Discriminatory Power and Concordance between ELISA-F29 and PCR in Individuals with Infection due to T.cruzi

El diagnóstico de la infección por Trypanosoma cruzi (T. cruzi) se realiza rutinariamente mediante pruebas serológicas mientras que el empleo de métodos moleculares se encuentra aún en proceso de estandarización. Objetivo: Evaluar la capacidad discriminatoria y concordancia entre una prueba serológica y una molecular para determinar la infección por T. cruzi. Métodos: Se realizó Reacción en Cadena de la Polimerasa (PCR) y la prueba de ELISA-F29 en 95 muestras de participantes de la cohorte "Cardiovascular health investigation and collaboration countries of America to assess the markers and outcomes of Chagas disease " CHICAMOCHA. Se evaluó la capacidad discriminatoria del ELISA-F29 respecto al resultado de PCR mediante la estimación del área bajo la curva ROC. Se estimó la tasa de falsos positivos al 25% y sensibilidad al 75%. Se determinó la concordancia mediante kappa de Cohen. Resultados: Se realizaron pruebas de PCR en dos momentos diferentes en 95 individuos (edad media: 38 años; 64% hombres), con tasas de positividad entre 1.1% – 2.2% para los primers S35-S36 y entre 18.3% – 34.7% para los primers 121-122, respectivamente. La capacidad discriminatoria del ELISAF29 respecto a PCR fue 0.62 (IC95%: 0.53; 0.70) y tasa de falsos positivos del 56% (IC95%: 42; 70). El punto de corte óptimo para el cociente de absorbancia fue 2.53 (sensibilidad 59% y especificidad 60%). Para el primer 121-122 los niveles de acuerdo observado y kappas estimados fueron: 52.6% y 0.10 (IC95%: -0.08, 0.28) para la primera medición, 62.4% y 0.09 (IC95%: -0.09, 0.28) para la segunda medición y 57.5% y 0.13 (IC95%: 0.01, 0.26) al evaluar simultáneamente las dos mediciones. Conclusiones: Los resultados demuestran una baja concordancia evidenciada por los valores de kappa determinados en el estudio. Es necesario afinar los estudios para evaluar la utilidad de las pruebas moleculares en el diagnóstico de la Enfermedad de Chagas. [Gómez-Laitón ED, Polo-Ardila LA, Castellanos-DomÍnguez YZ, Herrera VM, Villar JC. Capacidad discriminatoria y concordancia entre el ELISA-F29 y la PCR en individuos con infección por T. cruzi. MedUNAB 2015; 18 (1): 27-33].The diagnosis of infection with Trypanosoma cruzi (T. cruzi) is routinely performed by serological tests while the use of molecular methods is still in process of standardization. Objective: To evaluate the discriminatory capacity and agreement between a serological test and a polymerase chain reaction (PCR) to determine T. cruzi infection. Methodology: PCR and ELISA test-F29 were performed to 95 participants of "Cardiovascular health investigation and collaboration countries of America to assess the markers and outcomes of Chagas disease " (CHICAMOCHA). Discriminatory capacity of ELISA –F29 with respect to PCR results were evaluated by estimating the area of ROC curve. The false positive rate was estimated to 25% and sensitivity to 75%. The agreement was determined using Cohen's kappa. Results: PCR tests were performed at two different times in 95 individuals (mean age: 38; 64% male), with positivity rates between 1.1 to 2.2% for S35-S36 primers and from 18.3% to 34, 7% for primers 121-122, respectively. ELISA-F29 discriminatory capacity regarding PCR was 0.62 (95% CI: 0.53, 0.70). The false positive rate was 56% (95% CI: 42; 70). The optimal cutoff for absorbance ratio of ELISA-F29 was 2.53 (sensitivity 59%, specificity 60%). For the primers 121-122, levels of observed agreement and kappa estimates were 52.6% and 0.10 (95% CI: -0.08, 0.28) for the first measurement, 62.4% and 0.09 (95% CI: -0.09, 0.28) for the second measurement, and 57.5% and 0.13 (95% CI: 0.01, 0.26) for the two measurements simultaneously evaluated. Conclusions: The results show poor agreement evidenced by kappa values determined in the study. It is necessary to refine the studies to evaluate the utility of molecular testing in the diagnosis of Chagas disease.[Gómez-Laitón ED, Polo-Ardila LA, Castellanos-DomÍnguez YZ, Herrera VM, Villar JC. Discriminatory power and concordance between ELISA-F29 and PCR in individuals with infection due to T.cruzi. MedUNAB 2015; 18 (1): 27-33]

Capacidad discriminatoria y concordancia entre el ELISA-F29 y la PCR en individuos con infección por T. cruzi

Introduction: The diagnosis of infection with Trypanosoma cruzi (T. cruzi) is routinely performed by serological tests while the use of molecular methods is still in process of standardization.  Objective: To evaluate the discriminatory capacity and agreement between a serological test and a polymerase chain reaction (PCR) to determine T. cruzi infection. Methodology: PCR and ELISA test-F29 were performed to 95 participants of “Cardiovascular health investigation and collaboration countries of America to assess the markers and outcomes of Chagas disease” (CHICAMOCHA). Discriminatory capacity of ELISA –F29 with respect to PCR results were evaluated by estimating the area of ROC curve.  The false positive rate was estimated to 25% and sensitivity to 75%. The agreement was determined using Cohen's kappa. Results: PCR tests were performed at two different times in 95 individuals (mean age: 38; 64% male), with positivity rates between 1.1 to 2.2% for S35-S36 primers and from 18.3% to 34, 7% for primers 121-122, respectively. ELISA-F29 discriminatory capacity regarding PCR was 0.62 (95% CI: 0.53, 0.70). The false positive rate was 56% (95% CI: 42; 70). The optimal cutoff for absorbance ratio of ELISA-F29 was 2.53 (sensitivity 59%, specificity 60%). For the primers 121-122, levels of observed agreement and kappa estimates were 52.6% and 0.10 (95% CI: -0.08, 0.28) for the first measurement, 62.4% and 0.09 (95% CI: -0.09, 0.28) for the second measurement, and 57.5% and 0.13 (95% CI: 0.01, 0.26) for the two measurements simultaneously evaluated. Conclusions: The results show poor agreement evidenced by kappa values determined in the study. It is necessary to refine the studies to evaluate the utility of molecular testing in the diagnosis of Chagas disease.[Gómez-Laitón ED, Polo-Ardila LA, Castellanos-Domínguez YZ, Herrera VM, Villar JC. Discriminatory power and concordance between ELISA-F29 and PCR in individuals with infection due to T.cruzi. MedUNAB 2015; 18 (1): 27-33].Introducción: El diagnóstico de la infección por Trypanosoma cruzi (T. cruzi) se realiza rutinariamente mediante pruebas serológicas mientras que el empleo de métodos moleculares se encuentra aún en proceso de estandarización. Objetivo: Evaluar la capacidad discriminatoria y concordancia entre una prueba serológica y una molecular para determinar la infección por T. cruzi. Métodos: Se realizó Reacción en Cadena de la Polimerasa (PCR) y la prueba de ELISA-F29 en 95 muestras de participantes de la cohorte “Cardiovascular health investigation and collaboration countries of America to assess the markers and outcomes of Chagas disease” CHICAMOCHA. Se evaluó la capacidad discriminatoria del ELISA-F29 respecto al resultado de PCR mediante la estimación del área bajo la curva ROC. Se estimó la tasa de falsos positivos al 25% y sensibilidad al 75%. Se determinó la concordancia mediante kappa de Cohen. Resultados: Se realizaron pruebas de PCR en dos momentos diferentes en 95 individuos (edad media: 38 años; 64% hombres), con tasas de positividad entre 1.1% – 2.2% para los primers S35-S36 y entre 18.3% – 34.7% para los primers 121-122, respectivamente. La capacidad discriminatoria del ELISAF29 respecto a PCR fue 0.62 (IC95%: 0.53; 0.70) y tasa de falsos positivos del 56% (IC95%: 42; 70). El punto de corte óptimo para el cociente de absorbancia fue 2.53 (sensibilidad 59% y especificidad 60%). Para el primer 121-122 los niveles de acuerdo observado y kappas estimados fueron: 52.6% y 0.10 (IC95%: -0.08, 0.28) para la primera medición, 62.4% y 0.09 (IC95%: -0.09, 0.28) para la segunda medición y 57.5% y 0.13 (IC95%: 0.01, 0.26) al evaluar simultáneamente las dos mediciones. Conclusiones: Los resultados demuestran una baja concordancia evidenciada por los valores de kappa determinados en el estudio. Es necesario afinar los estudios para evaluar la utilidad de las pruebas moleculares en el diagnóstico de la Enfermedad de Chagas. [Gómez-Laitón ED, Polo-Ardila LA, Castellanos-Domínguez YZ, Herrera VM, Villar JC. Capacidad discriminatoria y concordancia entre el ELISA-F29 y la PCR en individuos con infección por T. cruzi. MedUNAB 2015; 18 (1): 27-33]

¿Puede asociarse el sedentarismo con hallazgos clínicos de alarma de enfermedad crónica en adultos jóvenes? Un análisis en el proyecto CHICAMOCHA

Introduction: The association between Sedentary Lifestyle (SL) and Chronic Non-Communicable Diseases (NCD) takes decades of exposure.  It is possible to be seen at an early stage in young adults due to some clinical findings.  Objective: Test the hypothesis that a sedentary lifestyle in young adults is associated with some signs or symptoms of alarm for the further development of NCD. Methodology: Using the initial evaluation (years 2000-2003) of CHICAMOCHA project, it was found that 1539 blood donors were healthy with negative screening test results (mean age 36, SD 8.3 years, 66% male).  The association between sedentary lifestyle and a series of clinical findings was studied.  Sedentary Lifestyle was defined as moderate-intense physical activity of ≤150 minutes/week (including work).  The primary outcome was the composite of 11 findings (5 symptoms and 6 signs) found in the medical assessment. We computed multivariate logistic regression models for both individual and pooled outcomes. Results: SL was found in 56.9% (IC95% 54.3–59.3) participants. In multivariate analysis SL was positively associated with single marital status and negatively associated with being employed. There were no significant associations between SL and the composite of 5 symptoms (Covariate-adjusted pooled OR 1.07, 95%CI 0.90–1.26), or 6 signs (Covariate-adjusted pooled OR 1.01, 95%CI 0.79–1.28).  However, a positive non-significant gradient in association with the number of findings (Covariate-adjusted OR for any one clinical finding OR=0.91, 95%CI 0.61–1.35; any two findings OR=1.20, 95%CI 0.84 – 1.73, or 3 or more findings OR=1.31, 95%CI 0.91–1.89) was observed. Conclusions: It was found that more than half of the studied population presented a sedentary lifestyle.  Even though this factor was not associated with individual signs and symptoms, a non-significant gradient was found, possibly related to a short exposure that may explain these results. [Villar JC, Herrera VM, Moreno-Medina KJ, Castellanos-Domínguez YZ, Martínez LX, Cortés OL. Can Sedentarism be Associated with Alarm Clinical Findings of Chronic Diseases in Young Adults?.  An Analysis in CHICAMOCHA Project.  CHICAMOCHA. MedUNAB 2015; 18(1):42-50]Introducción: La asociación entre sedentarismo y enfermedades crónicas no transmisibles (ECNT) requiere décadas de exposición. Es posible que esta se manifieste más tempranamente, por algunos hallazgos clínicos en adultos jóvenes. Objetivo: Probar la hipótesis de que en adultos jóvenes el sedentarismo se asocia con algunos signos o síntomas de alarma para el desarrollo posterior de ECNT. Metodología: Usando la evaluación inicial (años 2000-2003) del proyecto CHICAMOCHA, en 1539 donantes de sangre clínicamente saludables con pruebas de tamización negativas (edad media 36, DE 8,3 años, 66% hombres) se estudió la asociación entre sedentarismo y una serie de hallazgos clínicos. Se definió sedentarismo como reportar actividad física moderada-intensa ≤150 minutos/semana (incluyendo el trabajo). El desenlace primario fue el compuesto de 11 hallazgos (5 síntomas y 6 signos) de alarma encontrados en la valoración médica. La asociación fue estimada usando un modelo regresión logística ajustado por covariables. Resultados: Se encontró que 56.9% (IC95% 54.3–59.3) de los participantes eran sedentarios. En el análisis multivariado, el sedentarismo se asoció positivamente con el estado civil soltero y negativamente con estar empleado. No se encontraron asociaciones significativas en el compuesto agregado de 5 síntomas (OR ajustado 1.07, IC95% 0.90– 1.26), 6 signos (OR ajustado 1.01, IC95% 0.79 – 1.28). Sin embargo, se observó un gradiente positivo no significativo por el número de hallazgos presentes (1 hallazgo OR=0.91, IC95% 0.61–1.35), 2 hallazgos (OR=1.20, IC95% 0.84–1.73), 3 o más hallazgos (OR=1.31, IC95% 0.91–1.89) . Conclusiones: Más de la mitad de la población estudiada se encontró sedentaria. Aunque este factor no se encontró asociado con signos o síntomas individualmente, se identificó un gradiente no significativo con el número de estos hallazgos, posiblemente relacionado con el tiempo de exposición relativamente breve. [Villar JC, Herrera VM, Moreno-Medina KJ, Castellanos-Domínguez YZ, Martínez LX, Cortés OL. ¿Puede asociarse el sedentarismo con hallazgos clínicos de alarma de enfermedad crónica en adultos jóvenes? Un análisis en el proyecto CHICAMOCHA. MedUNAB 2015; 18 (1): 42-50]&nbsp

Poderia associar-se o sedentarismo as conclusoes clínicas de alarme de doencas crónicas em adultos jovens? Análise no projeto CHICAMOCHA

Introducción: La asociación entre sedentarismo y enfermedades crónicas no transmisibles (ECNT) requiere décadas de exposición. Es posible que esta se manifieste más tempranamente, por algunos hallazgos clÍnicos en adultos jóvenes. Objetivo: Probar la hipótesis de que en adultos jóvenes el sedentarismo se asocia con algunos signos o sÍntomas de alarma para el desarrollo posterior de ECNT. MetodologÍa: Usando la evaluación inicial (años 2000-2003) del proyecto CHICAMOCHA, en 1539 donantes de sangre clÍnicamente saludables con pruebas de tamización negativas (edad media 36, DE 8,3 años, 66% hombres) se estudió la asociación entre sedentarismo y una serie de hallazgos clÍnicos. Se definió sedentarismo como reportar actividad fÍsica moderada-intensa ≤150 minutos/semana (incluyendo el trabajo). El desenlace primario fue el compuesto de 11 hallazgos (5 sÍntomas y 6 signos) de alarma encontrados en la valoración médica. La asociación fue estimada usando un modelo regresión logÍstica ajustado por covariables. Resultados: Se encontró que 56.9% (IC95% 54.3–59.3) de los participantes eran sedentarios. En el análisis multivariado, el sedentarismo se asoció positivamente con el estado civil soltero y negativamente con estar empleado. No se encontraron asociaciones significativas en el compuesto agregado de 5 sÍntomas (OR ajustado 1.07, IC95% 0.90– 1.26), 6 signos (OR ajustado 1.01, IC95% 0.79 – 1.28). Sin embargo, se observó un gradiente positivo no significativo por el número de hallazgos presentes (1 hallazgo OR=0.91, IC95% 0.61–1.35), 2 hallazgos (OR=1.20, IC95% 0.84–1.73), 3 o más hallazgos (OR=1.31, IC95% 0.91–1.89) . Conclusiones: Más de la mitad de la población estudiada se encontró sedentaria. Aunque este factor no se encontró asociado con signos o sÍntomas individualmente, se identificó un gradiente no significativo con el número de estos hallazgos, posiblemente relacionado con el tiempo de exposición relativamente breve. [Villar JC, Herrera VM, Moreno-Medina KJ, Castellanos-DomÍnguez YZ, MartÍnez LX, Cortés OL. ¿Puede asociarse el sedentarismo con hallazgos clÍnicos de alarma de enfermedad crónica en adultos jóvenes? Un análisis en el proyecto CHICAMOCHA. MedUNAB 2015; 18 (1): 42-50]Introduction: The association between Sedentary Lifestyle (SL) and Chronic Non-Communicable Diseases (NCD) takes decades of exposure. It is possible to be seen at an early stage in young adults due to some clinical findings. Objective: Test the hypothesis that a sedentary lifestyle in young adults is associated with some signs or symptoms of alarm for the further development of NCD. Methodology: Using the initial evaluation (years 2000-2003) of CHICAMOCHA project, it was found that 1539 blood donors were healthy with negative screening test results (mean age 36, SD 8.3 years, 66% male). The association between sedentary lifestyle and a series of clinical findings was studied. Sedentary Lifestyle was defined as moderate-intense physical activity of ≤150 minutes/week (including work). The primary outcome was the composite of 11 findings (5 symptoms and 6 signs) found in the medical assessment. We computed multivariate logistic regression models for both individual and pooled outcomes. Results: SL was found in 56.9% (IC95% 54.3–59.3) participants. In multivariate analysis SL was positively associated with single marital status and negatively associated with being employed. There were no significant associations between SL and the composite of 5 symptoms (Covariate-adjusted pooled OR 1.07, 95%CI 0.90–1.26), or 6 signs (Covariate-adjusted pooled OR 1.01, 95%CI 0.79–1.28). However, a positive non-significant gradient in association with the number of findings (Covariate-adjusted OR for any one clinical finding OR=0.91, 95%CI 0.61–1.35; any two findings OR=1.20, 95%CI 0.84 – 1.73, or 3 or more findings OR=1.31, 95%CI 0.91–1.89) was observed. Conclusions: It was found that more than half of the studied population presented a sedentary lifestyle. Even though this factor was not associated with individual signs and symptoms, a non-significant gradient was found, possibly related to a short exposure that may explain these results. [Villar JC, Herrera VM, Moreno-Medina KJ, Castellanos-DomÍnguez YZ, MartÍnez LX, Cortés OL. Can Sedentarism be Associated with Alarm Clinical Findings of Chronic Diseases in Young Adults?. An Analysis in CHICAMOCHA Project. CHICAMOCHA. MedUNAB 2015; 18(1):42-50]Introdução: Aassociação entre sedentarismo e doenças crônicas não transmissíveis (DCNT) requer décadas de exposição. É possível que esta se manifeste mais cedo, pelo que se tem observado clinicamente em alguns adultos jovens. Objetivo: Testar a hipótese de que um estilo de vida sedentário em adultos jovens está associada com alguns sinaisousinaisdealertaparaodesenvolvimentode doençasnãotransmissíveis.Metodologia:Usandoa avaliação inicial (2000-2003) do projeto CHICAMOCHA, em 1539 doadores de sangue clinicamente saudáveis com testes de rastreio negativos (idade média de 36 anos, 8.3 anos, 66% do sexo masculino), estudou-se a associação entre sedentarismo e uma série de achados clínicos. O sedentarismo foi definido como atividade física moderada-intensa≤150minutos/semana(incluindotrabalho).O desfecho primário foi o composto de 11 resultados (cinco sintomas e 6 sinais) de alarme encontrados na avaliação médica. Aassociação foi estimada utilizando um modelo de regressão logística ajustado para co-variáveis. Resultados:Verificou-seque56.9%(IC95%54.3-59.3)dos participantes eram sedentários. Na análise multivariada, o sedentarismo foi positivamente associado com o estado civil de solteiro e negativamente ao fato de estar empregado. Nãoforamencontradasassociaçõessignificativasno agregado composto por 5 sintomas (ORajustado 1,07, IC95% 0,90-1,26), 6 sinais (ORajustado 1.01, IC95% 0.79–1.28). No entanto, é observado, um gradiente positivo, nada significativo pela descoberta presente (1 resultado OR= 0.91, IC95% 0.61-1.35), 2 resultados (OR= 1.20, IC95% 0.84-1.73), 3 ou mais resultados (OR= 1.31, IC95% 0.91–1.89). Conclusões:Mais da metade da população do estudo foi encontrada sedentária. Embora este fator não foi encontradoassociadocomsinaisousintomas individualmente,foiidentificadoumgradientenão significativo com o número destes achados, possivelmente relacionada com o tempo de exposição relativamente curto. [Villar JC, Herrera VM, Moreno-Medina KJ, Castellanos-Domínguez YZ, Martínez-Contreras LX, Cortés OL. Poderia associar-seosedentarismoàsconclusõesclínicasde alarme de doenças crônicas em adultos jovens? Análise no projeto CHICAMOCHA. MedUNAB2015; 18 (1): 42-50

"Cardiovascular Health Investigation and Collaboration to Assess the Markers and Outcomes of Chagas disease" (CHICAMOCHA): Concepto, métodos y características de una cohorte de donantes de sangre en Bucaramanga, Colombia

Introduction: Geographical and socio-demographic conditions expose Colombian population to the threat of vector-borne diseases (such as Chagas’ [CHAD]) and cardiovascular disease of atherosclerotic origin (CVD). Objective: To assemble a cohort study of young adults, to promote understanding of CHAD and CVD in Bucaramanga, Colombia. Methodology: A study of blood donors with serological screening for T.cruzi was designed. A database of consecutive donors with positive results (T[+]) was built. This group was compared with a random sample of T[-] individuals (1:4 ratio, within strata of bank and month of donation). Participants classified by serology and electrocardiography status underwent clinical interviews (additional cardiovascular tests to T[+] and a random sample to T[-] were performed. In the following years, T[+] individuals participated in randomized trials whereas those whereas those T[-] participated in repeated measurements to test CVD risk factors. Results: From 6,228 donors in the database (18 to 50 years old) registered in the database (1997-2203), 2,130 blood donors (mean age 36.4 (SD 8.4) years, 64% males, 73.4% living in low socioeconomic strata, 486 T[+]) agreed to participate. Our contact protocol, and follow-up procedure with participants allowed us to obtain repeatedly measurements of at least 80% of the participants.  Conclusions: CHICAMOCHA represents a social asset that builds local research capacity. Continued efforts are required to enhance its potential for research training, scholarly work and health care guidance. [Villar JC, Herrera VM, Cháves-Neira AM, Martínez-Contreras LX, Villar-Centeno LA, Ardila E, Marcell-Vásquez S, Vásquez SM. “Cardiovascular Health Investigation and Collaboration to Assess the Markers and Outcomes of Chagas disease” (CHICAMOCHA): Concept, methods and characteristics of a cohort of blood donors in Bucaramanga, Colombia. MedUNAB 2015; 18 (1): 14-26]Introducción: Colombia está expuesta simultáneamente a las enfermedades transmitidas por vectores como la Enfermedad de Chagas (ECHA), así como a la carga creciente de la enfermedad cardiovascular de origen aterosclerótico (ECV). Objetivo: Estudiar a través del ensamblaje de un estudio de cohorte de adultos jóvenes de Bucaramanga, el desarrollo de la ECHA y la ECV. Metodología: Se diseñó un estudio a partir de donantes de sangre con tamización serológica para T. cruzi. Se construyó una base de datos de donantes consecutivos con estatus positivo (T[+]) apareada (en relación 1:4, estratificada por banco y mes de donación) con donantes T[-]. Los participantes fueron clasificados por estado serológico y electrocardiograma y evaluados clínicamente (realizando pruebas adicionales de función cardiovascular a los T[+] y a una muestra aleatoria de T[-]). En los siguientes años se iniciaron ensayos clínicos en los participantes T[+] y mediciones repetidas en los T[-] para estudios de riesgo de ECV. Resultados: De 6,228 donantes (18 a 50 años de edad) registrados en la base (1997-2003), 2,130 donantes de sangre (edad media 36.4 [DE 8.4] años, 64.0% hombres, 73.4% residentes en los estratos 1-3, 486 T[+]) consintieron participar. El protocolo de contacto, seguimiento y recuperación de participantes ha logrado que se obtengan mediciones repetidas en al menos el 80% de los participantes. Conclusiones: CHICAMOCHA constituye un activo de valor social que aumenta las capacidades locales de investigación. Se requieren esfuerzos continuados para ensanchar sus posibilidades de formación de investigadores, g e n e r a c i ó n d e p r o d u c t o s d e c o n o c i m i e n t o y recomendaciones para el sistema de salud.[Villar JC, Herrera VM, Cháves-Neira AM, Martínez-Contreras LX, Villar-Centeno LA, Ardila E, Marcell-Vásquez S, Vásquez SM. “Cardiovascular Health Investigation and Collaboration to Assess the Markers and Outcomes of Chagas disease” (CHICAMOCHA): Concepto, métodos y características de una cohorte de donantes de sangre en Bucaramanga, Colombia. MedUNAB 2015; 18 (1): 14-26]&nbsp

“Pesquisa de sáudes cardiovascular e colaborcao para evaliar os marcadores e os resultados da foeca da Chagas”: coceito, metordos e características de grupo de doadores de sagre em Bucaramanga, Colombia

Colombia está expuesta simultáneamente a las enfermedades transmitidas por vectores como la Enfermedad de Chagas (ECHA), asÍ como a la carga creciente de la enfermedad cardiovascular de origen aterosclerótico (ECV). Objetivo: Estudiar a través del ensamblaje de un estudio de cohorte de adultos jóvenes de Bucaramanga, el desarrollo de la ECHA y la ECV. MetodologÍa: Se diseñó un estudio a partir de donantes de sangre con tamización serológica para T. cruzi. Se construyó una base de datos de donantes consecutivos con estatus positivo (T[+]) apareada (en relación 1:4, estratificada por banco y mes de donación) con donantes T[-]. Los participantes fueron clasificados por estado serológico y electrocardiograma y evaluados clÍnicamente (realizando pruebas adicionales de función cardiovascular a los T[+] y a una muestra aleatoria de T[-]). En los siguientes años se iniciaron ensayos clÍnicos en los participantes T[+] y mediciones repetidas en los T[-] para estudios de riesgo de ECV. Resultados: De 6,228 donantes (18 a 50 años de edad) registrados en la base (1997-2003), 2,130 donantes de sangre (edad media 36.4 [DE 8.4] años, 64.0% hombres, 73.4% residentes en los estratos 1-3, 486 T[+]) consintieron participar. El protocolo de contacto, seguimiento y recuperación de participantes ha logrado que se obtengan mediciones repetidas en al menos el 80% de los participantes. Conclusiones: CHICAMOCHA constituye un activo de valor social que aumenta las capacidades locales de investigación. Se requieren esfuerzos continuados para ensanchar sus posibilidades de formación de investigadores, g e n e r a c i ó n d e p r o d u c t o s d e c o n o c i m i e n t o y recomendaciones para el sistema de salud.[Villar JC, Herrera VM, Cháves-Neira AM, MartÍnez-Contreras LX, Villar-Centeno LA, Ardila E, Marcell-Vásquez S, Vásquez SM. "Cardiovascular Health Investigation and Collaboration to Assess the Markers and Outcomes of Chagas disease " (CHICAMOCHA): Concepto, métodos y caracterÍsticas de una cohorte de donantes de sangre en Bucaramanga, Colombia. MedUNAB 2015; 18 (1): 14-26]Geographical and socio-demographic conditions expose Colombian population to the threat of vector-borne diseases (such as Chagas’ [CHAD]) and cardiovascular disease of atherosclerotic origin (CVD). Objective: To assemble a cohort study of young adults, to promote understanding of CHAD and CVD in Bucaramanga, Colombia. Methodology: A study of blood donors with serological screening for T.cruzi was designed. A database of consecutive donors with positive results (T[+]) was built. This group was compared with a random sample of T[-] individuals (1:4 ratio, within strata of bank and month of donation). Participants classified by serology and electrocardiography status underwent clinical interviews (additional cardiovascular tests to T[+] and a random sample to T[-] were performed. In the following years, T[+] individuals participated in randomized trials whereas those whereas those T[-] participated in repeated measurements to test CVD risk factors. Results: From 6,228 donors in the database (18 to 50 years old) registered in the database (1997-2203), 2,130 blood donors (mean age 36.4 (SD 8.4) years, 64% males, 73.4% living in low socioeconomic strata, 486 T[+]) agreed to participate. Our contact protocol, and follow-up procedure with participants allowed us to obtain repeatedly measurements of at least 80% of the participants. Conclusions: CHICAMOCHA represents a social asset that builds local research capacity. Continued efforts are required to enhance its potential for research training, scholarly work and health care guidance. [Villar JC, Herrera VM, Cháves-Neira AM, MartÍnez-Contreras LX, Villar-Centeno LA, Ardila E, Marcell-Vásquez S, Vásquez SM. "Cardiovascular Health Investigation and Collaboration to Assess the Markers and Outcomes of Chagas disease " (CHICAMOCHA): Concept, methods and characteristics of a cohort of blood donors in Bucaramanga, Colombia. MedUNAB 2015; 18 (1): 14-26

Study protocol for the multicentre cohorts of Zika virus infection in pregnant women, infants, and acute clinical cases in Latin America and the Caribbean: The ZIKAlliance consortium

Background: The European Commission (EC) Horizon 2020 (H2020)-funded ZIKAlliance Consortium designed a multicentre study including pregnant women (PW), children (CH) and natural history (NH) cohorts. Clinical sites were selected over a wide geographic range within Latin America and the Caribbean, taking into account the dynamic course of the ZIKV epidemic. Methods: Recruitment to the PW cohort will take place in antenatal care clinics. PW will be enrolled regardless of symptoms and followed over the course of pregnancy, approximately every 4 weeks. PW will be revisited at delivery (or after miscarriage/abortion) to assess birth outcomes, including microcephaly and other congenital abnormalities according to the evolving definition of congenital Zika syndrome (CZS). After birth, children will be followed for 2 years in the CH cohort. Follow-up visits are scheduled at ages 1-3, 4-6, 12, and 24 months to assess neurocognitive and developmental milestones. In addition, a NH cohort for the characterization of symptomatic rash/fever illness was designed, including follow-up to capture persisting health problems. Blood, urine, and other biological materials will be collected, and tested for ZIKV and other relevant arboviral diseases (dengue, chikungunya, yellow fever) using RT-PCR or serological methods. A virtual, decentralized biobank will be created. Reciprocal clinical monitoring has been established between partner sites. Substudies of ZIKV seroprevalence, transmissio

¿Puede considerarse portadores asintomáticos a los donantes de sangre seropositivos para Trypanosoma cruzi?. Un estudio de validación en el proyecto CHICAMOCHA / Can Seropositive Blood Donors be Considered Asymptomatic Carriers for Trypanosoma cruzi?. A Validation Study in CHICAMOCHA Project / Poderiam ser considerados portadores assintomáticos os doadores de sangue Soropositivos para Trypanosoma cruzi? Um estudo de validação no projeto CHICAMOCHA

Introducción: Identificar el deterioro clínico de individuos seropositivos para la enfermedad de Chagas requiere observar la evolución de personas con infección establecida por Trypanosoma cruzi (T.cruzi), libres de signos y síntomas de cardiomiopatía en una línea de base. Objetivo: Realizar una comparación entre donantes de bancos de sangre de Bucaramanga con serología positiva y negativa para T. cruzi. Metodología: La muestra consistió en donantes elegibles con pruebas de tamización positivas para T. cruzi, pero negativas para otros agentes infecciosos tamizados por los bancos de sangre. Estos registros fueron apareados con una muestra aleatoria 1:4 de donantes con pruebas negativas a todas las pruebas de tamización. Los participantes fueron entrevistados para conocer aspectos sociodemográficos y de percepción de su estado de salud, se realizó examen físico y se tomaron muestras de sangre para exámenes paraclínicos. Se reportaron las frecuencias y proporciones de los participantes. Se hicieron pruebas de hipótesis de no diferencias entre los dos grupos con la prueba Chi cuadrado, con un nivel alfa de significancia de 5%. Resultados: La muestra consistió en 2,132 donantes de sangre incluidos entre mayo de 2000 y marzo de 2004. Mediante prueba serológica se identificaron 488 (22.9%) seropositivos y 1644 (77.1%) seronegativos. Los seropositivos fueron mayores en edad, presentaron indicadores socioeconómicos menos favorables y menor afiliación a seguridad social con el régimen contributivo y tenían una mejor percepción de su salud en comparación con los seronegativos (p<0.05). No se observaron diferencias estadísticamente significativas en cuanto a la percepción del funcionamiento de los tres sistemas evaluados (cardiovascular, urinario y gastrointestinal) en ambos grupos. Conclusiones: Los hallazgos del estudio permiten inferir que los donantes de sangre seropositivos para T. cruzi podrían considerarse como portadores asintomáticos, sin evidencia clínica de cardiomiopatía. [VillarJC, Herrera VM, Vega A, Moso F. ¿Puede considerarse portadores asintomáticos a los donantes de sangre seropositivos para Trypanosoma cruzi? Un estudio de validación en el proyecto CHICAMOCHA. MedUNAB 2015; 18 (1): 34-41] Introduction: In order to identify the clinical deterioration of seropositive individuals for Chagas disease, it is necessary to observe the evolution of people infected by Trypanosoma cruzi (T. cruzi), who do not show signs and symptoms of cardiomyopathy on a baseline. Objective: To compare blood donors with positive and negative serology for Trypanosoma cruzi in the city of Bucaramanga. Methodology: The sample consisted of eligible donors with positive screening tests for T. cruzi, but negative for other infectious agents screened by blood banks. These records were matched with a random sample 1: 4 donors who showed negative results to all the screening tests. Participants were interviewed to know their socio-demographic aspects and to get a perception of their health status. Physical exams were performed and blood samples were taken for laboratory tests. Frequencies and proportions of participants were reported. Hypothesis testing of no differences between the two groups using the Chi square test was performed, showing a 5% level of alpha significance. Resultados: The sample included 2132 blood donors between May 2000 and March 2004. By using serological tests, it was identified that 488 (22.9%) were seropositive and 1644 (77.1%) were seronegative. Seropositive donors were older people who belonged to a low socio-economic level and had no health insurance. They also had a better perception of their health compared to seronegative donors (p <0.05). The perception of how the three evaluated systems worked (cardiovascular, urinary and gastrointestinal) showed no statistically significant differences between the two groups. Conclusions: The study findings allow us to infer that seropositive blood donors for T. cruzi could be considered as asymptomatic carriers without clinical evidence of cardiomyopathy. [Villar-Centeno JC, Herrera, Vega A, Moso F. ¿XXXXXXX. MedUNAB 2015; 18 (1): 34-41] Introdução: Para identificar o deterioro clínico dos indivíduos soropositivos para a doença de Chagas é necessário acompanhar a evolução de indivíduos com infecção estabelecida pelo Trypanosoma cruzi (T. cruzi), livres de sinais e sintomas de cardiomiopatia numa linha de base. Objetivo: Fazer uma comparação entre os doadores dos bancos de sangue de Bucaramanga com sorologia positiva e negativa para T. cruzi. Metodologia: A amostra consistiu de doadores elegíveis com rastreamento positivo para T. cruzi, porém negativo para outros agentes infecciosos selecionados pelos bancos de sangue. Esses registros foram emparelhados com uma amostra aleatória de 1: 4 com testes negativos a todos os testes da triagem de doadores. Os participantes foram entrevistados para se conhecer aspectos sociodemográficos e perceber seus aspectos de saúde, foi realizado um exame físico e foram coletadas amostras de sangue para exames de laboratório. Relataram-se as frequências e proporções de participantes. Foi feito um teste de hipóteses de não diferenças entre os dois grupos com o teste do chi-quadrado, com um nível alfa de significância de 5%. Resultados: A mostra consistiu em 2132 doadores de sangue incluídos entre maio de 2000 e março de 2004. Pela prova sorológica identificaram-se 488 (22.9%) soropositivos y 1644 (77.1%) soronegativos. Os Soropositivos foram maiores de 18 anos, tinham indicadores socioeconômicos menos favoráveis, menor inscrição no seguro social com o regime contributivo e melhor percepção da sua saúde em relação aos soronegativos (p <0,05). Estatisticamente não se observaram diferenças significativas quanto à percepção do funcionamento dos três sistemas avaliados (cardiovascular, gastrointestinal e urinário) em ambos os grupos. Conclusões: resultados do estudo permitem concluir que os doadores soropositivos para T. cruzi no sangue poderiam ser vistos como portadores assintomáticos, sem evidência clínica de cardiomiopatia. [Villar JC, Herrera VM, Vega A, Moso F. Poderiam ser considerados portadores assintomáticos os doadores de sangue Soropositivos para Trypanosoma cruzi? Um estudo de validação no projeto CHICAMOCHA. MedUNAB 2015; 18 (1): 34-41

Study protocol for the multicentre cohorts of Zika virus infection in pregnant women, infants, and acute clinical cases in Latin America and the Caribbean: the ZIKAlliance consortium

Background: The European Commission (EC) Horizon 2020 (H2020)-funded ZIKAlliance Consortium designed a multicentre study including pregnant women (PW), children (CH) and natural history (NH) cohorts. Clinical sites were selected over a wide geographic range within Latin America and the Caribbean, taking into account the dynamic course of the ZIKV epidemic. Methods: Recruitment to the PW cohort will take place in antenatal care clinics. PW will be enrolled regardless of symptoms and followed over the course of pregnancy, approximately every 4 weeks. PW will be revisited at delivery (or after miscarriage/abortion) to assess birth outcomes, including microcephaly and other congenital abnormalities according to the evolving definition of congenital Zika syndrome (CZS). After birth, children will be followed for 2 years in the CH cohort. Follow-up visits are scheduled at ages 1-3, 4-6, 12, and 24 months to assess neurocognitive and developmental milestones. In addition, a NH cohort for the characterization of symptomatic rash/fever illness was designed, including follow-up to capture persisting health problems. Blood, urine, and other biological materials will be collected, and tested for ZIKV and other relevant arboviral diseases (dengue, chikungunya, yellow fever) using RT-PCR or serological methods. A virtual, decentralized biobank will be created. Reciprocal clinical monitoring has been established between partner sites. Substudies of ZIKV seroprevalence, transmission clustering, disabilities and health economics, viral kinetics, the potential role of antibody enhancement, and co-infections will be linked to the cohort studies. Discussion: Results of these large cohort studies will provide better risk estimates for birth defects and other developmental abnormalities associated with ZIKV infection including possible co-factors for the variability of risk estimates between other countries and regions. Additional outcomes include incidence and transmission estimates of ZIKV during and after pregnancy, characterization of short and long-term clinical course following infection and viral kinetics of ZIKV

Guidelines for the use and interpretation of assays for monitoring autophagy (4th edition)

In 2008, we published the first set of guidelines for standardizing research in autophagy. Since then, this topic has received increasing attention, and many scientists have entered the field. Our knowledge base and relevant new technologies have also been expanding. Thus, it is important to formulate on a regular basis updated guidelines for monitoring autophagy in different organisms. Despite numerous reviews, there continues to be confusion regarding acceptable methods to evaluate autophagy, especially in multicellular eukaryotes. Here, we present a set of guidelines for investigators to select and interpret methods to examine autophagy and related processes, and for reviewers to provide realistic and reasonable critiques of reports that are focused on these processes. These guidelines are not meant to be a dogmatic set of rules, because the appropriateness of any assay largely depends on the question being asked and the system being used. Moreover, no individual assay is perfect for every situation, calling for the use of multiple techniques to properly monitor autophagy in each experimental setting. Finally, several core components of the autophagy machinery have been implicated in distinct autophagic processes (canonical and noncanonical autophagy), implying that genetic approaches to block autophagy should rely on targeting two or more autophagy-related genes that ideally participate in distinct steps of the pathway. Along similar lines, because multiple proteins involved in autophagy also regulate other cellular pathways including apoptosis, not all of them can be used as a specific marker for bona fide autophagic responses. Here, we critically discuss current methods of assessing autophagy and the information they can, or cannot, provide. Our ultimate goal is to encourage intellectual and technical innovation in the field