careHPV Test Research Articles

Cervical cancer screening in rural Bhutan with the careHPV test on self-collected samples: an ongoing cross-sectional, population-based study (REACH-Bhutan)

ObjectivesThe Bhutanese Screening Programme recommends a Pap smear every 3 years for women aged 25–65 years, and coverage ranges from 20% to 60%, being especially challenging in rural settings. The...

Cervical cancer prevention in El Salvador (CAPE)—An HPV testing-based demonstration project: Changing the secondary prevention paradigm in a lower middle-income country

•CareHPV tests were used to compare screen-and-treat and colposcopy management.•Screen-and-treat strategy with HPV testing was found to be very cost-effective.•CAPE has screened >25,000 women in the Paracentral region.•Over 70% of screen-positive women received recommended treatment within six months.•CAPE is an example of public-private partnership resulting in paradigm change.

Performance of careHPV for detecting high-grade cervical intraepithelial neoplasia among women living with HIV-1 in Burkina Faso and South Africa: HARP study.

Background:The careHPV assay is a test for high-risk (HR) human papillomaviruses (HPV) detection designed to be affordable in resource-poor settings. We evaluated the performance of careHPV screening among 1052 women living with HIV/AIDS included in the HARP (HPV in Africa Research Partnership) study in Burkina Faso (BF) and South Africa (SA).Methods:Cervical samples were tested for HR-HPV by the careHPV and the INNO-LiPA HPV genotyping Extra assays. All women had Pap smear testing, visual inspection with acetic acid/Lugol's iodine (VIA/VILI) and colposcopy. Cervical biopsies were obtained for participants who were HR-HPV DNA positive by careHPV or who had abnormalities detected on cytology, VIA/VILI or colposcopy.Results:Overall, 45.1% of women had a positive careHPV test (46.5% in BF, 43.8% in SA). The careHPV positivity rate increased with the grade of cytological lesions. Sensitivity and specificity of careHPV for the diagnosis of CIN2+ (n=60, both countries combined) were 93.3% (95% confidence interval (CI): 83.8–98.2) and 57.9% (95% CI: 54.5–61.2), respectively. Specificity increased with CD4 count. careHPV had a similar clinical sensitivity but higher specificity than the INNO-LiPA assay for detection of CIN2+.Conclusions:Our results suggest that careHPV testing is a reliable tool for cervical cancer screening in HIV-1-infected women in sub-Saharan Africa.

Evaluation of careHPV, Cervista Human Papillomavirus, and Hybrid Capture 2 Methods in Diagnosing Cervical Intraepithelial Neoplasia Grade 2+ in Xinjiang Uyghur Women

The study aimed to evaluate the value of the Cervista human papillomavirus (HPV), Hybrid Capture 2 (HC-2), and careHPV tests in diagnosing cervical intraepithelial neoplasia grade 2 (CIN2) or worse in Xinjiang Uyghur women. Three high-risk human papillomavirus (HR-HPV) detection methods were studied on two different populations by different combination modes; a cytology specimen was obtained at the same time. An abnormal result of any test resulted in referral to colposcopy. Cervical biopsy was also performed. In population 1, HR-HPV-positive rates were 57.6% and 54.3% as detected by HC-2 and Cervista, respectively; κ = 0.892 for consistency check of HC-2 and Cervista (p < .001). Area under the receiver operating characteristic curve (AUC) of HC-2 and Cervista was 0.744 (95% confidence interval [CI]: 0.664∼0.824, p < .001) and 0.786 (95% CI: 0.715∼0.858, p < .001), respectively, for diagnosing CIN2+. The A9 probe can detect six subtypes of HPV, including HPV16, HPV31, HPV33, HPV35, HPV52, and HPV58. If one or more of these subtypes are postitive, then A9 will be positive. A diagnosis of class A9 by the Cerevista test correlated with pathological interpretations (chi-square = 43.063, p < .001). In population 2, HR-HPV-positive rates were 40.1% and 34.4%, respectively, by HC-2 and careHPV; κ value was 0.779 for the two tests (p < .001). AUC of HC-2 was 0.895 (95% CI: 0.849∼0.940, p < .001), and careHPV was 0.841 (95% CI: 0.770∼0.899, p < .001) for diagnosing CIN2+. Good consistency was shown between HC-2 and Cervista tests and also between the HC-2 and careHPV tests. In the detection of CIN2+, Cervista showed better specificity than HC-2, and interpretation of the A9 subgroup showed high predicted value. The HC-2 test demonstrated better sensitivity than careHPV in detection of CIN2+. HC-2, Cervista, and careHPV may be applied as a triage test for visual inspection with acetic acid/Lugol's iodine-positive or ThinPrep cytologic test-positive women. The careHPV test was comparatively economical and efficient and may be more suitable for resource-limited regions, such as Xinjiang. This study was designed to evaluate the value of the Cervista human papillomavirus (HPV), Hybrid Capture 2 (HC-2), and careHPV tests in diagnosing cervical intraepithelial neoplasia grade 2 (CIN2) or worse (CIN2+) lesions in Xinjiang Uyghur women. Results showed that there was good consistency between the HC-2 and Cervista tests, as well as between the HC-2 and careHPV tests. In detecting CIN2+, Cervista had higher specificity than HC-2, whereas analysis of the A9 subgroup had high predictive value. (The A9 probe can detect six subtypes of HPV, including HPV16, HPV31, HPV33, HPV35, HPV52, and HPV58. If one or more of these subtypes are postitive, then A9 will be positive.) The HC-2 test demonstrated better sensitivity than careHPV in detecting CIN2+. HC-2, Cervista, and careHPV could be applied as a triage test for visual inspection with acetic acid/Lugol's iodine-positive or ThinPrep cytologic test-positive women. The careHPV test was comparatively economical and efficient and may be more suitable for resource-limited regions, such as Xinjiang.

Public-Private Partnerships for the Development of New Devices for Screening and Treatment of Cervical Precancer for Emerging Economies

Abstract 74 PATH is a nonprofit organization involved in the development of new technologies for screening and treatment of precancerous lesions of the uterine cervix for the last 25 years. PATH had private-public partnerships with four private companies for the design, development, improvement, and/or field validation of two new technologies for screening (careHPV and OncoE6 Cervical Test) and two devices for treatment (CryoPen and the Liger Thermal Coagulator). This experience allows us to identify some commonalities among those companies: they all had the technical or scientific background for developing or improving the technologies needed, they were committed to creating technologies suitable for emerging economies, and their knowledge or presence in low-resource countries was limited. The characteristics of our collaboration with the private companies varied depending on the initial status of the technology. Two of the companies already had marketed technologies that required adaptation for suitability in low-resource settings, and the role of PATH was to support the planning and modification of the technology, bench and field testing of the prototypes, and/or clinical validation of the product. Meanwhile, the other two companies had the technological capacity and expertise for developing the required technologies, but they did not have a working prototype; therefore, the role of PATH involved supporting the design and development of the new technology, as well as the required bench testing and validations. The financial support required was variable; in some cases PATH provided technical support for developing a “proof of concept” prototype, which later extended to financial support from PATH or other organizations. In other cases, the complexity of the initial work required financial support to start the development of that “proof of concept.” In conclusion, public-private partnerships are very effective for the development of new, affordable, and suitable technologies for screening and treatment of cervical precancer in emerging economies. AUTHORS' DISCLOSURES OF POTENTIAL CONFLICTS OF INTEREST: Francesca Holme Travel, Accommodations, Expenses: Qiagen Rose Slavkovsky No relationship to disclose Jose Jeronimo No relationship to disclose

Can the careHPV test performed in mobile units replace cytology for screening in rural and remote areas?

Human papillomavirus (HPV) DNA testing can be crucial for women who have limited access to traditional screening. The current study compared the results obtained through HPV DNA testing with those obtained through cytology-based screening. A total of 3068 women aged 18 to 85 years were enrolled in an opportunistic cervical cancer screening program developed by the Barretos Cancer Hospital and performed by a team of health professionals working within a mobile unit from March to December 2012, followed by statistical analyses. For each patient, 2 different cervical samples were collected and preserved in a careHPV assay and SurePath medium, respectively. High-risk HPV (hr-HPV) DNA was detected in 10.0% of women, with the majority (86.7%) demonstrating no abnormal Papanicolaou test results. The following cytological samples were found to be hr-HPV positive: 8.2% of the normal samples; 39.4% of the samples with atypical squamous/glandular cells of undetermined significance; 38.5% of the samples with atypical squamous/glandular cells of undetermined significance, cannot exclude high-grade lesion; 55.3% of the samples with low-grade squamous intraepithelial lesions; and 100% of the samples with high-grade squamous intraepithelial lesions. Colposcopy examinations were performed among 33.4% of the women with positive results on at least 1 of the tests (HPV DNA positive and/or cytology with atypical squamous/glandular cells of undetermined significance, cannot exclude high-grade lesion or high-grade squamous intraepithelial lesions), and 59.5% of these women underwent biopsies. Among these samples, 18.2% were confirmed as cervical intraepithelial neoplasia. The careHPV test was demonstrated to be a feasible alternative to primary screening in low-resource settings accessed through the use of mobile units. Cancer Cytopathol 2016;124:581-8. © 2016 American Cancer Society.

Adjunct screening of cervical or vaginal samples using careHPV testing with Pap and aided visual inspection for detecting high-grade cervical intraepithelial neoplasia

ObjectiveTo evaluate the performance of careHPV DNA testing for human papillomavirus (HPV) on cervical and vaginal samples (CHPV and VHPV respectively) in adjunct screening together with visual inspection of the cervix by acetic acid (VIA) or Papanicolaou (Pap) tests in the detection of high-grade cervical intraepithelial neoplasia (CIN). Subjects and methodsA cross-sectional study examined 4658 women 30–59 years of age by performing screening tests for HPV using careHPV on cervical and vaginal samples together with Pap and VIA. The CHPV and VHPV test results were presented as a ratio of viral load expressed in relative light units (RLUs) to the mean RLU from a positive control set at 1pg/mL cut-off (CO). Performances of various pairs of screening tests in parallel and sequential settings were computed through the detection rates of CIN, percentages of unnecessary colposcopic referrals of screen positives, and compared with stand-alone tests. ResultsThe screening positivity of CHPV, VHPV, Pap and VIA ranged from 2.4% to 5.5%. The highest sensitivity (72%) was observed for the combination of CHPV and VIA in parallel, followed by 65.6% for CHPV and Pap, and 59% for all other combinations (VHPV and Pap, VHPV and VIA, and VIA and Pap). The percentage of unnecessary colposcopic referrals in the parallel setting of CINII+ detection ranged from 2.8% to 6.0%. Sequential testing of CHPV or VHPV with other tests yielded very low sensitivities with a reduction in unnecessary colposcopic referrals. ConclusionCervical careHPV testing (CHPV) in parallel with VIA was the option that performed best in the detection of high-grade CIN and could be a feasible option for low-resource countries (LRCs).

Human papillomavirus viral load on careHPV testing of self-collected vaginal samples vs. clinician-collected cervical samples

ObjectiveTo compare viral load on careHPV DNA testing in self-collected vaginal (VHPC) and clinician-collected cervical (CHPC) samples for the detection of high-grade cervical intra-epithelial neoplasia (CIN). Study designCross-sectional study. Ever-married women aged 30–59 years were targeted for cervical screening. On attendance for screening, vaginal self-sampling was performed by the woman, and an auxiliary nurse midwife subsequently performed a per-speculum examination, collected a CHPV sample and a Pap smear, and made a visual inspection of the cervix with acetic acid. The ratio of viral load expressed in relative light units to positive controls set at a cut-off of 1pg/ml was used for careHPV quantitative assessment. The median viral load was compared using non-parametric tests. Receiver operating characteristic (ROC) curves were constructed for the detection of CINII+ and CINIII+ in CHPV and VHPV samples. ResultsOverall, the median viral load in the 4658 women screened was higher in CHPV samples compared with VHPV samples (9.8-fold higher in cases of high-grade CIN). The median viral load was significantly higher among Pap-positive women compared with Pap-negative women in both CHPV and VHPV samples (p<0.01). Assessment by ROC analysis for the detection of high-grade CIN did not differ significantly between CHPV and VHPV samples. ConclusionViral load on careHPV testing was comparable between self- and clinician-collected samples for the detection of high-grade CIN. The self-sampling approach may be an option for screening in low-resource countries.

Optimal Positive Cutoff Points for careHPV Testing of Clinician- and Self-Collected Specimens in Primary Cervical Cancer Screening: an Analysis from Rural China

careHPV, a lower-cost DNA test for human papillomavirus (HPV), is being considered for cervical cancer screening in low- and middle-income countries. However, not a single large-scaled study exists to investigate the optimal positive cutoff point of careHPV test. We pooled data for 9,785 women participating in two individual studies conducted from 2007 to 2011 in rural China. Woman underwent multiple screening tests, including careHPV on clinician-collected specimens (careHPV-C) and self-collected specimens (careHPV-S), and Hybrid Capture 2 on clinician-collected specimens (HC2-C) as a reference standard. The primary endpoint was cervical intraepithelial neoplasia grade 3 or more severe (CIN3+) (n = 127), and secondary endpoint was CIN2+ (n = 213). The area under the curves (AUCs) for HC2-C and careHPV-C were similar (0.954 versus 0.948, P = 0.166), and better than careHPV-S (0.878; P < 0.001 versus both). The optimal positive cutoff points for HC2-C, careHPV-C, and careHPV-S were 1.40, 1.74, and 0.85, respectively. At the same cutoff point, careHPV-C was not significantly less sensitive and more specific for CIN3+ than HC2-C, and careHPV-S was significantly less sensitive for CIN3+ than careHPV-C and HC2-C. Raising the cutoff point of careHPV-C from 1.0 to 2.0 could result in nonsignificantly lower sensitivity but significantly higher specificity. Similar results were observed using CIN2+ endpoint. careHPV using either clinician- or self-collected specimens performed well in detecting cervical precancer and cancer. We found that the optimal cutoff points of careHPV were 2.0 on clinician-collected specimens and 1.0 on self-collected specimens.

A parallel study of careHPV and Hybrid Capture 2 human papillomavirus DNA testing for cervical cancer screening in rural China

Hybrid Capture 2 (HC2) has been demonstrated to be a feasible screening method for cervical cancer. Based upon HC2 technology, careHPV is a simple, rapid, accurate, and inexpensive screening test for women in low-resource settings. This study aims to characterize both the careHPV test and HC2 test, and to compare careHPV results of specimens stored in careHPV test collection medium (TCM) to HC2 results from partner specimens stored in Qiagen specimen transport medium and TCM. The positive rates of high-risk HPV in careHPV, HC2, and HC2 (TCM) were 13.2% (108/818), 13.2% (108/818), and 13.6% (111/818), respectively. The agreement rates of pairwise tests were 95.8% (95% CI: 94.5–97.2%), 96.7% (95% CI: 95.5–97.9%), and 97.2% (95% CI: 96.1–98.3%), respectively. The Kappa values of the pairwise tests were 0.82 (95% CI: 0.76–0.88), 0.86 (95% CI: 0.81–0.91), and 0.88 (95% CI: 0.83–0.93), respectively. Based on these findings, although careHPV is demonstrated to be a viable alternative to the HC2 test, improvements on the careHPV test are still required prior to its implementation as a suitable screening method for women in low-resource settings. Further studies on the significance and applicability of the careHPV test must be performed.

CareHPV cervical cancer screening demonstration in a rural population of north India

ObjectiveTo compare cervical careHPV screening in a rural community setting with other methods of cervical screening for the detection of high-grade cervical intra-epithelial neoplasia (CIN).Study design: Cross-sectional study. All ever-married women aged 30–59 years surveyed in an administrative area of Uttar Pradesh, India were targeted for screening by careHPV (cervical and vaginal samples), Pap test and visual inspection of the cervix following application of acetic acid (VIA). Women who screened positive were referred for colposcopy and the results were confirmed histologically. Sensitivity, specificity and predictive values for the detection of histological CINII+ and CINIII+ were assessed for each screening test. ResultsSixty-five percent (5032/7704) of the women invited for cervical screening agreed to participate in the study. Screen-positive rates for cervical careHPV, vaginal careHPV, Pap test and VIA were 3%, 2%, 3% and 6%, respectively. Data for women who did not complete all screening modes, women lost to follow-up and women with missing histological results were excluded before data analysis, resulting in a final sample size of 4658. Cervical careHPV had high sensitivity (85%) for the detection of CINIII+ lesions and moderate sensitivity (53%) for the detection of CINII+ lesions. Sensitivities for the detection of CINIII+ and CINII+ were 54% and 41% for vaginal careHPV, 62% and 44% for Pap test, and 8% and 22% for VIA, respectively. ConclusionCervical careHPV testing is superior to VIA and Pap test for the detection of high-grade CIN in a rural community setting.

ATL

This study evaluates the feasibility and performance of careHPV, a novel human papillomavirus (HPV) DNA test, when used for screening women for cervical cancer in low-resource settings. Clinician-collected (cervical) and self-collected (vaginal) careHPV specimens, visual inspection with acetic acid (VIA), and Papanicolaou test were evaluated among 16,951 eligible women in India, Nicaragua, and Uganda. Women with positive screening results received colposcopy and histologic follow-up as indicated. The positivity of each screening method was calculated overall, by site, and age. In addition, the clinical performance of each screening test was determined for detection of cervical intraepithelial neoplasia (CIN) grade 2 (CIN2+) and CIN grade 3. Moderate or severe dysplasia or cancer (taken together as CIN2+) was diagnosed in 286 women. The positivity rate ranged between 2.4% to 19.6% for vaginal careHPV, 2.9% to 20.2% for cervical careHPV, 5.5% to 34.4% for VIA, and 2.8% to 51.8% for Papanicolaou test. Cervical careHPV was the most sensitive for CIN2+ (81.5%; 95% confidence interval [CI], 76.5-85.8) and CIN grade 3 (85.3%; 95% CI, 78.6-90.6) at all sites, followed by vaginal careHPV (69.6% and 71.3%, respectively). The sensitivity of VIA ranged from 21.9% to 73.6% and Papanicolaou test from 40.7% to 73.7%. The pooled specificities of cervical careHPV, vaginal careHPV, VIA, and Papanicolaou test were 91.6%, 90.6%, 84.2%, and 87.7%, respectively. careHPV performed well in large multicountry demonstration studies conducted in resource-limited settings that have not previously been conducted this type of testing; its sensitivity using cervical samples or vaginal self-collected samples was better than VIA or Papanicolaou test. The feasibility of using careHPV in self-collected vaginal samples opens the possibility of increasing coverage and early detection in resource-constrained areas.

An Evaluation of Novel, Lower-Cost Molecular Screening Tests for Human Papillomavirus in Rural China

New, lower-cost tests that target high-risk human papillomavirus (HR-HPV) have been developed for cervical cancer screening in lower-resource settings but large, population-based screening studies are lacking. Women ages 25 to 65 years and living in rural China (n = 7,543) self-collected a cervicovaginal specimen, had 2 cervical specimens collected by a clinician, and underwent visual inspection after acetic acid (VIA). The self- and one clinician-collected specimens underwent HR-HPV DNA testing by careHPV (QIAGEN) and Hybrid Capture 2 (HC2; QIAGEN) and the other clinician-collected specimen was tested for HPV16, 18, and 45 E6 using OncoE6 (Arbor Vita Corporation). Women who screened positive for any test and a random sample of those negative on all tests underwent colposcopic evaluation. The percent test positive was 1.8% for HPV E6 oncoprotein, between 14% and 18% for HR-HPV DNA testing, and 7.3% for VIA. The sensitivity for cervical intraepithelial neoplasia grade 3 or more severe (CIN3(+); n = 99) was 53.5% for OncoE6, 97.0% for both careHPV and HC2 testing of the clinician-collected specimen, 83.8% for careHPV testing and 90.9% for HC2 testing of the self-collected specimen, and 50.5% for VIA. OncoE6 had the greatest positive predictive value (PPV), at 40.8% for CIN3(+), compared with the other tests, which had a PPV of less than 10%. OncoE6 tested 70.3% positive for HPV16, 18, or 45-positive CIN3(+) and tested negative for all HPV16-, 18-, or 45-negative CIN3(+) (P < 0.0001). HPV E6 oncoprotein detection is useful for identifying women who have cervical precancer and cancer.

Feasibility of Community-Based careHPV for Cervical Cancer Prevention in Rural Thailand

This study aimed to assess the safety, acceptability and feasibility of primary human papillomavirus (HPV) testing for cervical cancer prevention at the community level in a low-resource setting. After training a technician to run specimens on the careHPV unit, the study team traveled to a different village each day in rural Roi-et Province, Thailand. Women were tested for HPV using self-swab, followed by careHPV testing. Those with positive result were assessed immediately by visual inspection with acetic acid. Women positive for HPV and visual inspection with acetic acid were offered cryotherapy. Safety was determined by monitoring adverse events. Exit surveys assessed acceptability and feasibility. Feasibility was also assessed by measuring testing and triage throughputs. Technician training required 2.5 days to achieve competency. A total of 431 women were screened in 14 days, with an average of 31 women screened daily. No adverse events were reported. Women deemed the program overwhelmingly acceptable: 90.5% reported that they would take the self-swab again, 71.3% preferred the self-swab to a clinician swab. The program was also feasible: 99.8% of eligible women agreed to testing, 94.8% returned for same-day follow-up, and women only spent 30 to 50 minutes of their total time with the program from screening to results. Cervical cancer prevention programs based on self-swab HPV testing could be safe, acceptable, feasible, and effective at the community level in low-resource settings.

EYE ON CHINA

Fosun Pharmaceutical and Shanghai drugs open innovation model. QIAGEN gains SFDA approval to market careHPV Test. AstraZeneca's heart drug wins approval. SIMM explores a novel cationic core-shell lipo-nanoparticles for ocular gene drug delivery. TaiGen and TTY Biopharm jointly develop and commercialize a novel topoisomerase I inhibitor for cancer treatment. iHuman Institute inauguration held. Sihuan Pharmaceutical collaborates with NeuroVive to develop two innovative cardio-cerebral vascular products. PerkinElmer acquires China-based infectious disease diagnostics company.

Effectiveness and health economic analysis of strategies on cervical cancer screening and early diagnosis and treatment

To explore the appropriate strategies which are suitable for the areas with diverse health and economic resource settings in China by estimating the life outcomes and cost-effectiveness of several cervical cancer screening strategies. Markov model was used to calculate the long-term effectiveness, utility, benefit and cost among screened and unscreened cohorts in rural and urban areas, and then analyses of cost-effectiveness, cost-utility and cost-benefit were performed. The assessed screening strategies were acetic acid of visual inspection combined with Lugol's iodine staining (VIA/VILI), conventional Pap smear and simple HPV DNA testing (careHPV) in rural areas, and conventional Pap smear, simple HPV DNA testing (careHPV), HPV DNA testing (HC2) and liquid-based cytology (LBC) alone or combined with HPV DNA testing (LBC+HC2) in urban areas. We estimated the life outcomes and cost-effectiveness of the above screening strategies at one-year, 3-year and 5-year intervals. All of the screening strategies were effective to decrease cervical cancer mortality and to increase life years, with a trend of shorter screening interval having better effectiveness. However, no matter in urban or rural areas, compared with careHPV testing at 5-year interval, the costs of other screening strategies were 1.28 - 13.86 folds, 1.31 - 14.14 folds, and 1.27 - 12.80 folds higher to avoid one death, to save a year of life, and a QALY, and the benefit per cost of other screening strategies was 9.9%-90.2%. careHPV testing at 5-year interval has the best cost-effectiveness performance and the highest benefit-cost ratio with the moderate life outcomes. It is the optimal cervical cancer screening strategy to be generalized in our country. careHPV testing at 3 years interval can be considered in more developed areas to achieve better effectiveness.

Effectiveness of a simple rapid human papillomavirus DNA test in rural Nigeria.

Success of the new human papillomavirus (HPV) DNA test for low-resource settings (careHPV™ test; QIAGEN Gaithersburg Inc., Gaithersburg, MD) requires good test performance when operated by personnel with limited laboratory experience. We evaluated the transferability, reliability, and accuracy of the careHPV test nested within a cervical screening project in a large Nigerian village. CareHPV testing was performed on screen-positive (n = 345) and screen-negative (n = 42) women attending colposcopy (68.3% of referred). Biopsies of abnormal-appearing areas were processed and read in the U.S. CareHPV specimens taken immediately before colposcopy were processed up to four times (in the field) by two secondary school graduates without laboratory experience, trained for this study. Specifically, QIAGEN Gaithersburg trained a laboratory-inexperienced U.S. researcher, who trained the first local technician who, in turn, trained the second. Residual specimens were sent to the U.S. for MY09/MY11 PCR testing for 13 carcinogenic genotypes (HPV16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 68) plus HPV66 (included in careHPV). Intrarater agreement was 98.8% (κ = 0.97) and 98.9% (κ = 0.97) for Technicians 1 and 2, respectively, while inter-rater agreement was 96.3% (κ = 0.90). Agreement with MY09/MY11 PCR (virologic reference standard) was 89.3% (κ = 0.73) with 74.2% sensitivity and 95.7% specificity. The careHPV test detected 12 (80%) of 15 histologically confirmed cervical intraepithelial neoplasia Grade 2 (CIN2) or worse lesions, with an estimated 83.0% specificity to detect <CIN2. In a challenging low-resource setting with minimal intervention, the careHPV test performed adequately with high specificity but possibly lower sensitivity than HPV DNA tests currently used in controlled situations.

Risk factors for high‐risk human papillomavirus infection in unscreened Malian women

To investigate the epidemiology of human papillomavirus (HPV) infection in Malian women, for whom cervical cancer is the most common cancer and the second most common cause of cancer-related mortality. Pilot study of 202 women aged 15-65 to determine the prevalence rate of high-risk HPV infection among unscreened Malian women. Information on risk factors was collected through a standardized, structured interview and clinical examination. High-risk (HR) HPV DNA was detected using signal amplification methods (hybrid capture II). High-risk HPV DNA was detected in 12% of unscreened women, while visual inspection after application of acetic acid and Lugol's iodine (VIA/VILI) identified suspicious abnormalities in 2.5% of unscreened women. Histopathological evaluation of VIA/VILI-positive biopsies revealed no evidence of cervical intraepithelial neoplasia or cervical cancer. The majority of infections occurred among women in the 15-24 year old range. Compared to women who were married or widowed, single women were 3.5 times more likely to be infected with HR HPV. The prevalence of infection with cancer causing types of HPV in this study was 12%. These prevalence estimates are consistent with what has been reported previously for other West African countries.

Cost‐effectiveness analysis of cervical cancer prevention based on a rapid human papillomavirus screening test in a high‐risk region of China

This study assessed the cost-effectiveness of a new, rapid human papillomavirus (HPV)-DNA screening test for cervical cancer prevention in the high-risk region of Shanxi, China. Using micro-costing methods, we estimated the resources needed to implement preventive strategies using cervical cytology or HPV-DNA testing, including the Hybrid Capture 2 (hc2) test (QIAGEN Corp., Gaithersburg, MD) and the rapid HPV-DNA careHPV test (QIAGEN). Data were used in a previously published model and empirically calibrated to country-specific epidemiological data. Strategies differed by initial test, targeted age, frequency of screening, number of clinic visits required (1, 2 or 3) and service delivery setting (national, county and township levels). Outcomes included lifetime risk of cancer, years of life saved (YLS), lifetime costs and incremental cost-effectiveness ratios (cost per YLS). For all screening frequencies, the most efficient strategy used 2-visit rapid HPV-DNA testing at the county level, including screening and diagnostics in the first visit, and treatment in the second visit. Screening at ages 35, 40 and 45 reduced cancer risk by 50% among women compliant with all 3 screening rounds, and was US$ 150 per YLS, compared with this same strategy applied twice per lifetime. This would be considered very cost-effective evaluated against China's per-capita gross domestic product (US$ 1,702). By enhancing the linkage between screening and treatment through a reduced number of visits, rapid HPV-DNA testing 3 times per lifetime is more effective than traditional cytology, and is likely to be cost-effective in high-risk regions of China.

Perspective of cervical cancer prevention and control in developing countries and areas

Cervical cancer ranks the second common cancer in women, affecting women severely in developing countries. It is a critical issue to develop simple, rapid, accurate, safe, acceptable, and inexpensive screening tests which can be used in cervical cancer prevention programs in developing countries. Due to the shortage of funding and qualified cytological professionals in most developing countries, WHO has been actively promoting visual inspection with acetic acid/iodine solution (VIA/VILI) as the alternative approach to screening cervical cancer. After the discovery of a link between human papillomavirus (HPV) and cervical cancer, the HPV prophylactic vaccine and CareHPV test have been successfully developed. The cervical cancer will be the first cancer eliminated by the combination of vaccination, screening, early diagnosis and treatment.