Repository Planning, Design, and Engineering: Part II-Equipment and Costing.

Part II of this article discusses and provides guidance on the equipment and systems necessary to operate a repository. The various types of storage equipment and monitoring and support systems are presented in detail. While the material focuses on the large repository, the requirements for a small-scale startup are also presented.

Repository Planning, Design, and Engineering: Part I--Infrastructure.

This is a two-part review describing the planning, engineering, and design considerations for building a new repository for biological and environmental samples. Part I addresses the physical infrastructure requirements for a repository; Part II will cover equipment and costing. Planning for construction of a new repository is a complex process requiring comprehensive preplanning and adherence to many regulatory and safety requirements.

Quality management of biorepositories.

Biomedical investigators require high quality human tissue to support their research; thus, an important aspect of the provision of tissues by biorepositories is the assurance of high quality and consistency of processing specimens. This is best accomplished by a quality management system (QMS). This article describes the basis of a QMS program designed to aid biorepositories that want to improve their operations.

Homocysteine and vitamin B(12) concentrations and mortality rates in type 2 diabetes.

Objective: To assess the role of homocysteine as a risk factor for mortality in diabetic subjects.

Methods: Homocysteine, vitamin B(12), and folate concentrations were measured in stored sera of 396 diabetic Pima Indians aged > or = 40 years when examined between 1982 and 1985. Vital status was assessed through 2001.

Biochemical indicators of B vitamin status in the US population after folic acid fortification: results from the National Health and Nutrition Examination Survey 1999-2000.

Background: Mandatory folic acid fortification of cereal-grain products was introduced in the United States in 1998 to decrease the risk that women will have children with neural tube defects.

Objective: The objective was to determine the effect of folic acid fortification on concentrations of serum and red blood cell (RBC) folate, serum vitamin B-12, and plasma total homocysteine (tHcy) and methylmalonic acid (MMA) in the US population.

Design: Blood was collected from a nationally representative sample of approximately 7300 participants aged > or = 3 y in the National Health and Nutrition Examination Survey (NHANES) during 1999-2000 and was analyzed for these B vitamin-status indicators.

Hematological and iron-related analytes--reference data for persons aged 1 year and over: United States, 1988-94.

Objectives: This report presents national estimates of hematologic and iron-related analytes for persons 1 year of age and over, by age, sex, and race/ethnicity.

Methods: The analysis is based on data from the third National Health and Nutrition Examination Survey (NHANES III) (1988-94), which was designed to provide information on the health and nutritional status of the civilian noninstitutionalized U.S.

Selenium and colorectal adenoma: results of a pooled analysis.

Background: Secondary analyses of data from a large randomized clinical trial have suggested that intake of the trace element selenium reduces risk of colorectal neoplasia, but epidemiologic studies have not shown a consistent protective association.

Methods: We conducted a combined analysis of data from three randomized trials--the Wheat Bran Fiber Trial, the Polyp Prevention Trial, and the Polyp Prevention Study--which tested the effects of various nutritional interventions for colorectal adenoma prevention among participants who recently had an adenoma removed during colonoscopy. Selenium concentrations were measured from blood specimens from a total of 1763 trial participants, and quartiles of baseline selenium were established from the pooled data.

Prospective study of serum selenium concentrations and esophageal and gastric cardia cancer, heart disease, stroke, and total death.

Background: We previously reported an inverse association between prediagnostic serum selenium concentrations and the risk of esophageal squamous cell carcinoma (ESCC) and gastric cardia cancer (GCC) but not gastric noncardia cancer (GNCC) in a nested study from the Nutrition Intervention Trial in Linxian, China.

Objective: We examined the relation between baseline serum selenium and the subsequent risk of death from ESCC, GCC, GNCC, heart disease (HD), stroke, and total death over 15 y of follow-up (1986-2001).

Design: We measured baseline serum selenium concentrations in 1103 subjects randomly selected from a larger trial cohort.

Determination of folate vitamers in human serum by stable-isotope-dilution tandem mass spectrometry and comparison with radioassay and microbiologic assay.

Background: Current clinical methods for folate give different results and cannot measure the various forms of folate. We developed an isotope-dilution tandem mass spectrometric method coupled to liquid chromatography (LC/MS/MS) as a candidate reference method for 5-methyltetrahydrofolic acid (5MeTHF), 5-formyltetrahydrofolic acid (5FoTHF), and folic acid (FA) in human serum.

Methods: We quantitatively isolated folates from 275 microL of serum with a phenyl solid-phase extraction cartridge, then detected and quantified them in stabilized serum extracts by positive-ion electrospray ionization LC/MS/MS.

Prospective study of serum vitamin E levels and esophageal and gastric cancers.

Participants in the General Population Trial, a randomized nutrition intervention trial in Linxian, China, who received a combination of selenium, beta-carotene, and vitamin E supplements, had statistically significantly lower cancer mortality rates than those who did not receive the supplements. In the current study, we used a case-cohort design to examine the association between pre-trial serum vitamin E levels and the risks of developing esophageal and gastric cancers during the trial. We measured serum alpha- and gamma-tocopherol and cholesterol levels in 1072 case patients with incident esophageal squamous cell carcinoma (ESCC), gastric cardia cancer (GCC), or gastric noncardia cancer (GNCC) and in 1053 control subjects.

HFE genotype and transferrin saturation in the United States.

Purpose: Examine the penetrance (defined by high transferrin saturation [TS]) of C282Y and H63D in the U.S. population.

Erythrocyte protoporphyrin or hemoglobin: which is a better screening test for iron deficiency in children and women?

Background: Hemoglobin and erythrocyte protoporphyrin (EP) tests are commonly used to screen for iron deficiency. However, little research has been done to systematically evaluate the sensitivity and specificity of these 2 tests.

Objective: The objective of this study was to evaluate the sensitivity and specificity of hemoglobin and EP measurements in predicting iron deficiency in preschool children and in women of childbearing age.

Serum selenium levels in the US population: Third National Health and Nutrition Examination Survey, 1988-1994.

The published literature on serum selenium levels in the US population describes studies on small samples that may not be representative of the US population. This analysis provides the first nationally representative serum selenium levels in the US population by age group, sex, race-ethnicity, poverty income ratio (PIR), geographic region, and urban status. The Third National Health and Nutrition Examination Survey (NHANES III) is a national population-based cross-sectional survey with an in-person interview and serum selenium measurements.

Hyperhomocysteinemia and vitamin B-12 deficiency in elderly using Title IIIc nutrition services.

Background: The effect of the folate food fortification program on the prevalence of hyperhomocysteinemia in the older population with coexisting vitamin B-12 deficiency is not known.

Objective: The objective was to determine the prevalence of hyperhomocysteinemia and vitamin B-12 deficiency in elderly who were using Title IIIc nutrition services, after folate food fortification in the United States.

Design: Demographic, nutritional, cognitive, routine diagnostic, and serum methylmalonic acid (MMA) and total homocysteine (tHcy) tests were performed in a convenience sample of 103 elderly enrolled in nutrition service programs in rural northeast Georgia.

Blood folate levels on the Texas-Mexico border.

The Texas-Mexico border population has a high prevalence of neural tube defects (NTDs). In 1998, in an effort to reduce the risk of NTD-affected pregnancies, the US Food and Drug Administration mandated folic acid fortification of enriched grain products. Since then, the median serum folate and red blood cell (RBC) folate levels of US women aged 15 through 44 years has risen.

Hypovitaminosis D prevalence and determinants among African American and white women of reproductive age: third National Health and Nutrition Examination Survey, 1988-1994.

Background: Recent reports of rickets among African American children drew attention to the vitamin D status of these infants and their mothers. African American women are at higher risk of vitamin D deficiency than are white women, but few studies have examined determinants of hypovitaminosis D in this population.

Objective: We examined the prevalence and determinants of hypovitaminosis D among African American and white women of reproductive age.

Serum TSH, T(4), and thyroid antibodies in the United States population (1988 to 1994): National Health and Nutrition Examination Survey (NHANES III).

NHANES III measured serum TSH, total serum T(4), antithyroperoxidase (TPOAb), and antithyroglobulin (TgAb) antibodies from a sample of 17,353 people aged > or =12 yr representing the geographic and ethnic distribution of the U.S. population.