High-risk Human Papillomavirus DNA Testing Research Articles

A multicenter study on the accuracy of PAX1/JAM3 dual genes methylation testing for screening cervical cancer

Objective: To explore the value of cervical cytologic DNA methylation for screening cervical cancer. Methods: This study was a prospective multicenter study conducted from May to October 2022 in Peking Union Medical College Hospital, Zhejiang Provincial People's Hospital, and the Second Affiliated Hospital of Zhejiang University School of Medicine. Women who accepted opportunistic cervical cancer screening in gynecological outpatient clinics were subjected to liquid-based thin-layer cytology testing (TCT), high-risk human papillomavirus (hrHPV) DNA testing and PAX1/JAM3 dual-genes methylation testing (PAX1m/JAM3m). Colposcopy evaluation and biopsy were offered to women according to current guidelines. The accuracies of various testing methods and their combinations were compared based on histological diagnosis. Results: A total of 1 184 samples diagnosed by histopathology were included in this study, consisting of 541 cases (45.7%) of benign cervical tissue or chronic cervicitis, 273 (23.1%) of cervical intraepithelial neoplasia (CIN) 1, 168 (14.2%) of CIN2, 140 (11.8%) of CIN3, and 62 (5.2%) of cervical cancer. The sensitivity and specificity of PAX1m/JAM3m testing for detecting CIN2 or more severe lesions (CIN2+) were 74.1% and 95.9%, respectively. The sensitivity and specificity of PAX1m/JAM3m testing for detecting CIN3+were 87.6% and 86.8%, respectively. Receiver operating characteristic curve analysis showed that, for detecting CIN3+, the area under curve of PAX1m/JAM3m testing (0.872, 95%CI: 0.847-0.897) was significantly superior to TCT testing (0.580, 95%CI: 0.551-0.610) or hrHPV testing (0.503, 95%CI: 0.479-0.515) (all P values<0.05). Conclusions: The PAX1m/JAM3m test in cervical exfoliated cells has excellent accuracy for the diagnosis of both CIN2+and CIN3+, which is superior to traditional screening protocols and screening strategies.

Prevalence of high-risk human papillomavirus infection among women with diabetes mellitus in Accra, Ghana

BackgroundThere is increasing evidence of a higher risk and poorer prognosis of cervical cancer among women with diabetes mellitus (DM) compared to the general population. These are mediated by higher susceptibility to persistent high-risk human papillomavirus (hr-HPV) infection due to dysfunctional clearance in an immunocompromised state. We aimed to determine the prevalence of hr-HPV infection and cervical lesions in a cohort of women with DM in Ghana. We further disaggregated the prevalence according to DM type and explored factors associated with hr-HPV infection.MethodsThis retrospective descriptive cross-sectional study assessed 198 women with DM who underwent cervical screening via concurrent hr-HPV DNA testing and visual inspection with acetic acid in an outpatient department of the National Diabetes Management and Research Centre in Korle-Bu Teaching Hospital, Accra from March to May 2022. Univariate and multivariable binary logistic regression were used to explore factors associated with hr-HPV positivity.ResultsAmong 198 women with DM (mean age, 60.2 ± 12.1 years), the overall hr-HPV prevalence rate was 21.7% (95% CI, 16.1–28.1), disaggregated as 1.5% (95% CI, 0.3–4.4) each for HPV16 and HPV18 and 20.7% (95% CI, 15.3–27.0) for other HPV genotype(s). Respective hr-HPV prevalence rates were 37.5% (95% CI, 15.2–64.6) for type 1 DM, 19.8% (95% CI, 13.9–26.7) for type 2 DM, and 25.0% (95% CI, 8.7–49.1) for unspecified/other DM types. Past use of the combined contraceptive pill independently increased the risk of hr-HPV infection by approximately three times (adjusted odds ratio [aOR] = 2.98; 95% CI, 1.03 − 8.64; p-value = 0.045), whereas each unit increase in FBG level increased the odds of hr-HPV infection by about 15% (aOR = 1.15; 95% CI, 1.02 − 1.30; p-value = 0.021).ConclusionOur study points to a high prevalence of hr-HPV among women with DM and highlights a need for glycemic control among them as this could contribute to lowering their odds of hr-HPV infection. The low overall rates of HPV vaccination and prior screening also indicate a need to build capacity and expand the scope of education and services offered to women with DM as regards cervical precancer screening.

Comparing Cervical Cancer Screening Strategies in an Incarcerated Population.

Objective: To describe the prevalence of cervical intraepithelial neoplasia (CIN), high-risk human papillomavirus (hrHPV) infection, and cervical cancer in a high-risk, underscreened incarcerated population and to evaluate the performance of current cervical cancer screening options to detect cervical precancer (CIN 2/3) in this population. Study Design: Deidentified data were obtained from all cytological, hrHPV DNA, and histopathological testing of cervical biopsies performed on people incarcerated at the North Carolina Correctional Institute for Women between January 1, 2013, and December 31, 2020. These were linked to corresponding demographic data. The proportions of histopathological diagnoses of CIN2+ and CIN3+ immediately preceded by abnormal cytology testing or hrHPV testing were determined, and prevalence differences and 95% confidence intervals were calculated. Results: A total of 15,319 individuals incarcerated at the North Carolina Correctional Institute for Women had at least one cytology result during 2013-2020. Of these, 2,829 (18%) had abnormal cervical cytology, and 3,724 (24.3%) had positive hrHPV testing. The detection of CIN2+ was 95.9% by preceding abnormal cervical cytology, 89.9% by preceding positive hrHPV testing (p = 0.03), and 96.5% by preceding positive co-testing. The detection rate of CIN3+ was 96.6% by preceding abnormal cervical cytology, 90.8% by preceding positive hrHPV testing (p = 0.12), and 96.6% by positive co-testing. Conclusion: In our sample, primary cytology and co-testing detected CIN2+ at higher rates when compared with primary hrHPV testing. This reinforces that incarcerated populations do not fall into average-risk populations for which current cervical cancer screening options are designed, which should be considered when performing screening in this population.

Prevalence of high-risk human papillomavirus infection and cervical lesions among female migrant head porters (kayayei) in Accra, Ghana: a pilot cross-sectional study

BackgroundLittle attention has been given to the risk of high-risk human papillomavirus (hr-HPV) infection and cervical precancerous lesions among female migrant head porters (kayayei) in Ghana, as a vulnerable group, and to promote cervical screening in these women. This pilot study aimed to determine the prevalence of hr-HPV infection and cervical lesions among kayayei in Accra, the capital of the Greater Accra Region of Ghana and to describe our approach to triaging and treating these women.MethodsThis descriptive cross-sectional cohort study involved the screening of 63 kayayei aged ≥ 18 years at the Tema Station and Agbogbloshie markets in March 2022 and May 2022. Concurrent hr-HPV DNA testing (with the MA-6000 platform) and visual inspection with acetic acid (VIA) was performed. We present prevalence estimates for hr-HPV DNA positivity and VIA ‘positivity’ as rates, together with their 95% confidence intervals (CIs). We performed univariate and multivariable nominal logistic regression to explore factors associated with hr-HPV infection.ResultsGross vulvovaginal inspection revealed vulval warts in 3 (5.0%) and vaginal warts in 2 (3.3%) women. Overall, the rate of hr-HPV positivity was 33.3% (95% CI, 21.7–46.7), whereas the VIA ‘positivity’ rate was 8.3% (95% CI, 2.8–18.4). In the univariate logistic regression analysis, none of the sociodemographic and clinical variables assessed, including age, number of prior pregnancies, parity, past contraceptive use, or the presence of abnormal vaginal discharge showed statistically significant association with hr-HPV positivity. After controlling for age and past contraceptive use, only having fewer than two prior pregnancies (compared to having ≥ 2) was independently associated with reduced odds of hr-HPV infection (adjusted odds ratio, 0.11; 95% CI, 0.02–0.69).ConclusionIn this relatively young cohort with a high hr-HPV positivity rate of 33.3% and 8.3% of women showing cervical lesions on visual inspection, we posit that kayayei may have an increased risk of developing cervical cancer if their accessibility to cervical precancer screening services is not increased.

HPV DNA Testing and Mobile Colposcopy for Cervical Precancer Screening in HIV Positive Women: A Comparison Between Two Settings in Ghana and Recommendation for Screening.

Women living with HIV (WLHIV) have higher prevalence and persistence rates of high-risk human papillomavirus (hr-HPV) infection with a six-fold increased risk of cervical cancer. Thus, more frequent screening is recommended for WLHIV. This retrospective descriptive cross-sectional study was conducted to investigate and compare the prevalence of hr-HPV infection and abnormal findings on mobile colposcopy in two cohorts of WLHIV following cervical screening in rural and urban settings in Ghana. Through the mPharma 10 000 Women Initiative, WLHIV were screened via concurrent hr-HPV DNA testing (MA-6000; Sansure Biotech Inc., Hunan, China) and visual inspection (Enhanced Visual Assessment [EVA] mobile colposcope; MobileODT, Tel Aviv, Israel) by trained nurses. The women were screened while undergoing routine outpatient reviews at HIV clinics held at the Catholic Hospital, Battor (rural setting) and Tema General Hospital (urban setting), both in Ghana. Two-hundred and fifty-eight WLHIV were included in the analysis (rural, n = 132; urban, n = 126). The two groups were comparable in terms of age, time since HIV diagnosis, and duration of treatment for HIV. The hr-HPV prevalence rates were 53.7% (95% CI, 45.3-62.3) and 48.4% (95% CI, 39.7-57.1) among WLHIV screened in the rural vs urban settings (p-value = .388). Abnormal colposcopy findings were found in 8.5% (95% CI, 5.1-11.9) of the WLHIV, with no significant difference in detection rates between the two settings (p-value = .221). Three (13.6%) of 22 women who showed abnormal colposcopic findings underwent loop electrosurgical excision procedure (LEEP), leaving 19/22 women from both rural and urban areas with pending treatment/follow-up results, which demonstrates the difficulty faced in reaching early diagnosis and treatment, regardless of their area of residence. Histopathology following LEEP revealed CIN III in 2 WLHIV (urban setting, both hr-HPV negative) and CIN I in 1 woman in the rural setting (hr-HPV positive). There is a high prevalence of hr-HPV among WLHIV in both rural and urban settings in this study in Ghana. Concurrent HPV DNA testing with a visual inspection method (colposcopy/VIA) reduces loss to follow-up compared to performing HPV DNA testing as a standalone test and recalling hr-HPV positive women for follow up with a visual inspection method. Concurrent HPV DNA testing and a visual inspection method may also pick up precancerous cervical lesions that are hr-HPV negative and may be missed if HPV DNA testing is performed alone.

Liquid-based cytology screening in Gynecologic oncology

Liquid-based cytology (LBC) is transforming the diagnostic landscape of gynecologic oncology, offering enhanced accuracy in the early detection and effective management of cancers like cervical, ovarian, and endometrial. This article provides an in-depth review of the principles underpinning LBC, elaborates on its application in modern gynecologic oncology, and discusses the distinctive advantages that it holds over traditional cytology methods. Furthermore, the article recognizes the potential limitations of LBC, including cost implications and residual challenges with sample interpretation. The discussion also highlights the ability of LBC to synergistically work with additional testing methods such as high-risk HPV DNA testing, which enriches the diagnostic information gathered from each sample. With this comprehensive analysis, the article illustrates the compelling role of LBC in revolutionizing the quality of diagnostic samples and its consequent potential for improving patient outcomes in gynecologic oncology. This exploration paves the way for future research to further harness and optimize the benefits of LBC in advancing gynecologic healthcare.&#x0D; Keywords: Liquid-based cytology, Gynecology, Oncology

Prevalence of high-grade anal intraepithelial neoplasia in immunocompetent women treated for high-grade cervical intraepithelial neoplasia

BackgroundThe aim of the study was to evaluate the prevalence of high-grade anal intraepithelial neoplasia (AIN2-3) among immunocompetent women treated for high-grade cervical intraepithelial neoplasia (CIN2-3). Such knowledge is strongly needed to establish whether a screening program should be recommended in this group of patients. MethodsThis prospective study included a cohort of consecutive women with no known causes of immunosuppression treated with LEEP (loop electrosurgical excision procedure) for a histopathological diagnosis of CIN2-3 in our center between 2019 and 2021. Following the procedure, all patients were invited to undergo anal cytology and anal high-risk HPV-DNA testing (aHPV-DNA). In cases in which one or both tests resulted positive, a high-resolution anoscopy with a biopsy of suspicious lesions was performed. All women also completed a questionnaire on sexual habits. ResultsAt total of 100 women were enrolled in the study. Among these, eight patients had a concomitant or past diagnosis of anogenital warts, while one patient had received a previous diagnosis of high-grade vaginal intraepithelial neoplasia. Anal Pap smears were positive for low-grade lesions in three patients, while 73 women tested positive for aHPV-DNA. Histological examinations revealed the presence of AIN2-3 lesions in four patients (6.5%; 95% C.I., 1.8 to 15.7%), who subsequently underwent excisional treatment. ConclusionsWomen with a history of high-grade cervical intraepithelial neoplasia have an intermediate risk of developing high-grade anal intraepithelial neoplasia. Future studies are needed in order to assess an ideal screening approach for this condition.

Discussion on cervical cytology in postmenopausal women.

Considering the cervix at the climacteric period, important changes take place in the morphology of the epithelium and stroma due to hypoestrogenism. Therefore, the aim of the present study was to compare the presence of transformation zone cells in the cervix of premenopausal and postmenopausal women. In a private laboratory in São Paulo (Brazil) a retrospective analysis of cervical cytology results was performed. A total of 1,026,671 satisfactory cytology tests were evaluated between January 2010 and December 2015. A marked decline in transformation zone cells with age was evident, with a greater decrease in the ≥50 years age groups. Only 35% of women ≥50 years of age had transformation zone cells in cytology, while in those <50 years, the figure was 67.5% (P<0.001). The prevalence of negative cytological results in these two age groups was respectively 89.9% and 95.3%; however, it was observed that the most serious cytological results occurred in the group after menopause. Although cytology is the recommended screening method for cervical cancer in Brazil, the low number of transformation zone cells in cytology in menopausal patients could be less sensitive for screening of dysplasia and cancer. So, we suggest routine high-risk HPV DNA testing, when possible, given that this test is considered more sensitive for detecting cervical lesions in this group of patients. When HPV DNA testing is not possible, cytology should be collected, and for cytology sampling we suggest regular topical estrogenization and use of appropriate technique.

Self-sampling and HPV DNA testing for cervical precancer screening in a cohort of nuns in Ghana: a cross-sectional cohort study

The need for cervical cancer screening has been emphasised in at-risk cohorts of women to reduce their risk of cervical cancer. Some women with decreased risk of acquiring human papillomavirus (HPV) infections, such as Catholic nuns, receive less attention and on occasion are missed in cervical cancer screening programmes. This study aimed to determine the high-risk HPV (hr-HPV) prevalence in such a cohort to emphasise the need for cervical precancer screening among all women. To improve compliance, we employed self-sampling. This descriptive cross-sectional cohort study involved the data of 105 Catholic nuns subjected to cervical screening using self-samples in the Greater Accra, Volta, and Central regions of Ghana between June 4, 2022 and June 30, 2022. hr-HPV testing was performed on self-samples using the MA-6000 HPV DNA platform. Screen-positive nuns underwent follow-up pap smears and EVA colposcopy. In addition to descriptive analysis, univariate and multivariable nominal logistic regression was used to explore the relationship between hr-HPV positivity and selected continuous and categorical factors. 105 nuns from three convents were screened with hr-HPV DNA testing (MA-6000). Twenty-five tested positive for hr-HPV (prevalence of 23.8% (95% CI, 15.7-32.0) [HPV 18 only (n=2, 1.9%), non-HPV 16/18 genotypes (others) (n=22, 21.0%), and mixed infection with HPV 16 and other genotype(s) (n=1, 1.0%)]. Pap smears for all 25 hr-HPV-positives came in as negative for intraepithelial lesions or malignancy, whereas EVA mobile colposcopy showed minor abnormal findings in two (8.0%; 95% CI, 1.0-26.0), both of whom were managed conservatively. Our findings suggest that the hr-HPV prevalence in this cohort of nuns is similar to that of the general population. To meet the World Health Organization's target for cervical cancer elimination, it is important that all women are given access to cervical cancer screening and preventative services. Further, increasing 'anonymity' and privacy among nuns through self-sampling may be crucial to expanding choice, coverage, and uptake of screening in support of their health rights. None.

Use of Virus Genotypes in Machine Learning Diagnostic Prediction Models for Cervical Cancer in Women With High-Risk Human Papillomavirus Infection

High-risk human papillomavirus (hrHPV) is recognized as an etiologic agent for cervical cancer, and hrHPV DNA testing is recommended as the preferred method of cervical cancer screening in recent World Health Organization guidelines. Cervical cancer prediction models may be useful for screening and monitoring, particularly in low-resource settings with unavailable cytological and colposcopic examination results, but previous studies did not include women infected with hrHPV. To develop and validate a cervical cancer prediction model that includes women positive for hrHPV infection and examine whether the inclusion of HPV genotypes improves the cervical cancer prediction ability. This diagnostic study included diagnostic data from 314 587 women collected from 136 primary care centers in China between January 15, 2017, and February 28, 2018. The data set was separated geographically into data from 100 primary care centers in 6 districts for model development (training data set) and 36 centers in 3 districts for model validation. A total of 24 391 women identified with positive hrHPV test results in the cervical cancer screening program were included in the study. Data were analyzed from January 1, 2022, to July 14, 2022. Cervical intraepithelial neoplasia grade 3 or worse (CIN3+) was the primary outcome, and cervical intraepithelial neoplasia grade 2 or worse (CIN2+) was the secondary outcome. The ability of the prediction models to discriminate CIN3+ and CIN2+ was evaluated using the area under the receiver operating characteristic curve (AUROC), sensitivity, specificity, positive likelihood ratio, and negative likelihood ratio. The calibration and clinical utility of the models were assessed using calibration plots and decision curves, respectively. After excluding women without screening outcomes, the study included 21 720 women (median [IQR] age, 50 [44-55] years). Of 14 553 women in the training data set, 349 (2.4%) received a diagnosis of CIN3+ and 673 (4.6%) of CIN2+. Of 7167 women in the validation set, 167 (2.3%) received a diagnosis of CIN3+ and 228 (3.2%) of CIN2+. Including HPV genotype in the model improved the AUROC by 35.9% for CIN3+ and 41.7% for CIN2+. With HPV genotype, epidemiological factors, and pelvic examination as predictors, the stacking model had an AUROC of 0.87 (95% CI, 0.84-0.90) for predicting CIN3+. The sensitivity was 80.1%, specificity was 83.4%, positive likelihood ratio was 4.83, and negative likelihood ratio was 0.24. The model for predicting CIN2+ had an AUROC of 0.85 (95% CI, 0.82-0.88), with a sensitivity of 80.4%, specificity of 81.0%, positive likelihood ratio of 4.23, and negative likelihood ratio of 0.24. The decision curve analysis indicated that the stacking model provided a superior standardized net benefit when the threshold probability for clinical decision was lower than 23% for CIN3+ and lower than 17% for CIN2+. This diagnostic study found that inclusion of HPV genotypes markedly improved the ability of a stacking model to predict cervical cancer among women who tested positive for hrHPV infection. This prediction model may be an important tool for screening and monitoring cervical cancer, particularly in low-resource settings.

Diagnostic Performance of Urine-based HPV-DNA Test (CerviScan, Bio Farma) as Cervical Cancer Screening Tool in Adult Women

Objective: Detection of high-risk human papillomavirus (hr-HPV) in urine specimens has been introduced recently and a new local PCR kit has been developed in Indonesia (CerviScan, Bio Farma). The objective of this study was to obtain the accuracy of hr-HPV DNA testing using the new kit (CerviScan, Bio Farma) on urine specimens against the gold standard on cervical swabs.Method: Adult women (aged 20–50 years) underwent routine general check-up or Pap test were enrolled between July and September 2022. Pairs of urine and cervical swab specimens were obtained from all subjects. HPV-DNA tests were performed using the new local PCR kit (CerviScan, Bio Farma) and the standard procedure (COBAS® 6800 HPV, Roche Molecular System). Direct sequencing was added whenever there were dispute results between the two methods. Agreement between both methods was tested using Kappa statistics. Diagnostic performance test was done on CerviScan. Results: A total of 876 women completed the examination. Agreement between CerviScan and COBAS® 6800 was substantial (K=0.662; p&lt;0.001) and was almost perfect against COBAS® 6800 plus sequencing (K=0.828; p&lt;0.001). The accuracy of CerviScan on urine samples was 95.8% against COBAS® 6800 and increased to 97.8% after additional sequencing. The sensitivity and specificity of CerviScan on urine samples compared to cervical swabs are 73.1% and 97.3%, respectively.Conclusion: Urine-based HPV-DNA testing with CerviScan is a reliable tool to detect high-risk HPV subtypes. It could become an alternative method for HPV-DNA testing to improve the coverage of cervical cancer screening program.

Cervical precancer screening with HPV DNA testing and mobile colposcopy in women with sickle cell disease in Accra, Ghana.

Worldwide, about 20-25 million people are affected by sickle cell disease (SCD), with 60% of patients living in sub-Saharan Africa. Despite recent therapeutic advancements resulting in improved life expectancy among SCD patients, the prevalence of high-risk human papillomavirus (hr-HPV) and cervical lesions have not been studied in women with SCD. We determined the prevalence of hr-HPV and cervical lesions among women with SCD and recommended strategies for reducing cervical cancer incidence in this cohort. Through the mPharma 10,000 Women Initiative, women with SCD attending routine visits at the Ghana Institute of Clinical Genetics SCD clinic were screened by trained nurses. Screening was performed via concurrent MA-6000 hr-HPV DNA testing and enhanced visual assessment (EVA) mobile colposcopy from mobileODT. Among 168 participants screened (mean age, 43.0 years), the overall prevalence rates of hr-HPV infection and cervical lesions were 28.6% (95% CI, 21.7-35.4) and 3.6% (95% CI, 0.8-6.4), respectively. The hr-HPV prevalence rates stratified by haemoglobin genotype were 29.4% (95% CI, 19.7-39.1) and 28.6% (95% CI, 18.5-38.7) for genotypes SS and SC, respectively. None of the five women with the SF genotype tested hr-HPV positive, and the only patient with Sbthal genotype tested hr-HPV positive. Two women were EVA 'positive' but hr-HPV negative, whereas four were EVA positive and hr-HPV positive. Exploratory analysis revealed no significant associations between hr-HPV positivity and age, education level, marital status or parity. In the absence of a comprehensive national cervical screening programme aimed at including women with SCD as a special population, cervical cancer may increase in frequency among SCD patients. Thus, there is a need to build capacity and expand the scope of screening services for women with SCD.

High risk HPV testing for cervical cancer screening in a Puerto Rican population

The Human Papillomavirus (HPV) causes cervical cancer, the fourth most common cause of death in women in the United States (US). Several major screening clinical trials have demonstrated that high risk HPV (HR-HPV) DNA primary screen is more sensitive at determining the risk of cervical intraepithelial neoplasia level 3 or higher (CIN ≥ 3) than cytology alone and is similar to co-testing. In this cross-sectional study, we characterized a Hispanic population of 18,052 women ages 21–70 years with HR-HPV DNA testing and cytology to determine the prevalence of HR-HPV in the population and determine the likelihood of high grade squamous intraepithelial lesion (HSIL). We also compared cytology, HR-HPV DNA testing, and co-testing strategies to determine sensitivity, specificity, positive predictive value, and negative predictive value for HSIL in cervical biopsies. Results show that HR-HPV had a slightly higher sensitivity (94.2% vs 92.3%) compared to cytology for all high-grade disease (CIN2/3).

An integrated isothermal nucleic acid amplification test to detect HPV16 and HPV18 DNA in resource-limited settings.

High-risk human papillomavirus (HPV) DNA testing is widely acknowledged as the most sensitive cervical cancer screening method but has limited availability in resource-limited settings, where the burden of cervical cancer is highest. Recently, HPV DNA tests have been developed for use in resource-limited settings, but they remain too costly for widespread use and require instruments that are often limited to centralized laboratories. To help meet the global need for low-cost cervical cancer screening, we developed a prototype, sample-to-answer, point-of-care test for HPV16 and HPV18 DNA. Our test relies on isothermal DNA amplification and lateral flow detection, two technologies that reduce the need for complex instrumentation. We integrated all test components into a low-cost, manufacturable platform, and performance of the integrated test was evaluated with synthetic samples, provider-collected clinical samples in a high-resource setting in the United States, and self-collected clinical samples in a low-resource setting in Mozambique. We demonstrated a clinically relevant limit of detection of 1000 HPV16 or HPV18 DNA copies per test. The test requires six user steps, yields results in 45 min, and can be performed using a benchtop instrument and minicentrifuge by minimally trained personnel. The projected per-test cost is <$5, and the projected instrumentation cost is <$1000. These results show the feasibility of a sample-to-answer, point-of-care HPV DNA test. With the inclusion of other HPV types, this test has the potential to fill a critical gap for decentralized and globally accessible cervical cancer screening.

Diagnostic study of human papillomavirus DNA detection in cervical and vaginal samples using the filter paper card.

To determine the accuracy of high-risk human papillomavirus (HPV) DNA samples on filter paper in comparison to specimen transport medium (STM). This was a cross-sectional diagnostic study of 42 consecutive women who were prospectively recruited. Each had self-collected vaginal samples on filter paper, physician-collected cervical samples on filter paper, and physician-collected cervical samples in STM. HPV DNA testing was performed with a Hybrid Capture 2 system (Qiagen). Sensitivity, specificity, negative predictive value (NPV), positive predictive value (PPV), and agreement of filter paper methods with the standard procedure were calculated. The overall prevalence of HPV in STM was 67.5%. Detection of HPV DNA in the physician-collected cervical samples on filter paper had a sensitivity of 77.8%, a specificity of 100%, a PPV of 100%, and an NPV of 68.4%. The patient's self-sampling on filter paper had a sensitivity of 66.7%, a specificity of 100%, a PPV of 100%, and an NPV of 59.1%. The agreement between STM method and physician-collected sample on filter paper was substantial, (κ = 0.695, P < 0.001), while the agreement between STM and self-collected samples on filter paper was moderate (κ = 0.565, P < 0.001). Most patients reported that self-collection was acceptable (100%), painless (95%), and not embarrassing (95%). Filter paper, with dried self-collected vaginal samples, can be used to detect high-risk HPV with acceptable accuracy.

Abstract 81: The Introduction of a High Risk HPV DNA Test for the Cervical Cancer Screening Among Mongolian Women

Abstract Purpose: A global strategy developed by the World Health Organization aims to reduce cervical cancer burden by screening 70% of women with high performance tests at least twice during their lifetime. While Mongolia has implemented a PAP test-based cervical cancer screening program over the past few decades, cervical cancer remains the leading cause of death in the country. Therefore, it is necessary to introduce high-risk HPV DNA detection tests in cervical cancer screening program. Methods: Cervical screening was conducted in 6 districts of the UB and in 4 regional provinces between March 01 and July 01, 2019. A high risk HPV DNA test was conducted on all women using the careHPV test, and then all positive samples were double-tested using the PAP test. All positive women were followed by HPV genotyping test and colposcopy with direct biopsy or endocervical curettage as necessary. Results: A total of 2725 women were screened for HPV DNA, with 8.5%(239) of these detecting high risk HPV DNA, and 61% (138) of positive results having a negative result for intraepithelial neoplasia as determined by PAP tests. It was determined that 10% of samples contained atypical squamous cells of undetermined significance, 4% contained atypical squamous cells of unknown significance, and cannot exclude high grade, 17% of the samples contained low grade squamous intraepithelial lesions, and 10% contained high grade squamous intraepithelial lesions. A colposcopy examination was performed on 181 women who were high-risk HPV DNA positive. An abnormal colonoscopy result was observed in 18% of the women, for which biopsies were taken. A total of 31% of them were confirmed with CIN I, 31% with CIN II, 9% with CIN III, 11% with CIS, and 6% with SCC. Additionally, 105 high-risk HPV DNA-positive samples were genotyped for HPV. There were 25.7% of individuals who were found to have HPV genotype 16, 4.7% who were found to have HPV genotype 18, and 69.6% who were found to have other high-risk genotypes. Conclusion: By incorporating high-risk HPV DNA tests into cervical cancer screening program, its coverage and effectiveness could be increased. Citation Format: Enkhjargal Bayarsaikan. The Introduction of a High Risk HPV DNA Test for the Cervical Cancer Screening Among Mongolian Women [abstract]. In: Proceedings of the 11th Annual Symposium on Global Cancer Research; Closing the Research-to-Implementation Gap; 2023 Apr 4-6. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2023;32(6_Suppl):Abstract nr 81.

Concurrent HPV DNA testing and a visual inspection method for cervical precancer screening: A practical approach from Battor, Ghana.

Cytology-based cervical cancer screening programs have been difficult to implement and scale up in developing countries. Thus, the World Health Organization recommends a 'see and treat' approach by way of hr-HPV testing and visual inspection. We aimed to evaluate concurrent HPV DNA testing and visual inspection in a real-world low-resource setting by comparing the detection rates of concurrent visual inspection with dilute acetic acid (VIA) or mobile colposcopy and hr-HPV DNA testing to standalone hr-HPV DNA testing (using the careHPV, GeneXpert, AmpFire, or MA-6000 platforms). We further compared their rates of loss to follow-up. This retrospective, descriptive cross-sectional study included all 4482 women subjected to cervical precancer screening at our facility between June 2016 and March 2022. The rates of EVA and VIA 'positivity' were 8.6% (95% CI, 6.7-10.6) and 2.1 (95% CI, 1.6-2.5), respectively, while the hr-HPV-positivity rate was 17.9% (95% CI, 16.7-19.0). Overall, 51 women in the entire cohort tested positive on both hr-HPV DNA testing and visual inspection (1.1%; 95% CI, 0.9-1.5), whereas a large majority of the women tested negative (3588/4482, 80.1%) for both and 2.1% (95% CI, 1.7-2.6) tested hr-HPV-negative but visual inspection 'positive'. In total, 191/275 (69.5%) participants who tested hr-HPV positive on any platform, as a standalone test for screening, returned for at least one follow-up visit. In light of factors such as poor socioeconomic circumstances, additional transportation costs associated with multiple screening visits, and lack of a reliable address system in many parts of Ghana, we posit that standalone HPV DNA testing with recall of hr-HPV positives will be tedious for a national cervical cancer prevention program. Our preliminary data show that concurrent testing (hr-HPV DNA testing alongside visual inspection by way of VIA or mobile colposcopy) may be more cost-effective than recalling hr-HPV-positive women for colposcopy.

HPV DNA pozitif olguların servikal smear ile korelasyon sonuçları her zaman uyumlu mudur?

Aim: Cervical cancer is a type of genital cancer which come second after breast cancer in women and may cause death. However, it can be prevented with screening tests by ensuring early diagnosis. Most of cervical cancers (99.7%) are associated with Human Papilloma Virus (HPV) and it is known that HPV must be present for the generation of cervical cancer. Thus, 70% of the patients have been found to be positive for HPV-16 and HPV-18. Both the association with cervical cancer and HPV and data related to development of cancer and dysplasia was researched retrospectively in this study. It was aimed to analyze and use the results by examine if the smear results of the patients and the HPV results are compatible in all HPV positive cases.&#x0D; Material and Method: 1050 patients who were examined by gynecologist and taken Pap smear test at the end of the examination during July 2020 and March 2022, were included in our study. In all cases the Pap test was re-evaluated by the same pathologist using the 2014 Bethesda System. High-risk HPV (HR HPV) DNA (HPV types 16,18,31,33,35,39,45,51,52,56,58,59,66,68) tests results, applied to the patients at an external center, were reviewed. Results of patients diagnosed as LSIL, HSIL and cervical cancer by Pap smear test were evaluated again beside HPV DNA analyses and their clinical information. Chi-square test was used for statistical analysis. p

Comparison of the AmpFire and MA-6000 polymerase chain reaction platforms for high-risk human papillomavirus testing in cervical precancer screening

High-risk human papillomavirus (hr-HPV) testing for primary cervical precancer screening offers an opportunity to improve screening in low-middle income countries (LMICs). This study aimed to compare the analytic performances of the AmpFire and MA-6000 platforms for hr-HPV DNA testing in three groups of women screened for hr-HPV types in Ghana: group 1 with 33 GeneXpert-archived ThinPrep/liquid-based samples subjected to both tests, group 2 with 50 AmpFire-archived dry brush samples subjected to MA-6000 testing, and group 3 involving 143 cotton swab samples simultaneously subjected to both tests without archiving. The overall agreement rates were 73 %, 92 %, and 84 %, for groups 1–3, respectively, and 84 % (95 % CI, 78.6–88.6) for the entire group. Neither AmpFire nor MA-6000 was more likely to test hr-HPV positive in all three groups and the combined group. Group 1 showed fair agreement without statistical significance (κ = 0.224, 95 % CI, −0.118 to 0.565), while group 3 showed significant moderate agreement (κ = 0.591, 95% CI, 0.442–0.741). Group 2 showed an almost perfect significant level of agreement (κ = 0.802; 95 % CI, 0.616–0.987). Thus, both platforms showed statistically significant moderate to near-perfect agreement for detecting hr-HPV in cervicovaginal samples, with variation according to archiving conditions and duration between sample collection and retesting. For LMICs using these platforms for COVID-19 testing, as the COVID-19 pandemic subsides, the platforms can become available for running other tests such as hr-HPV DNA testing for cervical precancer screening.

Oral Human Papillomavirus Infection among Smokeless Tobacco-using Tribal Women in Mysuru, India.

Smokeless tobacco (SLT) is consumed by more than 300 million people worldwide. Studies show high use among Indian indigenous women who are also at high risk for oral cancers. Both human papillomavirus infection (HPV) and SLT have been associated with oral cancer, this study examined the presence of high-risk HPV in oral samples collected from tribal smokeless tobacco users in Mysuru, India. Between June and August 2019, 100 tribal females (50 SLT-users and 50 non-users) from rural Mysuru District, Karnataka, were enrolled in a cross-sectional study. Following informed consent, demographic data and oral samples were collected and processed using a digene HC2 High-Risk HPV DNA test (Qiagen, USA). On average participants were 45.5 (SD: ±6.6) years. Chronic SLT users were mostly married (73%), Hindu (100%), illiterate (62%), and employed (90%). One woman was positive for high-risk HPV infection. Oral HPV infection was low in this sample and this is consistent with the literature from other low and middle-income countries. SLT use is high in this group so interventions to reduce tobacco use are warranted.