Logistics of collection and transportation of biological samples and the organization of the central laboratory in the ELSA-Brasil

The ELSA (Estudo Longitudinal de Saúde do Adulto - Brazilian Longitudinal Study for Adult Health) is a multicenter cohort study which aims at the identification 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, inflammation, and total blood cell count. In addition, leukocyte DNA, urine, plasma and serum samples were stored. The central laboratory performed approximately 375,000 tests.

Clinical Laboratory Information Systems; Diagnostic Techniques and Procedures; Logistics; Hematologic Tests; Urinalysis; Multicenter Studies as Topic, methods; Cohort Studies

The authors declare that there are no confl icts of interest.

This manuscript was \submitted for publication and underwent a peer review process as any other manuscripts submitted to this publication, and anonymity was guaranteed for authors and reviewers. Editors and reviewers declare no confl icts of interest that may affect the peer-review process.

SCIMAGO INSTITUTIONS RANKINGS

Universidade de São Paulo, Hospital Universitário, Laboratório Clínico, São Paulo, SP, BrasilUniversidade de São PauloBrasilSão Paulo, SP, BrasilUniversidade de São Paulo, Hospital Universitário, Laboratório Clínico, São Paulo, SP, Brasil

Universidade Federal de Minas Gerais, Faculdade de Medicina, Departamento de Propedêutica Complementar, Belo Horizonte, MG, BrasilUniversidade Federal de Minas GeraisBrasilBelo Horizonte, MG, BrasilUniversidade Federal de Minas Gerais, Faculdade de Medicina, Departamento de Propedêutica Complementar, Belo Horizonte, MG, Brasil

Universidade Federal do Espírito Santo, Centro de Ciências da Saúde, Departamento de Ciências Fisiológicas, Vitória, ES, BrasilUniversidade Federal do Espírito SantoBrasilVitória, ES, BrasilUniversidade Federal do Espírito Santo, Centro de Ciências da Saúde, Departamento de Ciências Fisiológicas, Vitória, ES, Brasil

Universidade Federal do Rio Grande do Sul, Departamento de Medicina Social, Programa de Pós-Graduação em Epidemiologia, Porto Alegre, RS, BrasilUniversidade Federal do Rio Grande do SulBrasilPorto Alegre, RS, BrasilUniversidade Federal do Rio Grande do Sul, Departamento de Medicina Social, Programa de Pós-Graduação em Epidemiologia, Porto Alegre, RS, Brasil

Universidade Federal da Bahia, Instituto de Ciências da Saúde, Salvador, BA, BrasilUniversidade Federal da BahiaBrasilSalvador, BA, BrasilUniversidade Federal da Bahia, Instituto de Ciências da Saúde, Salvador, BA, Brasil

Fundação Oswaldo Cruz, Escola Nacional de Saúde Pública, Departamento de Epidemiologia e Métodos Quantitativos em Saúde, Rio de Janeiro, RJ, BrasilFundação Oswaldo CruzBrasilRio de Janeiro, RJ, BrasilFundação Oswaldo Cruz, Escola Nacional de Saúde Pública, Departamento de Epidemiologia e Métodos Quantitativos em Saúde, Rio de Janeiro, RJ, Brasil

Universidade do Estado de São Paulo, Faculdade de Medicina, Instituto do Coração, Laboratório de Genética e Cardiologia Molecular, São Paulo, SP, BrasilUniversidade do Estado de São PauloBrasilSão Paulo, SP, BrasilUniversidade do Estado de São Paulo, Faculdade de Medicina, Instituto do Coração, Laboratório de Genética e Cardiologia Molecular, São Paulo, SP, Brasil

Universidade de São Paulo, Hospital Universitário, Centro de Pesquisa Clínica e Epidemiológica, São Paulo, SP, BrasilUniversidade de São PauloBrasilSão Paulo, SP, BrasilUniversidade de São Paulo, Hospital Universitário, Centro de Pesquisa Clínica e Epidemiológica, São Paulo, SP, Brasil

Tables

Tables (2)

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Table 1
Fasting collection and collection after ingestion of a glucose solution or food load.

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Table 2
Types of performed tests, their purpose, utilized methodology and reference values.

Table 1 Fasting collection and collection after ingestion of a glucose solution or food load.

1 ^stcollection after 12-hour fasting	03 tubes (8.5 mL) with clot activator gel; 03 EDTA tubes (4 mL); 01 fluoride/oxalate tube (2 mL); 02 tubes (4,5 mL) containing citrate as anticoagulant; and 01 tube (4 mL) with heparin.
Fasting tests	Blood glucose, glycated hemoglobin (HbA1c), creatinine, sodium, potassium, uric acid, aspartate transaminase (AST), alanine transaminase (ALT), gamma-glutamyl transferase (γ GT), total cholesterol, HDL cholesterol, LDL cholesterol, triglycerides, TSH, insulin and free T4 only for the individuals who presented altered TSH, ultrasensitive C-reactive protein, and Serology for Chagas Disease.
Post-collection procedure	Non-diabetics: ingestion of a glucose solution to be submitted to the oral glucose tolerance test; Diabetics: food load composed of four toasts, four cheese cubes.
2 ^ndcollection 120 min after the beginning of the ingestion of the glucose solution for the non-diabetics and of the food load for the diabetics	Second collection two hours after the end of the ingestion of the glucose solution or food load in which the following tubes were collected through venipuncture with vacuum scalp: 01 tube (8,5 mL) with clot activator gel; 01 tube (4mL) with heparin; 01 fluoride/oxalate tube (2 mL).
Post-collection procedure	Snack

Table 2 Types of performed tests, their purpose, utilized methodology and reference values.

Test	Objective	Method	Equipment	Reference value

Blood glucose	Determination of diabetes	Hexokinase method (enzymatic) ²⁵	ADVIA 1200 Siemens®	Fasting: 70 to 99 mg/dL 120 minutes after ingestion of glucose solution:
				< 140 mg/dL: normal tolerance to glucose 140 to 199 mg/dL: glucose intolerance
				≥ 200 mg/dL: diabetes
Total cholesterol	Lipid metabolism	Cholesterol oxidase method (enzymatic colorimetric) ¹	ADVIA 1200 Siemens®	Desirable: < 200 mg/dL Borderline: 200-239 mg/dL High: > 240 mg/dL
HDL-cholesterol	Lipid metabolism	Homogeneous, colorimetric, without precipitation ³⁴	ADVIA 1200 Siemens®	Desirable values: Non-diabetics:> 40 mg/dL diabetics: > 45 mg/dL
Triglycerides	Lipid metabolism	Glycerol-phosphate peroxidase method according to Trinder (enzymatic colorimetric) ¹⁷	ADVIA 1200 Siemens®	< 150 mg/dl
LDL-cholesterol Used when triglycerides ≤ 400 mg/dl.	Lipid metabolism	Friedewald Equation		Desirable for:
				High risk patients: < 100 mg/dL
				Medium risk patients: <130 mg/dL
				Low risk patients: < 160 mg/dL
LDL-cholesterol Used when triglycerides > 400 mg/dl	Lipid metabolism	Homogeneous, enzymatic, colorimetric method without precipitation ²⁶	ADVIA 1200 Siemens®	Desirable for:
				High risk individuals: < 100 mg/dL Medium risk individuals:
				<130 mg/dL Low risk individuals:
				< 160 mg/dL
Creatinine	Renal function	Jaffe’s Method ²²	ADVIA 1200 Siemens®	Serum: 0.4 to 1.3 mg/dL 12-hour urine: not established
Uric acid	Purine metabolism marker	Uricase method (enzymatic colorimetric) ¹⁶	ADVIA 1200 Siemens®	Men: 3.5 to 7.2 mg/dL
				Women: 2.6 to 6.0 mg/dL
Aspartate aminotransferase	Identifier for hepatic steatosis	Modified IFCC (enzymatic) ²⁹	ADVIA 1200 Siemens®	Men: 10 to 35 U/L
				Women: 10 to 31 U/L
Alanine	Identificador para esteatose hepática	Modified IFCC (enzymatic) ²⁸	ADVIA 1200 Siemens®	Men: 9 to 43 U/L
				Women: 9 to 36 U/L
γ-glutamyl-transferase	Identifier for hepatic and alcoholic steatosis	Szasz Persijn (kinetic colorimetric) ³⁰	ADVIA 1200 Siemens®	Men: 2 a 30 U/L
				Women: 1 a 24 U/L
Ultrasensitive C-Reactive Protein	Inflammatory marker	Immunochemistry through nephelometry ¹⁴	nephelometer BN II Siemens®	For cardiovascular risk assessment:
				Low risk: < 1.0mg/L
				Medium risk: 1.0 a 3.0 mg/L
				High risk: > 3.0 mg/L
Glycated hemoglobin	Determination of diabetes	High-pressure chromatography (HPLC) ²⁰	Variant Bio Rad®	< 5.7% Normal tolerance to glucose
TSH	Etiological investigation	Immunoenzymatic assay ^23,35	Centaur Siemmens®	0.55 – 4.78 mcUI/mL
Free T4	Etiological investigation	Immunoenzymatic assay ^26,35	Centaur Siemmens®	0.89 to 1.76 ng/dL
Insulin	Carbohydrate metabolism	Immunoenzymatic assay ^23,35	Centaur Siemmens®	Fasting:3.0 - 25.0 mUI/L After ingestion of glucose solution:
				Not established
Urine Na	Food intake	Potentiometry with ion-selective electrode	ADVIA 1200 Siemens®	Not established
Urine K	Food intake	Potentiometry with ion-selective electrode	ADVIA 1200 Siemens®	Not established
Urine calcium	Food intake	Potentiometry with ion-selective electrode) ¹⁸	ADVIA 1200 Siemens®	Not established
Microalbuminuria	Endothelial function	Immunochemistry through nephelometry	nephelometer BN II Siemens®	Normal: < 20 μg/m in
				Microalbuminuria: 20 to 200 μg/min
				Macroalbuminuria: > 200 μg/min
Serology for Chagas Disease	Differential diagnosis in cardiomyopathies	ELISA with solid-phase microplates – reagent WIENER (CHAGASTEST) ¹⁵	Microplate incubator/reader	Not reactive

IFCC: International Federation of Clinical Chemistry and Laboratory Medicin

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Logistics of collection and transportation of biological samples and the organization of the central laboratory in the ELSA-Brasil

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[1] The authors declare that there are no confl icts of interest.

This manuscript was \submitted for publication and underwent a peer review process as any other manuscripts submitted to this publication, and anonymity was guaranteed for authors and reviewers. Editors and reviewers declare no confl icts of interest that may affect the peer-review process.