Hepatitis B Virus Infection among People Who Use Illicit Drugs: Prevalence, Genotypes and Risk Factors in the State of Amapá, Northern Brazil.

Background: Several records of high prevalence of HBV have been made in northern Brazil. Among risk groups for viral infection, people who use illicit drugs (PWUDs) stand out, especially if they inject drugs and engage in risky sexual behavior. Objectives: In this study, the prevalence, genotype distribution and factors associated with hepatitis B virus (HBV) exposure in PWUDs were estimated. Methods: This cross-sectional study used snowball sampling from nine different sites. Socio-demographic, economic, drug use and health-related information were collected of 308 PWUDs from nine municipalities in the state of Amapá, northern Brazil. Blood samples were tested for the presence of HBV using enzyme-linked immunosorbent assay (ELISA) and real-time polymerase chain reaction (PCR). Logistic regressions were run to identify factors independently associated with HBV exposure. Results: In total, seventy (22.7%) PWUDs were exposed to HBV, and 12 (3.9%) had DNA HBV. Genotypes A (58.4%), D (33.3%) and F (8.3%) were identified. Age ≥35 years, use of injectable drug, daily use of drugs, use of drugs over 12 years, unprotected sex, exchange sex for money/drugs, and >12 sexual partners in the last 12 months were associated with exposure to HBV. Conclusions: This study identified important information on the epidemiological scenario of HBV infection in PWUDs, highlighting the high prevalence of HBV exposure and the urgent need for measures for control and prevention, especially vaccination against this hepatotropic virus.

Nonconformities in clinical laboratories in Macapá, Amapá, Brazil, based on the RDC no. 302/2005/Anvisa / Não conformidades em laboratórios clínicos de Macapá, Amapá, Brasil, com base na RDC nº 302/2005/Anvisa

ABSTRACT Introduction: Clinical analysis laboratories are health care facilities that provide resources for outpatient and/or emergency diagnoses; they are regulated in Brazil by the Resolution of the Collegiate Board of Directors (RDC) no. 302, of October 13, 2005, of the Brazilian National Agency of Sanitary Surveillance (Anvisa). Objective: The aim of this study was to perform a normative evaluation in clinical analysis laboratories, based on RDC no. 302, of October 13, 2005. Material and method: This is a cross-sectional and descriptive study. Twelve clinical laboratories participated in the study. The data were obtained through a structured questionnaire and answered by the technical leaders of the participating laboratories, in the municipality of Macapá, Amapá, Brazil. Results: The average nonconformity found among the participants was 9.64%, which allowed an overall evaluation among them as satisfactory, in relation to the minimum requirements demanded by the standardization recommended by Anvisa. When the participants were analyzed individually, there was a variation from 4.82% to 21.69% of the nonconformities index. Other studies agree with the results, however there is disagreement in a research carried out in Porto Alegre, Rio Grande do Sul, Brazil, possibly due to the fact that the laboratories present in this study do not have a quality management system in their processes. Conclusion: Laboratories 2, 3, 4, 6, 9, 11, and 12 were rated as satisfactory. Laboratories 1, 5, 7, 8 and 10 were rated as partially satisfactory. No laboratories were rated as unsatisfactory.

RESUMEN Introducción: Los laboratorios clínicos son establecimientos de salud que ofrecen recursos para diagnósticos ambulatorios y/o de emergencia; son regulados en Brasil por la resolución del Directorio Colegiado (RDC) nº 302, de 13 de octubre de 2005, de la Agencia Nacional de Vigilancia Sanitaria (Anvisa). Objetivo: Este trabajo tuvo como objetivo efectuar una evaluación normativa en laboratorios clínicos, teniendo como base la RDC nº 302, de 13 de octubre de 2005. Material y método: Estudio transversal y descriptivo, con la participación de 12 laboratorios clínicos. Los datos se obtuvieron mediante cuestionario estructurado contestado por los responsables técnicos de los laboratorios participantes, en el municipio de Macapá, Amapá, Brasil. Resultados: La media de no conformidades entre los participantes fue de 9,64%, lo que permitió una evaluación general entre ellos como satisfactorios, con respecto a los requisitos mínimos exigidos por la Anvisa. Cuando los participantes fueron evaluados individualmente, hubo variación de 4,82% hasta 21,69% en el índice de no conformidades. Otros estudios presentaron resultados concordantes; sin embargo, hay desacuerdo en una investigación realizada en Porto Alegre, Rio Grande do Sul, Brasil, posiblemente porque los laboratorios participantes en ese estudio no tienen un sistema de gestión de calidad en sus procesos. Conclusión: Los laboratorios 2, 3, 4, 6, 9, 11 y 12 fueron evaluados como satisfactorios; los laboratorios 1, 5, 7, 8 y 10, como parcialmente satisfactorios. Ningún laboratorio fue evaluado como insatisfactorio.

RESUMO Introdução: Os laboratórios de análises clínicas são estabelecimentos de saúde que oferecem recursos aos diagnósticos ambulatoriais e/ou emergenciais; são regulamentados no Brasil pela Resolução da Diretoria Colegiada (RDC) nº 302, de 13 de outubro de 2005, da Agência Nacional de Vigilância Sanitária (Anvisa). Objetivo: Este trabalho teve como objetivo realizar uma avaliação normativa em laboratórios de análises clínicas, tendo como base a RDC nº 302, de 13 de outubro de 2005. Material e método: Estudo transversal e descritivo, com a participação de 12 laboratórios clínicos. Os dados foram obtidos por meio de questionário estruturado respondido pelos responsáveis técnicos dos laboratórios participantes, no município de Macapá, Amapá, Brasil. Resultados: A média de não conformidade encontrada entre os participantes foi de 9,64%, o que permitiu uma avaliação geral entre eles como satisfatórios, em relação aos requisitos mínimos exigidos pela normatização preconizada pela Anvisa. Quando os participantes foram avaliados individualmente, houve variação de 4,82% a 21,69% no índice de não conformidades. Outros estudos apresentam resultados concordantes; contudo, há discordância em uma pesquisa realizada em Porto Alegre, Rio Grande do Sul, Brasil, possivelmente pelo fato de os laboratórios presentes neste estudo não terem um sistema de gestão de qualidade nos seus processos. Conclusão: Os laboratórios 2, 3, 4, 6, 9, 11 e 12 foram avaliados como satisfatórios; os laboratórios 1, 5, 7, 8 e 10, como parcialmente satisfatórios. Nenhum laboratório foi avaliado como insatisfatório.

X-linked insertion/deletion polymorphisms: forensic applications of a 33-markers panel.

Insertion/deletion (INDEL) polymorphisms are diallelic markers with potential characteristics for use in forensics and biological anthropology, including: the simplicity of laboratory analysis, the possibility of genotyping many markers in a single PCR multiplex reaction, as well as analyzing markers with special inheritance types, such as those linked to the X chromosome (X-INDEL). In this work we developed a laboratory analysis methodology using a 33-INDEL marker panel for the X chromosome in a single PCR multiplex reaction, followed by a capillary electrophoresis run. We employed the panel to genotype a sample of 351 individuals of a mixed population from the Brazilian Amazon. The results demonstrate that the measurement of biostatistical parameters for forensic use in this population is compatible with prior estimates from other populations using current X-STR panels.