Validation of cell-based fluorescence assays: Practice guidelines from the ICSH and ICCS - Part IV - Postanalytic considerations

Cytometry Part B - Clinical Cytometry

Volumn 84, Issue 5, 2013, Pages 309-314

  Barnett, David ^a   Louzao, Raaul ^b   Gambell, Peter ^c   De, Jitakshi ^d   Oldaker, Teri ^e   Hanson, Curtis A ^f  

^a ROYAL HALLAMSHIRE HOSPITAL   (United Kingdom)

^b DUKE UNIVERSITY SCHOOL OF MEDICINE   (United States)

^c PETER MACCALLUM CANCER CENTRE   (Australia)

^d DeePath Medical Inc   (United States)

^e Genoptix Inc   (United States)

^f Mayo Clinic College of Medicine   (United States)

Author keywords

Cellular Analysis; Flow Cytometry; Qualitative Assays; Quality Assessment; Quality Control; Quantitative Assays

Indexed keywords

ACCREDITATION; BLOOD CELL COUNT; BLOOD SAMPLING; CLINICAL LABORATORY; FLOW CYTOMETRY; FLUORESCENCE ANALYSIS; IMAGE ANALYSIS; IMMUNOCYTOCHEMISTRY; IMMUNOHISTOCHEMISTRY; PRACTICE GUIDELINE; PRIORITY JOURNAL; QUALITY CONTROL; REVIEW;

CELLULAR ANALYSIS; FLOW CYTOMETRY; QUALITATIVE ASSAYS; QUALITY ASSESSMENT; QUALITY CONTROL; QUANTITATIVE ASSAYS;

CLINICAL LABORATORY TECHNIQUES; FLOW CYTOMETRY; FLUORESCENT DYES; HEMATOLOGY; HUMANS; PRACTICE GUIDELINES AS TOPIC; REFERENCE STANDARDS; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 84884179564     PISSN: 15524949     EISSN: 15524957     Source Type: Journal    
DOI: 10.1002/cyto.b.21107     Document Type: Review

References (20)

1. Béné MC, Nebe T, Bettelheim P, Buldini B, Bumbea H, Kern W, Lacombe F, Lemez P, Marinov I, Matutes E, Maynadié M, Oelschlagel U, Orfao A, Schabath R, Solenthaler M, Tschurtschenthaler G, Vladareanu AM, Zini G, Faure GC, Porwit A,. Immunophenotyping of acute leukemia and lymphoproliferative disorders: A consensus proposal of the European Leukemia Net Work Package 10. Leukemia 2011; 25: 567-574.
2. Stetler-Stevenson M, Davis BH, Wood B, Braylan R,. 2006 Bethesda International Consensus conference on flow cytometric immunophenotyping of hematolymphoid neoplasia. Cytom Part B: Clin Cytom 2007; 72B (Suppl 1): S3.
3. Davis BH, Holden JT, Bene MC, Borowitz MJ, Braylan RC, Cornfield D, Gorczyca W, Lee R, Maiese R, Orfao A, Wells D, Wood BL, Stetler-Stevenson M,. 2006 Bethesda International Consensus recommendations on the flow cytometric immunophenotypic analysis of hematolymphoid neoplasia: Medical indications. Cytom. Part B: Clin Cytom. 2007; 72B (Suppl 1): S5-S13.
4. Arnoulet C, Béné MC, Durrieu F, Feuillard J, Fossat C, Husson B, Jouault H, Maynadié M, Lacombe F,. Four- and five-color flow cytometry analysis of leukocyte differentiation pathways in normal bone marrow: a reference document based on a systematic approach by the GTLLF and GEIL. Cytometry 2010; 78B: 4-10.
5. International Council for Standardization in Haematology Expert Panel on Cytometry. International Society of Laboratory Hematology Task Force on platelet counting. Platelet counting by the RBC/platelet ratio method. A reference method. Am J Clin Pathol 2001; 115: 460-464.
6. Clinical and Laboratory Standards Institute. Enumeration of Immunologically Defined Cell Populations by Flow Cytometry; Approved Guideline, 2nd ed. CLSI document H42-A2. Wayne, PA: Clinical and Laboratory Standards Institute; 2007.
7. Buttarello M, Bulian P, Farina G, Temporin V, Toffolo L, Trabuio E, Rizzotti P,. Flow cytometric reticulocyte counting. Parallel evaluation of five fully automated analyzers: An NCCLS-ICSH approach. Am J Clin Pathol 2001; 115: 100-111.
8. Davis BH, Olsen SH, Ahmad E, Bigelow NC,. Neutrophil CD64 is an improved indicator of infection or sepsis in emergency department patients. Arch Pathol Lab Med 2006; 130: 654-661.
9. Borowitz MJ, Craig FE, Digiuseppe JA, Illingworth AJ, Rosse W, Sutherland DR, Wittwer CT, Richards SJ,; Clinical Cytometry Society. Guidelines for the diagnosis and monitoring of paroxysmal nocturnal hemoglobinuria and related disorders by flow cytometry. Cytom Part B: Clin Cytom 2010; 78B: 211-230.
10. Richards SJ, Whitby L, Cullen MJ, Dickinson AJ, Granger V, Reilly JT, Hillmen P, Barnett D,. Development and evaluation of a stabilized whole-blood preparation as a process control material for screening of paroxysmal nocturnal hemoglobinuria by flow cytometry. Cytom Part B: Clini Cytom 2008; 76B: 47-55.
11. Sutherland DR, Keeney M, Illingworth A,. Practical guidelines for the high-sensitivity detection and monitoring of paroxysmal nocturnal hemoglobinuria clones by flow cytometry. Cytom. Part B: Clin Cytom 2012; 82B: 195-208.
12. Béné MC, Kaeda JS,. How and why minimal residual disease studies are necessary in leukemia: A review from WP10 and WP12 of the European LeukaemiaNet. Haematologica 2009; 94: 1135-1150.
13. Rawstron AC, Villamor N, Ritgen M, Böttcher S, Ghia P, Zehnder JL, Lozanski G, Colomer D, Moreno C, Geuna M, Evans PA, Natkunam Y, Coutre SE, Avery ED, Rassenti LZ, Kipps TJ, Caligaris-Cappio F, Kneba M, Byrd JC, Hallek MJ, Montserrat E, Hillmen P,. International standardized approach for flow cytometric residual disease monitoring in chronic lymphocytic leukaemia. Leukemia 2007; 21: 956-964.
14. Rawstron AC, Orfao A, Beksac M, Bezdickova L, Brooimans RA, Bumbea H, Dalva K, Fuhler G, Gratama J, Hose D, Kovarova L, Lioznov M, Mateo G, Morilla R, Mylin AK, Omedé P, Pellat-Deceunynck C, Perez Andres M, Petrucci M, Ruggeri M, Rymkiewicz G, Schmitz A, Schreder M, Seynaeve C, Spacek M, de Tute RM, Van Valckenborgh E, Weston-Bell N, Owen RG, San Miguel JF, Sonneveld P, Johnsen HE,; European Myeloma Network. Report of the European Myeloma Network on multiparametric flow cytometry in multiple myeloma and related disorders. Haematologica 2008; 93: 431-438.
15. Walter RB, Gooley TA, Wood BL, Milano F, Fang M, Sorror ML, Estey EH, Salter AI, Lansverk E, Chien JW, Gopal AK, Appelbaum FR, Pagel JM,. Impact of pretransplantation minimal residual disease, as detected by multiparametric flow cytometry, on outcome of myeloablative hematopoietic cell transplantation for acute myeloid leukemia. J Clin Oncol 2011; 29: 1190-1197.
16. The Retention and Storage of Pathological Records and Specimens, 4th ed. Guidance from The Royal College of Pathologists and the Institute of Biomedical Science, 2009. www.rcpath.org.
17. Quality Management-Guidelines for training. International Standards Organization (ISO) 10015: 1999.
18. CLSI GP21-A3 Training and Competency Assessment; Approved Guideline-Third Edition.
19. CLSI GP26-A3 Application of a Quality Management System Model for Laboratory Services; Approved Guideline-Third Edition.
20. Standards for EQA Schemes in Laboratory Medicine, Clinical Pathology Accreditation.