Logistica de coleta e transporte de material biologico e organizacao do laboratorio central no ELSA-Brasil

Abstract

The ELSA (Estudo Longitudinal de Saúde do Adulto -Brazilian Longitudinal Study for Adult Health) is a multicenter cohort study which aims at the identifi cation of risk factors associated with type 2 diabetes and cardiovascular diseases in the Brazilian population. The paper describes the strategies for the collection, processing, transportation, and quality control of blood and urine tests in the ELSA. The study decided to centralize the tests at one single laboratory. The processing of the samples was performed at the local laboratories, reducing the weight of the material to be transported, and diminishing the costs of transportation to the central laboratory at the Universidade de São Paulo Hospital. The study included tests for the evaluation of diabetes, insulin resistance, dyslipidemia, electrolyte abnormalities, thyroid hormones, uric acid, hepatic enzyme abnormalities, infl ammation, and total blood cell count. In addition, leukocyte DNA, urine, plasma and serum samples were stored. The central laboratory performed approximately 375,000 tests.

Relationship between heart rate variability and subclinical thyroid disorders of the Brazilian Longitudinal Study of Adult Health (ELSA-Brasil)

“…The ELSA-Brasil protocol, fully published elsewhere (16–19), included 15,105 civil servants, aged 35–74 years from six institutions of six Brazilian cities. The study aimed to determine the incidence of cardiovascular diseases and diabetes and their associated risk factors.…”

Construcao do Estudo Longitudinal de Saude do Adulto (ELSA-Brasil)

“…The project's structure comprises six study sites, fi ve reading centers, 6 a central laboratory, 13 a biobank 17 and a data center. 12 The project is managed collectively and its governing body is the Research Steering Committee aided by assisting committees and an External Advisory Committee.…”

“…All six sites have conducted subject recruitment, 2 interviews, 10 medical assessments, 6,15 and biological sample collection, analysis, storage and transport. 13,17 They also follow up subjects according to the guidelines set forth by the Clinical Outcome Committee (COC). 5 The reading centers are run at specifi c sites (Rio Grande do Sul, São Paulo, Minas Gerais and Espírito Santo) with local technical and staff capabilities.…”

“…5 The reading centers are run at specifi c sites (Rio Grande do Sul, São Paulo, Minas Gerais and Espírito Santo) with local technical and staff capabilities. The central laboratory 13 and biobank 17 are hosted at the São Paulo site and the Data Center at the Rio Grande do Sul site. 12 The study sites developed standard procedures for performing complex assessment as well as provided training and certifi cation of their staff in testing and result reading.…”

“…It also established storage procedures to ensure quality of frozen samples including training of technical staff in result monitoring. 13,17 The Quality Assurance and Quality Control Committee established quality assurance and control procedures and encouraged with the support of site supervisors reliability and validity studies of variables being investigated. 20 The Ethics, Recruitment and Social Communication Committee set out guidelines for subject contact, communication with institutional review committees, and data confi dentiality in occupational cohorts to guarantee subjects' rights and data reliability.…”