Table 3.

Key lessons and recommendations

LessonRecommendation
Incorrect biologic specimens may be selected for assay (e.g., plasma instead of serum)Barcode stored biologic specimens to simplify tracking and characterization
Aliquots may be labeled incorrectlyEmploy standardized procedures for labeling and reporting
Include blind replicate samples
Assay results may be reported incorrectly even with automated reporting systemsStandardize assay reporting procedures
Pilot test assay reporting procedures that have changed
Include blind replicate samples
Proper collection, processing, and storage of biologic specimens are essentialSteps in collection, processing, and storage of biologic specimens must be clearly specified
For many biologic specimens, storage at −70°C is preferable to −20°C to prevent degradation or other forms of artificial protein modification
Proper frozen storage requires cryovial tubes with screw caps and silicon gaskets to prevent sample desiccation
When storing samples for future research, consider preparing multiple small aliquots at initial collection to prevent multiple freeze-thaw cycles and to reduce the likelihood of aliquoting errors related to inappropriate mixing of large sample volumes
Perform pilot assays on subsets of samples when there are any concerns about the suitability of the available biospecimens
Perform critical assays in experienced laboratoriesDevelop standard operating procedures for every assay thatinclude details of the laboratory’s internal QC practices
Develop external QC procedures to supplement these internal practices. These procedures should include:
 Blind replicate samples
 Proficiency samples from QC pools
Routinely examine QC dataJournals should ask for quality control data as part of standard reporting practice