Comparação da coleta das amostras de sangue na triagem pré-natal, utilizando o papel de filtro e punção venosana técnica de ELISA para detecção de sífilis / Comparison of the collection of blood samples in prenatal screening, using the filter paperand venipuncture technique ELISA for the detection of syphilis

A sífilis é uma doença infecciosa sistêmica, de evolução crônica e causada pelo Treponema pallidum, um espiroqueta de transmissão sexuale vertical, que pode produzir, respectivamente, as formas adquirida e congênita da doença. No Brasil, segundo o Ministério da Saúde (MS), embora a subnotificação de casos de sífilis seja alta, alguns dados disponíveis indicam a elevada magnitude deste problema infeccioso. Objetivo: comparar a coletadas amostras de sangue no papel de filtro (PF) e no plasma (padrão-ouro) na triagem pré-natal, utilizando anticorpos antitreponêmicos totais (IgG + IgM) no procedimento imunoquímico ELISA, registrado pelo Imunoscreen, da firma MBiolog. Métodos: foram estudadas 1.142 grávidas de quatro municípiosdo Estado de Rio de Janeiro: Itaboraí (N = 131), Itaguaí (N = 597), Niterói (N = 377) e São João de Meriti (N = 37) a partir do mês de novembro de 2008 até fevereiro de 2009. As grávidas foram submetidas a punção venosa e digital para a rotina da triagem pré-natal, sendo a última aplicada em PF. Foram calculados os limites de especificidade, sensibilidade e valores preditivos positivo e negativo para o estudo. Resultados: os resultados da sorologia parasífilis nas amostras do município de Itaboraí apresentaram ELISA positivo em 4,58%, os municípios de Itaguaí, Niterói e São João de Meriti mostraram positividade em 3,18%, 2,65% e 0%, respectivamente. Os procedimentos realizados tiveram uma sensibilidade e especificidade de 100% e os critérios preditivos positivos e negativos para todas as grávidas, estudados nas 1.142 amostras, foram de 100%. Conclusão: os resultados da sorologia para sífilis no sangue seco coletado em PF foram semelhantes aos da coleta por punção venosa, validando esta técnica.

Syphilis is a systemic disease of chronic evolution and caused by Treponema pallidum, a spirochete of sexual and vertical transmission,which can produce, respectively, the form of acquired and congenital disease. In Brazil, according to the Ministry of Health (MoH), although the underreporting of cases of congenital syphilis is high, some available data indicate the high magnitude of this problem that especially affects the weakness of pregnant women. Congenital syphilis causes great social impact, which results in deterioration of quality of life on a important stratum of the population,and indirect costs to the economy of the country, which, added to the direct costs resulting from hospitalizations and procedures for the treatment of its complications, increasing the total costs of care of public health. Objective: to compare the collection of blood samples on filter paper (FP) and plasma(gold standard) in prenatal screening, using anti-treponema total (IgG + IgM) in ELISA immunochemical. Methods: we studied 1,142 pregnant of the following cities: Itaboraí (N = 131), Itaguaí (N = 597), Niterói (N = 377) and St. João de Meriti (N = 37). Blood samples were collected from the finger and venipuncture of pregnant women in stations of collection of these counties, calculating elapsed time from sample collection to delivery of the report to thecouncil. We calculated the limits of sensitivity, specificity, positive predictive value and negative for the study. Results: Itaboraí showed positive ELISA in4.58%, in Itaguai, Niterói and St. João de Meriti showed, respectively, 3.18%, 2.65% and 0%. The procedures performed had a sensitivity and specificity of 100%, and the positive and negative predictive criteria for all pregnant women studied in 1,142 samples were 100%. All positive cases were reported to the Municipality within 10 days of sample collection. Conclusion: we conclude that the implementation of collection of dried blood on filter paper in pregnantwomen screening, was similar to that collected by venipuncture, validating this technology.

Comparación de calidad del papel de filtro hahnemuehel fp 2992 con el whatman (S& S) 903 en la conservación de la sangre seca para el estudio poblacional de anticuerpos HIV 1+2 / Comparison of quality between hahnemuehle 2992 and schleicher & amp; schuell 903 filter paper, in preservation of dried blood for the population study of HIV 1+2 antibodies

Intoducción: el papel de fi ltro (PF) como alternativa para la colecta de las muestras de sangre muestra cada día mayor interés en los investigadores y asistentes de salud que buscan mejorar los programas de pesquisaje masivo de la población. Muchos autores desde la apertura esta posibilidad en el siglo pasado iniciaron sus proyectos con la conservación de la muestra de sangre seca para estudios masivos neonatales. Desde los inicios desde siglo se han acrecentando los estudios y posibilidades para ampliar los estudios epidemiológicos de apoyo a la atención primaria de salud. Objetivo: valorar la calidad del papel de fi ltro (Hahnemuehle 2992) para la colecta de muestras de sangre para el tamisaje de anticuerpos HIV 1+2, como alternativa en la conservación de sangre seca en los laboratorios que usan esta alternativa y estrategia en los estudios de terreno. Métodos: fue realizado un diseño para el estudio comparativo de calidad entre el PF Schleicher & Schuell 903 que sirvió como patrón de Oro y el PF Hahnemuehle 2992, para la coleta y almacenamiento de muestras de sangre para el estudio de anticuerpos del virus HIV 1 y 2 con una técnica ELISA tipo Sándwich del subtipo O. Se compararon 150 señalesde absorbancia del mismo número de muestras de mujeres embarazadas, previo consentimiento escrito, para registrar su semejanza stadísticamentesegún los procedimientos estadísticos del Test de Fisher y Student (Test T) con un valor de seguridad de P > 0,05. También se compararon los valores de absorbancia de los casos que resultaron positivos según el cutt off acertado para cada placa realizada y la infl uencia del hematocrito en los resultados en PF. Se calcularon los criterios de sensibilidad, especifi cidad y valor predictivo del universo total de 604 embarazadas incluidas en el estudio. Resultados: se encontró correspondencia entre los valores de especifi cidad, sensibilidad y valor predictivo positivo entre el procedimiento usando con los dos PF en el universo estudiado, así como los valores de T = 0,008 para el análisis de comparación de medias entre la absorbancia obtenida con los dos PF para de P < 0,0001. Conclusión: se concluye que la comparación del PF Hahnemuehle 2992 con el Schleicher & Schuell 903 para el estudio de muestras de sangre seca para la detección de anticuerpos de HIV 1+2 por ensayo ELISA es signifi cativamente semejante y cuentan con la misma calidad.

Introduction: the fi lter paper (dried blood spot- DBS) as an alternative for blood sample collection shows an increased interest of scientifi c investigators and health assistants that search to improve massive research programs of the population. Since the opening of this possibility in the last century, many authors started their projects using dried blood spots for massive neonatal studies. Since the beginning of this century, studies and possibilities are being increased using this alternative, enlarging the epidemiologic studies that support basic care on health. Objective: to assess the fi lter paper quality (Hahnemuehle 2992)for collecting blood samples for HIV 1+2 antibodies screening as an alternative to the conservation of dry blood in the laboratory using this alternative strategy and in camp studies. Methods: a design for a comparative study of quality between Schleicher and Schuell 903 paper- used as golden standard- and Hahnemuehle 2992 paper was realized, for the collection and storage of dried blood for the HIV 1+2 antibody study, using ELISA assay (sandwich, subtype O). A hundred and fi fty (150) signals of absorbance of the same number of pregnant samples, with previous written consent, to register their similarity, using statistic procedures of the Test of Fisher and Student (test T) with a security value of P > 0,05. The absorbance values of the positive cases (accordinga settled cut off for each plate) and sensitivity were also compared, specifi city and predictive value criteria were calculated on a total of 604 pregnant of the study. Results: it was detected correspondence of sensitivity, specifi city and positive predictive values, in the procedures using the two types of filter papers, as well as the value of T = 0,008 for the analysis of the average comparison between the obtained absorbance with the two types to P < 0,0001. It was concluded that Hahnemuehle 2992 fi lter paper compared with Schleicher and Schuell 903 shows signifi cantly similar and have the same quality for the detection of HIV 1+2 antibodies using ELISA test. Conclusion: it was concluded that Hahnemuehle 2992 fi lter paper compared with Schleicher and Schuell903 shows signifi cantly similar and have the same quality for the detection of total antibodies HIV 1 + 2 of using ELISA test.

Comparación de calidade del pepel de filtro hahnemuehle 2992 con el schleicher & schuell 903 en la conservación de la sangre seca para el estudio poblacional de anticuerpos igm e igg de la sífilis / Comparison of quality between hahnemuehle 2992 and schleucher & schuell 903 filter paper, in the preservation of dried blood for the population study of igm and igg antbodies to syphilis

Introducción: la alternativa para la colecta de las muestras de sangre en el papel de filtro (PF) muestra cada día mayor interés en los investigadores yasistentes de salud que buscan mejorar los programas de pesquisaje masivo de la población. Muchos autores desde la apertura esta posibilidad en el siglo pasado iniciaron sus proyectos con la conservación de la muestra de sangre seca para estudios masivos neonatales. . Objetivo: valorar la calidad del papel de filtro (Hahnemuehle, 2992) para la colecta de muestras de sangre para el tamisaje de sífilis, como alternativa en la conservación de sangre seca en los laboratorios que usan esta alternativa y estrategia en los estudios de terreno. Métodos: fue realizadoun diseño para el estudio comparativo de calidad entre el PF Schleicher & Schuell 903 que sirvió como patrón de oro y el PF Hahnemuehle 2992, para a coleta e almacenamiento de muestras de sangre para el estudio de anticuerpos totales (IgM e IgG) contra el Treponema pallidum con una técnica ELISA tipo Sándwich. Se compararon 140 señales de absorbancia del mismo número de muestras de mujeres embarazadas, previo consentimiento escrito, para registrar su semejanza estadísticamente según los procedimientos estadísticos del Test de Fisher y Student (Test T) con un valor de seguridad de P > 0,05. Resultados: se encontró correspondencia entre los valores de especificidad, sensibilidad y valor predictivo positivo entre el procedimiento usando con los dos PF en el universo estudiado, así como los valores de T = 0,344331 para el análisis de comparación de medias entre la absorbancia obtenida con los dos PF para de P < 0,001. Conclusión: se concluye que la comparación del PF Hahnemuehle 2992 con el Schleicher & Schuell 903 para el estudio de muestras de sangre seca para la detección de anticuerpos totales del Treponema pallidum por ensayo ELISA es significativamente semejante y cuentan con la misma calidad.

Introduction: the filter paper (dried blood spot DBS) as an alternative of blood sample collection shows an increased interest of scientific investigators and health assistants that search to improve massive research programs of the population. Since the opening of this possibility in the last century, many authors started their projects using dried blood spots for massive neonatal studies. Objective: to assess the filter paper quality (Hahnemuehle, 2992) for collecting blood samples for sifilis screening as an alternative to the conservation of dry blood in the laboratory using this alternative strategyand in camp studies. Methods: a design for a comparative study of quality between Schleicher and Schuell 903 paper used as golden standard- andHahnemuehle 2992 paper was realized, for the collection and storage of dried blood for the totals antibodies (IgM and IgG) against the Treponema pallidum study, using ELISA assay (sandwich type). A hundred and forty (140) signals of absorbance of the same number of pregnant samples, with previous written consent, to register their similarity, using statistic procedures of the Test of Fisher and Student (test T) with a security value of P > 0,05. It was also compared the absorbance values of the positive cases (according a settled cut off for each plate) and sensitivity,specificity and predictive value criteria were calculatedon a total of 604 pregnant of the study. Results: it was detected correspondence of sensitivity, specificity and positive predictive values, in the procedures using the two types of fi lter papers, as well as the value of T = 0,344331 for the analysis of the average comparison between the obtained absorbance with the two types to P < 0,001. Conclusion: it was concluded that Hahnemuehle 2992 fi lter paper compared with Schleicher and Schuell 903 shows signifi cantly similar and have the same quality for the detection of totals antibodies Treponema pallidum of using ELISA test.