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ABSTRACT Introduction: Although the criteria and recommendations are well defined to improve the quality of cervical cytopathology tests (Pap smear) in Brazil, the quality indicators of several laboratories are below the recommended standards. Objective: To evaluate the quality indicators of cervical cytopathology tests carried out by the Brazilian Unified Health System [Sistema Único de Saúde (SUS)]. Method: Cross-sectional study based on the results of cervical cytopathology tests conducted in the municipality of Cascavel, Paraná, Brazil, from January 2012 to December 2018. The study included 141,191 tests and the following variables were analyzed: sample suitability, cervical cytopathology tests result, and internal quality monitoring indicators recommended by the Brazilian Ministry of Health. Results: The percentage of unsatisfactory tests did not exceed 0.97%. The representation of the squamocolumnar junction ranged from 63% to 67.4%. The percentage of altered exams among the satisfactory samples ranged from 0.46% to 6.44%. The positivity index ranged from 0.46% to 6.44%, while the high-grade squamous intraepithelial lesion/satisfactory indicator ranged from 0.21% to 1.06%, atypical squamous cells of undetermined significance/altered ranged from 22.47% to 49.93%, atypical squamous cells of undetermined significance/satisfactory ranged from 0.1% to 2.57%: and atypical squamous cells of undetermined significance/squamous intraepithelial lesions ranged from 0.31 to 1.02. Conclusion: In 2012 and 2013, the high-grade squamous intraepithelial lesion/satisfactory and the positivity index indicators were below the recommended parameters, and in the remaining years, these indicators were within the parameters recommended. Consequently, a greater number of truly cancer precursor lesions were identified, demonstrating the importance of internal quality control in the prevention of cervical cancer.
RESUMEN Introducción: Aunque criterios y recomendaciones están bien definidos para la mejora de calidad de las pruebas citopatológicas en Brasil, los indicadores de calidad de varios laboratorios se encuentran por debajo de los estándares recomendados. Objetivo: Evaluar los indicadores de calidad de las pruebas citopatológicas de cuello uterino realizadas por el sistema público de salud en Brasil (SUS). Método: Estudio transversal basado en los resultados de pruebas colpocitológicas llevadas a cabo en el municipio de Cascavel, Paraná, Brasil, de enero de 2012 a diciembre de 2018. Se incluyeron 141.191 pruebas; las siguientes variables se analizaron: adecuación de la muestra, resultado de la prueba citopatológica e indicadores de monitoreo interno de calidad recomendados por el Ministerio de Salud. Resultados: El porcentaje de pruebas insatisfactorias no superó 0,97%. La representación de la unión escamo-columnar varió de 63% a 67,4%. El porcentaje de pruebas alteradas entre las muestras satisfactorias varió de 0,46% a 6,44%. El índice de positividad varió de 0,46% a 6,44%, mientras el indicador de lesión intraepitelial de alto grado/satisfactorios, de 0,21% a 1,06%; atipias escamosas de significado indeterminado/alterados, de 22,47% a 49,93%; atipias escamosas de significado indeterminado/satisfactorios, de 0,1% a 2,57%; y razón atipias escamosas de significado indeterminado/lesiones intraepiteliales escamosas, de 0,31 a 1,02. Conclusión: En 2012 y 2013, los indicadores de lesión epitelial de alto grado/satisfactorios e índice de positividad se encontraban por debajo de los parámetros recomendados; en los otros años, esos indicadores estaban dentro de los parámetros recomendados. Por consiguiente, se identificó mayor número de lesiones realmente precursoras del cáncer, demostrando la importancia del control interno de calidad en la prevención del cáncer de cuello uterino.
RESUMO Introdução: Ainda que critérios e recomendações estejam bem definidos para melhoria da qualidade do exame citopatológico no Brasil, os indicadores de qualidade de vários laboratórios apresentam-se abaixo dos padrões recomendados. Objetivo: Avaliar os indicadores de qualidade dos exames citopatológicos do colo do útero realizados pelo Sistema Único de Saúde (SUS). Método: Estudo transversal com base nos resultados dos exames citopatológicos realizados no município de Cascavel, Paraná, Brasil, de janeiro de 2012 a dezembro de 2018. Foram incluídos 141.191 exames; as seguintes variáveis foram analisadas: adequabilidade da amostra, resultado do exame citopatológico e indicadores de monitoramento interno da qualidade recomendados pelo Ministério da Saúde. Resultados: A porcentagem de exames insatisfatórios não ultrapassou 0,97%. A representação da junção escamocolunar variou de 63% a 67,4%. A porcentagem de exames alterados entre as amostras satisfatórias variou de 0,46% a 6,44%. O índice de positividade variou de 0,46% a 6,44%, enquanto o indicador lesão intraepitelial de alto grau/satisfatórios, de 0,21% a 1,06%; atipias escamosas de significado indeterminado/alterados, de 22,47% a 49,93%; atipias escamosas de significado indeterminado/satisfatórios, de 0,1% a 2,57%; e razão atipias escamosas de significado indeterminado/lesões intraepiteliais escamosas, de 0,31 a 1,02. Conclusão: Em 2012 e 2013, os indicadores de lesão intraepitelial de alto grau/satisfatórios e índice de positividade encontravam-se abaixo dos parâmetros recomendados; nos demais anos, esses indicadores estavam dentro dos parâmetros recomendados. Consequentemente, foi identificado um maior número de lesões verdadeiramente precursoras do câncer, demonstrando a importância do controle interno da qualidade na prevenção do câncer do colo do útero.
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BACKGROUND: High rates of false-negative results constitute a routine problem in cytology laboratories. Of currently available internal quality control methods, 10% random review is the least effective in detecting false-negatives in routine screening. There is evidence that 100% rapid review and rapid prescreening perform well for this purpose. This study compared the performance of rapid prescreening and 100% rapid review as internal quality control methods for cervical cytology exams. METHODS: Over 27 months, 12,208 cervical cytology smears were submitted to rapid prescreening and routine screening. The 100% rapid review method was performed on all smears classified as negative or unsatisfactory at routine screening. Conflicting results obtained with either method were reviewed in detail to define final diagnosis, which was considered the gold standard for evaluating the performance of rapid prescreening and 100% rapid review. RESULTS: Compared with final diagnosis, the sensitivity of routine screening and rapid prescreening was 72.9% and 75.6%, respectively. Considering only smears classified as negative or unsatisfactory at routine screening, the sensitivity of rapid prescreening and 100% rapid review was 90.2% and 57,0%, respectively. Of 244 cases (2.0%) of false-negative results at routine screening, rapid prescreening identified 220 cases (1.80%), whereas 100% rapid review identified 140 (1.15%). Rapid prescreening detected all cases of HSIL identified as false-negatives. CONCLUSIONS: Rapid prescreening is more effective than 100% rapid review for the detection of false-negatives at routine screening, thus providing subsidies for the performance of cervical cytology, the principal function of which is to detect precursor lesions of cervical cancer.
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Tamizaje Masivo/métodos , Enfermedades del Cuello del Útero/diagnóstico , Neoplasias del Cuello Uterino/diagnóstico , Frotis Vaginal/métodos , Reacciones Falso Negativas , Femenino , Humanos , Control de Calidad , Estándares de Referencia , Sensibilidad y Especificidad , Enfermedades del Cuello del Útero/patología , Enfermedades del Cuello del Útero/prevención & control , Neoplasias del Cuello Uterino/patología , Neoplasias del Cuello Uterino/prevención & controlRESUMEN
BACKGROUND: Rapid prescreening (RPS) is an internal quality-control (IQC) method that is used both to reduce errors in the laboratory and to measure the sensitivity of routine screening (RS). Little direct comparison data are available comparing RPS with other more widely used IQC methods. METHODS: The authors compared the performance of RPS, 10% random review of negative smears (R-10%), and directed rescreening of negative smears based on clinical risk criteria (RCRC) over 1 year in a community clinic setting. RESULTS: In total, 6,135 smears were evaluated. The sensitivity of RS alone was 71.3%. RPS detected significantly more (132 cases) false-negative (FN) cases than either R-10% (7 cases) or RCRC (32 cases). RPS significantly improved the overall sensitivity of the laboratory (71.3-92.2%; P = .001); neither R-10% nor RCRC significantly changed the sensitivity of RS. RPS was not as specific as the other methods, although nearly 68% of all abnormalities detected by RPS were verified as real. RPS of 100% of smears required the same amount of time as RCRC but required twice as much time as R-10%. CONCLUSIONS: The current results demonstrated that RPS is a much more effective IQC method than either R-10% or RCRC. RPS detects significantly more errors and can improve the overall sensitivity of a laboratory with either a modest increase or no increase in overall time spent on IQC. R-10% is an insensitive IQC method, and neither R-10% nor RCRC can significantly improve the overall sensitivity of a laboratory.
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Técnicas Citológicas/normas , Frotis Vaginal/normas , Reacciones Falso Negativas , Femenino , Humanos , Control de Calidad , Distribución Aleatoria , Sensibilidad y EspecificidadRESUMEN
A study was carried out in 135 women of reproductive age to evaluate the role of the Papanicolaou smear performed in cervical and vaginal samples for the diagnosis of bacterial vaginosis (BV), to validate the method for this diagnosis and to evaluate the reproducibility of the criterion used. The cervical and vaginal smears were stained using the Papanicolaou method and evaluated by two separate observers. The finding of 20% or more clue cells was considered positive for the presence of BV. This diagnostic criterion presented a sensitivity of 87%, specificity of 94%, a positive predictive value of 81%, and a negative predictive value of 96%, both in cervical and vaginal samples. There was excellent agreement in the diagnosis of BV between the two observers (kappa, 0.87) and between cervical and vaginal samples (kappa, 0.92). Therefore, the presence of 20% or more clue cells in the Papanicolaou smear is an accurate and reproducible criterion for the diagnosis of BV and may be used in screening for this infection, eliminating the need for further vaginal sample collection.
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Prueba de Papanicolaou , Frotis Vaginal/métodos , Vaginosis Bacteriana/diagnóstico , Adolescente , Adulto , Femenino , Humanos , Persona de Mediana Edad , Valor Predictivo de las Pruebas , Reproducibilidad de los Resultados , Sensibilidad y EspecificidadRESUMEN
Todos os sistemas de avaliação do desempenho dos Laboratórios de Citopatologia exigem um programa de controle interno e externo da qualidade. Este estudo tem por objetivo avaliar a concordância dos diagnósticos citopatológicos do Laboratório Rômulo Rocha com os diagnósticos da Unidade de Monitoramento Externo da Qualidade (UMEQ), bem como, avaliar a freqüência de casos discordantes, falso-positivos e falso-negativos. Foram enviados a UMEQ 537 esfregaços selecionados pelo sistema SISCOLO durante o ano de 2003, incluindo todos os casos positivos, todos os insatisfatórios e no mínimo 5% dos exames negativos. Apenas seis casos foram considerados discordantes pela UMEQ, dos quais três casos foram considerados negativos pelo Rômulo Rocha, destes, dois foram reavaliados como ASC e um como ASC/AG, um caso negativo foi reavaliado como insatisfatório, um caso de NIC 2/HPV foi reavaliado como ASC e um caso de NIC 1/HPV reavaliado como NIC 2/HPV pela UMEQ. A concordância diagnóstica entre o Rômulo Rocha e a UMEQ foi de 0,99 de acordo com o coeficiente Kappa. Este estudo mostrou estrito controle interno da qualidade desenvolvido no Laboratório Rômulo Rocha. Sua prática pode ser útil para orientar diversas medidas de educação continuada.
Systems of laboratory development assessment in cytopathology require an intern and external quality control. The aim of the present study was to assess concordance of cytopathologic diagnosis in the Laboratory Rômulo Rocha with cytopathologic diagnosis carried out in the External Quality Control Unit (UMEQ), as well as to evaluate frequency of discordant cases, false-positive and false-negative. For this, 537 smears were randomly selected by SISCOLO throughout the year 2003, including all positive and unsatisfactory cases and at least 5% of the negative ones. Only six discordant cases were detected. Three of these cases were considered negative by Rômulo Rocha, two were rescreened as ASC and one case was rescreened ASC/AG, one negative case was rescreened as unsatisfactory, one case NIC 2/HPV was rescreened as ASC and another case NIC 1/HPV was rescreened as NIC 2/HPV by UMEQ. The diagnostic agreement between Rômulo Rocha and UMEQ was 0.99 according to kappa coefficient. Results of the study reveal that the Rômulo Rocha uses a very strict quality control, which can be helpful in guiding students in continued education programs.
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Humanos , Femenino , Displasia del Cuello del Útero , Reacciones Falso Negativas , Reacciones Falso Positivas , Control de Calidad , Técnicas y Procedimientos DiagnósticosRESUMEN
No Brasil, o câncer cervical está entre as quatro primeiras taxas de incidência e mortalidade, representando um sério problema de saúde pública que pode ser evitado se lesões pré cancerosas forem detectadas precocemente. Observações epidemiológicas sugerem que o HPV seja o principal fator de risco do câncer cervical. O Objetivo deste estudo foi determinar a prevalência das lesões por HPV em uma determinada população de Santo Angelo, pela citologia. Foram analisados 472 exames citológicos no período de agosto de 2001 a janeiro de 2002. Desses exames, 449 (95,13 por cento) foram negativos para malignidade, 6 (1,27 por cento.