Primary Cervical Cancer Screening and Triage Using an mRNA Human Papillomavirus Assay and Visual Inspection

2013 ◽  
Vol 23 (3) ◽  
pp. 513-518 ◽  
Author(s):  
Lucybeth Nieves ◽  
Christine L. Enerson ◽  
Suzanne Belinson ◽  
Jennifer Brainard ◽  
Andres Chiesa-Vottero ◽  
...  

ObjectiveMexican Cervical Cancer Screening Study II (MECCS II) seeks to develop a highly sensitive and highly specific screening program able to be adapted to all socioeconomic levels in Mexico. The objectives of MECCS II are (1) to compare the sensitivity and specificity for cervical intraepithelial neoplasia (CIN) 3 or cancer of self-collected vaginal specimens tested for high-risk types of the human papillomavirus (HR-HPV) by APTIMA with those tested for HR-HPV by Hybrid Capture 2 (HC2); and (2) determine the efficacy of cryotherapy in the treatment of HR-HPV–positive and acetic acid–aided visual inspection (VIA)–positive and -negative women after VIA triage.MethodsThe study was conducted in rural Mexico. Women aged 30 to 50 years, nonpregnant, with no history of hysterectomy or pelvic irradiation and varied histories of screening, participated. A direct endocervical sample was tested for cytology, HC2, and APTIMA assay (AHPV). Subjects positive on any test were recalled for triage VIA, biopsies, and immediate cryotherapy. Tests were compared using McNemar test.ResultsTwo thousand forty-nine patients have complete results. Mean age of the patients was 39.2 years; 7.7% presented with ≥atypical squamous cells of uncertain significance (ASCUS), 1.8% ≥low-grade squamous intraepithelial neoplasia, and 0.5% ≥high-grade squamous intraepithelial neoplasia. Two percent of patients had ≥CIN2, and 0.78% had ≥CIN3 (including 2 with invasive disease). The sensitivity of ThinPrep (>ASCUS), HC2, and AHPV for >CIN3 for direct endocervical collection was 87.5%, 100%, and 100%, respectively. The specificity of ThinPrep (>ASCUS), HC2, and AHPV for >CIN3 was 94.1%, 92.2%, and 93.5%, respectively. Specificities of HC2 and AHPV differed significantly. The overall percentage of agreement among HPV assays (HC2 vs APTIMA) is 97%. Four hundred sixty-nine women returned for VIA. Two hundred ninety-one women were treated with cryotherapy.ConclusionsThe specificity of the APTIMA assay along with high sensitivity is an advantage for primary screening. Follow-up evaluation will be important to determine the true impact of potential undertreatment in the screening algorithm. Self-sampling applications are explored.

2009 ◽  
Vol 19 (1) ◽  
pp. 27-32 ◽  
Author(s):  
Jerome L. Belinson ◽  
Robert G. Pretorius ◽  
Christine Enerson ◽  
Francisco Garcia ◽  
Eduardo Pérez Cruz ◽  
...  

The Mexican Cervical Cancer Screening (MECCS) study took place in the State of Michoacán. Primary screening was by self-sampling for high-risk human papillomavirus (HR-HPV). The objectives were to increase the specificity of primary HPV screening by requiring 2 positive HPV tests 1 year apart in women whose secondary screen was negative according to an acetic acid-aided visual inspection (VIA). In addition, we postulated that the sensitivity of VIA would be sufficient to identify large preinvasive lesions and cancers unsuitable for cryotherapy if applied in a see-and-treat algorithm.A total of 8621 women (aged 30-50 years) were screened, and 14.3% were positive for HR-HPV. In phase 1, 11.9% of the HPV-positive women were VIA-positive and were referred for colposcopy with directed and random biopsies. If VIA-negative, women repeated the self-sample 1 year later to detect persistent HR-HPV (25.2% were positive). If persistently HR-HPV-positive in phase 2, patients again had VIA, then all women (both VIA-positive and -negative) received directed and random biopsies. If cryotherapy had been used to treat HPV- and VIA-positive women in phase 1 or persistent HR-HPV-positive (phase 2), the potential risk of undertreatment would have been 4.1%, and 66.4% of the treated patients would have had normal or cervical intraepithelial neoplasia I on biopsy. The VIA triage would refer 0.73% of the patients to colposcopy owing to the lesion size, location, or the presence of a cancer. On the basis of this pilot study, we are encouraged to explore and evaluate a rapid, more sensitive, and more specific self-test.


2021 ◽  
Vol 13 ◽  
pp. 175883592110109
Author(s):  
Binhua Dong ◽  
Huachun Zou ◽  
Xiaodan Mao ◽  
Yingying Su ◽  
Hangjing Gao ◽  
...  

Background: China’s Fujian Cervical Pilot Project (FCPP) transitioned cervical cancer screening from high-risk human papillomavirus (HR-HPV) nongenotyping to genotyping. We investigated the clinical impact of this introduction, comparing performance indicators between HR-HPV genotyping combined with cytology screening (HR-HPV genotyping period) and the previous HR-HPV nongenotyping combined with cytology screening (HR-HPV nongenotyping period). Methods: A retrospective population-based cohort study was performed using data from the FCPP for China. We obtained data for the HR-HPV nongenotyping period from 1 January 2012 to 31 December 2013, and for the HR-HPV genotyping period from 1 January 2014 to 31 December 2016. Propensity score matching was used to match women from the two periods. Multivariable Cox regression was used to assess factors associated with cervical intraepithelial neoplasia of grade 2 or worse (CIN2+). The primary outcome was the incidence of CIN2+ in women aged ⩾25 years. Performance was assessed and included consistency, reach, effectiveness, adoption, implementation and cost. Results: Compared with HR-HPV nongenotyping period, in the HR-HPV genotyping period, more CIN2+ cases were identified at the initial screening (3.06% versus 2.32%; p < 0.001); the rate of colposcopy referral was higher (10.87% versus 6.64%; p < 0.001); and the hazard ratio of CIN2+ diagnosis was 1.64 (95% confidence interval, 1.43–1.88; p < 0.001) after controlling for health insurance status and age. The total costs of the first round of screening (US$66,609 versus US$65,226; p = 0.293) were similar during the two periods. Higher screening coverage (25.95% versus 25.19%; p = 0.007), higher compliance with age recommendations (92.70% versus 91.69%; p = 0.001), lower over-screening (4.92% versus 10.15%; p < 0.001), and reduced unqualified samples (cytology: 1.48% versus 1.73%, p = 0.099; HR-HPV: 0.57% versus 1.34%, p < 0.001) were observed in the HR-HPV genotyping period. Conclusions: Introduction of an HR-HPV genotyping assay in China could detect more CIN2+ lesions at earlier stages and improve programmatic indicators. Evidence suggests that the introduction of HR-HPV genotyping is likely to accelerate the elimination of cervical cancer in China.


Biomédica ◽  
2019 ◽  
Vol 39 (1) ◽  
pp. 65-74
Author(s):  
Óscar Gamboa ◽  
Mauricio González ◽  
Jairo Bonilla ◽  
Joaquín Luna ◽  
Raul Murillo ◽  
...  

Introduction: Direct visual inspection for cervical cancer screening remains controversial, whereas colposcopy-biopsy is considered the gold standard for diagnosis of preneoplastic cervical lesions.Objectives: To determine the rates of cervical intraepithelial neoplasia grade 2 or more and of false positives for colposcopy and direct visual inspection.Materials and methods: Women aged 25-59 underwent direct visual inspection with acetic acid (VIA), Lugol’s iodine (VIA-VILI), and colposcopy. Punch biopsies were obtained for all positive tests. Using histology as the gold standard, detection and false positive rates were compared for VIA, VIA-VILI, and colposcopy (two thresholds). Sensitivity and false positive ratios with the corresponding 95% confidence intervals were estimated.Results: We included 5,011 women in the analysis and we obtained 602 biopsies. Positivity rates for colposcopy high-grade and low-grade diagnosis were 1.6% and 10.8%. Positivity rates for VIA and VIA-VILI were 7.4% and 9.9%. VIA showed a significantly lower detection rate than colposcopy with low-grade diagnosis as the threshold (SR=0.72; 95% CI 0.57-0.91), and significantly lower false positive rate (FPR=0.70; 95% CI 0.65-0.76). No differences between VIA-VILI and colposcopy low-grade threshold were observed. VIA and VIA-VILI showed significantly higher detection and false positive rates than colposcopy high-grade threshold. Sensitivity rates for visual inspection decreased with age and false positive rates increased. For all age groups, false positive rates for VIA and VIA-VILI were significantly higher than colposcopy.Conclusions: Detection rates for VIA-VILI similar to colposcopy low-grade threshold represent a chance to reduce cervical cancer mortality through see-and-treat approaches among women with limited access to health care. Lower detection rates suggest reviewing high-grade colposcopy findings as the threshold for biopsy in certain settings.


2020 ◽  
pp. 1276-1281 ◽  
Author(s):  
Paul Thistle ◽  
Rabea Parpia ◽  
Debanjan Pain ◽  
Hang Lee ◽  
Justen Manasa ◽  
...  

PURPOSE High-risk human papillomaviruses (hrHPV) are the primary cause of cervical cancer. Human papillomavirus (HPV) vaccination is expected to prevent cervical cancers caused by the HPV types included in vaccines and possibly by cross-protection from other types. This study sought to determine the hrHPV type distribution in women at a rural Zimbabwe hospital. METHODS We implemented a cross-sectional study at the Karanda Mission Hospital. Using the Visual Inspection with Acetic Acid Cervicography technique, clinicians collected cervical swabs from 400 women presenting for screening for cervical cancer. Samples were initially analyzed by Cepheid GeneXpert; candidate hrHPV genotypes were further characterized using the Anyplex II HPV28 Detection Kit. RESULTS Twenty-one percent of the 400 women were positive for a high-risk genotype when using the GeneXpert analyzer; 17% were positive when using the multiplex analysis. Almost two thirds of the hrHPV women had a single DNA type identified, whereas one third had multiple genotypes, ranging from 2 to 5. hrHPV was observed more frequently in HIV-positive than in HIV-negative women (27% v 15%). Of the 113 isolates obtained, 77% were hrHPV genotypes not included in the bivalent or quadrivalent vaccines, and 47% represented DNA types not covered in the nonavalent vaccine. Forty-seven percent of the women with hrHPV harbored a single genotype that was not covered by the nonavalent vaccine. CONCLUSION A large fraction of hrHPV isolates from women participating in a cervical cancer screening program in northern Zimbabwe are DNA types not covered by the bivalent, quadrivalent, or nonavalent vaccines. These findings suggest the importance of characterizing the hrHPV DNA types isolated from cervical neoplasia in this population and determining whether cross-immunization against these genotypes develops after administration of the vaccines in current use.


2012 ◽  
Vol 30 (15_suppl) ◽  
pp. e12009-e12009
Author(s):  
Surbhi Grover ◽  
Melody Ju ◽  
Lilie L. Lin ◽  
Shobha Krishnan

e12009 Background: Visual inspection with acetic acid and Lugol’s iodine (VIA/VILI) is increasingly reframed as a bridge modality through which low resource countries can provide cervical cancer screening while waiting for the more effective HPV DNA tests to become affordable. Often the screening programs are organized by government bodies that lack the trust of the local communities and hence such programs suffer from poor participation. Here we aim to describe a locally-sustained VIA/VILI screening program in rural Kutch district in India directed by Kutch Mahlia Vikas Sangathan (KMVS), a local NGO committed to women empowerment. Methods: All capacity-building measures (funding, training, materials, and healthcare workers) were rooted in the local community. Heath workers were sent to Tata Memorial Cancer Center in Mumbai for training. NGO members held information sessions prior the screening camps educating women about the significance of screening. A three-visit screening model using VIA/VILI was implemented. At first visit, all women were consented and screened. VIA/VILI positive women returned for a second visit for biospy. Biopsy positive women then returned for a third visit to arrange for treatment. All the screening camps were conducted in community buildings such as schools with the collaboration of the village leaders. Results: Screening camps were set up in 17 villages in 2010-2011, screening a total of 832 married women upto the age of 50. There were 0 cervical intraepithelial neoplasia (CIN) positive lesions or invasive cancers found. None of the women were lost to follow-up. Conclusions: It is feasible to develop a community level screening program and to provide cancer prevention needs from within a community. Future directions include further evaluation of downstream protocols after VIA/VILI tests, increasing health worker diagnostic and treatment capacity, and determining positive recruitment factors in women attending screening camps. The KMVS screening program has been well-received and has been approached by several other NGO’s and training centers seeking to build similar community-based cervical cancer screening programs.


2020 ◽  
Vol 7 (2) ◽  
pp. 239-246
Author(s):  
J. S. Misra ◽  
A. N. Srivastava ◽  
Shivani Singh

Carcinoma cervix is a major health problem faced by Indian women and situation is very alarming in rural population because of illiteracy and poverty. There is urgent need of creating awareness regarding the risk factors of cervical cancer such as early marriage and multiparity in the rural women and the importance of early detection of the cervical cancer. With aim for providing single life time Pap smear cover to the rural women, cervical cancer screening program was initiated in May 2013 by Era's Lucknow, Medical College and Hospital, Lucknow, through organizing camps in the villages of Lucknow ,west. Till December 2019, a total of 183 camps have been organized and 5209 women attended these camps (28.5%). Pap smear examination could be done in only 2912 women (55.9%). The incidence of squamous intraepithelial lesions of cervix (SIL) was found to be very high in these women (17.1%) though majority of SIL were of low grade (LSIL). This may be related to the poor personal genital hygiene prevailing in rural women due to illiteracy. In the present review, the SIL incidence has been extensively analyzed in relation to different predisposing factors of cervical carcinogenesis and problems faced during camp organization and the benefits derived from these camps to rural women have been highlighted.


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