References
- Findlay JW , SmithWC, LeeJWet al. Validation of immunoassays for bioanalysis: a pharmaceutical industry perspective. J. Pharm. Biomed. Anal. 21 (6), 1249–1273 (2000).
- Wu DY , Patti-DiazL, HillCG. Development and validation of flow cytometry methods for pharmacodynamic clinical biomarkers. Bioanalysis2 (9), 1617–1626 (2010).
- O’Hara DM , XuY, LiangZ, ReddyMP, WuDY, LitwinV. Recommendations for the validation of flow cytometric testing during drug development: II assays. J. Immunol. Methods363 (2), 120–134 (2011).
- Green CL , BrownL, StewartJJ, XuY, LitwinV, McCloskeyTW. Recommendations for the validation of flow cytometric testing during drug development: I instrumentation. J. Immunol. Methods363 (2), 104–119 (2011).
- Wood B , JevremovicD, BénéMCet al. Validation of cell-based fluorescence assays: practice guidelines from the ICSH and ICCS – part V – assay performance criteria. Cytometry B Clin. Cytom. 84 (5), 315–323 (2013).
- Béné MC , MartiGE. ICSH/ICCS practice guidelines special issue. Cytometry B Clin. Cytom. 84 (5), 279–280 (2013).
- Davis BH , WoodB, OldakerT, BarnettD. Validation of cell-based fluorescence assays: practice guidelines from the ICSH and ICCS – part I – rationale and aims. Cytometry B Clin. Cytom. 84 (5), 282–285 (2013).
- Davis BH , DasguptaA, KussickS, HanJY, EstrelladoA, GroupIIW. Validation of cell-based fluorescence assays: practice guidelines from the ICSH and ICCS – part II – preanalytical issues. Cytometry B Clin. Cytom. 84 (5), 286–290 (2013).
- Tanqri S , VallH, KaplanDet al. Validation of cell-based fluorescence assays: practice guidelines from the ICSH and ICCS – part III – analytical issues. Cytometry B Clin. Cytom. 84 (5), 291–308 (2013).
- Barnett D , LouzaoR, GambellPet al. Validation of cell-based fluorescence assays: practice guidelines from the ICSH and ICCS – part IV – postanalytic considerations. Cytometry B Clin. Cytom. 84 (5), 309–314 (2013).
- Ferbas J , SchroederMJ. Instrument validation for regulated studies. In : Flow Cytometry in Drug Discovery and Development. LitwinV, MarderP ( Eds). John Wiley & Sons Inc., NJ, USA, 267–277 (2010).
- Perfetto SP , AmbrozakD, NguyenR, ChattopadhyayPK, RoedererM. Quality assurance for polychromatic flow cytometry using a suite of calibration beads. Nat. Protoc. 7 (12), 2067–2079 (2012).
- Degheidy H , AbbasiF, MostowskiHet al. Consistent, multi-instrument single tube quantification of CD20 in antibody bound per cell based on CD4 reference. Cytometry B Clin. Cytom. 90 (2), 159–167 (2016).
- Perfetto SP , ChattopadhyayPK, WoodJet al. Q and B values are critical measurements required for inter-instrument standardization and development of multicolor flow cytometry staining panels. Cytometry A85 (12), 1037–1048 (2014).
- O’Hara DM , TheobaldV, EganACet al. Ligand binding assays in the 21st century laboratory: recommendations for characterization and supply of critical reagents. AAPS J. 14 (2), 316–328 (2012).
- Cunliffe J , DerbyshireN, KeelerS, ColdwellR. An approach to the validation of flow cytometry methods. Pharm. Res. 26 (12), 2551–2557 (2009).
- Geist BJ , EganAC, YangTY, DongY, ShankarG. Characterization of critical reagents in ligand-binding assays: enabling robust bioanalytical methods and lifecycle management. Bioanalysis5 (2), 227–244 (2013).
- Organisation for Economic Co-operation and Development . OECD series on principles of good laboratory practice and compliance monitoring. OECD Publishing, Paris, France (1998).
- Brown L , GreenCL, JonesNet al. Recommendations for the evaluation of specimen stability for flow cytometric testing during drug development. J. Immunol. Methods418, 1–8 (2015).
- Shalekoff S , Page-ShippL, TiemessenCT. Effects of anticoagulants and temperature on expression of activation markers CD11b and HLA-DR on human leukocytes. Clin. Diagn. Lab. Immunol. 5 (5), 695–702 (1998).
- Hernandez MR , BozzoJ, TondaR, GalanAM, OrdinasA, EscolarG. Effect of anticoagulants on activation of polymorphonuclear leukocytes induced by shear stress. Int. J. Immunopathol. Pharmacol. 14 (3), 139–144 (2001).
- Pinto LA , TrivettMT, WallaceDet al. Fixation and cryopreservation of whole blood and isolated mononuclear cells: influence of different procedures on lymphocyte subset analysis by flow cytometry. Cytometry B Clin. Cytom. 63 (1), 47–55 (2005).
- Canonico B , BettiM, LuchettiFet al. Flow cytometric profiles, biomolecular and morphological aspects of transfixed leukocytes and red cells. Cytometry B Clin. Cytom. 78 (4), 267–278 (2010).
- Warrino DE , DeGennaroLJ, HansonM, SwindellsS, PirruccelloSJ, RyanWL. Stabilization of white blood cells and immunologic markers for extended analysis using flow cytometry. J. Immunol. Methods305 (2), 107–119 (2005).
- Wood B . 9-color and 10-color flow cytometry in the clinical laboratory. Arch. Pathol. Lab. Med. 130 (5), 680–690 (2006).
- McLaughlin BE , BaumgarthN, BigosMet al. Nine-color flow cytometry for accurate measurement of T cell subsets and cytokine responses. Part I: panel design by an empiric approach. Cytometry A73 (5), 400–410 (2008).
- McLaughlin BE , BaumgarthN, BigosMet al. Nine-color flow cytometry for accurate measurement of T cell subsets and cytokine responses. Part II: panel performance across different instrument platforms. Cytometry A73 (5), 411–420 (2008).
- Shapiro HM . Practical Flow Cytometry. John Wiley & Sons, Inc. (2005).
- Orfao A . Phenotypic analysis. Current Protocols in Cytometry. Wiley Online Library (2009).
- Spidlen J , MooreW, ParksDet al. Data File Standard for Flow Cytometry, version FCS 3.1. Cytometry A77 (1), 97–100 (2010).
- O’Neill K , AghaeepourN, SpidlenJ, BrinkmanR. Flow cytometry bioinformatics. PLoS Comput. Biol. 9 (12), e1003365 (2013).
- Naumann U , LutaG, WandMP. The curvHDR method for gating flow cytometry samples. BMC Bioinformatics11, 44 (2010).
- Maecker HT , McCoyJP, NussenblattR. Standardizing immunophenotyping for the Human Immunology Project. Nat. Rev. Immunol. 12 (3), 191–200 (2012).
- Tung JW , HeydariK, TirouvanziamR, SahafB, ParksDR, HerzenbergLA. Modern flow cytometry: a practical approach. Clin. Lab. Med. 27 (3), 453–468 ; v (2007).
- Hulspas R , O’GormanMR, WoodBL, GratamaJW, SutherlandDR. Considerations for the control of background fluorescence in clinical flow cytometry. Cytometry B Clin. Cytom. 76 (6), 355–364 (2009).
- Lee JW , WeinerRS, SailstadJMet al. Method validation and measurement of biomarkers in nonclinical and clinical samples in drug development: a conference report. Pharm. Res. 22 (4), 499–511 (2005).
- Lee JW , DevanarayanV, BarrettYCet al. Fit-for-purpose method development and validation for successful biomarker measurement. Pharm. Res. 23 (2), 312–328 (2006).
- Cummings J , RaynaudF, JonesL, SugarR, DiveC. Fit-for-purpose biomarker method validation for application in clinical trials of anticancer drugs. Br. J. Cancer103 (9), 1313–1317 (2010).
- Hill C , WuD, FerbasJ, LitwinV, ReddyM. Regulatory compliance and method validation. In : Flow Cytometry in Drug Discovery and Development. LitwinV, MarderP ( Eds). John Wiley & Sons, Inc., NJ, USA, 243–266 (2010).
- Litwin V . CYTO 2014 tutorial “Understanding Analytical Method Validation as Applied to Flow Cytometry” (2014). http://isac-net.org/PDFS/df/df2b0b45-95e4-4221-952b-21052f384771.pdf.
- Maecker HT , McCoyJP, AmosMet al. A model for harmonizing flow cytometry in clinical trials. Nat. Immunol. 11 (11), 975–978 (2010).
- Xu Y , RichardsS. Pharmacokinetics by flow cytometry: recommendations for development and validation of flow cytometric method for pharmacokinetic studies. In : Flow Cytometry in Drug Discovery and Development. LitwinV, MarderP ( Eds). John Wiley & Sons, Inc., NJ, USA (2010).