Table 2.

Examples of second-order biospecimen issues for new biomarkers

What is the minimum specimen size?
What quantities are involved (e.g., microliters of fluid, micrograms of tissue, number of cells)?
Are nonstandard specimen-handling procedures required?
Are frozen tissues, alternative fixatives, or nonroutine blood-collection tubes required?
Have common variables of biospecimen handling been tested as a source of assay variability?
What are some issues involving fluids (e.g., temperature, time, separation technologies)?
What are some issues involving tissues (e.g., fixative, fixation times, processing times, specimen storage)?
Have other analytes been shown to interfere with the assay?
Is a document available that specifies an adequate vs. inadequate biospecimen for this assay?