title: Validation of cell-based fluorescence assays: practice guidelines from the ICSH and ICCS - part III - analytical issues.
abstract: Clinical diagnostic assays, may be classified as quantitative, quasi-quantitative or qualitative. The assay's description should state what the assay needs to accomplish (intended use or purpose) and what it is not intended to achieve. The type(s) of samples (whole blood, peripheral blood mononuclear cells (PBMC), bone marrow, bone marrow mononuclear cells (BMMC), tissue, fine needle aspirate, fluid, etc.), instrument platform for use and anticoagulant restrictions should be fully validated for stability requirements and specified. When applicable, assay sensitivity and specificity should be fully validated and reported; these performance criteria will dictate the number and complexity of specimen samples required for validation. Assay processing and staining conditions (lyse/wash/fix/perm, stain pre or post, time and temperature, sample stability, etc.) should be described in detail and fully validated.
authors.affiliation: Biogen Idec, San Diego, CA, USA.
authors.forename: Shabnam
authors.initials: S
authors.lastname: Tangri
authors.forename: Horacio
authors.initials: H
authors.lastname: Vall
authors.forename: David
authors.initials: D
authors.lastname: Kaplan
authors.forename: Bob
authors.initials: B
authors.lastname: Hoffman
authors.forename: Norman
authors.initials: N
authors.lastname: Purvis
authors.forename: Anna
authors.initials: A
authors.lastname: Porwit
authors.forename: Ben
authors.initials: B
authors.lastname: Hunsberger
authors.forename: T Vincent
authors.initials: TV
authors.lastname: Shankey
mesh_terms: D001853:Bone Marrow / Q000473:pathology; D001854:Bone Marrow Cells / Q000473:pathology; D019411:Clinical Laboratory Techniques / Q000379:methods*; D005434:Flow Cytometry / Q000379:methods* / Q000592:standards; D005456:Fluorescent Dyes; D006405:Hematology / Q000592:standards*; D006801:Humans; D007963:Leukocytes, Mononuclear / Q000473:pathology; D017410:Practice Guidelines as Topic; D012015:Reference Standards; D012680:Sensitivity and Specificity
chemical_list: D005456:Fluorescent Dyes
keywords: Flow Cytometry; laboratory hematology; practice guideline; regulatory science; standardization