BLOOD AND URINE SAMPLING FOR QC AND QA PROCEDURES FOR GCRC CORE LABORATORY

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This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. The Core Lab provides assay services to GCRC investigators, and it is essential that we have a mechanism to monitor the reliability of our assays. It is common clinical laboratory practice to use blood samples from a limited number of normal subjects to document shifts in measurable analyte values due to change in specific reagents, kit lot, blood collection tubes or assay method. Also, although it is beyond the scope of our resources to establish analyte reference ranges, blood collected from a limited number of normal subjects can be used to verify reference ranges provided by assay manufacturers. These studies will determine whether assays run within the GCRC Core Lab perform in an analytically sound and reliable manner. Blood samples collected from a limited number of normal subjects (n = 20) will determine whether significant (>10%) shifts in measurable values occur due to changes in reagent, kit lot, tube type or change in assay methodology. Blood collected from normal subjects will be used to verify reference ranges, by determining whether mean values from 20 subjects fall within the 95% interval established by the kit manufacturer. More specifically, if the mean of our normal population falls outside of the 95% interval, the hypothesis that we have a valid reference interval for that test will be questioned and further investigation will be initiated. The study population will include healthy male and female adults (18-65 years of age).