careHPV Test Research Articles

Risk assessment of careHPV testing for the detection of cervical precancerous lesions: 5-year follow-up of a screening program in China

BackgroundCareHPV is a highly promising screening HPV assay that functions as a simplified and rapid point-of-care test, making it particularly well-suited for low-resource areas. It exhibits high sensitivity for detecting cervical precancerous lesions in cross-sectional study design. However, there is still limited evidence on the long-term protection of careHPV testing in the practical setting. MethodsA government-led cervical cancer screening program was implemented in Ordos City, China, specifically targeting female residents aged 35-64 years since 2016. CareHPV specimens were collected and visual inspection with acetic acid and Lugol iodine (VIA/VILI) was performed in the baseline screening. Women who were HPV-positive at baseline were invited for a one-year follow-up screening. At the same time, those who were HPV-negative were scheduled for a 5-year rescreening. Women diagnosed with cervical intra-epithelial neoplasia grade 2 or worse (CIN2+) would be referred to clinical treatment as per the clinical guidelines. The current study includes participants who had valid baseline screening results and attended follow-ups with valid careHPV results conducted between January 2017 and December 2021, aiming to assess the long-term risk stratification for careHPV. Cumulative incidence rate (CIRs) and hazard ratio (HRs) for CIN2+ were calculated, using survival analysis. ResultsAmong the 179,306 women enrolled in the baseline screening between 2016 and 2020, 12.60% tested positive for careHPV, with 657 cases of CIN2+ identified. The final analysis included 18,562 women in our study, of whom 58.54% were careHPV-positive at baseline. The final analysis consisted of 17,905 women who underwent screening between 2016 and 2020 and attended follow-ups from 2017 to 2021, with valid HPV results, and 657 women who identified as CIN2+ at the baseline. The 5-year CIRs were 0.003 and 0.101 among women who tested negative and positive for baseline careHPV, respectively. The 5-year CIRs for developing CIN2+ during follow-ups were 0.009, 0.009, and 0.11 for the groups of women who transitioned from careHPV-negative to positive (831, 4.64%), careHPV-positive to negative (6688, 37.35%), and maintained a stable positive careHPV status (3535, 19.74%), respectively. ConclusionsOur findings support the long-term safety and protection of careHPV testing in 5-year follow-ups of screening programs. CareHPV represents a viable option for regions with limited healthcare resources.

Prevalence, persistence, clearance and risk factors for HPV infection in rural Uyghur women in China

BackgroundThe incidence of cervical cancer in Uyghur women ranks first among those in Han and other ethnic minority groups. We aimed to understand the natural history of HPV in Uyghur women.MethodsA longitudinal cohort study on the natural history of HPV infection in rural Uyghur women in China was conducted between May 2013 and May 2014. A total of 11000 women from South Xinjiang underwent HPV screening by careHPV and liquid-based cytology. Ultimately, a total of 298 women with positive HPV and normal biopsy results or CIN1 were enrolled to participate in a study including follow-up HPV testing for two years.ResultsThe HPV infection rate in Uyghur women was 9.15%. Among the participants, the careHPV test showed that 298 women were HPV-positive, and histology showed CIN1 or normal results for these women at baseline. Among these patients, after 24 months of initial recruitment, 92 (30.87%) patients had persistent HPV infections, and 206 (69.13%) had cleared HPV infection. Univariate analysis showed that persistent HPV infection was associated with age and shower frequency (P < 0.001 and P = 0.047, respectively).ConclusionsOur results suggest that women over the age of 50 years who have been infected with HR-HPV for more than 1 year should be regularly screened and monitored for HPV. In addition, education should be strengthened to improve poor health habits in these women.

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.

Clinical performance of a newly developed domestic urine-based HPV test for cervical cancer screening in China.

Although urine-based human papillomavirus(HPV) detection is promising in cervical cancer screening, it has not yet been well-developed. Women aged 30-65 were invited to participate in the current study to provide one urine and two paired vaginal samples. Urine was detected by polymerase chain reaction(PCR)-based HPV test (urine-based HPV test). Two vaginal samples were tested by careHPV and GenPlex® HPV genotyping assay, respectively. Women with vaginal HPV positive were called back for colposcopy and biopsied if clinically indicated. The consistency was 79.0% (κ = 0.563) and 80.5% (κ = 0.605) between the urine-based HPV test, careHPV test, and GenPlex® HPV genotyping assay. Against CIN2detection, the careHPV test showed 77.4% sensitivity, and 71.0% specificity, while the GenPlex® HPV genotyping assay had a sensitivity of 100% and a specificity of 58.7%. For urine-based HPV test, the corresponding rates were 96.8% and 58.7%. Moreover, no significant differences were observed between the urine-based HPV test and careHPV test (p = 0.3395) and GenPlex® HPV genotyping assay (p = 0.338). The newly developed urine-based HPV test demonstrated acceptable consistency and comparable clinical performance with referenced HPV tests for vaginal samples. Therefore, urine-based HPV detection could be a useful alternative for women with difficulties to access cervical cancer screening.

Human papillomavirus testing on self-collected samples to detect high-grade cervical lesions in rural Bhutan: The REACH-Bhutan study.

"REACH-Bhutan" aimed to evaluate the feasibility and clinical performance of a community-based screening program for cervical cancer in rural Bhutan using self-collected samples for high-risk human papillomavirus (HR-HPV) testing. In April/May 2016, 2590 women aged 30-60 years were screened across rural Bhutan by providing a self-collected sample for careHPV testing. All careHPV-positive women, plus a random sample of careHPV-negative women, were recalled for colposcopy and biopsy. Self-samples also underwent GP5+/6+ polymerase chain reaction (PCR)-based HR-HPV DNA detection and genotyping. Cross-sectional screening indices were estimated against histological high-grade squamous intraepithelial lesions or worse (hHSIL+), including imputation of hHSIL+ in women without colposcopy. HR-HPV positivity was 10.2% by careHPV and 14.8% by GP5+/6+ PCR. Twenty-two cases of hHSIL+ were histologically diagnosed, including one invasive cancer; an additional 7 hHSIL+ were imputed in women without colposcopy. HR-HPV testing by GP5+/6+ showed higher sensitivity for hHSIL+ (89.7%, 95% CI 72.6-97.8) than careHPV (75.9%, 95% CI 56.5-89.7). Negative predictive value was also slightly higher for GP5+/6+ (99.9%, 95% CI 99.6-100) than careHPV (99.7%, 95% CI 99.4-99.9). Specificity, however, was lower for GP5+/6+ (86.1%, 95% CI 84.6-87.4) than careHPV (90.6%, 95% CI 89.4-91.7), as was positive predictive value (6.9%, 95% CI 4.5-9.9 vs. 8.5%, 95% CI 5.4-12.6). Of 377 HR-HPV-positive women by GP5+/6+, 173 (45.9%) were careHPV-positive, including 54.7% HPV16-positive and 30.2% HPV18-positive women. The final REACH-Bhutan results show that screening for cervical cancer with self-collection of samples and HR-HPV testing, in addition to our previous report of achieving high participation, can also perform well to detect women with hHSIL+.

Risk assessment of self-sampling HPV tests based on PCR, signal amplification to guide the appropriate screening intervals: A prospective study in China

ObjectiveWe assessed the longitudinal risk of developing cervical intraepithelial neoplasia (CINs) with self-sampling human papillomavirus (HPV) tests, based on polymerase chain reaction (PCR) and signal amplification (careHPV), to explore the appropriate intervals for cervical cancer screening. MethodsA prospective study was conducted in China during 2017–2020. Participants were invited for PCR and careHPV tests with self-samples at baseline. Women positive in either HPV test underwent colposcopy and biopsy if necessary. Women with baseline CIN grade one (CIN1) or less were followed up over 3 years. The absolute risk was assessed by the immediate risk (IR) and cumulative risk (CR), and the relative risk was assessed by the hazard ratio (HR) with a 95% confidence interval (CI). ResultsA total of 8,126 women were included in the final analysis. Women positive for the PCR HPV test had comparable IRs of CIN2+ and CIN3+ to those positive on the careHPV test. With triage by HPV genotyping, women with HPV 16/18 infection had the highest IRs of CIN2+ (21.15%) and CIN3+ (9.67%). For CR, women negative for PCR HPV test had a lower risk of CIN2+ than that reported in women negative on careHPV test (0.57% versus 0.98%, HR = 0.58, 95% CI: 0.38, 0.87), but no significant difference was found in the CRs of CIN3+ between them (0.25% versus 0.39%, HR = 0.64, 95% CI: 0.34, 1.20). Among women with CIN1 or less at baseline, women who were persistent or recurrent positive on careHPV or PCR HPV test had a higher risk of developing CIN3+ (11.36%-14.59%), compared with women remained HPV negative from baseline throughout follow-up (≤0.28%). ConclusionsRoutine screening with 3-year intervals is acceptable for self-sampling HPV tests based on PCR or careHPV test. Women positive on HPV16/18 triaging at baseline or with CIN1 or less at baseline while being persistent or recurrent positive on careHPV or PCR HPV test during 3-year follow-up require immediate colposcopy or treatment.

HPV testing for cervical cancer screening in Mozambique: challenges and recommendations

Background Cervical cancer is the fourth most common cancer affecting women worldwide and is the leading cause of cancer and related deaths among women in Mozambique. The World Health Organization (WHO) recommends screening with human papillomavirus (HPV) testing, but it has not yet been implemented in many low- and middle-income countries (LMICs). We conducted a cervical cancer screening study in Mozambique using the careHPV test (QIAGEN, Germantown, MD, USA). This study aimed to describe our experience with HPV testing for cervical cancer screening in Maputo, Mozambique, including challenges and lessons learned. Methods We conducted a cervical cancer screening pilot demonstration project at the General Hospital of Mavalane in Maputo, Mozambique, from April 2018 to September 2019, using primary HPV testing with careHPV. We performed the direct observations and discussions with participating laboratory experts, technicians, nurses and physicians from Mozambique, Brazil and the United States. Results HPV testing was successfully implemented. The main challenges we experienced were inadequately equipped laboratory facilities, a lack of laboratory and clinical staff expertise, and difficulties procuring equipment, tests and laboratory supplies. These challenges were overcome by increasing the budget to better equip the laboratory, building relationships with procurement and importation specialists and training sessions for laboratory personnel and medical providers. Conclusions Our findings suggest that primary HPV testing is achievable in Mozambique. Several challenges were identified and are being addressed for a successful scale-up.

Performance of point-of-care testing for cervical cancer screening

Objective: To evaluate the performance of point-of-care testing for cervical cancer and precancerous lesions screening. Methods: In September 2020, 197 and 273 women were selected by using simple random sampling method from "self-sampling" cohort and "physician-sampling" cohort established in Xiangyuan county, Shanxi Province, China, respectively. Cervical exfoliated cells were collected by women themselves or gynecologists. All samples were detected by POCT and women with positive result were directly referred for colposcopy. Subsequently, all the samples were detected by careHPV and PCR test. Colposcopy and punch biopsy were performed for women with POCT negative but careHPV or PCR test positive at another visit. Using histopathological diagnosis as the gold standard, we calculated sensitivity, specificity and drew the receiver operating characteristic (ROC) curves. The accuracy of POCT was analyzed and compared to that of careHPV and conventional PCR test in cervical cancer and precancerous lesions screening. Results: The median (Q1 , Q3) age of 470 women was 51 (45, 57) years old. Based on self-sampling, the sensitivity and specificity of POCT for CIN2+ were 100.00% (95%CI: 56.56%-100.00%) and 28.95% (95%CI: 22.97%-35.76%), respectively. Compared with POCT, POCT HPV16/18 test had similar sensitivity and higher specificity of 89.47% (95%CI: 84.30%-93.08%). Self-sampling POCT HPV16/18 test had an AUC of 0.947 (95%CI:0.910-0.985), which was higher than that of careHPV and PCR test. Physician-sampling POCT test had 100.00% sensitivity (95%CI: 64.57%-100.00%) and 55.85% specificity (95%CI: 49.83%-61.70%) for detecting CIN2+. POCT HPV16/18 test had lower sensitivity (71.43%, 95%CI: 35.90%-91.76%) and higher specificity (92.45%, 95%CI: 88.63%-95.06%). POCT HPV16/18 test generally showed similar AUC on both self-collected samples and clinician-collected samples (0.947 vs 0.819, P=0.217). Conclusion: POCT HPV16/18 test is an effective method with relatively high sensitivity and specificity for cervical cancer screening.

At what age should the Uyghur minority initiate cervical cancer screening if screened using careHPV.

BackgroundThe careHPV test as a primary screening method for cervical cancer has been proven to be the best option for Uyghur women in Xinjiang in a previous study. In this research, we aim to discuss the appropriate age for Uyghur women in Xinjiang to be screened for cervical cancer using careHPV.MethodsEleven thousand women aged 20–69 years old (mean age 38.93 ± 9.74) from South Xinjiang were screened using careHPV and liquid‐based cytology, and the positive results were referred for colposcopy and cervical biopsy. A questionnaire regarding basic social characteristics, sexual practices, and reproductive history was administered to each woman. The age‐specific prevalence of HPV positivity, cytology abnormality, and cervical intraepithelial neoplasia (CIN) 2+ in ≥25, ≥30, and ≥35 age groups were analyzed, and the diagnostic value of careHPV in the three age groups was evaluated. The chi‐squared test was used to compare the differences between age groups. The sensitivity, specificity, positive predictive value, negative predictive value, and area under the receiver operating characteristic curve were calculated.ResultsThe women were mostly married (76.3%) and delivered at 15–19 years of age (61.4%). The HPV infection rate was 9.15% and detection rates of CIN2+ and invasive cervical cancer were 1.53% (1530/100,000) and 0.25% (250/100,000), respectively. The first peak of HPV(+) appeared at the age of 30–34, while CIN2+ appeared at 35–39. CareHPV performed similarly well in the three age groups.ConclusionBased on the results of our study, Uyghur women in Xinjiang should be recommended to initiate cervical cancer screening at the age of 30 years when screened using careHPV.

Abstract 11: Neglected Elements of Cancer Control During The COVID-19 Pandemic in Africa: Call for Action from 2019-2020 African Cancer Research and Control ECHO Programme

Abstract Purpose: As the world is learning to live with the coronavirus (COVID-19) pandemic, there is a shift in cancer control priorities and focus, with innovations to ensure continuity of cancer treatment and patient support during the COVID-19 pandemic. However, cancer control requires a comprehensive approach to minimize cancer incidence, mortality and improve the quality of life of those living with cancer. Hence, this analysis aimed to identify areas of cancer control affected by the COVID-19 pandemic that would equally affect cancer incidence, morbidity and mortality in Africa. Methods: The Africa Cancer Research and Control ECHO® Programme (Africa Cancer ECHO) is a community of practice that meets in an online platform to discuss cancer control challenges and solutions in the Africa region. The Africa Cancer ECHO conducted eleven sessions from April to August 2020 about the emerging COVID-19 pandemic, its impact on cancer control in Africa, and country-level practices as presented through case and didactic presentations. Sessions were analysed thematically to identify elements of cancer control that are adversely affected as a result of the COVID-19 pandemic and how they have been addressed. Results: HPV vaccination, cancer screening and early detection services, palliative care (PC) services, and cancer registration were particularly adversely affected, and in many cases have not yet resumed in some African countries. Recommendations included: use of affordable point of care HPV tests with immediate results; introducing COVID-19 testing along with HPV-testing; transitioning PC services from hospice to home care; and embracing Information Technology to enhance cancer registration. Conclusion: Cancer prevention, screening, supportive care, and surveillance services need to be urgently revitalised in Africa. The Africa Cancer ECHO platform highlights the need for generation of locally-relevant, evidence-based strategies that will safeguard past gains and continue to maximize the reduction of cancer incidence, morbidity and mortality during the COVID-19 pandemic. Citation Format: Annet Nakaganda, Nwamaka Lasebikan, Elise M. Garton, Benda Kithaka, Mishka K. Cira. Neglected Elements of Cancer Control During The COVID-19 Pandemic in Africa: Call for Action from 2019-2020 African Cancer Research and Control ECHO Programme [abstract]. In: Proceedings of the 9th Annual Symposium on Global Cancer Research; Global Cancer Research and Control: Looking Back and Charting a Path Forward; 2021 Mar 10-11. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2021;30(7 Suppl):Abstract nr 11.

Genotype distribution and behavioral risk factor analysis of human papillomavirus infection among Kazak women in Xinjiang Uygur Autonomous Region

Objective: To investigate the prevalence and genotype distribution of high-risk human papillomavirus (HR-HPV) and the correlation between cervical lesions and analyze the risk factors for HR-HPV infection. Methods: In June 2018, a population-based study for cervical cancer screening in Tuoli county of Xinjiang Uygur Autonomous Region was conducted. A total of 2 000 Kazak women aged 25-64 years were included in the study. Three cervical exfoliated cells samples were collected from them for careHPV, PCR HPV, p16(INK4a), and liquid-based cytology (LBC) tests. Women with any positive test were referred for colposcopy with biopsies taken at abnormal sites. Histo-pathological diagnoses were used as the gold standard. Results: The overall prevalence of HPV was 14.55%, among which the infection rate of HR-HPV was 12.90%, which was even higher in the 50-54 years age group. The most prevalent genotypes of HR-HPV were HPV16 (2.80%), HPV51(2.35%), HPV52 (1.70%), HPV56 (1.50%), and HPV39 (1.20%). The most common HPV infection was a single infection (71.48%). In the age group of 50-54 years, the multiple infection rates were higher, with the majority of double infection (69.88%), and HPV42 and 56 were the most common co-infection types. HPV16 (31.82%), HPV51 (27.27%) and HPV18 (13.64%) were higher in cervical intraepithelial neplasia grade 1, HPV16 (57.14%) was higher in cervical intraepithelial neplasia grade 2, and HPV16 (55.56%) and HPV18 (33.33%) were higher in cervical intraepithelial neplasia grade 3 or worse. Results from the multivariate logistic regression analysis showed that higher education, menopause, and syphilis infection increased the HPV infection. Conclusions: The most common prevalence genotypes of HR-HPV among Kazak women were HPV16, HPV51, and HPV52. The infection rate of HR-HPV among Kazak women was correlated with education level, menopausal status, and syphilis infection. Measures should be taken targeting high-risk factors. This result suggests that STD patients and women aged 50 and above should be encouraged for screening.

Reproducibility of a Rapid Human Papillomavirus Test at Different Levels of the Healthcare System in Tanzania: The AISHA Study

To inform policy makers in Tanzania if and how best to implement rapid HPV testing, we assessed the interobserver reproducibility of careHPV test at three different levels of the healthcare system in an urban and a rural region of Tanzania. Women aged 30 to 50 years were screened by careHPV testing in two primary healthcare centers (PHC), two district hospitals (DiH), and two regional hospitals (ReH). Aliquots were retested at regional (ReH) and national referral laboratories (NRL). Reproducibility was evaluated using agreement and kappa index measures. Intralaboratory reproducibility was also evaluated in a set of 10 positive and 10 negative samples. Samples from 1,134 women were locally tested and retested at ReH and/or NRL. Test results from Dar es Salaam ReH and Kilimanjaro PHC showed clear quality problems including suspicion of contamination during testing or aliquoting. After excluding these samples, 18.8% of 743 women were HPV positive at clinic level. The resulting careHPV reproducibility at different levels of the healthcare system was very good [agreement 95.7%, 95% confidence interval (CI), 94.0-96.9; kappa, 0.86, 95% CI, 0.81-0.91]. Intralaboratory agreement was also very good across four different experiments, with Fleiss' kappa between 0.87 (95% CI, 0.61-1.00) and 1.00 (0.75-1.00). Rapid HPV testing was highly reproducible between lower and higher levels of the healthcare system in Tanzania; however, performance seems to be operator dependent. The careHPV test seems to be a feasible option for cervical cancer screening in an organized, decentralized system and in limited-resource settings if quality assurance measures are in place.

The Capulana study: a prospective evaluation of cervical cancer screening using human papillomavirus testing in Mozambique

BackgroundCervical cancer is the leading cause of cancer and related deaths among women in Mozambique. There is limited access to screening and few trained personnel to manage women with abnormal...

Feasibility, Acceptability, and Efficacy of a Community Health Worker-Driven Approach to Screen Hard-to-Reach Periurban Women Using Self-Sampled HPV Detection Test in India.

PURPOSEDetection of high-risk human papillomavirus (HPV) in self-collected vaginal samples can significantly improve participation of hard-to-reach women; however, the implementation of such an approach in a real-life setting, especially in countries with limited resources, has certain challenges. Our study aimed to evaluate the feasibility, acceptability, and efficacy of implementing an HPV self-sampling–based approach to screen a socioeconomically disadvantaged, unscreened population with support from community health workers (CHWs) for community mobilization, counseling, and navigation. Different triaging options for HPV-positive women were also assessed.METHODSWomen age 30 to 65 years from low socioeconomic periurban areas who had never been screened before were motivated by CHWs to attend local community centers and provide self-collected vaginal samples for careHPV testing. Screen-positive women were informed and navigated by CHWs to attend colposcopy clinics where cervical biopsy and same-day ablative treatment were offered.RESULTSWomen readily accepted to provide self-collected samples after counseling by CHWs. Screen positivity was 6.4%, and CHWs successfully navigated 65% of HPV-positive women to colposcopy. Cervical intraepithelial neoplasia (CIN) 2+ detection rate was 9.7 per 1,000 women screened. The HPV test had a positive predictive value of 15.3% to detect CIN 2+ lesions. Triage using visual inspection with acetic acid significantly improved the positive predictive value (49.5% to detect CIN 2+), but missed a significant number of CIN 2+ lesions. Colposcopy sensitivity was also suboptimal. Of 51 women with lesions, 80% underwent ablative treatment and the majority accepted same-day treatment.CONCLUSIONCHW-driven self-sampling for HPV testing is feasible, well-accepted, and effective for screening unscreened hard-to-reach women. The screen-and-treat approach can ensure strong linkage between screening and treatment.

Performance of AmpFire HPV assay on neck cervical lymph node aspirate and oropharyngeal samples

Early determination of high-risk human papillomaviruses causing oropharyngeal squamous cell carcinomas (OPSCC) may influence treatment. The objectives were to evaluate the performance of a new rapid isothermal nucleic acid amplification point of care HPV test (AmpFire HPV) on fine needle neck aspirates (FNA) of cervical lymph nodes and oropharyngeal swabs and saliva (OPS) which had been previously tested by the cobas HPV assay. The comparison was performed on 56 FNA and 81 OPS. The two assays showed strong agreement (94.6 %, K = 0.88) on FNA and fair agreement (65.4 %, K = 0.34) on OPS. AmpFire HPV performed on FNA demonstrated a sensitivity of 76.7 % and specificity of 81.8 % for the prediction of p16 antigens in OPSCC with results available in 1.5 h.

Comparative performance evaluation of different HPV tests and triaging strategies using self-samples and feasibility assessment of thermal ablation in 'colposcopy and treat' approach: A population-based study in rural China.

Human papillomavirus (HPV) test, self-sampling and thermal ablation for cervical intraepithelial neoplasia (CIN) have been developed separately to increase screening coverage and treatment compliance of cervical cancer screening programmes. A large-scale study in rural China screened 9,526 women with their combinations to explore the optimal cervical cancer-screening cascade in the real-world. Participants received careHPV and polymerase chain reaction (PCR) HPV tests on self-collected samples. Women positive on either HPV test underwent colposcopy, biopsy and thermal ablation in a single visit. Samples positive on either HPV test were retested for genotyping. Absolute and relative performance of HPV tests, triage strategies, 'colposcopy and thermal ablation' approach were statistically evaluated. PCR HPV test detected 33.3% more CIN grade two or worse (CIN2+) at a cost of 28.1% more colposcopies compared to careHPV. Sensitivities of PCR HPV and careHPV tests to detect CIN2+ were 96.7 and 72.5%. Specificities for the same disease outcome were 82.1 and 86.0%. Triaging HPV-positive women with HPV16/18 genotyping considerably improved the positive predictive value for CIN2+ (4.8-5.0 to 18.2-19.2%). Ninety-six women positive on HPV and having abnormal colposcopy were eligible for thermal ablation and all accepted same-day treatment, contributing to 64.6% being treated appropriately (CIN1+ on histopathology), which reached up to 84.8% among women positive on HPV 16/18 triage. No serious side-effects/complications were reported. The combination of PCR HPV test followed by HPV 16/18 triaging on self-collected samples and colposcopy of triage positive women followed by immediate thermal ablation might be the appropriate screening cascade for rural China.

Evaluation of multiple screening methods for cervical cancers in rural areas of Xinjiang, China.

This study is to evaluate the screening methods of cervical cancers for rural females in Kash bachu, Xinjiang, China.A total number of 3000 married females were surveyed, and subjected to the gynecological examination. In these subjects, 1993 females received the careHPV (human papillomavirus) test, while 1007 females underwent the visual inspection with acetic acid (VIA) and visual inspection with Lugol's iodine (VILI). The subjects positive for careHPV detection were subjected to Cervista, Cobas 4800, and Aptima HPV detection, and Thinprep Cytologic Test (TCT). The subjects positive for 1 detection only received colposcopy cervical biopsy.A total of 569 subjects received the cervical biopsy, and the positive rate was 2.3% (69/3000), while the detection rate for CIN (cervical intraepithelial neoplasia) II and above levels was 1.13% (34/3000). Receiver operator characteristic (ROC) curve analysis showed that, the area under the curve (AUC) value for the careHPV test was 0.671, which was higher than the VIA/VILI (0.619), suggesting higher diagnostic value for the careHPV test. For the Cervista, Cobas 4800, Aptima HPV detection, and TCT methods, the highest AUC value was observed for the TCT method, indicating that the TCT method is the most valuable for the cervical cancer screening.The diagnostic value of careHPV test is superior to the VIA/VILA detection method. The TCT method has the greatest value for the cervical cancer screening. The Cervista HPV detection method should be considered where the conditions are limited.

Why the Cost of Purchasing the careHPV Test in Myanmar Was Many Times Greater Than That Reported in the International Literature

Background: Human papillomavirus (HPV) testing is recommended for primary or coprimary screening for cervical cancer (CC screening) in countries of all income levels. Inclusion of low-income countries (LICs) in these recommendations was in part due to development and evaluation of the careHPV test kit (QIAGEN, supported by PATH), a simple, accurate, affordable HPV screening test. In numerous published economic analyses, cost of equipment and supplies (E&amp;S) and conducting a careHPV test in LICs was estimated to be $US5/test. When we sought to purchase the E&amp;S for 1000 careHPV tests in Myanmar to begin a pilot test of HPV-based CC screening in a Ministry of Health and Sports (MOHS) women's hospital, we were quoted a price of US$42/test. Aim: Determine why the price for the careHPV test in Myanmar was so much greater than that reported in the literature. Methods: We reviewed published economic analyses and conducted a cost analysis of E&amp;S purchased for careHPV testing in Myanmar. We obtained assistance from QIAGEN and PATH to negotiate the lowest possible price for proprietary E&amp;S, and nonproprietary E&amp;S was purchased at the lowest domestic or international price. Standard methods of economic evaluation were used, classifying E&amp;S as capital (C) or recurrent (R). We converted costs to United States dollars ($), calculated $/test and obtained the charge to patients for other CC screening tests in Myanmar. Results: QIAGEN only sold the careHPV test through a local distributor, who added a larger profit than permitted. We negotiated a purchase price of $36/test for proprietary E&amp;S, including test system hardware ($25,555 [C]), training panel ($1540 [C]), cervical brushes ($788 [R]), transport medium ($788 [R]), and microtiter plates ($6982 [R]). R included a 38% markup for transportation, duties, and profits. Required nonproprietary E&amp;S purchased included: refrigerator ($1081 [C]), two pipetters ($1100 [C]), power source ($150 [C]), pipette tips ($156 [R]), and plate sealers ($38 [R]). The final cost was $38,294 ($38/test; C: $29,426 [$29/test]; R: $8,868 [$9/test]). If no additional C was required, the E&amp;S for 20,000 tests would cost $10/test. Although the charge for careHPV has not been set, the MOHS charge for a conventional Pap is $1.50. In the private sector, the charge for Pap is $8 (conventional) to $20 (automated), and between $50 and $125 for HPV tests. Conclusion: Our $38 cost/test is conservative since it was negotiated and did not include patient time, MOHS labor or other program implementation costs. The reported $5/test did not include some required E&amp;S and assumed purchase and scale-up to 20,000 tests in the first year, further reducing cost/test. In contrast, in Myanmar and other LICs, scale-up of CC screening programs has been slow, costly, and problematic. Advocates for careHPV based CC screening should be aware that initial costs may be high. Cost-effectiveness models should be adjusted to include a wider possible range of costs.

Detection of High Oncogenic Risk Human Papilloma Virus With CareHPV Test in Women Attended in Health Units in Copán Honduras

Background and context: Persistent infection with high-risk human papilloma virus (HR-HPV) is identified as the main cause of premalignant and malignant cervical diseases. The identification of HR-HPV by viral DNA has been used in multiple studies to characterize the infection, the careHPV test presented HR-HPV prevalence in Latin American countries of: Costa Rica (16%), Mexico (14.5%), Colombia (14.9%), and Chile (14.0%). Cervical cancer represents a public health problem in Latin America, and in Honduras is the main cause of cancer in women. Half of Honduran women at risk are not systematically screened for cervical cancer. Aim: Identifying women at risk for premalignant lesions with rapid and efficient tests can guarantee timely treatment. Strategy/Tactics: Retrospective, descriptive, cross-sectional study at Copán health units (La Entrada, Florida, Trinidad and San Juan Planes), where the results of the careHPV test were analyzed to determine HR-HPV genotypes, in 540 women between 30 and 65 year from September 2016 to March 2017. Program/Policy process: Positive patients received VIAA, and colposcopy/biopsy according to national cervical cancer screening guideline 2015. Outcomes: 458 negative women for HR-HPV 85% and 82 positive women 15%. The age group with the highest prevalence of HR-HPV was 30-49 years. Of 69 positive women, 64 received visual inspection with acetic acid (93%), 47 resulted with negative VIAA (73%), 2 with positive VIAA suspected invasive cancer, both were referred to colposcopy/biopsy, and 15 women with positive VIAA (24%) referred to cryotherapy. What was learned: The prevalence of infection by HR-HPV in the study group was 15%, similar to that reported in the literature. Standardizing the use of careHPV as a screening test can guarantee the prevention of invasive stages of cervical cancer.

Evaluating a community-based cervical cancer screening strategy in Western Kenya: a descriptive study

BackgroundThe incidence of cervical cancer in Kenya is among the highest in the world. Few Kenyan women are able to access screening, thus fueling the high cervical cancer burden. Self-collected human papilloma Virus (HPV) tests, administered during community-health campaigns in rural areas may be a way to expand access to screening.MethodsIn December 2015, we carried out a four-day community health campaign (CHC) to educate participants about cervical cancer prevention and offer self-administered HPV screening. Community enumeration, outreach and mobilization preceded the CHC. Samples were sent to Migori County Hospital for HPV DNA testing using careHPV Test Kits. Women were notified of results through their choice of short message service (SMS), phone call, home visit or clinic visit. HPV positive women were referred for cryotherapy following a screen-and-treat strategy.ResultsDoor-to-door enumeration identified approximately 870 eligible women in Ngodhe Community in Migori County. Among the 267 women attending the campaign, 255 women enrolled and collected samples: 243 tests were successfully resulted and 12 were indeterminate. Of the 243 resulted tests, 47 (19%) were positive for HPV, with young age being the only significant predictor of positivity. In multivariate analysis, each additional year of age conferred about a 4% decrease in the odds of testing positive (95% CI 0.1 to 7%, p = 0.046). Just over three-quarters of all women (195/255), were notified of their results. Those who were unable to be reached were more likely to prefer receiving results from clinic (54/60, 90%) and were less likely to have mobile phones (24/60, 73%). Although 76% of HPV positive women were notified of their results, just half (51%) of those testing positive presented for treatment. HPV positive women who successfully accessed the treatment facility did not differ from their non-presenting counterparts by demographics, health history, desired route of notification or access to a mobile phone.ConclusionNearly a third of eligible women in Ngodhe Community attended the CHC and were screened for cervical cancer. Nearly all women who attended the CHC underwent cervical cancer screening by self-collected HPV tests. Three-quarters of all participants received results, but just half of HPV positive participants presented for treatment in a timely fashion, suggesting that linkage to treatment remains a major challenge.Trial registrationNCT02124252, Registered 25 April 2014.