) were adequate for reporting including 533 cases (97.98%) showing negative for intraepithelial lesion or malignancy (NILM) and 11 cases (2.02%) showing epithelial cell abnormality (ECA). In non-IUCD users, 541 cases (98.36%) were adequate for reporting. Among these, 538 cases (99.44%) showed NILM and 3 cases (0.56%) showed ECA. Conclusion: In IUCD users, the prevalence of infections and ECA is higher than non-IUCD users.

Context.—Reports for atypical squamous cells of undetermined significance (ASC-US) and histologic findings are rare in China.Objective.—To analyze the correlation findings of ASC-US cytology with high-risk human papillomavirus (hrHPV) test and histopathologic follow-ups.Design.—ASC-US cases with hrHPV test and histologic follow-ups between 2011 and 2015 were analyzed at a College of American Pathologists–certified laboratory.Results.—A total of 2 206 588 Papanicolaou (Pap) tests were performed, including 1 513 265 liquid-based cytology preparations (68.58%), and 693 323 conventional Pap tests (31.42%). The overall ASC-US reporting rate was 3.77% (83 199 of 2 206 588), with the highest in women aged 40 to 49 years. Of 18 574 women with ASC-US Pap and HPV testing, the hrHPV positivity rate was 34.98% (6498 of 18 574) with the highest in women younger than 30 years. A total of 6012 women with ASC-US Pap test findings had histologic follow-ups within 6 months; the overall cervical intraepithelial neoplasia 2 and above (CIN2+) detection rate was 7.87% (473 of 6012). One thousand nine hundred nine women with ASC-US Pap and HPV testing had histologic results. CIN2+ lesion was found in 13.98% (124 of 887) of women with ASC-US Pap/HPV-positive test results, significantly higher than 2.84% (29 of 1022) for women with ASC-US Pap/HPV-negative test results. Cervical squamous cell carcinoma was found in 3.95% (35 of 887) of women with ASC-US/HPV-positive test results.Conclusions.—This is one of the largest studies to investigate HPV and histologic follow-up findings in women with ASC-US in China. The ASC-US reporting rate, HPV positivity rate, and CIN2+ detection rate were all within the currently recognized benchmark ranges. These findings may contribute to establishing a baseline for better understanding of the status of cervical screening in China.

Objective: The purpose of this study was to examine the correlation between histological findings in women with HSIL or ASC-H who have undergone loop electrosurgical excisional procedure with “Three-Step Approach” and “See-and-Treat Procedure".Study Design: A retrospective review was performed in 171 women with cytologically detected HSIL or ASC-H. Sixty five women with HSIL cytology and 35 women with ASC-H cytology were managed by “Three-Step Approach”, 35 women with ASC-H and 36 women with HSIL cytology were managed by "See-and-Treat Procedure”. Rates of histopathological findings were compared in two strategies with respect to previous cytology.Results: Fifteen women with ASC-H (42.9%), and 24 women with HSIL (68.5%) had CIN 2-3 at loop electrosurgical excisional procedure specimens in the “See-and-Treat” group whereas 14 women with ASC-H (38.8%), and 43 women with HSIL (66.2%) had CIN 2-3 at loop electrosurgical excisional procedure specimens in the “Three-Step Approach” group. There was no significant difference in the rate of CIN 2+ lesions when two strategies were compared in women with HSIL and ASC-H (p=0.71 and p=0.72, respectively). The overtreatment rates were 22.9% and 48.6% for HSIL and ASC-H cytology, respectively in the “See and Treat” group.Conclusion: In the ASC-H group, the rate of CIN 2+ lesions is significantly high (51.4%). It seems rational to perform “See-and-Treat procedure” in the setting of ASC-H smears although the overtreatment rate seems to be high. Because of the rate of overtreatment, the “Three-Step Approach” seems to be more reasonable in women with ASC-H cytology who also have fertility concerns. After a cytological diagnosis of HSIL, “see and treat” approach seems to be a safe and time saving strategy.

Background Hyperchromatic crowded groups (HCGs) are often classified as atypical squamous cells, cannot exclude a high grade squamous intraepithelial lesion (ASC-H) on ThinPrep Pap tests. This study reports on the association of HCG's with high grade squamous intraepithelial lesions (HSIL) involving endocervical glands. Methods Over a 3-year period (January 1, 2018-December 31, 2020), 115 (0.2%) of 63,817 Pap tests were diagnosed as ASC-H. Histologic follow-up was available in 76 (66%) cases; 42 (55%) cervical biopsies; and 34 (45%) cervical cones/LEEPs. Results Based on the histologic results, 49 ASC-H cases showed HSIL/CIN 3 and form the basis of this study. ThinPrep Pap tests showed two cell patterns; atypical immature squamous metaplastic cells and HCGs, each of which was difficult to distinguish from HSIL. On histologic correlation all 10 ASC-H Pap Tests with individual atypical immature squamous metaplastic cells showed HSIL/CIN 3 without endocervical gland involvement and 37 (95%) of the 39 Pap Tests with HCGs showed HSIL/CIN 3 with endocervical gland involvement. Conclusion The results of this study support the premise that a subset of HCGs represent endocervical gland involvement by HSIL as opposed to a glandular lesion; in particular endocervical adenocarcinoma in-situ.

Introduction The 2014 Bethesda System categorizes squamous lesions as low-grade squamous intraepithelial lesions (LSIL) and high-grade squamous intraepithelial lesions (HSIL). It also includes intermediate morphologic terminology, such as atypical squamous cells of undetermined significance (ASC-US) and atypical squamous cells, cannot rule out a high grade squamous intraepithelial lesion (ASC-H). Consensus is lacking if when ASC-H is present in an unequivocal LSIL (LSIL + ASC-H) versus ASC-H alone predicts a neoplasm with a different biologic behavior and which is its association with high-risk human papillomavirus (HPV). Materials and methods We reviewed the Columbia University Medical Center Pathology department patient’s database from October 2012 through December 2014 and found 2498 cytology samples of LSIL, ASC-H, HSIL, and LSIL + ASC-H with both follow-up histologic samples and HPV tests by Roche cobas. Our objective was to identify, if any, differences in biologic behavior and HPV status present in LSIL + ASC-H compared with ASC-H and other lesions. Results CIN2+ was documented in tissue examination in 102 from 311 LSIL + ASC-H (32.8%), 101 from 219 ASC-H (46.1%), 252 from 326 HSIL+ (77.3%), and 150 from 1642 LSIL (9.08%). HPV distribution shows significant differences between all diagnostic categories. Conclusions LSIL + ASC-H appears to have a distinctive HPV distribution pattern that clearly differs from ASC-H and LSIL and approaches HSIL; however, the predictive value for CIN2+ appears higher for ASC-H than LSIL + ASC-H. Our literature review identified conflicting findings, probably suggesting a lack of reproducibility in cytologic criteria and the need for consistent inclusion of ASC-H and LSIL when both are present.

Background: Cervical cytology in postmenopausal women is challenging due to physiologic changes of the hypoestrogenic state. Misinterpretation of an atrophic smear as atypical squamous cells of uncertain significance (ASCUS) is one of the most common errors. We hypothesize that high-risk human papillomavirus (hrHPV) testing may be more accurate with fewer false positive results than co-testing of hrHPV and cervical cytology for predicting clinically significant cervical dysplasia in postmenopausal women. Materials and Methods: We conducted a retrospective analysis of 924 postmenopausal and 543 premenopausal women with cervical Pap smears and hrHPV testing. Index Pap smear diagnoses (ASCUS or greater vs. negative for intraepithelial lesion) and hrHPV testing results were compared with documented 5-year clinical outcomes to evaluate sensitivity and specificity of hrHPV compared with co-testing. Proportions of demographic factors were compared between postmenopausal women who demonstrated hrHPV clearance versus persistence. Results: The prevalence of hrHPV in premenopausal and postmenopausal women was 41.6% and 11.5%, respectively. The specificity of hrHPV testing (89.6% [87.4–91.5]) was significantly greater compared with co-testing (67.4% [64.2–70.4]) (p

The present study attempted to analyse human papillomavirus (HPV) genotype distribution and its association with cervical cytology results in women in western China. The present retrospective analysis was performed in 1089 female outpatients with a positive HPV test result who had undergone a cervical cytology test at the gynaecological clinic, West China Second Hospital, Sichuan University, China, between January 2014 and December 2016. Of the 1089 patients with HPV infection, multiple HPV genotypes were detected in 220 patients (20.20%). Among the 1368 HPV genotypes detected, 1145 (83.70%) were high-risk subtypes. The most common genotypes were HPV-52 (18.64%), HPV-16 (16.59%), HPV-58 (13.23%), HPV-18 (6.80%), HPV-56 (5.56%) and HPV-59 (5.56%). Cervical cytology revealed abnormal cells in 430 (39.49%) patients. The most common diagnoses were atypical squamous cells of undetermined significance (ASC-US; 236 cases, 54.88%), low-grade squamous intraepithelial lesions (LSIL; 151 cases, 35.12%), high-grade squamous intraepithelial lesions (HSIL; 63 cases, 14.65%) and atypical glandular cells (AGC; 21 cases, 4.88%). HPV-66 was significantly associated (P = 0.037) with ASC; HPV-52 and HPV-56 were significantly associated with LSIL (P = 0.009 and 0.026, respectively); HPV-16 (P < 0.001), HPV-33 (P = 0.014) and HPV-58 (P = 0.003) were significantly associated with HSIL; and HPV-16 (P = 0.005) was significantly associated with AGC. HPV-16, HPV-52 and HPV-58 are associated with different diagnoses in patients with positive cervical cytological findings.

BACKGROUND Cervical cytology screening is usually laborious with a heavy workload and poor diagnostic consistency. The authors have developed an artificial intelligence (AI) microscope that can provide onsite diagnostic assistance for cervical cytology screening in real time. METHODS A total of 2167 cervical cytology slides were selected from a cohort of 10,601 cases from Shenzhen Maternity and Child Healthcare Hospital, and the training data set consisted of 42,073 abnormal cervical epithelial cells. The recognition results of an AI technique were presented in a microscope eyepiece by an augmented reality technique. Potentially abnormal cells were highlighted with binary classification results in a 10× field of view (FOV) and with multiclassification results according to the Bethesda system in 20× and 40× FOVs. In addition, 486 slides were selected for the reader study to evaluate the performance of the AI microscope. RESULTS In the reader study, which compared manual reading with AI assistance, the sensitivities for the detection of low-grade squamous intraepithelial lesions and high-grade squamous intraepithelial lesions were significantly improved from 0.837 to 0.923 (P < .001) and from 0.830 to 0.917 (P < .01), respectively; the κ score for atypical squamous cells of undetermined significance (ASCUS) was improved from 0.581 to 0.637; the averaged pairwise κ of consistency for multiclassification was improved from 0.649 to 0.706; the averaged pairwise κ of consistency for binary classification was improved from 0.720 to 0.798; and the averaged pairwise κ of ASCUS was improved from 0.557 to 0.639. CONCLUSIONS The results of this study show that an AI microscope can provide real-time assistance for cervical cytology screening and improve the efficiency and accuracy of cervical cytology diagnosis.

BACKGROUND The objective of this study was to describe the determinants of adequacy and positivity of the p16/Ki-67 assay in a human papillomavirus (HPV)-positive screening population enrolled within the New Technologies for Cervical Cancer 2 (NTCC2) study. METHODS ThinPrep slides were immunostained for p16/Ki-67; each slide had 3 reports from different laboratories. The authors included population-related, sampling-related/staining-related, and interpretation-related variables in the analyses. Adequacy and positivity proportions were stratified by variables of interest. Univariate and multivariate logistic models were used to identify determinants of adequacy and positivity. RESULTS In total, 3100 consecutive HPV-positive cases were analyzed. Because every slide was interpreted by 3 centers, 9300 reports were obtained, including 905 (9.7%) that were inadequate and 2632 (28.3%) that were positive. The percentage of cases in which all 3 reports were inadequate increased with increasing age of the women and with inadequate cytology. The highest percentage of adequacy in all 3 reports and of cases with all 3 reports positive was observed in specimens from women who had grade ≥2 cervical intraepithelial neoplasia (CIN2+), atypical squamous cells of undetermined significance or more severe (ASC-US+) cytology, or mRNA positivity. The number of inadequate reports was significantly associated with increasing age, inadequate cytology, mRNA negativity, and scant cellularity. A positive p16/Ki-67 report was associated with an ASC-US+ result and with a positive mRNA result in cases both with and without CIN2+ but was associated with an HPV type 16 and/or 18 infection only in CIN2+ cases. The presence of CIN2+ was strongly associated with dual staining positivity. CONCLUSIONS The interpretation of p16/Ki-67 results may be influenced by several different variables, all of which are part of the steps in the procedure, and by the characteristics of the screened population.