Avaliação do rastreamento do câncer do colo do útero e sua periodicidade em um município de Santa Catarina / Assessment of cervical cancer screening and its periodicity in a city of Santa Catarina state

Modelo do estudo: Estudo de Prevalência. Objetivo do estudo: Conhecer a prevalência dos resultados alterados dos exames preventivos para câncer do colo do útero e a sua regularidade na coleta. Metodologia: Estudo observacional, transversal e retrospectivo. Foram estudadas 3.425 mulheres usuárias do Sistema Único de Saúde e 9.436 exames citopatológicos de novembro de 2003 a janeiro de 2014. Resultados: A mediana da idade foi de 35 anos (25,0 - 46,0, percentil 25 a 75%). No primeiro exame citopatológico, 2,7% das mulheres apresentaram alterações em células epiteliais. As Células escamosas atípicas de significado incerto (ASC-US) (n=54; 1,7%) e as lesões intra-epiteliais de baixo grau (LIEBG) (n=24; 0,7%) foram as mais frequentes. Ao longo do período observado houveram 87 novas alterações citopatológicas, totalizando 173 exames alterados em 9.436 analisados. Quanto a regularidade, 58,5% pacientes repetiram a segunda coleta. Conclusões: Houve um perfil predominante de mulheres jovens, sendo o diagnóstico de ASC-US o mais frequente. A flora bacteriana mais frequente foi Lactobacillus principalmente em mulheres jovens. (AU)

Study Model: Prevalence Study. Study objective: To determine the prevalence of the abnormal cervical cancer screening test (PAP) and regularity in repeat it. Methods: An observational, cross-sectional and retrospective study. 3,425 women, users of the Brazilian Unified Health System, and 9,436 cytopathology, conducted from November 2003 to January 2014, were studied. Results: The median age was 35 years (25.0 to 46.0, 25 to 75% percentile). In the first PAP, 2.7% of women examined had alterations in epithelial cells. The atypical squamous cells of uncertain significance (ASC-US) (n = 54; 1.7%), and low-grade intraepithelial lesion (LSIL) (n = 24; 0.7%) were the most frequent alterations found. During the observed period, 87 new abnormal PAPs were found, totalling 173 altered tests in 9436 analysed. Regarding regularity of test, 58.5% patients repeated the second PAP. Conclusions: There was a preferential profile of young women, and the diagnosis of ASC-US was the most frequently found. Lactobacillus, especially in young women, was the main bacterial flora. (AU)

HPV-based strategy in follow-up of patients treated for high-grade cervical intra-epithelial neoplasia: 5-year results in a public health surveillance setting.

OBJECTIVE: Human papillomavirus (HPV) DNA testing is used increasingly for measuring the outcome of treatment for high-grade cervical intra-epithelial neoplasia (CIN2+). However, there is no international consensus regarding the number of tests and follow-up visits necessary in the post-treatment surveillance. A negative HPV DNA test result may permit relaxing the intensive post-treatment surveillance, but this possibility has not been standardized by all institutions to date. STUDY DESIGN: In 2008, the surveillance programme covering the Emilia-Romagna region in northern Italy adopted the HPV DNA test as a routine tool in the follow-up of women treated for CIN2+. Data from a prospective 5-year study are reported herein. Three hundred and ten patients treated for CIN2+ with a loop electrosurgical excision procedure underwent HPV DNA testing, cytology and colposcopy at 6 months post treatment. If all three tests were negative, women were tested at 18 months with cytology and colposcopy. If any of the three tests were positive, women were tested at 12, 18 and 24 months with cytology and colposcopy. When appropriate, a colposcopy-directed biopsy or CIN2+ retreatment was performed. After 18-24 months, the patients were tested annually with cytology for 3 years. RESULTS: None of the 172 (55%) women who were HPV negative at 6 months were found to have residual/recurrent CIN2+ during the surveillance period. In contrast, among the 138 (45%) HPV-positive women, 17 cases of residual/recurrent CIN2+ (17/138; 12.3%) were identified between 6 and 24 months. CONCLUSION: HPV DNA testing at six months after treatment for CIN2+ effectively identifies women who are disease free (HPV negative), and for whom a single follow-up at 18 months is sufficient.

Assessment of human papilloma virus infection in adult laryngeal papilloma using a screening test.

OBJECTIVES: Human papilloma virus (HPV) infection is involved in both juvenile and adult laryngeal papilloma. We wished to determine which types of adult laryngeal papilloma were clinically related to HPV infection. We hypothesized that multiple-site and recurrent papillomas would have a strong relationship to HPV and conducted the present study to test this hypothesis. METHODS: Thirteen male patients with adult laryngeal papilloma who underwent resection of papilloma between August 2006 and September 2009 were studied. We examined the relationships between whether the tumor was solitary or multiple, presence or absence of recurrence after surgery, and HPV infection. High-risk HPV types (HPV-DNA types 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, and 68) and low-risk HPV types (6, 11, 42, 43, and 44) were tested by a liquid-phase hybridization method. In addition, HPV typing was performed for patients positive for low-risk HPV types. Twenty patients with laryngeal carcinoma or laryngeal leukoplakia were enrolled as the control group. RESULTS: In the laryngeal papilloma group, all patients tested were negative for high-risk HPV and 69.2% were positive for low-risk HPV. Typing performed for seven of the patients who tested positive for low-risk HPV showed that one patient was positive for HPV-11, whereas the remaining six patients were positive for HPV-6. All patients with recurrent laryngeal papillomatosis (RLP) were positive for low-risk HPV. All patients who were positive for low-risk HPV had RLP. Tumor samples from repeat operations were positive for low-risk HPV in all patients tested. HPV was not detected in the control group. CONCLUSIONS: The relationship between RLP and low-risk HPV was strong, with all cases that were positive for low-risk HPV showing recurrence. Tumor tissue resected at the time of repeat surgery was positive for low-risk HPV in all cases tested.

[Results and cost evaluation of triage with high risk HPV test in cervical cancer screening. A pilot study in Piedmont (North-West Italy)]. / Risultati e valutazione economica del triage con ricerca dell'HPV ad alto rischio nello screening dei tumori cervicali. Uno studio pilota in Piemonte.

OBJECTIVE: causal relation between high risk Papilloma virus and cervical carcinoma is definitely ascertained. HPV test is suggested both as primary screening test and as triage test for selecting women who should undergo colposcopy examination. Evidence is clear for triage after ASC-US cytology. A recent study suggested the implementation after LSIL cytology in women 35 or older but the issue is controversial.We present a pilot study on the implementation of HPV test triage in the framework of cervical cancer screening. The study was conducted in respect to: participation, predictive value, and cost analysis, separately for ASC-US and LSIL cytology. DESIGN: HPV test was offered to women with Pap test result ASC-US or LSIL (35 and over), as an add-on to the "Prevenzione serena Screening Program" protocol. All samples were analyzed in the same specialized laboratory. HPV positive women were invited to colposcopy, negative will be invited at the scheduled interval for negative screening tests. SETTING AND PARTICIPANTS: Piedmont (NW Italy), LHAs of Novara and Verbano. In the 1-year study period 15,614 Pap tests were performed: 153 women were eligible for the triage. MAIN OUTCOME MEASURES: Participation at HPV test, HPV test results, costs. RESULTS: ninety two percent of women invited to HPV test actually participated: 66.9% of them were positive (52.8% after ASC-US and 82.8% after LSIL). Regarding colposcopy and histological results, CIN2+ were 9.4% of positive HPV tests in ASC-US group and 17.1% in LSIL group. Cost analysis showed limited differences between triage (offered after ASC-US and LSIL cytology) and traditional protocol. Triage is economically convenient when limited to women with ASC-US cytology. CONCLUSION: the pilot study demonstrated the feasibility of adding a triage phase with HPV test in cervical cancer screening protocol. Additional cost is balanced by the saving due to the reduction in the number of colposcopy exams: the process is economically convenient when limited to women with ASC-US cytology. When extended to LSIL cytology the marginal cost increases because of the higher prevalence of HPV positive results and total cost of triage with HPV test is close to the cost of immediate colposcopy referral.

Células escamosas atípicas cervicais: conduta clínica / Cervical atypical squamous cells: clinical management

O diagnóstico precoce e o rastreamento das lesões precursoras do câncer do colo uterino são de extrema importância. O diagnóstico citológico ainda é a principal ferramenta para a prevenção. O uso de testes para detectar o DNA-HPV associado à citologia tem sido proposto, visto que existem evidências epidemiológicas de que o papilomavírus humanos (HPV) é causa necessária para a ocorrência do câncer cervical. De acordo com a classificação de Bethesda 2001, células escamosas atípicas (ASC) são alterações citológicas sugestivas de lesão intraepitelial, qualitativa ou quantitativamente insuficientes para uma interpretação definitiva. Elas são subdivididas em ASC-US (células escamosas atípicas de significado indeterminado possivelmente não neoplásicas) e ASC-H (células escamosas atípicas não sendo possível excluir lesão intraepitelial de alto grau). O seguimento ideal para mulheres com diagnóstico de ASC é controverso e existem dúvidas sobre como realizá-lo, bem como qual o tratamento mais apropriado. O objetivo desta revisão consiste em avaliar o seguimento e tratamento das mulheres com diagnóstico citológico de ASC. Foi realizada revisão da literatura de estudos indexados em banco de dados como MEDLINE, PubMed e LILACS.

Early diagnosis and screening of precursor lesions of cervical cancer are extremely important. The cytological diagnosis is still the main tool to prevention. The use of tests to detect DNA-HPV combined with cytology has been proposed, since there are epidemiological evidences that human papillomavirus (HPV) is a necessary cause for the occurrence of cervical cancer. According to the 2001 Bethesda classification atypical squamous cells (ASC), there are cytological changes suggestive of squamous intraepithelial lesion that are qualitatively or quantitatively insufficient for a definitive interpretation. It is subdivided into ASC-US (atypical squamous cells of undetermined significance may not neoplastic) and ASC-H (atypical squamous cells is not possible to exclude high-grade intraepithelial lesion). The ideal follow-up for women diagnosed with ASC is controversial and there are doubts about how to accomplish it and the most appropriate treatment. The objective of this review is to evaluate the monitoring and treatment of women with cytological diagnosis of ASC. We performed a literature review of studies indexed in databases such as MEDLINE, PubMed and LILACS.

Risk assessment and clinical impact of liquid-based cytology, oncogenic human papillomavirus (HPV) DNA and mRNA testing in primary cervical cancer screening (the FASE study).

OBJECTIVE: New commercial HPV RNA assays require further validation studies in population-based cervical cancer screening settings. To assess the performance of (FDA-approved) APTIMA® HPV Assay (AHPV), Hybrid Capture 2 (HC2), in-house PCR genotyping, and ThinPrep LBC in population-based screening, stratified by three histological gold standards. STUDY DESIGN: A multi-center trial in 5006 women undergoing routine screening in France was designed to compare the absolute and relative risks of diagnosing CIN3+ and CIN2+ lesions by different diagnostic tests. RESULTS: Reproducibility between the primary and second pathology reading was excellent for CIN3+ and CIN2+ endpoints (Cohen's kappa 0.948 and 0.854). Absolute risks (PPV) of different tests (AHPV, HC2, PCR genotyping, LBC) in diagnosing CIN2+ (15-20%) and CIN3+ (4-6%) were similar for the first, second, and consensus pathology readings. The relative risks of diagnosing these lesions by the four tests were also similar when the first, second or third pathology readings were employed. AHPV had the highest absolute risk of both histological endpoints, and detects 5% to 15% more CIN3+ and CIN2+ lesions, respectively, than LBC. Compared with HC2 assay, the relative risk of AHPV is 24% to 29% higher, with a significant difference in CIN2+ detection. With LBC as reference, AHPV had the best sensitivity/specificity balance measured by AUC (area under ROC curve) comparison test (significant for CIN2+), and the colposcopy referral rate (9.2%) comparable to that of LBC (8.7%). CONCLUSIONS: These data corroborate the suitability of AHPV for the primary cervical cancer screening.

Human papillomavirus (HPV) detection and Papanicolaou cytology in low-resource women in Posadas city, Misiones, Argentina / Detección del virus papiloma humano (HPV) y citología de Papanicolaou en mujeres de bajos recursos de la ciudad de Posadas, Misiones, Argentina

The objective of this study was to determine the prevalence of HPV infection and cervical lesions present in women who attended a health center in a low-resource area of the city of Posadas, Misiones, Argentina. Cervical cell samples (n = 163) were processed for Papanicolaou cytology and HPV-PCR tests. Socio-cultural risk factors were estimated using the odds ratio (OR, CI 95 %). Cervical lesions were detected in 14.7 % of women. The general prevalence of HPV infection was of 38 %. The most common types among the total population were HPV-16 (9.8 %) and HPV-33 (9.3 %). HPV-16 was detected in association with 29.2 % and 6.5 % of women with and without cervical lesions, respectively, the OR being 5.3 (1.8-15.8). Risk factors for HPV-16 infection were a smoking habit and a history of previous sexually-transmitted diseases. These data are important for the implementation of prevention programs, including an appropriate introduction of vaccination and the baseline for virological surveillance in the vaccine era.

El objetivo de este estudio fue determinar la prevalencia de la infección por HPV y de lesiones cervicales en mujeres asistidas en un centro de salud situado en un área de bajos recursos de la ciudad de Posadas, Misiones, Argentina. Las muestras (n = 163) fueron examinadas mediante las pruebas de Papanicolaou y de PCR para HPV. Los factores socio-culturales de riesgo fueron identifcados mediante el cálculo de la odds ratio (OR, IC 95 %). Se detectaron lesiones cervicales en el 14,7 % de las mujeres. La prevalencia de infección por HPV fue de 38 %. Los tipos más frecuentes en la población total fueron HPV-16 (9,8 %) y HPV-33 (9,3 %). El HPV-16 se detectó asociado al 29,2 % y al 6,5 % de las mujeres con lesiones del cuello uterino y sin ellas, respectivamente, con un OR de 5,3 (1,8-15,8). Los factores de riesgo para la infección por HPV-16 fueron el hábito de fumar y el antecedente de enfermedades de transmisión sexual. Estos datos son importantes para la ejecución de los programas de prevención, incluyendo una introducción adecuada de la vacunación y la línea de base para la vigilancia virológica en la era de la vacuna.

Human papillomavirus: science and technologies for the elimination of cervical cancer.

INTRODUCTION: Academic research has made a significant advancement in understanding the viral causes of cervical cancer and generating the technology for prevention, both at the primary and secondary levels. Human papillomaviruses (HPVs) have been recognized as the first necessary cause of cervical cancer, the second most common cancer in women worldwide. AREAS COVERED: This paper reviews the epidemiological evidence of the causality of HPV in relation to cervical cancer, other genital tract cancers and some cancers of the oral cavity and oropharynx. The review also covers HPV DNA testing as a screening tool. DNA probes of high-risk HPV types in different formats have been fully validated as primary screening tests, as secondary triage tests and as a prognostic marker following treatment of high grade squamous intraepithelial lesions (HSIL). They consistently showed significant superiority over the conventional Pap smears. Biomarkers of the activation of oncogenes (HPV mRNA, p16 and other) are being tested as screening options to improve in sensitivity and specificity, with promising results. HPV vaccines against the two most common HPV types in cancer have completed their Phase III trials with excellent results in efficacy and safety. Combined strategies of HPV vaccination and HPV-based screening tests could theoretically control cervical cancer in any population in which a large coverage with both preventive options is ensured. Accessibility of developing countries to vaccination and low-cost HPV screening options are the barriers to overcome at present. EXPERT OPINION: This paper provides a synthesis of the evidence available supporting the novel paradigm for cervical cancer prevention that has reached a large consensus within the mainstream HPV and cervical cancer prevention research communities. The available technology for prevention and its developments allows real opportunities for cervical cancer elimination in defined populations to be foreseen.

Screening for cervical cancer: when theory meets reality.

Cervical cancer screening reduces morbidity and mortality due to cervical cancer. However, there are many factors that determine the success of any cervical cancer prevention effort: the prevalence of human papillomavirus infection in general population, the existence of an organized screening program and the corresponding coverage, the existence and quality of the field and laboratory facilities for screening and diagnostic follow-up, and the facilities available for treating diagnosed lesions. Monitoring the patient path or "chain of action" for each patient with an abnormal screening result is of crucial importance. Cost-effectiveness models are widely used by decision-makers to determine which cervical cancer screening program would maximize health benefits within a given, usually limited, set of resources. Regardless of their level of sophistication, however, these models cannot replace empirical evaluations of the effectiveness of screening programs.Cervical cancer prevention activities need to be monitored and evaluated in each country where they are introduced to see that they meet performance standards. Policy-makers responsible for allocating resources for cervical cancer prevention have a duty to allocate resources not only for cervical cancer screening, but also for screening program surveillance.

Evaluation of primary HPV-DNA testing in relation to visual inspection methods for cervical cancer screening in rural China: an epidemiologic and cost-effectiveness modelling study.

BACKGROUND: A new lower-cost rapid-throughput human papillomavirus (HPV) test (careHPV, Qiagen, Gaithersburg, USA) has been shown to have high sensitivity for the detection of high grade cervical intraepithelial neoplasia. METHODS: We assessed the outcomes and cost-effectiveness of careHPV screening in rural China, compared to visual inspection with acetic acid, when used alone (VIA) or in combination with Lugol's iodine (VIA/VILI). Using data on sexual behaviour, test accuracy, diagnostic practices and costs from studies performed in rural China, we estimated the cost-effectiveness ratio (CER) and associated lifetime outcomes for once-lifetime and twice-lifetime screening strategies, and for routine screening at 5-yearly, 10-yearly and IARC-recommended intervals. The optimal age range for once-lifetime screening was also assessed. RESULTS: For all strategies, the relative ordering of test technologies in reducing cervical cancer incidence and mortality was VIA (least effective); VIA/VILI; careHPV@1.0 pg/ml and careHPV@0.5 pg/ml (most effective). For once-lifetime strategies, maximum effectiveness was achieved if screening occurred between 35-50 years. Assuming a participation rate of ~70%, once-lifetime screening at age 35 years would reduce cancer mortality by 8% (for VIA) to 12% (for careHPV@0.5) over the long term, with a CER of US$557 (for VIA) to $959 (for careHPV@1.0) per life year saved (LYS) compared to no intervention; referenced to a 2008 GDP per capita in Shanxi Province of $2,975. Correspondingly, regular screening with an age-standardised participation rate of 62% (which has been shown to be achievable in this setting) would reduce cervical cancer mortality by 19-28% (for 10-yearly screening) to 43-54% (using IARC-recommended intervals), with corresponding CERs ranging from $665 (for 10-yearly VIA) to $2,269 (for IARC-recommended intervals using careHPV@1.0) per LYS. CONCLUSIONS: This modelled analysis suggests that primary careHPV screening compares favourably to visual inspection screening methodologies in rural China, particularly if used as part of a regular screening program.

Human papillomavirus (HPV) detection and Papanicolaou cytology in low-resource women in Posadas city, Misiones, Argentina.

The objective of this study was to determine the prevalence of HPV infection and cervical lesions present in women who attended a health center in a low-resource area of the city of Posadas, Misiones, Argentina. Cervical cell samples (n = 163) were processed for Papanicolaou cytology and HPV-PCR tests. Socio-cultural risk factors were estimated using the odds ratio (OR, CI 95 %). Cervical lesions were detected in 14.7 % of women. The general prevalence of HPV infection was of 38 %. The most common types among the total population were HPV-16 (9.8 %) and HPV-33 (9.3 %). HPV-16 was detected in association with 29.2 % and 6.5 % of women with and without cervical lesions, respectively, the OR being 5.3 (1.8-15.8). Risk factors for HPV-16 infection were a smoking habit and a history of previous sexually-transmitted diseases. These data are important for the implementation of prevention programs, including an appropriate introduction of vaccination and the baseline for virological surveillance in the vaccine era.

Quality assessment for human papillomavirus testing.

There are over 30 commercial, as well as numerous in-house assays, available for human papillomavirus testing. Laboratories performing such assays would need to assess accuracy and reproducibility of their results by incorporating ongoing internal control as well as participating in external quality-assurance schemes (EQAS) as part of their quality assurance program. Several EQAS are available and participation in which is a requirement for laboratories engaged in HPV testing. It is important that laboratories select the appropriate panels for detection of targeted types covered by assay used. Failure to do so can possibly alter patient management and increase the cost of treatment.

Promising strategies for cervical cancer screening in the post-human papillomavirus vaccination era.

Human papillomavirus (HPV) vaccination is expected to reduce the burden of cervical cancer in most settings; however, it is also expected to interfere with the effectiveness of screening. In the future, maintaining Pap cytology as the primary cervical screening test may become too costly. As the prevalence of cervical dysplasias decreases, the positive predictive value of the Pap test will also decrease, and, as a result, more women will be referred for unnecessary diagnostic procedures and follow-up. HPV DNA testing has recently emerged as the most likely candidate to replace cytology for primary screening. It is less prone to human error and much more sensitive than the Pap smear in detecting high-grade cervical lesions. Incorporating this test would improve the overall quality of screening programs and allow spacing out screening tests, while maintaining safety and lowering costs. Although HPV testing is less specific than Pap cytology, this issue could be resolved by reserving the latter for the more labour-efficient task of triaging HPV-positive cases. Because most HPV-positive smears would contain relevant abnormalities, Pap cytology would be expected to perform with sufficient accuracy under these circumstances. HPV Pap triage would also provide a low-cost strategy to monitor long-term vaccine efficacy. Although demonstration projects could start implementing HPV testing as a population screening tool, more research is needed to determine the optimal age to initiate screening, the role of HPV typing and other markers of disease progression, and appropriate follow-up algorithms for HPV-positive and Pap-negative women.

Association between physician specialty and uptake of new medical technologies: HPV tests in Florida Medicaid.

BACKGROUND: It is well established that specialists often adopt new medical technologies earlier than generalists, and that racial and ethnic minority patients are less likely than White patients to receive many procedures and prescription drugs. However, little is known about the role that specialists or generalists may play in reducing racial and ethnic disparities in uptake of new medical technologies. Human papillomavirus (HPV) DNA tests, introduced as a cervical cancer screening tool in 2000, present a rich context for exploring patterns of use across patient and provider subgroups. OBJECTIVE: To identify patient characteristics and the provider specialty associated with overall and appropriate use of HPV DNA tests over time, and to examine the associations between clinical guidelines and adoption of the test in an underserved population. DESIGN: Retrospective longitudinal study using Florida Medicaid administrative claims data. PARTICIPANTS: Cervical cancer screening test claims for 415,239 female beneficiaries ages 21 to 64 from July 2001 through June 2006. MAIN MEASURES: Overall and appropriate use of HPV DNA tests. KEY RESULTS: Although minority women were initially less likely than White women to receive HPV DNA tests, test use grew more rapidly among Black and Hispanic women compared to White women. Obstetricians/gynecologists were significantly more likely than primary care providers to administer HPV DNA tests. Release of the first set of clinical guidelines was associated with a large increase in the use of HPV DNA tests (adjusted odds ratio: 2.46, p<0.0001); subsequent guidelines were associated with more modest increases. CONCLUSIONS: Uptake of new cervical cancer screening protocols can occur quickly among traditionally underserved groups and may be aided by early adoption by specialists.

Assessment of HPV DNA test value in management women with cytological findings of ASC-US, CIN1 and CIN2.

The aim of this retrospective study was to answer the following questions: 1) is HPV DNA test for high-risk types able to predict lesion behaviour in women with cytological abnormalities lower than CIN3 (ASC-US, CIN1 and CIN2); 2) how to predict the histological diagnosis CIN3, and 3) is its use in diagnostic management in these patients justified or not? The study included 345 women (11 ASC-US, 312 CIN1 and 22 CIN2) that underwent conventional diagnostic management (repeat cytology and colposcopy with or without histology) and HPV testing for high-risk HPV types by PCR method. The value of HPVDNA test in predicting lesion regression/persistence was assessed in 275 subjects without histology. In 70 subjects, diagnostic accuracy (sensitivity, specificity, and positive and negative predictive value) of repeat cytology and HPV DNA test in predicting severe intraepithelial lesion (CIN3) was determined on the basis of colposcopy guided biopsy. The prevalence of persistent lesions was significantly higher in the group of HPV positive than in the group of HPV negative subjects (37.7% vs. 16.4%; p < 0.001). Positive HPV test was associated with a 3.1-fold risk of lesion persistence [OR (95% CI) = 3.095 (1.65-5.82)]. However, on screening to predict the outcome of cytologically diagnosed cervical lesion with sensitivity of 39.7% and positive predictive value of 37.7% showed that a positive test could not be considered a reliable indicator of lesion persistence. In contrast, the specificity of 82.5% and negative predictive value of 83.6% suggested that a negative test result could be taken as a good indicator of lesion regression. In comparison with repeat cytology, HPV test showed higher sensitivity (69.2% vs. 61.5%) but significantly lower specificity (63.2% vs. 93.0%) and positive predictive value (30.0% vs. 66.7%), and comparable negative predictive value (90.0% vs. 91.4%) in predicting histologically verified CIN3. In one patient with a histological diagnosis of squamous cell carcinoma with minimal invasion, repeat cytology indicated CIN3, whereas HPV test was negative. Due to authors experience in women with cytological abnormalities lower than CIN3, HPV testing is not a method to reliably predict lesion behaviour (regression, persistence) or presence of CIN3. HPV testing is of limited value in daily routine and should not be widely used until it is definitely demonstrated to be superior to conventional methods in improving the sensitivity, specificity and positive predictive value of CIN3 and invasive carcinoma detection.

Cost-effectiveness of conventional cytology and HPV DNA testing for cervical cancer screening in Colombia.

OBJECTIVE: To assess cost-effectiveness of conventional cytology and HPV DNA testing for cervical-cancer screening in Colombia. MATERIAL AND METHODS: The National Cancer Institute of Colombia (NCIC) in 2007 developed a Markov model on the natural history of cervical cancer; no screening, conventional cytology, and HPV DNA testing were compared. Only direct costs were used. Outcomes comprise cervical cancer mortality, years of life saved, and lifetime costs. Discounted incremental cost-effectiveness ratios were estimated and sensitivity analyses were conducted for key parameters. RESULTS: Depending on the screening strategy a 69-81% mortality reduction might be expected. The HPV DNA testing every five years is a cost-effective strategy (Incremental Cost-Effectiveness Ratio (ICER): USD$44/YLS) if the cost per test is under USD$31. The effectiveness was sensitive to coverage and primarily to follow-up. CONCLUSIONS: HPV DNA testing is a cost-effective alternative for screening in Colombia. Not only high coverage but high follow-up rates are critical for successful screening programs.

Cost-effectiveness of conventional cytology and HPV DNA testing for cervical cancer screening in Colombia / Costo-efectividad de la citología y la tamización con pruebas de ADN-VPH para cáncer de cuello uterino en Colombia

OBJECTIVE: To assess cost-effectiveness of conventional cytology and HPV DNA testing for cervical-cancer screening in Colombia. MATERIAL AND METHODS: The National Cancer Institute of Colombia (NCIC) in 2007 developed a Markov model on the natural history of cervical cancer; no screening, conventional cytology, and HPV DNA testing were compared. Only direct costs were used. Outcomes comprise cervical cancer mortality, years of life saved, and lifetime costs. Discounted incremental cost-effectiveness ratios were estimated and sensitivity analyses were conducted for key parameters. RESULTS: Depending on the screening strategy a 69-81 percent mortality reduction might be expected. The HPV DNA testing every five years is a cost-effective strategy (Incremental Cost-Effectiveness Ratio (ICER): USD$44/YLS) if the cost per test is under USD$31. The effectiveness was sensitive to coverage and primarily to follow-up. CONCLUSIONS: HPV DNA testing is a cost-effective alternative for screening in Colombia. Not only high coverage but high follow-up rates are critical for successful screening programs.

OBJETIVO: evaluar el costo-efectividad de la citología convencional y la prueba de ADN-VPH para tamización de cáncer cervical en Colombia. MATERIAL Y MÉTODOS: el Instituto Nacional de Cancerología de Colombia construyó en 2007 un modelo de Markov de historia natural del cáncer cervical. Se comparó "no tamización", citología convencional y prueba de ADN-VPH. Se utilizaron costos directos. Los desenlaces fueron mortalidad, años de vida ganados y costos. Se calcularon razones de costo-efectividad incremental. Se realizaron análisis de sensibilidad para parámetros clave. RESULTADOS: la mortalidad se redujo 69-81 por ciento según la estrategia. La tamización con ADN-VPH cada cinco años es costo-efectiva (ICER (Razón de Costo-Efectividad incremental por sus siglas en inglés): 44 dólares por año de vida saludable) si los costos por prueba son menores a 31 dólares. La efectividad fue más sensible al seguimiento que a la cobertura. CONCLUSIONES: La tamización con prueba ADN-VPH es costo-efectiva para Colombia. No solamente altas coberturas, sino también altos porcentajes de seguimiento son críticos para el éxito de la tamización.

[Assessment of HPV detection assays for use in cervical cancer screening programs]. / Evaluación de las técnicas de detección del VPH en los programas de cribado para cáncer de cuello uterino.

OBJECTIVE: Detection of high-risk human papillomavirus types (HPV) infection is an important tool in the screening of cervical cancer and triage of cytological abnormalities. The different techniques for detection of this cancer need to be contrasted and validated for use in population screening. MATERIAL AND METHODS: Cervical cell samples were collected from 166 women attending a dermatology clinic in Oviedo (Spain). We evaluated the performance of three different assays for VPH detection. The methods utilized were 1) In-house PCR-EIA using LI consensus primers MY09/ MY11, 2) A PCR-reverse line blot hybridization (PCR-LBH) that uses LI consensus PGMY primers. 3) Hybrid Capture 2. All assays were performed blinded. The kappa statistic was used to test for global agreement between assay pairs. RESULTS: HPV DNA was detected in 24,7%, 25,3% and 29,5% of the women, respective to the assay. The overall agreement between the in-house PCR, PCR-LBH and HC2 was (73.5%) with all kappa values between assay pairs exceeding 0.56 (p<0.001). CONCLUSION: The three HPV assays were equally accurate in estimating high-risk HPV prevalence and HPV-related lesions. The method for HPV detection must be decided depending on the goals of the search (screening, follow-up or molecular studies).