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Defining the intended application of the biomarker (for example, will it be used for internal decision making, exploratory research, or as a diagnostic) will determine the rigor of method validation and assay documentation needed.
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The need to integrate chromosome aberration and the challenge assays with other relevant assays for better documentation of biological effects and for more precise prediction of health risk will be presented.
Quality control metrics suggested by the Affymetrix Axiom 2.0 Assay Manual Workflow documentation were adopted and applied.
Individual laboratories are responsible for meeting the CLIA/CAP quality assurance standards with respect to appropriate sample documentation, assay validation, general proficiency, and quality control measures.
Currently, a major focus is being placed on Metadata recovery and the curation of a large variety of data repositories containing valuable knowledge in terms of assay data, scientific documentation or clinical data.
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This Standardized Proficiency Testing Program is the first available for the evaluation and documentation of assay equivalency for laboratories performing HIV-1 neutralizing antibody assays and may provide guidance for the development of future proficiency testing programs for other assay platforms.
A positive urinary antigen assay was the only laboratory documentation in 48% of subjects with S. pneumoniae.
Standardization of procedures - ranging from acquisition, handling, and storage of biosamples, through assay procedures, together with rigorous documentation - is critical.
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