SOLICITATION NOTICE
H -- Characterization of QC Pools, Testing of Stability Samples, and Operational QC Testing
- Notice Date
- 2/19/2009
- Notice Type
- Presolicitation
- NAICS
- 541380
— Testing Laboratories
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, Westat (NINDS PRIME CONTRACTOR), 1650 Research Blvd., Rockville, Maryland, 20850
- ZIP Code
- 20850
- Solicitation Number
- WESTAT_8208-08-03
- Response Due
- 3/20/2009
- Archive Date
- 4/4/2009
- Point of Contact
- Russell Walker,, Phone: 240/453-5624
- E-Mail Address
-
russellwalker@westat.com
- Small Business Set-Aside
- N/A
- Description
- 1.0 Background The National Children’s Study (NCS) is a major longitudinal cohort study that will follow children from before birth to at least 21 years of age and will evaluate the effects of a variety of environmental factors, including chemical, physical, biological, and psychosocial factors, on children’s health and well-being. Researchers will analyze how these elements interact with each other and what helpful and/or harmful effects they might have on children’s health. Data will be collected from children and their families from different areas of the country, from varied backgrounds, and of different family types. In order to study the main hypotheses for the National Children’s Study, a variety of data will be collected from participants, including biological specimens. Biospecimens from a potential mother, father, and/or child will either be collected by a data collector or self-collected by the participant, and will take place at defined visits during the study. Study Centers from across the nation will manage the data collection within their area and will work with the Program Office (National Institute of Child Health and Disease (NICHD), Environmental Protection Agency (EPA), and Centers for Disease Control (CDC)) and the Westat Coordinating Center to meet the needs of the study. The study will begin with 7 Study Centers but will add on Study Centers over the first 11 years of the study to reach approximately 105 Study Centers. With a longitudinal study of this magnitude, it is essential that the quality of specimens and data be assured from the collection through testing for various analytes. The purpose this SOW is to obtain laboratory services as part of the quality assurance and control plans for the NCS. There are four major tasks to be supported: 1) characterization and storage of quality control (QC) pools; 2) measurement of analytes from a select number of biospecimens collected in early in the study from each Study Center; 3) conducting a methods study using Microfluidics, or “lab on a chip”; and, 4) analysis of biospecimens for pilot studies conducted to test stability of biospecimens under a variety of collection, processing, and storage conditions. 2.0 Characterization of Quality Control Pools QC specimen pools will be shipped from the NCS repository to the Contractor for characterization. The analytes to be assayed and methodologies are summarized in Appendix 1. For each analyte listed, the measurements must be made in duplicate in 20 sequential analytical runs to obtain maximum among- and within-run variation to calculate the mean, standard deviation, and coefficient of variation for precision and accuracy estimates for the quality control pools. Forty laboratory measures will be performed on each analyte in a given matrix. It is expected that all measurements will be completed within 30 working days of specimen receipt. 3.0 Operational Quality Control Testing The Contractor will analyze specimens collected at seven NCS Study Centers during the pilot phase. The first specimens will be submitted for laboratory analysis in June 2009 (see Appendix 2). Specimens will be collected using NCS protocols and transferred to the NCS repository. For the first 2 Study Center specimens, 308 specimens will be measured for each analyte measured in blood. Urine specimens will be collected using a urine collection container from adults and diapers from infants resulting in a total number of 616 urine measures. Salivary cortisol measurements will be performed on collections of 6 specimens (3 specimens over 2 days per subject) resulting in a total number of 1778 assays. Specimens will be shipped to the laboratory for analysis according to the time table outlined in Appendix 2. Blind QC samples will be seeded into the study participant specimens as a method of internal quality assessment for the study operations.
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